medical engineering business plan

How to write a business plan for a medical device manufacturer?

Writing a business plan for a medical device manufacturer can be an intimidating task, especially for those just starting.

This in-depth guide is designed to help entrepreneurs like you understand how to create a comprehensive business plan so that you can approach the exercise with method and confidence.

We'll cover: why writing a medical device manufacturer business plan is so important - both when starting up, and when running and growing the business - what information you need to include in your plan, how it should be structured, and what tools you can use to get the job done efficiently.

Let's get started!

In this guide:

Why write a business plan for a medical device manufacturer?

• What information is needed to create a business plan for a medical device manufacturer?
• What goes in the financial forecast for a medical device manufacturer?
• What goes in the written part of a medical device manufacturer business plan?
• What tool can I use to write my medical device manufacturer business plan?

Being clear on the scope and goals of the document will make it easier to understand its structure and content. So before diving into the actual content of the plan, let's have a quick look at the main reasons why you would want to write a medical device manufacturer business plan in the first place.

To have a clear roadmap to grow the business

It's rarely business as usual for small businesses. The economy follows cycles where years of growth are followed by recessions, and the business environment is always changing with new technologies, new regulations, new competitors, and new consumer behaviours appearing all the time...

In this context, running a business without a clear roadmap is like driving blindfolded: it's dangerous at best. That's why writing a business plan for a medical device manufacturer is essential to create successful and sustainable businesses.

To write an effective business plan, you will need to take stock of where you are (if you are already in business) and where you want the business to go in the next three to five years.

Once you know where you want your medical device manufacturer to be, you'll have to identify:

• what resources (human, equipment, and capital) are needed to get there,
• at what pace the business needs to progress to get there in time,
• and what risks you'll face along the way.

Going through this process regularly is beneficial, both for startups and existing companies, as it helps make informed decisions about how best to allocate resources to ensure the long-term success of the business.

To anticipate future cash flows

Regularly comparing your actual financial performance to the projections in the financial forecast of your medical device manufacturer's business plan gives you the ability to monitor your business's financial health and make necessary adjustments as needed.

This practice allows you to detect potential financial issues, such as unexpected cash shortfalls before they escalate into major problems. Giving you time to find additional financing or put in place corrective measures.

Additionally, it helps you identify growth opportunities, like excess cash flow that could be allocated to launch new products and services or expand into new markets.

Staying on track with these regular comparisons enables you to make well-informed decisions about the amount of financing your business might require, or the excess cash flow you can expect to generate from your main business activities.

To secure financing

Whether you are a startup or an existing business, writing a detailed medical device manufacturer business plan is essential when seeking financing from banks or investors.

This makes sense given what we've just seen: financiers want to ensure you have a clear roadmap and visibility on your future cash flows.

Banks will use the information included in the plan to assess your borrowing capacity (how much debt your business can support) and your ability to repay the loan before deciding whether they will extend credit to your business and on what terms.

Similarly, investors will review your plan carefully to assess if their investment can generate an attractive return on investment.

To do so, they will be looking for evidence that your medical device manufacturer has the potential for healthy growth, profitability, and cash flow generation over time.

Now that you understand why it is important to create a business plan for a medical device manufacturer, let's take a look at what information is needed to create one.

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Information needed to create a business plan for a medical device manufacturer

Drafting a medical device manufacturer business plan requires research so that you can project sales, investments and cost accurately in your financial forecast, and convince the reader that there is a viable commercial opportunity to be seized.

Below, we'll focus on three critical pieces of information you should gather before starting to write your plan.

Carrying out market research for a medical device manufacturer

Carrying out market research before writing a business plan for a medical device manufacturer is essential to ensure that the financial projections are accurate and realistic.

Market research helps you gain insight into your target customer base, competitors, pricing strategies and other key factors which can have an impact on the commercial success of your business.

In particular, it is useful in forecasting revenue as it provides valuable data regarding potential customers’ spending habits and preferences.

1. Your medical device manufacturer may discover a trend in consumer preferences for more convenient or user-friendly products. 2. Market research might reveal a trend in demand for products that offer additional features or higher performance than those currently on the market.

This information can then be used to create more accurate financial projections which will help investors make informed decisions about investing in your medical device manufacturer.

Developing the sales and marketing plan for a medical device manufacturer

Budgeting sales and marketing expenses is essential before creating a medical device manufacturer business plan.

A comprehensive sales and marketing plan should provide an accurate projection of what actions need to be implemented to acquire and retain customers, how many people are needed to carry out these initiatives, and how much needs to be spent on promotions, advertising, and other aspects.

This helps ensure that the right amount of resources is allocated to these activities in order to hit the sales and growth objectives forecasted in your business plan.

The staffing and equipment needs of a medical device manufacturer

As you embark on starting or expanding your medical device manufacturer, having a clear plan for recruitment and capital expenditures (investment in equipment and real estate) is essential for ensuring your business's success.

Both the recruitment and investment plans must align with the timing and level of growth projected in your forecast, and they require appropriate funding.

Staffing costs may include salaries for engineers, technicians, and other personnel who are responsible for designing, producing, and testing the medical device. Equipment costs may include the purchase of materials and supplies such as raw materials, components, and machinery needed to produce the medical device. Other costs may include the cost of renting space for production, purchasing additional machinery, and the cost of maintenance and repairs.

To create a realistic financial forecast, you also need to consider other operating expenses associated with the day-to-day running of your business, such as insurance and bookkeeping.

With all the necessary information at hand, you are ready to begin crafting your business plan and developing your financial forecast.

What goes into your medical device manufacturer's financial forecast?

The financial forecast of your medical device manufacturer will enable you to assess the profitability potential of your business in the coming years and how much capital is required to fund the actions planned in the business plan.

The four key outputs of a financial forecast for a medical device manufacturer are:

• The profit and loss (P&L) statement ,
• The projected balance sheet ,
• The cash flow forecast ,
• And the sources and uses table .

Let's take a closer look at each of these.

The projected P&L statement

The projected P&L statement for a medical device manufacturer shows how much revenue and profits your business is expected to generate in the future.

Ideally, your medical device manufacturer's P&L statement should show:

• Healthy growth - above inflation level
• Improving or stable profit margins
• Positive net profit

Expectations will vary based on the stage of your business. A startup will be expected to grow faster than an established medical device manufacturer. And similarly, an established company should showcase a higher level of profitability than a new venture.

The forecasted balance sheet of your medical device manufacturer

The projected balance sheet of your medical device manufacturer will enable the reader of your business plan to assess the overall financial health of your business.

It shows three elements: assets, liabilities and equity:

• Assets: are productive resources owned by the business, such as equipment, cash, and accounts receivable (money owed by clients).
• Liabilities: are debts owed to creditors, lenders, and other entities, such as accounts payable (money owed to suppliers).
• Equity: includes the sums invested by the shareholders or business owners and the profits and losses accumulated by the business to date (which are called retained earnings). It is a proxy for the value of the owner's stake in the business.

Analysing your medical device manufacturer projected balance sheet provides an understanding of your medical device manufacturer's working capital structure, investment and financing policies.

In particular, the readers of your plan can compare the level of financial debt on the balance sheet to the equity value to measure the level of financial risk (equity doesn't need to be reimbursed, while financial debt must be repaid, making it riskier).

They can also use your balance sheet to assess your medical device manufacturer's liquidity and solvency:

• A liquidity analysis: focuses on whether or not your business has sufficient cash and short-term assets to cover its liabilities due in the next 12 months.
• A solvency analysis: takes and longer view to assess whether or not your business has the capacity to repay its debts over the medium-term.

The cash flow forecast

A projected cash flow statement for a medical device manufacturer is used to show how much cash the business is generating or consuming.

The cash flow forecast is usually organized by nature to show three key metrics:

• The operating cash flow: do the core business activities generate or consume cash?
• The investing cash flow: how much is the business investing in long-term assets (this is usually compared to the level of fixed assets on the balance sheet to assess whether the business is regularly maintaining and renewing its equipment)?
• The financing cash flow: is the business raising new financing or repaying financiers (debt repayment, dividends)?

As we discussed earlier, cash is king and keeping an eye on future cash flows an imperative for running a successful business. Therefore, you can expect the reader of your medical device manufacturer business plan to pay close attention to your cash flow forecast.

Also, note that it is customary to provide both yearly and monthly cash flow forecasts in a business plan - so that the reader can analyze seasonal variation and ensure the medical device manufacturer is appropriately funded.

The initial financing plan

The initial financing plan - also called a sources and uses table - is an important tool when starting a medical device manufacturer.

It shows where the money needed to set up the business will come from (sources) and how it will be allocated (uses).

Having this table helps understand what costs are involved in setting up the medical device manufacturer, how the risks are distributed between the shareholders and the lenders, and what will be the starting cash position (which needs to be sufficient to sustain operations until the business breaks even).

Now that the financial forecast of a medical device manufacturer business plan is understood, let's focus on what goes into the written part of the plan.

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The written part of a medical device manufacturer business plan

The written part of a medical device manufacturer business plan is composed of 7 main sections:

• The executive summary
• The presentation of the company
• The products and services
• The market analysis
• The strategy
• The operations
• The financial plan

Throughout these sections, you will seek to provide the reader with the details and context needed for them to form a view on whether or not your business plan is achievable and your forecast a realistic possibility.

Let's go through the content of each section in more detail!

1. The executive summary

In your medical device manufacturer's business plan, the first section is the executive summary — a captivating overview of your plan that aims to pique the reader's interest and leave them eager to learn more about your business.

When crafting the executive summary, start with an introduction to your business, including its name, concept, location, how long it has been running, and what sets it apart. Briefly mention the products and services you plan to offer and your target customer profile.

Following that, provide an overview of the addressable market for your medical device manufacturer, current trends, and potential growth opportunities.

Next, include a summary of key financial figures like projected revenues, profits, and cash flows.

Finally, in the "ask" section, detail any funding requirements you may have.

2. The presentation of the company

The second section in your medical device manufacturer's business plan should focus on the structure and ownership, location, and management team of the company.

The structure and ownership part provides an overview of the legal structure of the business, who the owners are and how much each has invested and owns. If you are seeking financing it is important that the reader gets a clear picture of which legal entity is receiving the funds, and who controls the business.

The location part should give an overview of the premises from which the company is operating, and why that location is of particular interest (catchment area, accessibility, amenities nearby, etc.).

When describing the location of your medical device manufacturer, you may want to emphasize its access to a highly-educated workforce, competitive costs, and strong transportation networks. You could point out its proximity to a major metropolitan area, which could provide access to potential customers and other resources. Additionally, you might want to highlight that the region has a long history of successful manufacturing operations and is home to a wide range of industries. All of these factors could make it an attractive option for a third party financier.

Finally, you should introduce the management team. Explain each member's role, background, and experience.

It is also important to emphasize any past successes that the members of the management team have achieved, and how long they've been working together, as this will help potential lenders or investors understand why they should trust in their leadership.

3. The products and services section

The products and services section of your business plan should include a detailed description of what your company offers, who are the target customers, and what distribution channels are part of your go-to-market. 

For example, your medical device manufacturer might offer customers a variety of medical devices such as hearing aids, catheters, and wheelchairs. They might also provide customers with repair services and product maintenance in order to ensure the product is functioning properly and safely. Additionally, they might offer educational resources about their products to teach customers how to safely and properly use the device. These services and products help customers stay healthy and safe while using medical devices.

4. The market analysis

When you present your market analysis in your medical device manufacturer business plan, it's crucial to include detailed information about customers' demographics and segmentation, target market, competition, barriers to entry, and any relevant regulations.

The main objective of this section is to help the reader understand the size and attractiveness of the market while demonstrating your solid understanding of the industry.

Begin with the demographics and segmentation subsection, providing an overview of the addressable market for your medical device manufacturer, the key trends in the marketplace, and introducing different customer segments along with their preferences in terms of purchasing habits and budgets.

Next, focus on your target market, zooming in on the specific customer segments your medical device manufacturer aims to serve and explaining how your products and services fulfil their distinct needs.

For example, your target market might include elderly individuals who need medical devices to help them maintain their independence. This segment includes people who need wheelchairs, walkers, hearing aids, and other medical devices. Additionally, they often have insurance plans that cover these medical devices, making them a viable target market for a medical device manufacturer.

Then proceed to the competition subsection, where you introduce your main competitors and highlight what sets you apart from them.

Finally, conclude your market analysis with an overview of the key regulations applicable to your medical device manufacturer.

5. The strategy section

When you write the strategy section of your medical device manufacturer business plan, remember to cover key elements such as your competitive edge, pricing strategy, sales & marketing plan, milestones, and risks and mitigants.

In the competitive edge subsection, elaborate on what makes your company stand out from competitors. This becomes especially important if you're a startup, aiming to carve a place for yourself amidst established players in the marketplace.

The pricing strategy subsection should demonstrate how you plan to maintain profitability while offering competitive prices to attract customers.

Outline your sales & marketing plan, detailing how you'll reach out to new customers and retain existing ones through loyalty programs or special offers.

For the milestones subsection, outline your company's achievements to date and your main objectives for the future, complete with specific dates to set clear expectations for progress.

Lastly, the risks and mitigants subsection should address the main risks that could affect your plan's execution. Explain the measures you've put in place to minimize these risks, assuring potential investors or lenders.

Your medical device manufacturer could face the risk of product failure or recalls. This could be due to a defect in the device itself, or it could be caused by user error or misuse. In either case, this could result in large financial losses, as well as serious damage to the manufacturer's reputation and brand. Another risk your medical device manufacturer may face is increased competition from other manufacturers. This could result in lower profits as well as a decrease in market share for the product. It could also lead to price wars and other competitive tactics, which may be costly and time consuming.

6. The operations section

In your business plan, it's also essential to provide a detailed overview of the operations of your medical device manufacturer.

Start by covering your team, highlighting key roles and your recruitment plan to support the expected growth. Outline the qualifications and experience required for each role and your intended recruitment methods, whether through job boards, referrals, or headhunters.

Next, clearly state your medical device manufacturer's operating hours, allowing the reader to assess staffing levels adequately. Additionally, mention any plans for varying opening times during peak seasons and how you'll handle customer queries outside normal operating hours.

Then, shift your focus to the key assets and intellectual property (IP) necessary for your business. If you rely on licenses, trademarks, physical structures like equipment or property, or lease agreements, make sure to include them in this section.

You might have key assets such as proprietary technology and brand recognition. For example, the manufacturer could have patented technology that is used in the medical devices they produce, or they could have a well-known brand name that is associated with quality and trust. Additionally, they could have valuable intellectual property such as designs, trademarks, and trade secrets that they could use to protect their products from being copied or counterfeited.

Lastly, include a list of suppliers you plan to work with, detailing their services and main commercial terms, such as price, payment terms, and contract duration. Investors are interested in understanding why you've chosen specific suppliers, which may be due to higher-quality products or established relationships from previous ventures.

7. The presentation of the financial plan

The financial plan section is where we will present the financial forecast we talked about earlier in this guide.

Now that you have a clear idea of what goes in your medical device manufacturer business plan, let's look at the solutions you can use to draft yours.

What tool should I use to write my medical device manufacturer's business plan?

In this section, we will be reviewing the two main solutions for creating a medical device manufacturer business plan:

• Using specialized online business plan software,
• Outsourcing the plan to the business plan writer.

Using an online business plan software for your medical device manufacturer's business plan

The modern and most efficient way to write a medical device manufacturer business plan is to use business plan software .

There are several advantages to using specialized software:

• You can easily create your financial forecast by letting the software take care of the financial calculations for you without errors
• You are guided through the writing process by detailed instructions and examples for each part of the plan
• You can access a library of dozens of complete business plan samples and templates for inspiration
• You get a professional business plan, formatted and ready to be sent to your bank or investors
• You can easily track your actual financial performance against your financial forecast
• You can create scenarios to stress test your forecast's main assumptions
• You can easily update your forecast as time goes by to maintain visibility on future cash flows
• You have a friendly support team on standby to assist you when you are stuck

If you're interested in using this type of solution, you can try The Business Plan Shop for free by signing up here .

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Hiring a business plan writer to write your medical device manufacturer's business plan

Outsourcing your medical device manufacturer business plan to a business plan writer can also be a viable option.

These writers possess valuable experience in crafting business plans and creating accurate financial forecasts. Additionally, enlisting their services can save you precious time, enabling you to concentrate on the day-to-day operations of your business.

It's important to be mindful, though, that hiring business plan writers comes with a cost. You'll be paying not just for their time but also for the software they use, and their profit margin.

Based on experience, a complete business plan usually requires a budget of at least £1.5k ($2.0k) excluding tax, and more if revisions are needed after initial meetings with lenders or investors - changes often arise following these discussions.

When seeking investment, be cautious about spending too much on consulting fees. Investors prefer their funds to contribute directly to business growth. Thus, the amount you spend on business plan writing services and other consulting services should be negligible compared to the amount you raise.

Another aspect to consider is that while you'll receive the output of the business plan, you usually won't own the actual document. It will be saved in the consultant's business plan software, which will make updating the plan challenging without retaining the consultant on a retainer.

Given these factors, it's essential to carefully weigh the pros and cons of outsourcing your medical device manufacturer business plan to a business plan writer and decide what best suits your business's unique needs.

Why not create your medical device manufacturer's business plan using Word or Excel?

Using Microsoft Excel and Word (or their Google, Apple, or open-source equivalents) to write a medical device manufacturer business plan is a terrible idea.

For starters, creating an accurate and error-free financial forecast on Excel (or any spreadsheet) is very technical and requires both a strong grasp of accounting principles and solid skills in financial modelling.

As a result, it is unlikely anyone will trust your numbers unless - like us at The Business Plan Shop - you hold a degree in finance and accounting and have significant financial modelling experience in your past.

The second reason is that it is inefficient. Building forecasts on spreadsheets was the only option in the 1990s and early 2000s, nowadays technology has advanced and software can do it much faster and much more accurately.

And with the rise of AI, software is also becoming smarter at helping us detect mistakes in our forecasts and helping us analyse the numbers to make better decisions.

Also, using software makes it easy to compare actuals vs. forecasts and maintain our forecasts up to date to maintain visibility on future cash flows - as we discussed earlier in this guide - whereas this is a pain to do with a spreadsheet.

That's for the forecast, but what about the written part of my medical device manufacturer business plan?

This part is less error-prone, but here also software brings tremendous gains in productivity:

• Word processors don't include instructions and examples for each part of your business plan
• Word processors don't update your numbers automatically when they change in your forecast
• Word processors don't handle the formatting for you

Overall, while Word or Excel may be viable options for creating a medical device manufacturer business plan for some entrepreneurs, it is by far not the best or most efficient solution.

• Using business plan software is a modern and cost-effective way of writing and maintaining business plans.
• A business plan is not a one-shot exercise as maintaining it current is the only way to keep visibility on your future cash flows.
• A business plan has 2 main parts: a financial forecast outlining the funding requirements of your medical device manufacturer and the expected growth, profits and cash flows for the next 3 to 5 years; and a written part which gives the reader the information needed to decide if they believe the forecast is achievable.

We hope that this in-depth guide met your expectations and that you now have a clear understanding of how to write your medical device manufacturer business plan. Do not hesitate to contact our friendly team if you have questions additional questions we haven't addressed here.

Also on The Business Plan Shop

• How to write a business plan to secure a bank loan?
• Key steps to write a business plan?
• Top mistakes to avoid in your business plan

Do you know entrepreneurs interested in starting or growing a medical device manufacturer? Share this article with them!

Founder & CEO at The Business Plan Shop Ltd

Guillaume Le Brouster is a seasoned entrepreneur and financier.

Guillaume has been an entrepreneur for more than a decade and has first-hand experience of starting, running, and growing a successful business.

Prior to being a business owner, Guillaume worked in investment banking and private equity, where he spent most of his time creating complex financial forecasts, writing business plans, and analysing financial statements to make financing and investment decisions.

Guillaume holds a Master's Degree in Finance from ESCP Business School and a Bachelor of Science in Business & Management from Paris Dauphine University.

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Medical Design and Outsourcing

Starting a medical device company: everything you need to know

June 27, 2016 By Rogene Evans

Once you’ve got some scratch, you’ll need to think about outsourcing product design and development and prototyping services.

All set? Now you need to think about getting your device on the market.  Once you’ve gotten that figured, you should figure out how to keep your FDA or CE Mark approval through your quality systems.

And you still need to get paid, right? You need to build a reimbursement strategy into your plan.

Finally, to protect the intellectual property underlying all of this effort, you need to understand U.S. patent law.

Raising capital in a VC-light environment

Venture capital hasn’t completely deserted the medical device sector, but most analysts agree that VCs are simply not as interested in medtech as they are in other sectors like biotech. Medtech attracted less than $5 billion in 2014, only 5.9% of all U.S. venture dollars that year, according to the Ernst & Young Pulse of the Industry report.

And it’s startups that are feeling the pressure most deeply. VC backing of earlier-stage medtechs now makes up a smaller share of a smaller pie “due to the retreat of several stalwart medtech-focused VCs at a time when corporate venture investors have yet to fill the gap,” according to the report. Seed, Series A and Series B rounds dropped 8% in 2014-2015 from fiscal 2013-2014 and made up only 29% of medtech venture investments in 2014-15.

Think small

Although VC has diminished, other funding sources are out there – the biggest change is that they’re just much smaller:

• Angel investors – Often individuals with deep pockets and an interest in a specific disease or condition. Get busy networking with as many high-net-worth people as you can. • Private placement – Use a private placement – the sale of securities to a relatively small number of select investors – to fund your vision by raising money from individual donors. • Incubators – Public, private or academic incubators offer subsidized business accommodation, academic support and business mentoring, and connections with resources for prototyping, testing and clinical trials. • Entrepreneurial competitions – Universities or large companies, hoping to attract technology partners, often offer technology contests with sometimes significant payouts in cash and in-kind services. • Crowdfunding – Most effective after the early development phase, when the funds are needed for validation or prototyping. The same high risk and high capital needs medical technology that made VCs chary of medical technology make the crowd a less optimal source of cash. • City, state, & county resources – Local governments often use tax breaks and other incentives to draw entrepreneurs to development zones. And your area likely has technical associations formed to boost the industry, some with their own tech incubators. Trade associations offer access to universities or hospitals for clinical testing and connections to local angel investors and competitions. They can also provide opportunities for networking and mentorship.

As Aum Cardiovascular CEO Marie Johnson puts it, “They don’t give you money because they’re in love with the story.” (Johnson raised $5 million for Aum via private placement.) The best advice for any medical device startup is that today, no medtech investment pitch, no matter the source receiving it, succeeds without compelling clinical date, a clear unmet and demonstrable cost savings over current treatments.

Are you ready for an outsourcer? Here’s how to find out.

Outsourcing your product development doesn’t have to mean losing control of your technology. Although it’s one of the biggest decisions a startup will make, working with a contract supplier can deliver unexpected benefits.

Gary Boseck, VP of technical operations at Vention Medical, says there are ways for startups to prepare for the challenges that come with working with an outsourcing partner.

And partnership, he says, is really the key word. “CMOs want their clients to succeed. They have a vested interest in helping develop a technology that has potential in the market and their expertise can contribute to the likelihood of success.”

Getting a trusted CMO involved early in the process could even have some unexpected benefits. Boseck says some CMOs will provide funding for their most promising startup clients. Others hold contests to attract the best startup technologies and assist in developing those platforms for the market.

Readiness is all

It’s not an easy road from ideation to production, Boseck notes. “As the saying goes, ‘If it were easy, someone would have already done it.’” That’s precisely the point: Contract manufacturers have done it, and they’re willing and able to help startups do it as well.

There are a few questions medtech startups should ask themselves when considering whether to look outside the company for product development:

• Can you provide well-defined and stable product requirements? Although adjustments are expected and often necessary, keep in mind that mission creep can kill deadlines, Boseck notes. • Do you have clear priorities? Whatever the challenges, your end goals should be very well defined. • Can you provide timely feedback to the team? Manufacturing can’t take place in a vacuum. Startups, which often have limited staff, should commit to having a dedicated liaison with their CMO partner. • Will you actively engage with the CMO development team? This might be as easy as getting a team member on site frequently. • Do you understand the development process? If not, ask more questions. • What are the terms? Make sure IP and ownership of the work product is well defined.

Another important aspect of engaging with a CMO is the selection process, often a rigorous and challenging one, Boseck says. Some CMOs actively try to entice startups, but just because they claim to be experts “they may not meet your specific requirements,” he cautions. Boseck advises budding medtech entrepreneurs to evaluate CMOs based on the following criteria:

• Their expertise matches the project need. This should encompass design expertise, clinical familiarity, and component and assembly experience. • The CMO offers the full spectrum of needed services. These should include concept ideation and prototyping, clinical production and scalable commercial production. • The CMO is accessible and responsible. This is the due diligence portion of the analysis. You’ll need to talk to a variety of clients, and conduct some online research, just to start. A good CMO has a reputation for building good working relationships, with an emphasis on trust and transparency.

Quality and compliance for startups: What you can ignore and what you can’t

Quality systems might be the last thing on your startup’s mind, as other activities take precedence. But it’s not a good idea to overlook the development of your quality system at the beginning.

“I think it’s a good idea to put process and product planning in place right from the start, simply because once things get going, they get going fast,” notes Timothy Lozier, director of marketing for ETQ. “You might be too worried about R&D, product and supply chain, and then market approval, to think about compliance. But it will come to you, and you don’t want to get caught off-guard.”

“Establish a quality management system that suits the company size and expected growth,” adds Christine Santagate, client solutions advisor with Regulatory Quality & Solutions. “Make sure that it’s something that the current staff can manage and maintain. When a company institutes a [quality management system] that’s too large, they set themselves up for failure to comply with their own system.”

Implementing and maintaining a QMS is a crucial part of regulatory compliance. The medical device quality system is primarily concerned with production and post-production. FDA 21 CFR Part 820 defines the quality regulations for the U.S. market. Otherwise, ISO 13485 can be used to build a quality system for global markets.

Although it’s time-consuming and expensive, establishing a total quality management system need not be as challenging as it sounds. The key is to build the system as you develop, focusing on the relevant aspects of quality and ignoring the others until they’re needed.

“You have to find something you can scale with,” says Lozier. “There are systems out there that let you start off small-scale and simple (yet effective), but as you grow you can grow the solution with your business.”

Startups should begin building their quality and compliance programs during the development phase, he advises, by focusing on design controls, risk management, document control and record management, and supplier management.

Design controls, essential for a QMS, can also help with the design process by capturing key aspects of development to prove your product meets user needs and is safe and effective. Likewise, risk management works with design controls to create documents and records throughout product development, to demonstrate that you’ve considered the risks and are doing something about them. Document management is the process that helps those pieces of the puzzle stay together.

“The concept of planning and gaining control over the process is that as you grow, you’ll always have them to lean on,” Lozier explains. “People can follow a process, but if it’s not documented, then you run into issues.”

Lozier emphasizes centralizing documentation, process and product planning.

“Too often, companies take that first step towards documenting their processes, but it resides in spreadsheets, file systems, and other, more decentralized, often manual methods. Having a system that’s able to manage and track these things, as well as serve as a central resource, is important to ensuring consistency in the operation. One source of the truth outweighs the risks associated with errant copies floating around the operation.”

Lozier cites tools that offer free or scalable methods to handle compliance events, issue actions, and launch corrective & preventive actions (CAPAs). ETQ, for example, offers traqpath, a free download, and VERSE, a cloud-based quality management system that brings in document control/training and CAPA. In addition, both tools have a supplier component to them, which can help startups send actions and CAPAs to suppliers through secure external assignments.

Many vendors have programs that are specifically designed to help companies scale compliance.

“These aren’t expensive tools, but are built with startups in mind,” says Lozier. “The benefit is that if you’re a startup and you’re looking to just put the pieces in place, you can do that for a low cost to your business, or even for free. That way, you’re not ignoring it, or factoring in major investment on something you may not need now.”

Committing assets to compliance is a “future-proofing” investment, he says. “You’re going to have to meet the compliance standards and regulations as you grow, and, just like documenting your processes and controlling and tracking your quality and compliance operations, you don’t want to be caught in growth mode and playing catch-up.”

How to plan your regulatory strategy

The regulatory burden for startup medical device businesses might be the most rigorous of any industry, and with good reason – making products for implantation or use in the human body requires hurdling a pretty high safety and efficacy bar.

So building a regulatory strategy from the very beginning is crucial, and there some key considerations every medtech startup should keep in mind, according to Christine Santagate, client solutions advisor at Regulatory Quality & Solutions.

First off, Santagate advises, startups should remember to budget for the testing and related costs associated with regulatory processes.

“The regulatory strategy is really an extension of the overall business plan and the costs associated should roll up into the overall budget. Unfortunately, testing and registration costs are sometimes overlooked when creating a business plan,” she explains. “The testing times and costs of sterilization validation, environmental testing, aging, biocompatibility and possibly clinical trials are sometimes not fully understood, as the initial focus is usually on technology and not on the entire life cycle.”

Another early consideration is where to pursue approval first. The relative ease of obtaining a CE Mark in Europe compared with the FDA’s more stringent requirements has been an attraction in the past, but Santagate says that’s changing.

“It used to be easier to gain approval in Europe, but things are changing quickly. With the updated ISO 13485 and pending IVDR updates, notified bodies [in Europe] are going to have their hands full,” she says. “Small startups should focus on gaining approval in the country that allows the most opportunity and is manageable and sustainable for their small staff.”

If the U.S. is the first target for commercialization, planning a detailed approach ahead of time helps determine which pathway to pursue, depending on the type of device being developed. It can help to find a trusted partner with the expertise in this area, to develop a regulatory strategy up front and identify potential paths to market – and its associated risks.

“This strategy will assess applicable FDA regulations, device classification options, potential predicate device and product claims, indications and contra-indication options, and potential regulatory risks based on the company’s marketing claims, product requirements, risk analysis, etc.,” Santagate notes. “The advantage in working with a consulting group is that they stay up to date on all regulation changes. A group like R&Q has 80+ full time consultants with experience spanning nearly all FDA device classes and they can provide an experienced, independent review.”

If your device is Class III, requiring the FDA’s most-stringent pre-market approval path, establishing a relationship with the agency and keeping the lines open should be your primary considerations.

“Make sure that indications are clear and supported and that any study design is robust and appropriate data points are collected to support the submission,” Santagate advises. “It’s all in the preparation – this is a long process and up-front focus and attention to detail will be well worth the effort.”

Santagate says a sound regulatory strategy can be an unexpected benefit for startups on the funding trail.

“Potential investors are able to see that the company has a planned path forward, based on risk. It provides an additional layer of preparedness and overall understanding of the full funding requirements – and how those funds will be used,” she says.

Reimbursement tops the ‘must-do’ list

Five years ago, if you asked a medical device executive about their top worry, regulatory – specifically, the cost and uncertainty around winning favor with the FDA – nearly always came first.

Today, those same executives are more likely to cite reimbursement as their top issue. Driven by the declining number of physicians owing their own practices – 70% in 2002, compared with about 25% in 2011, according to the U.S. Medical Group Management Assn. – and the resulting shift to group purchasing organizations, reimbursement has vaulted to the top of the list of must-do items for new medical device concerns.

“Reimbursement comes up in just about every discussion I’ve ever had with investors,” says David Rosa, the former president & CEO of Sunshine Heart in Eden Prairie, Minn. “Today, they’re all looking to de-risk their investment, and they all want to know, up front, the likelihood of reimbursement.”

“The hardest questions you’re going to get are on the reimbursement side,” adds Preceptis Medical president & CEO Steve Anderson. “It goes to the heart of everything we’ve been doing. Five years ago, we would’ve said, ‘Oh, reimbursement, I don’t need to worry about that.’ But this is the big issue today. It’s a big issue, and a big opportunity.

“It really is all about the money. The first real money we spent was on an outside analysis on reimbursement strategy. So it was fundamental to everything we’ve done,” Anderson says.

In fact, Minneapolis-based Preceptis chose to develop its therapy to help children with hearing problems in part because of its relatively simple reimbursement path, he adds.

Bob Thompson, president of Gahanna, Ohio-based Comprehensive Reimbursement Solutions, says the key is targeting a truly unmet need.

“There’s a lot of opportunity out there,” Thompson says. “If you direct your products toward unmet medical needs, you’ll see the benefits – particularly if you deal with the quality and cost-control issues that hospitals and payers are feeling.”

The challenges vary by country, so it’s important to become familiar with the ins and outs of local reimbursement policies in your target markets before you start spending on product development. One challenge common to most markets is the gap between reimbursement rates and the actual value of the technology. In many countries, rates are set using cost-based formulae by device or procedure type.

Because winning reimbursement hinges on clinical data, startups should plot their reimbursement strategy in parallel with their clinical and regulatory plans. That’s because collecting Class I data from randomly controlled trials and post-approval Class II data is key to a favorable review from a payer. Startups should also have a strategy for disseminating that data to peer-reviewed publications and at medical conferences once it’s collected.

In the U.S., an increasing number of payers are exploring value-based reimbursement models, not least the Centers for Medicare & Medicaid Services. Last July Medicare announced a program to bundle reimbursement payments for hip and knee replacement procedures, saying it wants to “hold hospitals accountable for the quality of care they deliver to Medicare fee-for-service beneficiaries.”

Startups that can demonstrate that their devices both improve outcomes and can be reimbursed based on that improvement stand a better chance of winning a favorable decision from payers.

February 1, 2018 at 9:00 am

Nice write up.

My question is, whether does a medical start-up needs to be ISO13485 or just their contract supplier needs to be?

If the company is already ISO9001 certified but intends to diverse into a medical device design company (but gets contract manufacturers to manufacture and control the quality), is the ISO9001 good enough? Pls advise. Thanks.

February 21, 2018 at 5:07 pm

Good question, Raymond. I don’t have the answer. Any readers able to help Raymond on this?

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How To Write a Business Plan for Medical Equipment in 9 Steps: Checklist

By alex ryzhkov, resources on medical equipment.

• Financial Model
• Business Plan
• Value Proposition
• One-Page Business Plan
• SWOT Analysis
• Business Model
• Marketing Plan

The medical equipment industry in the US is experiencing rapid growth, driven by increasing demand for healthcare services and advancements in technology. According to Statista , the global medical equipment market is projected to reach a value of $534.55 billion by 2025, with a compound annual growth rate of 5.14% from 2017 to 2025.

For entrepreneurs looking to enter this lucrative industry, having a well-written business plan is essential. In this blog post, we will provide you with a step-by-step checklist on how to write a business plan for medical equipment, ensuring that you are well-prepared to launch and succeed in this competitive market.

The first step in writing a business plan for medical equipment is to conduct thorough market research. This will involve gathering data on market size, growth potential, and key trends in the industry. By understanding the current market landscape, you can identify opportunities and challenges that may impact your business.

Once you have a clear understanding of the market, it is important to define your target audience. Who are your ideal customers? Are you targeting hospitals, clinics, or individual healthcare providers? By narrowing down your target audience, you can tailor your marketing efforts to effectively reach and engage with them.

Identifying potential competitors is another crucial step in writing a business plan. Who are the major players in the medical equipment industry? What products or services do they offer? Understanding your competition will allow you to differentiate your offerings and develop a unique selling proposition that sets you apart.

In addition to analyzing competitors, it is important to stay informed about industry trends and regulations. Medical equipment is subject to strict regulations and standards to ensure safety and efficacy. Keeping up with these regulations will help you stay compliant and avoid any legal issues in the future.

With a solid understanding of the market, target audience, and competition, you can now establish a clear value proposition. What makes your medical equipment unique or superior to existing options? Clearly articulating your value proposition will attract potential customers and set the foundation for your business success.

Developing a comprehensive pricing strategy is also key. Consider factors such as production costs, market demand, and competitor pricing when determining the optimal price for your products. Finding the right balance will help ensure profitability and maintain competitiveness in the market.

Every business in the medical equipment industry must comply with legal and regulatory requirements. Determining the necessary licenses, permits, and certifications for your business is crucial to avoid any legal complications. Be sure to thoroughly research and understand these requirements before launching your business.

Assessing the financial feasibility of your business is another important step. Consider factors such as startup costs, operating expenses, and projected revenue to determine whether your business idea is financially viable. This will help you secure funding and make informed decisions about your business's future.

Lastly, a detailed sales and marketing plan is essential for effectively promoting and selling your medical equipment. Outline your marketing strategies, target channels, and key messages to reach your target audience. A well-developed sales plan will help you generate leads, close deals, and drive business growth.

In conclusion, writing a business plan for medical equipment requires careful research and planning. By following this nine-step checklist, you will be well-equipped to launch and succeed in the highly competitive medical equipment industry.

Conduct Market Research

Before diving into the process of writing a business plan for medical equipment, it is crucial to conduct thorough market research. This step is essential as it provides valuable insights into the industry, target audience, and potential competition. Here are some key aspects to consider during the market research phase:

• Industry Analysis: Begin by analyzing the medical equipment industry, including its current size, growth rate, and future projections. Understand the primary players, market trends, and any technological advancements that may impact the industry.
• Target Audience: Identify your target audience, which may consist of hospitals, clinics, or healthcare providers. Gather demographic information, such as their location, size, and specific needs or challenges they may face.
• Competitor Analysis: Identify the major players in the market and analyze their products, pricing strategies, and distribution channels. Determine what sets them apart and how you can differentiate your business.
• Customer Needs: Understand the specific needs and preferences of your target audience. What challenges do they face, and how can your medical equipment address those needs?
• Utilize online resources, industry reports, and trade publications to gather valuable data about the medical equipment industry.
• Conduct surveys or interviews with potential customers to gain insights into their needs and preferences.
• Attend industry conferences and networking events to connect with experts and gain a deeper understanding of the market.
• Consider hiring a market research firm to conduct a comprehensive analysis of the medical equipment market.

By conducting thorough market research, you can gain a clear understanding of the industry dynamics, identify your target audience, and determine how your medical equipment business can effectively meet their needs. This research will serve as a solid foundation for the subsequent steps in writing a comprehensive business plan.

Define The Target Audience

Defining the target audience is a crucial step in creating a successful business plan for medical equipment. It allows you to identify the specific group of people or organizations who will benefit from your products and services. This step helps you tailor your marketing efforts and product development to meet the needs and preferences of your target audience.

When defining your target audience, consider the following factors:

• Demographics: Analyze the characteristics of your potential customers such as age, gender, income level, and location. Understanding these demographics will help you create targeted marketing campaigns and allocate resources effectively.
• Needs and Pain Points: Determine the specific needs or problems that your target audience is facing. For example, hospitals may require advanced diagnostic equipment to improve patient care, while smaller clinics may be looking for cost-effective solutions. Identifying these pain points will enable you to develop products that address these challenges.
• Buying Behavior: Study how your target audience makes purchasing decisions. Are they more likely to purchase medical equipment directly or through a distributor? Do they prioritize quality over affordability? Understanding their buying behavior will help you position your products effectively in the market.

Tips for Defining the Target Audience:

• Conduct surveys or interviews with potential customers to gather insights about their needs and preferences.
• Study the market and industry reports to understand the current trends and demands in the medical equipment sector.
• Segment your target audience into different groups based on their unique characteristics and tailor your marketing strategies accordingly.
• Regularly revisit and update your target audience definition as market dynamics and customer preferences may change over time.

By defining a clear target audience, you can focus your efforts on meeting their specific needs and preferences. This will help you develop an effective marketing strategy, improve customer satisfaction, and ultimately drive the success of your medical equipment business.

Identify Potential Competitors

One crucial step in creating a business plan for a medical equipment company is identifying your potential competitors. Understanding who you are up against in the market allows you to gauge the level of competition and strategically position your business for success. Here are some important considerations when identifying potential competitors:

• Research Existing Companies: Conduct thorough research to identify companies that already operate in the medical equipment industry. Look for both local and national competitors to get a comprehensive view of the market.
• Analyze Product Offerings: Examine the products and services offered by your potential competitors. Identify their strengths and weaknesses, including any unique selling points or competitive advantages they may have.
• Study Market Share: Look into the market share held by each competitor. This information will give you insight into the strength and dominance of each player in the industry.
• Assess Pricing Strategy: Investigate the pricing strategies of your competitors. Determine if they offer products at different price points or if they utilize any promotional offers or discounts.
• Identify Target Customers: Understand who your competitors are targeting as their primary customer base. This will help you define your own target audience and establish a competitive advantage.
• While identifying potential competitors, focus not only on large and well-established companies but also keep an eye on emerging startups that may disrupt the market.
• Utilize online resources, industry publications, and trade shows to gather information about existing and new players in the medical equipment industry.

Identifying potential competitors is essential for creating a solid business plan. By thoroughly researching the market and understanding your competition, you will be better equipped to develop strategies that differentiate your medical equipment business and attract customers.

Analyze Industry Trends and Regulations

When starting a business in the medical equipment industry, it is crucial to thoroughly analyze industry trends and regulations . Understanding the current landscape can help you make informed decisions and stay ahead of the competition. Here are some key areas to focus on during your analysis:

• Market demand: Research the demand for medical equipment in your target area and identify any emerging trends. This will help you determine if there is a viable market for your products and what specific needs to address.
• Technology advancements: Keep up to date with the latest technological advancements in the medical equipment industry. Innovations can significantly impact the demand for certain products, and staying ahead of these developments can give you a competitive edge.
• Regulations and compliance: Familiarize yourself with the regulatory requirements specific to the medical equipment industry. Ensure that your products comply with all relevant standards and obtain the necessary certifications. Non-compliance can result in legal issues and hinder your ability to operate.
• Reimbursement policies: Understand the reimbursement policies of healthcare providers, such as Medicare and private insurance companies. Knowing how these policies impact the purchasing decisions of medical equipment can help you tailor your pricing strategies and target the right customers.
• Competitor analysis: Identify and analyze your competitors in the medical equipment industry. Determine their strengths, weaknesses, product offerings, pricing strategies, and target markets. This information will help you differentiate yourself and develop a competitive advantage.

Tips for Analyzing Industry Trends and Regulations:

• Subscribe to industry publications, newsletters, and relevant online forums to stay updated on the latest trends and regulatory changes.
• Network with professionals in the healthcare industry to gain insights and learn from their experiences.
• Attend conferences, trade shows, and exhibitions related to medical equipment to learn about new technologies and industry best practices.
• Consult with legal experts or regulatory consultants to ensure a thorough understanding of the regulations and compliance requirements.

Establish A Clear Value Proposition

One of the most crucial steps in writing a business plan for medical equipment is establishing a clear value proposition for your products or services. Your value proposition is what sets you apart from your competitors and outlines the unique benefits and advantages that your medical equipment offers to potential customers.

To establish a strong value proposition, it is essential to thoroughly understand the needs and pain points of your target audience. Conduct market research to identify the specific challenges that healthcare providers face when it comes to medical equipment. This will help you tailor your value proposition to address these specific needs.

When defining your value proposition, highlight the key features and functionalities of your products that directly solve the problems and challenges faced by healthcare professionals. Clearly communicate how your medical equipment can improve patient outcomes, enhance operational efficiency, or reduce healthcare costs.

• Clearly articulate the unique selling points of your products or services.
• Highlight the direct benefits and advantages for healthcare providers and patients.
• Showcase any certifications or quality standards that your medical equipment meets.
• Provide case studies or testimonials to demonstrate the effectiveness of your products.
• Keep your value proposition concise and easy to understand.

In addition, address any competitive advantages that your business has over existing players in the market. This could include factors such as superior quality, faster delivery, exceptional customer service, or innovative technology. These unique selling points will help differentiate your medical equipment business from competitors and attract potential customers.

Remember, a strong value proposition is essential for effectively marketing and selling your medical equipment. It should clearly communicate the value and benefits that your products or services offer, and why healthcare providers should choose your business over others in the market.

Develop a Comprehensive Pricing Strategy

When it comes to selling medical equipment, having a well-defined pricing strategy is crucial for the success of your business. Here are some important factors to consider as you develop your pricing strategy:

• Cost Analysis: Begin by conducting a thorough cost analysis of your products, including manufacturing costs, overhead expenses, and any additional costs associated with distribution and marketing. This will help you determine the base price that covers your expenses and allows for a reasonable profit margin.
• Competitive Analysis: Research and analyze the pricing strategies of your competitors in the medical equipment industry. Take note of their pricing structures and identify any gaps or opportunities where you can offer more value or differentiate yourself.
• Value-based Pricing: Consider the unique features and benefits of your medical equipment and how they provide value to your target audience. Price your products based on this perceived value, and make sure to communicate the advantages and benefits to potential customers.
• Market Demand: Take into account the current demand for medical equipment in the market. If the demand is high and the competition is fierce, you may be able to set slightly higher prices. However, if the market is saturated or there is low demand, you may need to adjust your pricing strategy accordingly.
• Discounts and Incentives: Determine whether offering discounts or incentives can be a part of your pricing strategy. This can include volume discounts for large orders, special pricing for loyal customers or bundled packages that offer additional value to buyers.
• Profit Margin: Calculate the desired profit margin for your business. Consider both short-term profitability and long-term growth goals. Ensure that your pricing strategy allows you to cover expenses, generate profits, and invest in future product development and expansion.
• Regularly review and update your pricing strategy to adapt to market changes and stay competitive.
• Consider conducting surveys or gathering customer feedback to assess whether your pricing is perceived as fair and reasonable.
• Offering flexible payment options, such as leasing or financing, can make your products more accessible to potential customers.
• Keep an eye on the costs of your competitors' products and adjust your pricing accordingly to maintain your competitive edge.

Determine The Necessary Legal And Regulatory Requirements

When starting a business in the medical equipment industry, it is crucial to understand and comply with the legal and regulatory requirements that govern this sector. Failing to meet these requirements can lead to serious consequences, such as fines, legal penalties, and damage to your company's reputation. Here are some important steps to help you determine and navigate the necessary legal and regulatory requirements for your medical equipment business:

• Research industry-specific regulations: Start by researching and familiarizing yourself with the specific regulations that apply to the medical equipment industry. This includes understanding the requirements set forth by government agencies such as the Food and Drug Administration (FDA), Federal Trade Commission (FTC), and Occupational Safety and Health Administration (OSHA). Stay up to date on any changes or updates in regulations that may affect your business.
• Consult legal and compliance experts: It is highly recommended to seek legal counsel or consult with compliance experts who specialize in the medical equipment field. These professionals can provide valuable guidance and ensure that your business is fully compliant with all applicable laws and regulations.
• Secure necessary licenses and certifications: Depending on the type of medical equipment you intend to sell, you may need to obtain specific licenses and certifications. For example, certain medical devices may require FDA approval or certification. Research and understand the requirements for your particular products and ensure the necessary certifications are obtained before you can legally sell them.
• Implement quality control processes: A key factor in meeting legal and regulatory requirements is implementing robust quality control processes. Establish stringent quality control measures to ensure that your products meet the required safety and performance standards. This may involve conducting regular inspections, testing, and maintenance of your equipment.
• Ensure proper documentation and labeling: Accurate and comprehensive documentation is essential for compliance. Make sure to maintain records of your equipment, including manufacturing, distribution, and usage details. Properly label your products with all necessary information, such as warnings, usage instructions, and safety precautions.

Here are some additional tips to consider:

• Stay informed of any recalls or safety alerts related to medical equipment and take prompt action if any of your products are affected.
• Regularly review and update your compliance processes and procedures to adapt to any new or revised regulations.

Assess The Financial Feasibility Of The Business

Assessing the financial feasibility of your medical equipment business is a crucial step to determine whether your venture has the potential to be profitable and sustainable. Here are some important factors to consider:

• Capital Requirements: Calculate the initial and ongoing costs of starting and operating your business. This includes expenses such as equipment purchase, leasing or renting a facility, inventory, marketing, and employee salaries. It is essential to have a clear understanding of your financial needs to secure the necessary funding.
• Revenue Projections: Develop a comprehensive sales forecast to estimate your potential revenue. Consider factors such as market demand, competition, pricing, and sales channels. It is crucial to be realistic and conservative in your projections to avoid overestimating revenue.
• Profitability Analysis: Conduct a thorough analysis of your projected expenses and revenue to determine your expected profitability. This includes calculating your gross profit margin, operating expenses, and net profit margin. Monitor key financial ratios, such as return on investment (ROI) and return on equity (ROE), to ensure your business can generate sustainable returns.
• Cash Flow Management: Evaluate your cash flow projections to ensure you have sufficient cash on hand to cover your expenses. Consider seasonal fluctuations, payment terms with suppliers and customers, and potential delays in payment. Effective cash flow management is essential for the smooth operation of your business.

Tips for assessing the financial feasibility of your medical equipment business:

• Consult with a financial advisor or accountant to ensure accuracy and comprehensive analysis of your financial projections.
• Research industry benchmarks and standards to benchmark your financial performance against competitors.
• Consider potential risks and uncertainties, such as changes in regulations or shifts in market demand, and develop contingency plans.
• Regularly review and update your financial projections as your business evolves to ensure accuracy and adaptability.

Create A Detailed Sales And Marketing Plan

A successful business plan for medical equipment must include a detailed sales and marketing plan that outlines the strategies and tactics to effectively reach and engage with your target audience. This plan will serve as a roadmap for your sales and marketing activities, helping you to maximize your business's visibility, attract customers, and generate revenue.

1. Identify your target market: Clearly define your target audience within the healthcare industry. Consider factors such as the size of the hospitals, clinics, and healthcare providers you will target, their specific needs and preferences, and their purchasing power.

2. Develop a strong brand image: Build a compelling brand that resonates with your target market. Your brand should reflect the quality and reliability of your medical equipment and differentiate you from competitors. Utilize professional branding elements and consistently portray your brand voice across all marketing channels.

3. Utilize digital marketing strategies: Leverage various digital marketing tactics to promote your business and engage with potential customers. Develop a user-friendly website that showcases your products and services, optimize it for search engines, and create valuable content such as blogs and educational resources that demonstrate your expertise in the field.

4. Establish a strong online presence: Utilize social media platforms, such as LinkedIn, Twitter, and Facebook, to connect with healthcare professionals and organizations. Share relevant industry news, updates about your products, and success stories to build credibility and engage with your target audience.

• Consider partnering with influential medical professionals or healthcare organizations to enhance your brand's credibility and reach a wider audience.
• Invest in search engine optimization (SEO) to improve your website's visibility on search engine result pages, increasing organic traffic and potential leads.
• Utilize email marketing campaigns to nurture leads and maintain relationships with existing customers.
• Attend industry conferences and trade shows to network, demonstrate your products, and connect with potential customers.

5. Leverage traditional marketing channels: In addition to digital strategies, incorporate traditional marketing channels such as print advertisements, direct mail campaigns, and industry publications. These channels can help enhance your reach within the healthcare industry.

6. Build a strong sales team: Hire experienced sales professionals who understand the healthcare industry and can effectively communicate the value and benefits of your medical equipment. Provide them with comprehensive product training and support to ensure they are well-equipped to sell your products.

7. Monitor and measure your marketing efforts: Implement tracking systems to measure the effectiveness of your marketing strategies. Collect data on metrics such as website traffic, conversion rates, lead generation, and customer satisfaction. Analyze this data regularly to optimize your marketing efforts and identify areas for improvement.

8. Pivot and adapt: Stay informed about industry advancements and market trends. Be prepared to adapt your sales and marketing plan as needed to effectively meet the evolving needs and preferences of your target audience.

9. Set achievable targets and goals: Establish realistic sales targets and goals for your business. Break them down into smaller, measurable objectives and regularly review your progress. Adjust your strategies and tactics accordingly to ensure you stay on track and achieve your desired outcomes.

In conclusion, a detailed sales and marketing plan is essential for the success of your medical equipment business. By understanding your target market, establishing a strong brand, utilizing digital and traditional marketing strategies, and continuously monitoring and adapting your efforts, you can effectively promote your products, attract customers, and drive revenue for your business.

Writing a business plan for a medical equipment company is crucial for success in the competitive healthcare industry. By following a step-by-step checklist, you can ensure that your plan covers all the necessary aspects, from market research to sales and marketing strategies. By conducting thorough research, identifying your target audience, and analyzing industry trends, you can establish a strong foundation for your business. Additionally, developing a clear value proposition, pricing strategy, and understanding the legal and regulatory requirements will help you navigate the complexities of the medical equipment market. Ultimately, with a well-structured and comprehensive business plan, you can position your company for growth and profitability in the ever-expanding healthcare sector.

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Medical Practice Business Plan Template

Written by Dave Lavinsky

Medical Practice Business Plan

Over the past 20+ years, we have helped over 500 entrepreneurs and business owners create business plans to start and grow their medical practices. On this page, we will first give you some background information with regards to the importance of business planning. We will then go through a medical practice business plan template step-by-step so you can create your plan today.

Download our Ultimate Medical Practice Business Plan Template here >

What Is a Business Plan?

A business plan provides a snapshot of your medical office as it stands today, and lays out your growth plan for the next five years. It explains your business goals and your strategy for reaching them. It also includes market research to support your plans.

Why You Need a Business Plan

If you’re looking to start a medical practice, or grow your existing medical practice, you need a business plan. A business plan will help you raise funding, if needed, and plan out the growth of your medical practice in order to improve your chances of success. Your business plan is a living document that should be updated annually as your company grows and changes.

Sources of Funding for Medical Practices

With regards to funding, the main sources of funding for a medical office are personal savings, credit cards, bank loans and angel investors. With regards to bank loans, banks will want to review your business plan and gain confidence that you will be able to repay your loan and interest. To acquire this confidence, the loan officer will not only want to confirm that your financials are reasonable, but they will also want to see a professional plan. Such a plan will give them the confidence that you can successfully and professionally operate a business. Personal savings and bank loans are the most common funding paths for medical practices.

Finish Your Business Plan Today!

How to write a business plan for a medical business.

If you want to start a medical private practice or expand your current one, you need a business plan. Below we detail what should be included in each section of your business plan.

Executive Summary

Your executive summary provides an introduction to your business plan, but it is normally the last section you write because it provides a summary of each key section of your plan.

The goal of your Executive Summary is to quickly engage the reader. Explain to them the type of medical office you are operating and the status. For example, are you a startup, do you have a practice that you would like to grow, or are you operating practices in multiple markets?

Next, provide an overview of each of the subsequent sections of your plan. For example, give a brief overview of the industry. Discuss the type of practice you are operating. Detail your direct competitors. Give an overview of your target customers. Provide a snapshot of your marketing plan. Identify the key members of your team. And offer an overview of your financial plan.  

Company Analysis

In your company analysis, you will detail the type of medical office you are operating.

For example, you might operate one of the following types of medical practices:

• Group medical practice : this type of medical practice consists of two or more physicians providing medical care in the same facility. The physicians typically have different specialties, which allow them to collaborate and consult with each other.
• Private medical practice: this type of medical practice involves only one physician working along. A private practice usually serves a limited number of patients and operates with a small staff.
• Hospital-based medical practice: this type of medical practice is an ancillary medical office that is owned by a nearby hospital. The hospital will manage the practice and employ the doctors and nurses to work in their facilities and ancillary clinics.

In addition to explaining the type of medical practice you will operate, the Company Analysis section of your business plan needs to provide background on the business.

Include answers to question such as:

• When and why did you start the business?
• What is your business model?
• What is your mission statement?
• What milestones have you achieved to date? Milestones could include the number of patients served, number of positive reviews, reaching X amount of patients served, etc.
• Your legal structure. Are you incorporated as an S-Corp? An LLC? A sole proprietorship? Explain your business structure here.

Industry Analysis

In your industry analysis, you need to provide an overview of the medical industry.

While this may seem unnecessary, it serves multiple purposes.

First, researching the medical industry educates you. It helps you understand the market in which you are operating. 

Secondly, market research can improve your strategy, particularly if your research identifies market trends.

The third reason for market research is to prove to readers that you are an expert in your industry. By conducting the research and presenting it in your plan, you achieve just that.

The following questions should be answered in the industry analysis section:

• How big is the medical industry (in dollars)?
• Is the market declining or increasing?
• Who are the key competitors in the market?
• Who are the key suppliers in the market?
• What trends are affecting the industry?
• What is the industry’s growth forecast over the next 5 – 10 years?
• What is the relevant market size? That is, how big is the potential market for your medical office? You can extrapolate such a figure by assessing the size of the market in the entire country and then applying that figure to your local population.

Customer Analysis

The customer analysis section must detail the customers you serve and/or expect to serve.

The following are examples of customer segments: individuals, families, seniors, and anyone needing a type of medical service.

As you can imagine, the customer segment(s) you choose will have a great impact on the type of medical office you operate. Clearly, families would respond to different marketing promotions than seniors, for example.

Try to break out your target customers in terms of their demographic and psychographic profiles. With regards to demographics, include a discussion of the ages, genders, locations and income levels of the customers you seek to serve.

Psychographic profiles explain the wants and needs of your target customers. The more you can understand and define these needs, the better you will do in attracting and retaining your customers.

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Competitive Analysis

Your competitive analysis should identify the indirect and direct competitors your business faces and then focus on the latter.

Direct competitors are other medical offices. 

Indirect competitors are other options that customers have to purchase from that aren’t direct competitors. This includes hospitals, clinics, teledocs, and online health forums.

With regards to direct competition, you want to describe the other practices with which you compete. Most likely, your direct competitors will be other practices located very close to your business location.

For each such competitor, provide an overview of their businesses and document their strengths and weaknesses. Unless you once worked at your competitors’ businesses, it will be impossible to know everything about them. But you should be able to find out key things about them such as:

• What types of medical services do they provide?
• What areas do they serve?
• What types of patients do they serve?
• What is their pricing (premium, low, etc.)?
• What are they good at?
• What are their weaknesses?

With regards to the last two questions, think about your answers from the customers’ perspective. And don’t be afraid to ask your competitors’ customers what they like most and least about them.

The final part of your competitive analysis section is to document your areas of competitive advantage. For example:

• Will you provide services that your competitors don’t offer?
• Will you provide faster patient waiting time?
• Will you provide better patient service?
• Will you offer better pricing?

Think about ways you will outperform your competition and document them in this section of your plan.  

Marketing Plan

Traditionally, a marketing plan includes the four P’s: Product, Price, Place, and Promotion. For a medical office, your marketing plan should include the following:

Product : In the product section, you should reiterate the type of practice that you documented in your Company Analysis. Then, detail the specific services you will be offering. For example, in addition to medical services, will you provide nutrition and diet guidelines, insurance claim processing, family and loved one communication, and any other services?

Price : Document the prices you will offer and how they compare to your competitors. Essentially in the product and price sub-sections of your marketing plan, you are presenting the services you offer and their prices.

Place : Place refers to the location of your practice. Document your location and mention how the location will impact your success. For example, is your medical office located near a school, a busy neighborhood, an office complex, or an urban setting, etc.? Discuss how your location might be the ideal location for your patients.

Promotions : The final part of your marketing plan is the promotions section. Here you will document how you will drive customers to your location(s). The following are some promotional methods you might consider:

• Advertising in local papers and magazines
• Commercials
• Social media marketing
• Local radio advertising
• Word-of-mouth

Operations Plan

While the earlier sections of your business plan explained your goals, your operations plan describes how you will meet them. It should have two distinct sections as follows.

Everyday short-term processes include all of the tasks involved in running your practice, including patient and family communication and scheduling, managing appointments, inventory of medical supplies, accounting, billing, payroll, etc.

Long-term goals are the milestones you hope to achieve. These could include the dates when you expect to obtain your XXth patient, or when you hope to reach $X in revenue. It could also be when you expect to expand your medical practice to a new location.  

Management Team

To demonstrate your practice’s ability to succeed, a strong management team is essential. Highlight your key players’ backgrounds, emphasizing those skills and experiences that prove their ability to grow a company. 

Ideally you and/or your management team members have direct experience in managing medical practices. If so, highlight this experience and expertise. But also highlight any experience that you think will help your business succeed.

If your team is lacking, consider assembling an advisory board. An advisory board would include 2 to 8 individuals who would act like mentors to your business. They would help answer questions and provide strategic guidance. If needed, look for advisory board members with experience in managing a medical practice or a physician or nurse in the local medical field.  

Financial Plan

Your financial plan should include your 5-year financial statement broken out both monthly or quarterly for the first year and then annually. Your financial statements include your income statement, balance sheet and cash flow statements.

Income Statement

An income statement is more commonly called a Profit and Loss statement or P&L. It shows your revenues and then subtracts your costs to show whether you turned a profit or not.

In developing your income statement, you need to devise assumptions. For example, will you take on one new patient at a time or multiple new patients offering a variety of medical services ? And will sales grow by 2% or 10% per year? As you can imagine, your choice of assumptions will greatly impact the financial forecasts for your business. As much as possible, conduct research to try to root your assumptions in reality.

Balance Sheets

Balance sheets show your assets and liabilities. While balance sheets can include much information, try to simplify them to the key items you need to know about. For instance, if you spend $50,000 on building out your medical practice, this will not give you immediate profits. Rather it is an asset that will hopefully help you generate profits for years to come. Likewise, if a bank writes you a check for $50,000, you don’t need to pay it back immediately. Rather, that is a liability you will pay back over time.

Cash Flow Statement

: Your cash flow statement will help determine how much money you need to start or grow your business, and make sure you never run out of money. What most entrepreneurs and business owners don’t realize is that you can turn a profit but run out of money and go bankrupt. 

In developing your Income Statement and Balance Sheets be sure to include several of the key costs needed in starting or growing a medical practice:

• Cost of furniture and build-out
• Cost of medical supplies and equipment
• Payroll or salaries paid to staff
• Business and medical malpractice insurance
• Taxes and permits
• Legal expenses

Attach your full financial projections in the appendix of your plan along with any supporting documents that make your plan more compelling. For example, you might include your list of medical services your practice will offer, types of patients you will be targeting, and the areas your practice will serve.  

Putting together a business plan for your medical practice is a worthwhile endeavor. If you follow the template above, by the time you are done, you will truly be an expert. You will really understand the industry, your competition, and your customers. You will have developed a marketing plan and will really understand what it takes to launch and grow a successful medical practice.  

Medical Practice Business Plan FAQs

What is the easiest way to complete my medical practice business plan.

Growthink's Ultimate Medical Practice Business Plan Template allows you to quickly and easily complete your Medical Practice Business Plan.

Where Can I Download a Medical Clinic Business Plan PDF?

You can download our medical clinic business plan PDF here. This is a business plan template you can use in PDF format.

What is the Goal of a Business Plan's Executive Summary?

The goal of your Executive Summary is to quickly engage the reader. Explain to them the type of medical practice business you are operating and the status; for example, are you a startup, do you have a medical practice business that you would like to grow, or are you operating a chain of medical practice businesses?

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Other Helpful Business Plan Articles & Templates

Medical Business Plan

You cannot start and run a successful medical business without writing and implementing a comprehensive business plan.   A business plan gives you a complete framework for researching and analyzing the market, identifying possible opportunities, financing the project, and scaling it all together. Here are some of the best examples of medical business plans worth having a look.

Medical Practice Business Plan Template

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Best Medical Business Plan Examples & Templates

 medical business plan example.

Size: 8.86 MB

If writing a medical business plan were easy, every business aspirant would do it with ease. To be clear, a comprehensive business plan for a new healthcare facility takes time to put together. But, what if you are green in this in the first place? The best thing to do is to look at a sample plan to get a clear picture of what a comprehensive strategy for a health facility looks like. This PDF file is a unique sample of a well-written business strategy for a healthcare facility. The plan covers everything you need to know about establishing a healthcare center, from business objectives and guiding principles to demographic analysis and their access to care.

Printable Medical Business Plan

Size: 780 KB

It doesn’t make sense to start a medical business without a strategy in place. You need to identify your audience, sturdy the market, conduct a SWOT analysis , and develop a marketing technique. This calls for a comprehensive business plan and here is an example that you can download and use as a guide to writing your own strategy. This sample will help you to understand a few things. First, you’ll learn how to write a clear summary of the proposed medical business. Second, you will see what a detailed business description looks like. Third, you will dive deep into learning and understanding the competition. Then, you will learn about financial strategy, which is important for starting and running a healthcare business at scale.

Free Medical Business Plan Example

Size: 88 KB

It is important to understand that a business plan does not have to be complicated. It doesn’t have to be dozens or hundreds of pages either. In fact, you can set up and run a successful medical business with a very simple business plan . This PDF document is an example of a very simple business strategy, which a clear indication that even lean business plans can help you take a step in the right direction. This plan covers a number of sections, including an executive summary for the proposed business, proposed services, market evaluation, and marketing approach. Click the link above to download the PDF file.

Medical Practice Business Plan Example

Size: 237 KB

This PDF document is one of the most comprehensive medical business plans that you can read to understand what a professionally written business strategy looks likes. The 37-page file features a unique outline, which makes the entire document easy to scan. This file has a lot of information. From the executive summary and market sturdy to SWOT and market analysis , there is quite a lot to learn. The author uses a simple language throughout the document. So, whether you are green to writing a business proposal or you just need a simple example for reference, this is a good template to download.

Medical Startup Business Plan Example

Size: 219 KB

You cannot start and run a successful business without a plan. In fact, many businesses that begin to operate without a strategy often close within the first six months. This happens across various industries, even in medical business. Now that you have made up your mind to start a medical business, you first need to write a business plan. If you have never written one before, don’t worry. You can just download this PDF file, read the entire strategy example, and then use the same knowledge that you pick from it to write a comprehensive business plan of your own. Click the link above to download this template.

 Medical Business Plan Example for Clinic

Size: 262 KB

Ask every serious entrepreneur what it takes to start and run a successful business and they’ll tell you that the first thing you need is a business plan. This tells you that a successful business depends on a comprehensive strategy . Now that you have made up your mind that it is time for you and your stakeholders to start a clinic in your locale, it’s important to write a business plan before investing money in the project. The plan will enable you to determine whether the business is feasible to pursue. By finding, connecting with, and studying the target market, it becomes easy to understand your business even before starting it. Download this medical plan for the clinic to learn more.

 Private Hospital Business Plan Example

Size: 2.15 MB

Even if you have enough funding to start a private hospital, you’ll need to do in-depth research and then come up with a solid business plan that will help you set up the enterprise. At the end of the day, your goal is to run a successful business . This is something you can’t do if you start with a proper strategy. Remember, the success of your private medical startup will depend on the structure of the plan. The success of the upcoming business will depend on the structure of the plan. In other words, a business plan is a must-have.

 Simple Medical Business Plan Example

Size: 141 KB

You already know that it is difficult to run a successful business without a plan. So, if you want to set up a new medical facility in your area, first start by writing a business plan for the foreseen startup. The PDF file above is a unique example of a business plan that you can use for reference. This guide is important because it focuses on the most important elements that make up a comprehensive business plan.

 Comprehensive Business Plan for Medical Facility

You can use this sample template to write a comprehensive business plan for a medical facility. Some of the highlights include identifying challenges and determining their respective opportunities. This gives you a clear understanding of the market that you would like to target so that you can align your medical services to their needs once you start operation.

 Short Medical Business Plan Example

Size: 264 KB

If you are the kind of a medical business enthusiast who prefers to write a short business plan, this example is suitable for you. The content of the file includes an executive summary, market analysis, business growth, marketing strategy, and financial projection.

Text prompt

• Instructive
• Professional

Create a study plan for final exams in high school

Develop a project timeline for a middle school science fair.

Engineering Business Plan Template & Guidebook

Are you starting an engineering business? The demand for skilled and knowledgeable engineering services has never been higher. Starting an engineering business can be a fulfilling and profitable venture. However, it's important to have a solid business plan in place to ensure the success of your business. Our Engineering Business Plan Template & Guidebook is designed to help you easily create a comprehensive business plan for your engineering business. This guidebook provides step-by-step instructions on how to create each section of your business plan, as well as helpful tips and examples to ensure that your plan is thorough and effective. With our template and guidebook, you can confidently put together a solid business plan to help you achieve your engineering business goals.

Get worry-free services and support to launch your business starting at $0 plus state fees.

• How to Start a Profitable Engineering Business [11 Steps]
• 10+ Best & Profitable Engineering Business Ideas [2023]
• 25 Catchy Engineering Business Names:
• List of the Best Marketing Ideas For Your Engineering Business:

How to Write a Engineering Business Plan in 7 Steps:

1. describe the purpose of your engineering business..

The first step to writing your business plan is to describe the purpose of your engineering business. This includes describing why you are starting this type of business, and what problems it will solve for customers. This is a quick way to get your mind thinking about the customers’ problems. It also helps you identify what makes your business different from others in its industry.

It also helps to include a vision statement so that readers can understand what type of company you want to build.

Here is an example of a purpose mission statement for a engineering business:

An engineering business could have the following purpose mission statement: "Our purpose is to provide innovative engineering solutions that help our clients meet their goals and improve their operations. We are committed to using the latest technology and best practices to deliver high-quality, cost-effective designs that are tailored to the unique needs of each project. Through our expertise and dedication to excellence, we strive to be a trusted partner to businesses, organizations, and individuals in the pursuit of their engineering objectives."

2. Products & Services Offered by Your Engineering Business.

The next step is to outline your products and services for your engineering business. 

When you think about the products and services that you offer, it's helpful to ask yourself the following questions:

• What is my business?
• What are the products and/or services that I offer?
• Why am I offering these particular products and/or services?
• How do I differentiate myself from competitors with similar offerings?
• How will I market my products and services?

You may want to do a comparison of your business plan against those of other competitors in the area, or even with online reviews. This way, you can find out what people like about them and what they don’t like, so that you can either improve upon their offerings or avoid doing so altogether.

3. Build a Creative Marketing Stratgey.

If you don't have a marketing plan for your engineering business, it's time to write one. Your marketing plan should be part of your business plan and be a roadmap to your goals. 

A good marketing plan for your engineering business includes the following elements:

Target market

• Who is your target market?
• What do these customers have in common?
• How many of them are there?
• How can you best reach them with your message or product?

Customer base 

• Who are your current customers? 
• Where did they come from (i.e., referrals)?
• How can their experience with your engineering business help make them repeat customers, consumers, visitors, subscribers, or advocates for other people in their network or industry who might also benefit from using this service, product, or brand?

Product or service description

• How does it work, what features does it have, and what are its benefits?
• Can anyone use this product or service regardless of age or gender?
• Can anyone visually see themselves using this product or service?
• How will they feel when they do so? If so, how long will the feeling last after purchasing (or trying) the product/service for the first time?

Competitive analysis

• Which companies are competing with yours today (and why)? 
• Which ones may enter into competition with yours tomorrow if they find out about it now through word-of-mouth advertising; social media networks; friends' recommendations; etc.)
• What specific advantages does each competitor offer over yours currently?

Marketing channels

• Which marketing channel do you intend to leverage to attract new customers?
• What is your estimated marketing budget needed?
• What is the projected cost to acquire a new customer?
• How many of your customers do you instead will return?

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4. Write Your Operational Plan.

Next, you'll need to build your operational plan. This section describes the type of business you'll be running, and includes the steps involved in your operations. 

In it, you should list:

• The equipment and facilities needed
• Who will be involved in the business (employees, contractors)
• Financial requirements for each step
• Milestones & KPIs
• Location of your business
• Zoning & permits required for the business

What equipment, supplies, or permits are needed to run a engineering business?

To run an engineering business, you will need a team of trained and certified engineers, as well as a range of specialized equipment and tools, such as computers, software, and testing equipment, for carrying out engineering projects and services. You will also need a well-equipped office or workspace for your staff. In addition to these items, you may also need the following equipment and supplies:

• CAD and other design software
• Project management and scheduling tools
• Office supplies, such as pens, paper, and envelopes
• Marketing materials, such as brochures and business cards
• File storage and organization system

Depending on the specific nature of your business and the regulations in your area, you may also need additional permits or licenses to operate legally. It is important to research and comply with all applicable laws and regulations to ensure the safety and success of your engineering business.

5. Management & Organization of Your Engineering Business.

The second part of your engineering business plan is to develop a management and organization section.

This section will cover all of the following:

• How many employees you need in order to run your engineering business. This should include the roles they will play (for example, one person may be responsible for managing administrative duties while another might be in charge of customer service).
• The structure of your management team. The higher-ups like yourself should be able to delegate tasks through lower-level managers who are directly responsible for their given department (inventory and sales, etc.).
• How you’re going to make sure that everyone on board is doing their job well. You’ll want check-ins with employees regularly so they have time to ask questions or voice concerns if needed; this also gives you time to offer support where necessary while staying informed on how things are going within individual departments too!

6. Engineering Business Startup Expenses & Captial Needed.

This section should be broken down by month and year. If you are still in the planning stage of your business, it may be helpful to estimate how much money will be needed each month until you reach profitability.

Typically, expenses for your business can be broken into a few basic categories:

Startup Costs

Startup costs are typically the first expenses you will incur when beginning an enterprise. These include legal fees, accounting expenses, and other costs associated with getting your business off the ground. The amount of money needed to start a engineering business varies based on many different variables, but below are a few different types of startup costs for a engineering business.

Running & Operating Costs

Running costs refer to ongoing expenses related directly with operating your business over time like electricity bills or salaries paid out each month. These types of expenses will vary greatly depending on multiple variables such as location, team size, utility costs, etc.

Marketing & Sales Expenses

You should include any costs associated with marketing and sales, such as advertising and promotions, website design or maintenance. Also, consider any additional expenses that may be incurred if you decide to launch a new product or service line. For example, if your engineering business has an existing website that needs an upgrade in order to sell more products or services, then this should be listed here.

7. Financial Plan & Projections

A financial plan is an important part of any business plan, as it outlines how the business will generate revenue and profit, and how it will use that profit to grow and sustain itself. To devise a financial plan for your engineering business, you will need to consider a number of factors, including your start-up costs, operating costs, projected revenue, and expenses. 

Here are some steps you can follow to devise a financial plan for your engineering business plan:

• Determine your start-up costs: This will include the cost of purchasing or leasing the space where you will operate your business, as well as the cost of buying or leasing any equipment or supplies that you need to start the business.
• Estimate your operating costs: Operating costs will include utilities, such as electricity, gas, and water, as well as labor costs for employees, if any, and the cost of purchasing any materials or supplies that you will need to run your business.
• Project your revenue: To project your revenue, you will need to consider the number of customers you expect to have and the average amount they will spend on each visit. You can use this information to estimate how much money you will make from selling your products or services.
• Estimate your expenses: In addition to your operating costs, you will need to consider other expenses, such as insurance, marketing, and maintenance. You will also need to set aside money for taxes and other fees.
• Create a budget: Once you have estimated your start-up costs, operating costs, revenue, and expenses, you can use this information to create a budget for your business. This will help you to see how much money you will need to start the business, and how much profit you can expect to make.
• Develop a plan for using your profit: Finally, you will need to decide how you will use your profit to grow and sustain your business. This might include investing in new equipment, expanding the business, or saving for a rainy day.

Frequently Asked Questions About Engineering Business Plans:

Why do you need a business plan for a engineering business.

A business plan is a document that outlines the goals and objectives of a business, as well as the strategies and tactics that will be used to achieve those goals. It is important to have a business plan for your engineering business because it helps to focus the efforts of the company, communicate the business's goals and objectives to potential investors, and provide a roadmap for the business to follow. Additionally, a business plan can be used to help secure funding from investors or lenders, who will want to see that the business has a solid plan in place before they provide funding.

How to write a business plan for your engineering business?)

To build a business plan for your engineering business, start by researching your industry, competitors, and target market. Use this information to define your business's goals and objectives, as well as the strategies and tactics that you will use to achieve those goals. Next, create a financial plan that outlines your projected income, expenses, and profit. This should include a projected income statement, cash flow statement, and balance sheet. Once you have all of this information, you can use it to create a comprehensive business plan that outlines the goals and objectives of your business, as well as the strategies and tactics that you will use to achieve those goals. A well-written engineering business plan contains the following sections: Purpose, Products & Services, Marketing Plan (including Marketing Strategy), Operations/Management Plan (including Operations/Management Strategy), Financial Plan (including Financial Forecasts), and Appendixes.

Can you write a engineering business plan yourself?

Yes, you can write a engineering business plan yourself. Writing a business plan is a valuable exercise that can help you clarify your business idea, identify potential challenges and opportunities, and develop a roadmap for success. While there are many resources and templates available to help you write a business plan, the process of creating one is ultimately up to you.

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I'm Nick, co-founder of newfoundr.com, dedicated to helping aspiring entrepreneurs succeed. As a small business owner with over five years of experience, I have garnered valuable knowledge and insights across a diverse range of industries. My passion for entrepreneurship drives me to share my expertise with aspiring entrepreneurs, empowering them to turn their business dreams into reality.

Through meticulous research and firsthand experience, I uncover the essential steps, software, tools, and costs associated with launching and maintaining a successful business. By demystifying the complexities of entrepreneurship, I provide the guidance and support needed for others to embark on their journey with confidence.

From assessing market viability and formulating business plans to selecting the right technology and navigating the financial landscape, I am dedicated to helping fellow entrepreneurs overcome challenges and unlock their full potential. As a steadfast advocate for small business success, my mission is to pave the way for a new generation of innovative and driven entrepreneurs who are ready to make their mark on the world.

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Healthcare and Medical Business Plan

JUL.15, 2013

A healthcare business plan is a document that outlines the strategies, goals, and financial targets of a healthcare venture. Writing a healthcare business plan helps you understand your market, competitors, and funding sources. It also guides your operations, marketing, and growth.

This article explains how to write a business plan in healthcare using an example. Refer to our medical practice business plan for tips and best practices to make your business plan professional and persuasive.

Healthcare Business Plan Example

To illustrate the process of writing a healthcare business plan, we will use Oaktree Family Health, a fictional family medical clinic based in San Francisco. This medical clinic will offer general and preventative healthcare services. For more services, please check our dentistry startup business plan .

The business plan for Oaktree Family Health comprises several essential components, which include:

• Executive summary
• Industry analysis
• Product offering
• Customer focus
• Management team
• Marketing plan
• Financial plan

We will outline each component and provide tips on how to write it effectively.

Healthcare Business Plan Executive Summary

Oaktree Family Health is a family medical clinic in San Francisco that offers quality and affordable healthcare for low to moderate-income people. We provide general and preventative healthcare services. We target the residents and workers in the San Francisco Bay Area who have limited access to healthcare due to various factors.

We are seeking $250,000 in funding to start and operate our clinic. We will use the funds for the following purposes:

• Lease and renovate a 2,000-square-foot facility
• Purchase medical equipment and supplies
• Hire and train four medical practitioners and four supporting staff
• Obtain licenses and permits
• Launch a website and social media accounts
• Conduct marketing and advertising campaigns

We expect to generate $1.2 million in revenue in the first year, with a net profit margin of 15%. Oaktree Family Health is an attractive business opportunity that benefits our investors and community. Refer to our wellness business plan for detailed coverage.

Industry Analysis

The healthcare and medical industry is experiencing significant growth, with various sectors contributing to its expansion. Some key statistics and growth rates include:

• The global healthcare market is projected to reach $665.37 billion by 2028. (Source – Insider Intelligence )
• Healthcare profit pools are estimated to grow at a 4 percent CAGR from $654 billion in 2021 to a larger amount in 2026. (Source – McKinsey )

The growth of the healthcare industry is driven by several factors, such as:

• Aging population
• Rising health awareness
• Technological innovation

The healthcare industry can be segmented into various categories:

• Physicians and clinics
• Home health care
• Others such as dental, optical, chiropractic, and alternative medicine. We have covered these in our business plans for pharmacy .

Advertising and Promotion in Healthcare Business Plans

The advertising and promotion section of your business plan for a healthcare startup shows how you market your services to your customers. It also tells your marketing effort goals, budget, and metrics. The advertising and promotion section should have these elements:

• Marketing goals
• Marketing budget
• Marketing mix
• Marketing metrics

Here is an example of an advertising and promotion section for Oaktree Family Health:

Oaktree Family Health’s Marketing Goals

• Increase brand awareness and recognition among low to moderate-income people in the San Francisco Bay Area who have limited access to healthcare by 50% in the first year.
• Generate at least 500 leads and 100 new customers per month in the first year, with a 20% conversion rate and an 80% retention rate.
• Boost sales and revenue by 25% in the first year, with a 15% net profit margin.

Oaktree Family Health’s Marketing Budget

Our budget for the first year is $50,000, which is 4% of the projected revenue. The initial investment and cash flow will fund the budget. We will use the budget as follows:

• Website development and maintenance: $10,000 (20%)
• Social media marketing: $10,000 (20%)
• Online advertising: $10,000 (20%)
• Offline advertising: $10,000 (20%)
• Public relations and events: $10,000 (20%)

Oaktree Family Health’s Marketing Mix

Our marketing mix consists of the following elements:

• Product – Oaktree Family Health provides general and preventive healthcare services like check-ups, minor surgeries, and gynecology. The services are affordable, accessible, and personalized, meeting the client’s needs and preferences. The services are delivered by well-trained and compassionate medical practitioners and staff, using advanced technology and equipment.
• Price – Oaktree Family Health charges reasonable fees and accepts cash, credit cards, and insurance. It also offers discounts and payment plans for eligible clients based on their income and health. The pricing strategy is value-based, which reflects the value and benefits of the services, as well as the costs and risks of providing them.
• Place – Oaktree Family Health operates from a 2,000-square-foot facility in San Francisco. The facility is close to public transportation, schools, and community centers. It has ample parking space and a modern and comfortable environment.
• Website: Professional, user-friendly site with info on services, prices, location, contact details
• Social media: Active accounts on Facebook, Twitter, and Instagram
• Online advertising: Google, Facebook, Yelp, Instagram ads
• Offline advertising: Newspapers, magazines, radio, flyers
• Public relations and events: Press releases, interviews, health fairs, workshops, seminars

Oaktree Family Health’s Marketing Metrics

Our marketing metrics consist of the following indicators and methods:

• Website Traffic – Measured with Google Analytics to evaluate performance
• Conversion Rate – Calculated and optimized with Google Analytics
• Customer Satisfaction – Measured via surveys, reviews, ratings, testimonials
• Sales and Revenue – Tracked with accounting software and financial statements

OGSCapital for your Healthcare Business Plan

The experienced business planning advisors at OGSCapital offer end-to-end support for healthcare enterprises needing to create an effective business plan. Our knowledgeable team works hand-in-hand with clients to grasp your healthcare business vision, targets, and necessities. With OGSCapital’s customized guidance, healthcare organizations receive skilled assistance through every step of crafting a business plan—from initial research to final presentation.

We have helped thousands of entrepreneurs and businesses across various industries and regions to achieve their goals and dreams, and we can do the same for you. Whether you start a new healthcare business, expand an existing one, or seek funding or partnership, we can help you create a business plan for healthcare services to impress and persuade your target audience.

Frequently Asked Questions

1. What are the components found in a business plan?

The key components of a medical-related business plan are an executive summary, company description, market analysis, organization and management plan, products or services, marketing and sales strategy, financial projections, and an appendix. Refer to our medical transportation business plan to learn more.

2. Can I write a business plan myself?

Yes, you can write a business plan for a healthcare organization yourself. However, we recommend consulting experts like OGSCapital or using business plan templates like the industrial hemp business plan to ensure you cover all crucial information.

Download Medical Business Plan Sample in pdf

OGSCapital’s team has assisted thousands of entrepreneurs with top-rate business plan development, consultancy and analysis. They’ve helped thousands of SME owners secure more than $1.5 billion in funding, and they can do the same for you.

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100 Best universities for Mechanical Engineering in Russia

Updated: February 29, 2024

• Art & Design
• Computer Science
• Engineering
• Environmental Science
• Liberal Arts & Social Sciences
• Mathematics

Below is a list of best universities in Russia ranked based on their research performance in Mechanical Engineering. A graph of 714K citations received by 136K academic papers made by 158 universities in Russia was used to calculate publications' ratings, which then were adjusted for release dates and added to final scores.

We don't distinguish between undergraduate and graduate programs nor do we adjust for current majors offered. You can find information about granted degrees on a university page but always double-check with the university website.

1. Moscow State University

For Mechanical Engineering

2. Tomsk State University

3. St. Petersburg State University

4. Bauman Moscow State Technical University

5. Ufa State Aviation Technical University

6. Peter the Great St.Petersburg Polytechnic University

7. Tomsk Polytechnic University

8. Ural Federal University

9. South Ural State University

10. National Research University Higher School of Economics

11. Moscow Aviation Institute

12. Novosibirsk State University

13. ITMO University

14. N.R.U. Moscow Power Engineering Institute

15. National Research Nuclear University MEPI

16. Kazan Federal University

17. National University of Science and Technology "MISIS"

18. Moscow Institute of Physics and Technology

19. Samara National Research University

20. Moscow State Technological University "Stankin"

21. Novosibirsk State Technical University

22. RUDN University

23. Southern Federal University

24. Saratov State University

25. Ufa State Petroleum Technological University

26. Samara State Technical University

27. Siberian Federal University

28. Kazan National Research Technical University named after A.N. Tupolev - KAI

29. Perm State Technical University

30. Omsk State Technical University

31. Saint Petersburg State Electrotechnical University

32. Moscow Polytech

33. Saint-Petersburg Mining University

34. Magnitogorsk State Technical University

35. Saratov State Technical University

36. Moscow State University of Railway Engineering

37. Lobachevsky State University of Nizhni Novgorod

38. Nizhny Novgorod State Technical University

39. Tula State University

40. Belgorod State Technological University

41. Far Eastern Federal University

42. Novgorod State University

43. belgorod state university.

44. Finance Academy under the Government of the Russian Federation

45. Moscow Medical Academy

46. Kazan State Technological University

47. Russian State University of Oil and Gas

48. siberian state aerospace university.

49. Tambov State Technical University

50. Voronezh State University

51. Siberian State Industrial University

52. Saint Petersburg State Institute of Technology

53. Kalashnikov Izhevsk State Technical University

54. St. Petersburg State University of Architecture and Civil Engineering

55. Mendeleev University of Chemical Technology of Russia

56. Murmansk State Technical University

57. South-Western State University

58. Ogarev Mordovia State University

59. Tomsk State University of Control Systems and Radioelectronics

60. south-russian state university of economics and service.

61. Perm State University

62. Kuzbass State Technical University

63. Russian National Research Medical University

64. Plekhanov Russian University of Economics

65. Ulyanovsk State Technical University

66. Ulyanovsk State University

67. Penza State University

68. Kuban State University of Technology

69. Polzunov Altai State Technical University

70. Chelyabinsk State University

71. Yaroslavl State University

72. University of Tyumen

73. National Research University of Electronic Technology

74. Leningrad State University

75. Moscow State Pedagogical University

76. Udmurt State University

77. Irkutsk State University

78. North-Eastern Federal University

79. Bashkir State University

80. Russian Presidential Academy of National Economy and Public Administration

81. Kuban State University

82. Kuban State Agricultural University

83. St. Petersburg State University of Aerospace Instrumentation

84. Kemerovo State University

85. Immanuel Kant Baltic Federal University

86. Orenburg State University

87. Baltic State Technical University "Voenmeh"

88. Tomsk State University of Architecture and Building

89. Chuvash State University

90. ivanovo state power university.

91. Irkutsk National Research Technical University

92. Orel State University

93. State University of Management

94. Tomsk State Pedagogical University

95. Volgograd State University

96. Petrozavodsk State University

97. Tver State University

98. Northern Arctic Federal University

99. Omsk State Transport University

100. Kaliningrad State Technical University

The best cities to study Mechanical Engineering in Russia based on the number of universities and their ranks are Moscow , Tomsk , Saint Petersburg , and Ufa .

Engineering subfields in Russia

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Best Global Universities for Mechanical Engineering in Russia

These are the top universities in Russia for mechanical engineering, based on their reputation and research in the field. Read the methodology »

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Here are the best global universities for mechanical engineering in Russia

Tomsk polytechnic university.

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• # 74 in Best Universities for Mechanical Engineering
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How to Write a Business Plan for an Outpatient Medical Practice

Noah Parsons

16 min. read

Updated February 7, 2024

Free Download:  Sample Medical Practice Business Plan Template

So you’re thinking about starting your own outpatient medical practice.

You probably have many good reasons to open a private practice. Private practices can be lucrative, although it requires you to spend time building relationships with patients while also attending to all business processes that are part of running your practice .

Maybe you want more autonomy over your practice and your workflow. Or maybe you hope to expand your services to underserved areas or specific populations based on your expertise.

If you’re thinking about starting an outpatient medical practice, one of the first things you should do is write a business plan. Even if you’re able to self-fund your practice and don’t need outside investment, your business plan is a great tool for thinking through all the different aspects of building a profitable and sustainable practice.

You should go into this thinking about your business plan as a living document, not something you do once and then file away forever. Use it as a tool, especially around your financials. Revisit and update it regularly by comparing your forecasts to your actuals and adjusting as necessary.

To help you get started, you can download our free business plan template . If you’ve never written a business plan before, Bplans also offers a library of sample medical business plans that you can review or even download to use as a model.

• Executive summary

The first section that will appear in your business plan is the executive summary . But before you dive right in, it’s the section of your plan that you should actually write last. It’s a summary and an overview of your outpatient medical practice and your plans, so it will be easy to put together after you’ve written the rest of your plan.  

Executive summaries are short—keep it to one to two pages. Keep in mind that if you’re using your plan to get funding, investors and banks tend to read your executive summary to get a sense of whether to read on and consider your request. Do not neglect it; just write it last.

Your executive summary will include the following sections:

• Who you are: Your business name, location, and contact information.  
• What you offer and the problem your business solves: What does your practice offer and why is it needed? This is your value proposition .
• Target market: Who is your ideal patient? Do they self-pay or use insurance? Be specific.
• Competition: Who else is offering similar services?
• Team: Who is on your management team?
• Financial summary: Explain your business model, startup costs, revenues, and liabilities to the company. Mention your funding needs.
• Milestones and traction: How have you validated that there’s a need for your practice in your location?

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Position your practice’s business opportunity

Now that you’re familiar with what’s included in your executive summary, tuck that information away, and get to work on the rest of your plan.

Think of the next few sections of your plan as the overarching description of your practice’s business opportunity. You’ll cover the problem you’ve identified and the solution that your practice offers. Then you’ll think through your ideal customer , your competition , and your opportunities for growth . This section area should describe the services you provide and how they benefit your patients.

• Problem and solution

First, describe the problem that you’ve identified and how your practice solves that problem. Here’s a brief example:

The problem : There is a lack of affordable pediatric and gynecological care available in coastal areas of Lane County, Oregon. Many patients have to travel miles to the closest practice.  

The solution : Dr. Gardner plans to open Ocean Lane Outpatient Care to serve smaller Oregon coastal communities scattered outside of major towns with major hospitals. Due to her focus on pediatric and gynecological care, Dr. Gardner’s particular services are especially valuable in this location due to the lack of available service providers in the area. Dr. Gardner’s practice will accept private insurance and Medicaid, as well as a sliding scale for patients in a certain income bracket.   

The services section identifies what kind of medical practice you are opening. Restate who your practice serves and what kind of services you specialize in. Talk about how your practice approaches treatment and what goals you have in addition to providing quality care. Here’s an example from a sample business plan for a medical practice.

Include a breakdown of all services furnished by the clinic, being as granular as possible. For example:

Gynecology:

• Annual women’s wellness exam

Pediatrics:

• Immunizations
• Youth eating disorder treatment
• Target market

Next, talk about your ideal patients. If you’re in the earliest stages, you’ll want to do some research that verifies your hypotheses.

For example, Dr. Gardner would have needed to verify her assumption that people in coastal towns in Oregon are in need of pediatric and gynecological services—a need that isn’t currently satisfied by available resources.

A formal market analysis can help verify that there’s a need for your particular practice in your intended location.  

Your target market section should include:

• TAM, SAM, and SOM: Total Available Market (TAM), Segment of the Available Market (SAM), Share of the Market (SOM). Here, you are looking at the difference between targeting everyone: TAM (all people who need medical care—so all humans in your area), versus your ideal clients: SAM (maybe this is those with certain insurance or ability to self-pay), versus the number of new patients you think you can realistically reach: SOM, especially within your first few years. The idea is that not everyone will be an ideal patient. It matters because you can waste a lot of money with marketing outreach to everyone, instead of targeting a specific population that is more likely to be looking for your services.
• Buyer persona : Imagine there’s one specific patient who represents your ideal patient. Be specific. Maybe she’s 34 years old, has private insurance, is relatively healthy, but needs more regular medical care and advice.  
• Competition and competition matrix : List competitors and analyze what makes them competitive. For instance, your competitors might be large hospitals because of the wide range of services they offer. You might also be competing with local chiropractors or other alternative medicine practices that already have a foothold in local communities.
• Future products and services : Name the products/services you will offer as your practice grows and earns more money and as your patients develop new needs. Maybe you will want to open a second location when you gain enough patients. Or maybe you will want to extend your practice’s hours of operation.

Ideal patient profile

Your ideal patient profile identifies the type of patient whom you hope to attract and retain. To clarify, this does not mean you only serve your ideal patient type. Rather, focusing your outreach efforts on attracting your ideal patient will allow you to grow your practice more effectively than targeting a large number of patients who may or may not be in the market for your practice’s specialty.

When developing your ideal patient profile, consider:

• Who you enjoy working with
• Who needs the services you provide
• Who can and will pay your pricing (or have an insurance plan that you want to accept)

For instance, because Dr. Gardner specializes in preventive and curative care, a patient seeking palliative treatment for terminal cancer is not the ideal patient. This patient would not receive the best care for their needs from Dr. Gardner’s services.

Acquiring a new patient is six to seven times more expensive than retaining a current patient. In order to support and retain current patients, develop a strategy to proactively meet their needs and set benchmarks to measure the success of your strategy.

• Execution: How your practice will respond to the opportunity

First, your business plan laid out the opportunity at hand. Now, the rest of your plan will focus on how to take advantage of that opportunity. Now is the time to lay out what you’ll do to attract patients and set up a viable business model with healthy financials.

Components of this section include:

• Your marketing and sales plan
• Strategic partnerships or alliances
• Your operations plan
• Your team and company information
• Financial plan
• Milestones and metrics that you’ll need to hit to be viable
• Your key assumptions and risks
• Your funding ask and exit strategy, if applicable
• Marketing and sales plan

The marketing and sales component of your plan should include how you plan to reach the patients in your target market, how you’ll bill for your services, and what you need to do to bring in the right number and type of patients.

• Positioning : Describe how you will present your company to your customers with your positioning statement . Think about answering these questions: What are you offering your patients that they can’t get elsewhere? Why should they pick you instead of another practice? Where do you see yourself in the competitive landscape? Use this model to help:

“For [target market description] who [target market need], [how our business offering meets the need]. Unlike [key competition], it [most distinguishing feature].”

For [coastal community members] who [require gynecological care], Ocean Lane Outpatient Care [provides both pediatric and women’s health services]. Unlike [other area medical practices], Ocean Lane Outpatient Care is [conveniently located near the communities it serves and can fill the gap between pure pediatric care and full-blown adult care for young women].

• Pricing and billing : Medical pricing is complex, especially if you plan to work with insurance companies. Practice Builders says that “a 10 percent increase in pricing can result in a much better return than a 10 percent reduction in costs—or even a 10 percent increase in patient volume.”

Make sure you price your services at what they are worth and explain your pricing to your patients. Consider the demographics your practice serves when you choose your pricing. Research other practices in the area and learn more   about how you can choose the best prices for your patients and your practice.Also, consider how you will get patients to keep coming back to your practice. Sometimes you can increase sales by upselling and cross-selling , or offering complementary services.

If you accept insurance, the contracts you set up with insurance companies for reimbursement will probably dictate your pricing, so this is a good place to talk about your negotiation strategy as well.

• Update your website and social media frequently and ensure your website is mobile-friendly and share-friendly with credible links added.
• Make sure all communications with and about patients are HIPAA-compliant . Download a HIPAA Compliance Guide to ensure you are following regulations.
• Maintain a positive online reputation for your practice as a key management technique. You can do this by claiming your profile on any third-party sites that list it. Encourage your patients to review you online, too.
• Strategic alliances : List any people or organizations with whom you are working. You will most likely need to partner with a regional lab for medical testing. Opening an on-site lab can be costly for a smaller practice. You will most likely need to partner with a nearby hospital as part of a referral system or to share select services and equipment.

The operations section of your business plan covers how your business works, from the logistics to the technology.

• Technology: Describe how your technology works, but do not go into too much detail. Investors can ask for more information if they want to. Will you rent or buy equipment ? The technology you need ranges from simple items like thermometers to more complex items like centrifuges.
• Billing and information storage: Provide a brief overview of how you will manage information technology and patient records to promote safety, efficiency, and compliance with HIPPA  regulations and industry standards. Explain your usage of Electronic Medical Record (EMR) software in this section.
• Payment types you accept: Consider payment types such as private pay, private insurance, Medicaid/Medicare, etc. What kind of referrals can you offer to the uninsured or those who cannot afford your services?
• Milestones and metrics

In this part of your plan, you set measurable, achievable milestones, such as the number of new patients added per month in the first year of operations. Milestones can be about any aspect of your medical practice as long as they emphasize growth. For metrics , decide which numbers to check regularly to track your company’s health. This area should also include information about traction (past successes) and risks:

• Traction: Look back at major milestones you have achieved. Hopefully, they demonstrate that your business model works and that you are filling a need for your market. If you’re looking to attract private funders, this section is important since it shows your initial success .
• Key assumptions and risks : Acknowledge the assumptions you are basing your business on. Set out to prove them right if you can. Also, discuss risks so that investors know you have considered what could go wrong and that you have a plan for dealing with challenges. Malpractice suits and changing healthcare regulations are risks specific to the healthcare field. Malpractice insurance is a must for addressing the former. Changing healthcare regulations can affect the volume of patients who are able to afford your services.

Your team can be more important than your product or service. Describe your team here, even if it is just you and a receptionist who answers the phone in your office building.

• Management team and qualifications: Address who works for you, what do they do, and how much you pay them. Compile the details of their relevant experience and education.
• Hiring plans : Outline who, if anyone, you need to hire to fill skills gaps in your management team and how much you plan to pay them.
• Company overview

The company overview tells about who you and your staff are and appeals to potential investors. Keep it short—it should be the shortest chapter of your business plan but is still very important.

It needs to include these elements:

• Mission statement : Your mission statement articulates your goals for what your company does for its customers, employees, and owners. It will read something like this: “Our mission is to provide X (services) for Y (customers) by Z (methods).” For instance, Ocean Lane Outpatient Care is dedicated to providing quality care for all the inhabitants of coastal Lane County by providing affordable and versatile services.”
• Intellectual property : List any patents you have or have pending, and mention any core technology you are licensing from another company.
• Legal structure and ownership : Explain your business structure and who owns how much of it. More on considerations for physicians and legal structure here.
• Business location : Describe the company’s location and any facilities it owns.
• Company history if it’s an existing company

Having a solid financial plan is critical, whether you’re seeking funding or not.  A typical financial plan includes projections by month for the first year and annual projection for the next three to five.

Include these key elements:

• Profit and loss statement : this explains how your business made a profit or incurred a loss in a given amount of time (typically three months) by listing all revenue and expenses, then documenting the total amount of net profit or loss.
• Cash flow statement: documentation of how much cash the business brought in, how much it paid out, and the amount of its ending cash balance (on a monthly basis).
• Balance sheet : snapshots how your company is performing at a given moment by including how much money you have in the bank, how much your customers owe you, and how much you owe your vendors.
• Sales forecast : projections of what you think you will sell in a given timeframe (one to three years).
• Business ratios : Comparisons of your company’s financials with numbers from the industry profile.
• Keep it brief. For example, Dr. Gardner will employ administrative aides and nurses.
• Use of funds : Needed if you’re seeking investment or a loan. This section explains how you will use investors’ money.
• Exit strategy : You only need this if you’re seeking outside investment. An exit strategy is a method by which entrepreneurs and investors, especially those that have invested large sums of money, transfer ownership of their business to a third party to recoup money invested in the business. Common exit strategies include being acquired by another company, the sale of equity, or a management or employee buyout.

When writing your financial plan, make sure to consider startup costs . For a medical practice, average startup costs can include initial fees, malpractice insurance, cost of renting or leasing office space, and the cost of any legal or tax advisors.

Consider submitting your plan to at least five to 10 banks if you need help financing your startup costs. Many banks have divisions designated to providing loans to new dental and medical practices , so submit your plan to that division if you can. Startup costs can be high in the medical field, so make sure not to underestimate them.

Finally, your appendix is the holder for any supporting information such as charts, images, graphs, and more. If you need to include large sets of data or pages of information, put it here. That way, it is available but does not distract from the plan’s most important pieces.

For instance, you can expand on your personnel plan with charts of each employee’s annual insurance costs. You can also include versions of your profit and loss statements and other financials that extend further into the future.

Don’t forget to go back to your executive summary! Remember to keep it brief and write it based on what you have written already.

When you’re ready to write your business plan, there are an array of resources available to you. Download our free business startup checklist to think about the next steps. Also, check out our free business plan template . Reviewing sample business plans in the medical field can help you get a better sense of the process and information you’ll provide. Downloading this plan for a family medicine clinic will probably be most helpful if you’re setting up a primary care practice.

Remember that this plan is a living document. Schedule a regular business plan review meeting. You should review your trajectory and compare your financial projections to your actuals frequently to keep your practice on track.

See why 1.2 million entrepreneurs have written their business plans with LivePlan

Noah is the COO at Palo Alto Software, makers of the online business plan app LivePlan. He started his career at Yahoo! and then helped start the user review site Epinions.com. From there he started a software distribution business in the UK before coming to Palo Alto Software to run the marketing and product teams.

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South Korea's Yoon vows not to back down in the face of doctors' strike over medical school plan

Hyung-Jin Kim

Associated Press

Copyright 2024 The Associated Press. All rights reserved.

People watch a TV screen showing the live broadcast of South Korean President Yoon Suk Yeols addressing the nation at the Seoul Railway Station in Seoul, South Korea, Monday, April 1, 2024. President Yoon vowed Monday not to back down in the face of vehement protests by doctors seeking to spike his plan to drastically increase medical school admissions, as he called their walkouts an illegal collective action that poses "a grave threat to our society. (AP Photo/Ahn Young-joon)

SEOUL – South Korea’s president vowed Monday not to back down in the face of vehement protests by doctors seeking to derail his plan to drastically increase medical school admissions, as he called their walkouts “an illegal collective action” that poses "a grave threat to our society.”

About 12,000 medical interns and residents in South Korea have been on strike for six weeks, causing hundreds of cancelled surgeries and other treatments at university hospitals. In support of their action, many senior doctors at their teaching schools have also submitted resignations though they haven’t stopped treating patients.

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Officials say they want to raise the yearly medical school cap by 2,000 from the current 3,058 to create more doctors to deal with the country’s rapidly aging population. Doctors counter that schools can’t handle such an abrupt increase in students and that it would eventually hurt the country’s medical services. But critics say doctors, one of the best-paid professions in South Korea, are simply worried that the supply of more doctors would result in lower future incomes.

Public surveys show that a majority of ordinary South Koreans support the government plan. But observers say many people are increasingly fed up with the protracted confrontation between the government and doctors, threatening to deal a blow to governing party candidates ahead of next week’s parliamentary elections.

In a nationally televised address, President Yoon Suk Yeol said adding 2,000 medical students is the minimum increase needed to address a shortage of physicians in rural areas, the military and essential but low-paying professions like pediatrics and emergency departments. Yoon said South Korea's doctor-to-patient ratio — 2.1 physicians per 1,000 people — is far below the average of 3.7 in the developed world.

“Increasing the number of doctors is a state project that we can't further delay,” Yoon said.

Yoon urged the striking doctors to return to work, saying they have a responsibility to protect people's lives in line with the local medical law. He also said the government remains open to talks if doctors come up with a unified proposal that adequately explains their calls for a much smaller increase in the medical school enrollment quota.

“I can't tolerate an attempt to carry through their thoughts by force without due logic and grounds,” Yoon said. “The illegal collective action by some doctors has become a grave threat to our society.”

Yoon said the recruitment plan won't lead to lower earnings for doctors, citing what he called expected increases in national income and demand for medical services in the fast-aging society. He said the average income of South Korean doctors is the highest in the developed world.

Later Monday, the Korean Medical Association , which represents doctors in South Korea, criticized Yoon for repeating what his government has already argued to support the recruitment plan.

"It was an address that brought us greater disappointment because we had high hopes” for some changes in the government's position, Kim Sung-geun, a spokesperson for KMA’s emergency committee, told reporters.

Yoon said the government is taking final administrative steps to suspend the licenses of the strikers but added he doesn't want to punish the young doctors. This implies that his government is willing to soften punitive measures on the strikers if they return to work soon.

Yoon recently ordered officials to pursue “a flexible measure” to resolve the dispute and seek constructive consultations with doctors at the request of ruling party leader Han Dong-hoon.

It's unclear if the government and doctors can find a breakthrough to settle their standoff anytime soon. Last week, KMA elected Lim Hyun-taek, a hardliner who has called for a decrease in the medical school admission cap, as its new chief.

After his election Tuesday, Lim said that doctors can sit down for talks with the government if Yoon apologizes and dismisses top health officials involved in the recruitment plan. Lim also threatened to launch an all-out fight if any doctors receive punitive steps over their recent protests.

The striking junior doctors represent a fraction of the total doctors in South Korea — estimated at 115,000 by Yoon and 140,000 by a doctors' association. But in some major hospitals, they account for about 30% to 40% of doctors, assisting qualified doctors and department chiefs during surgeries and other treatments while training.

Doctors say the government enrollment plan lacks measures to resolve key medical issues such as how to increase the number of physicians in some key but unpopular professions. They say newly recruited students would also try to work in the capital region and in high-paying fields like plastic surgery and dermatology. They say the government plan would also likely result in doctors performing unnecessary treatments due to increased competition.

Copyright 2024 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.

Local 10 News @ 11PM : Apr 03, 2024

Local 10 news @ 6pm : apr 03, 2024, local 10 news @ 5pm : apr 03, 2024, joe biden and bernie sanders collaborate to lower health care costs, local 10 news @ 4pm : apr 03, 2024.

$3 Million Gift Funds New Scholarships for Working Students at the University of Houston

• University and Campus

A new, $3 million gift will help reinforce the University of Houston’s long-standing mission to provide students with a world-class education and ensure they are given every opportunity to succeed in and out of the classroom.

The Houston Works Scholarship Fund will provide scholarship support to working junior and senior students in select majors at the C.T. Bauer College of Business, all majors at the Cullen College of Engineering and select majors in the Technology Division.

“It is no secret that the University of Houston is home to hard working students, and that goes double for those Cougars holding down full-time jobs while taking classes,” said Diane Chase, senior vice president for academic affairs and provost at UH. “This generous gift will provide support for many of our Coogs balancing school with professional obligations. Beyond its impact at UH, it will bolster our region by helping future leaders focus on their studies and prepare to make an impact within their respective communities.”

The generous gift is a significant step in the University’s larger effort to raise $300 million for scholarships.

“Scholarships are more than financial support; they are a testament to the belief in our students' potential,” said Eloise Brice, vice president for advancement and alumni at UH. “By supporting working students, this generous gift reaffirms our commitment to their success and creates a legacy that honors the University’s core values of hard work and commitment."

Funded by an anonymous donor, the scholarship award for full-time students who work at least 20 hours per week will be $4,000 per academic semester, or a maximum annual award of $8,000.

"This generous gift helps to ensure that Bauer College undergraduate students have their opportunity to continue their education and further pursue their goals of graduation, job placement and career success," Dean Paul A. Pavlou said. "These scholarships will reduce students' financial burden and allow them to take advantage of all the experiential learning opportunities available at Bauer College, where The Future Is Our Business!"

The Houston Works Scholarship Fund aims to empower working students to achieve their academic and career goals. Donations to the fund, which will be matched dollar-for-dollar up to $1 million, will make a lasting impact on the lives of students and contribute to the development of a skilled and educated workforce, further strengthening our community and society.

"Thanks to this gift, our students are not just learning, they are innovating, leading, creating, exploring and discovering,” said Pradeep Sharma, interim dean of the Cullen College of Engineering. “This gift will allow the College to continue graduating talented students to meet the needs of the industry."

Recipients of the scholarship awards will be determined by the Office of Scholarship and Financial Aid based on students’ applications and working hours. Students must be pursuing a degree in one or more of the following majors: 

• All engineering majors in the Cullen College of Engineering
• Supply Chain Management
• Management Information Systems
• Mechanical Engineering Technology
• Electrical Power Engineering Technology
• Construction Management
• Computer Information Systems
• Computer Engineering Technology
• Supply Chain and Logistics Technology

Students can apply now through the  UH Scholarship Universe portal  for awards in the Fall 2024/Spring 2025 academic calendar. For more information, contact the Office of Scholarship and Financial Aid.

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4 Things You Need to Know About Health Care Cyberattacks

Despite the explosion in ransomware hacks like the one against Change Healthcare, regulation is spotty and few new safeguards have been proposed to protect patient data, vulnerable hospitals and medical groups.

By Reed Abelson and Margot Sanger-Katz

The recent cyberattack on the billing and payment colossus Change Healthcare revealed just how serious the vulnerabilities are throughout the U.S. health care system, and alerted industry leaders and policymakers to the urgent need for better digital security.

Hospitals, health insurers, physician clinics and others in the industry have increasingly been the targets of significant hacks, culminating in the assault on Change, a unit of the giant UnitedHealth Group, on Feb. 21.

The ransomware attack on the nation’s largest clearinghouse, which handles a third of all patient records, had widespread effects. Fixes and workarounds have alleviated some distress, but providers are still unable to collect billions of dollars in payments. Many smaller hospitals and medical offices are still having trouble getting paid more than a month after Change was first forced to shut down many of its systems.

Even now, very little information about the exact nature and scope of the attack has been disclosed. UnitedHealth said that it had advanced more than $3 billion to struggling providers, and that it expected more of Change’s services to be available in the coming weeks as it brought the systems back online.

The F.B.I. and the Department of Health and Human Services are investigating the Change hack, including whether patients’ records and personal information have been compromised. Because Change’s network acts as a digital switchboard that connects information from a patient’s first doctor visit to a diagnosis like cancer or depression and then subsequent treatment to a health insurer for benefits and payments, there is a risk that people’s medical history could be exposed for years.

The attack on Change is just the most far-reaching example of what has become nearly commonplace in the health care industry. Ransomware attacks, in which criminals shut down computer systems unless the owners pay the hackers, affected 46 hospital systems last year , up from 25 in 2022, according to the data security firm Emsisoft. Hackers have also taken down companies that provide services such as medical transcription and billing in recent years.

How big is the problem?

Cybersecurity consultants and government officials have consistently identified health care as the sector of the U.S. economy most susceptible to attacks, and as much a part of the nation’s critical infrastructure as energy and water.

“We should all be terrified,” said D.J. Patil, the head of technology at the insurance company Devoted Health and the former chief data scientist of the federal Office of Science and Technology Policy. He and others emphasized the inadequate protections in U.S. health systems, despite dramatic events such as the 2017 ransomware attack that locked up medical records at the National Health Service in Britain, leading to massive disruption for patients.

“The entire sector is severely under-resourced when it comes to cybersecurity and information security,” said Errol Weiss, chief security officer for the Health Information Sharing and Analysis Center, which he described as a virtual neighborhood watch for the industry.

The Change attack has drawn a lot more government attention to the problem. The White House and federal agencies have held several meetings with industry officials. Congressional lawmakers have also begun inquiries, and senators have summoned UnitedHealth’s chief executive, Andrew Witty, to testify this spring.

The financial sector has worked to identify and fortify vulnerable areas to make it less prone to systemic attacks. But “health care has not gone through a mapping exercise to understand” exactly where the major choke points are that are at risk for hacks, said Erik Decker, the chief information security officer for Intermountain Health, a major regional health system headquartered in Salt Lake City.

“We have a lesson learned — we need to do that,” said Mr. Decker, who also serves as chairman of a private-sector working group on cybersecurity in health care that advises the federal government.

Wall Street and the nation’s banking system have had strong financial incentives to fortify their defenses because a hacker could steal their money, and the sector faces tougher government regulation.

Health care hacks can have deadly consequences.

Studies have shown that hospital mortality rises in the aftermath of an attack. Doctors are unable to look up past medical care, communicate notes to colleagues or check patient allergies, for example.

Scheduled surgeries are canceled, and ambulances are sometimes rerouted to other hospitals even in emergencies because the cyberattack has disrupted electronic communications or medical records and other systems. Research suggests that hacks have a cascading effect, lowering the quality of care at nearby hospitals forced to take on additional patients.

“Cybersecurity has become a patient safety issue,” said Steve Cagle, the chief executive of Clearwater, a health care compliance firm.

In some cases, hackers have made sensitive patient health data public. Lehigh Valley Health Network refused to pay a ransom that was demanded by the same entity suspects of the attack on Change Healthcare. The hackers then posted online nude photographs of patients receiving treatment for breast cancer, according to a lawsuit brought by one of the victims. Hundreds of patients’ photographs were stolen.

Why is the health care industry a target?

Medical records can command multiple times the amount of money that a stolen credit card does. And unlike a credit card, which can be quickly canceled, a person’s medical information cannot be changed.

“We can’t cancel your diagnosis and send you a new one,” said John Riggi, national adviser for cybersecurity and risk for the American Hospital Association, a trade group.

But he also said the records had value “because it’s easy to commit health care fraud.” Health insurers, unlike banks, often don’t employ elaborate methods to detect fraud, making it easy to submit false claims.

People worried about stolen social security numbers and other financial information can sign up for a credit-monitoring agency, but patients have little recourse if their personal health information is stolen.

Hospital networks and other health care groups have also been quick to pay ransoms to try to limit exposure for patients, a decision that only rewards and encourages hackers. The F.B.I. advises targets of ransomware attacks not to pay, but most hospitals do because the stakes are so high. In the case of Change Healthcare, the company is said to have paid a $22 million ransom, according to reporting by Wired .

Why aren’t hospitals and doctors doing more?

Despite the risk, smaller hospitals and doctors’ practices often don’t have the money to pay for enhanced security measures or the expertise to examine serious threats.

And older technology is rarely compatible with the latest cybersecurity standards; a hodgepodge of connected products and vendors leaves digital side doors open, luring hackers. Because hacks had largely been aimed at individual hospital systems before Change was hobbled, groups underestimated their risk.

Jacki Monson, a senior vice president of Sutter Health and the chair of the National Committee on Vital and Health Statistics, said, “People have to decide what they’re going to invest in, and cybersecurity is not usually the top of the list.”

What is the government’s response?

The regulatory framework is also old and fragmented. Hospitals are allowed to select among a range of security standards, and there is no advance auditing of compliance.

Digital security is divided among different offices within H.H.S., and much of the agency’s regulatory power still relies on a 1996 law, written before the development of modern digital health systems or the rise of ransomware hacking. The government’s regulatory focus has been on privacy and compliance rather than fortifying against attacks.

The regulation of insurer data security is even more spotty, since health insurers are largely regulated at the state level. Many vendors like Change, which provide digital services to hospitals but are not health care providers themselves, can also slip through regulatory cracks, Ms. Monson said.

That may change. The Biden administration is calling for H.H.S. to ensure that hospitals have adequate protections. The administration is also considering revisions to the regulations about how health data is shared, and may impose clearer rules for digital security measures for hospitals.

Senator Ron Wyden of Oregon, the Democratic chairman of the Senate Finance Committee, has signaled an interest in establishing tougher new rules.

“Today, there are no federal mandatory technical cybersecurity standards for the health care industry, even though people have been talking about it for ages, something like decades,” he said during a recent hearing on the president’s budget. “I want to be clear: That needs to change now.”

Updating systems across the board may be expensive, particularly for smaller organizations operating on tight budgets. When the government required hospitals to meet cybersecurity standards to set up electronic health records 20 years ago, it paired strict rules with major financial incentives.

The Biden administration has asked for an initial $800 million to help improve hospital systems as part of its recent budget proposal. But it is not clear whether Congress will be able or willing to provide funding for modernization today.

And some hospitals will continue to spend money on the latest M.R.I. technology or more nurses over stringent digital protections.

“Without additional resources to raise the bar, those health care providers and those health care payers are going to continue to make choices to pay for treatment or for cybersecurity,” said Iliana Peters, a former federal health official specializing in data security who is now a lawyer at Polsinelli, a law firm in Washington, D.C.

Reed Abelson covers the business of health care, focusing on how financial incentives are affecting the delivery of care, from the costs to consumers to the profits to providers. More about Reed Abelson

Margot Sanger-Katz is a reporter covering health care policy and public health for the Upshot section of The Times. More about Margot Sanger-Katz