How to open a medical device manufacturer?
There's no doubt that starting a medical device manufacturing business requires a lot of work, but with expert planning, you'll be well on your way to creating a profitable business venture.
This guide will give you a low down on all of the major steps involved, from choosing a legal structure to creating a financial forecast and registering your business.
We will also walk you through the process of checking whether or not your idea can be viable given market conditions.
Let's embark on this exciting journey together!
What is the business model of a medical device manufacturing business?
Before thinking about starting a medical device manufacturing business, you'll need to have a solid understanding of its business model (how it generates profits) and how the business operates on a daily basis.
Doing so will help you decide whether or not this is the right business idea for you, given your skillset, personal savings, and lifestyle choices.
Looking at the business model in detail will also enable you to form an initial view of the potential for growth and profitability, and to check that it matches your level of ambition.
The easiest ways to acquire insights into how a medical device manufacturing business works are to:
- Speak with medical device manufacturing business owners
- Undertake work experience with a successful medical device manufacturing business
- Participate in a training course
Speak with medical device manufacturing business owners
Talking to seasoned entrepreneurs who have also set up a medical device manufacturing business will enable you to gain practical advice based on their experience and hindsight.
Learning from others' mistakes not only saves you time and money, but also enhances the likelihood of your venture becoming a financial success.
Undertake work experience with a successful medical device manufacturing business
Gaining hands-on experience in a medical device manufacturing business provides insights into the day-to-day operations, and challenges specific to the activity.
This firsthand knowledge is crucial for effective planning and management if you decide to start your own medical device manufacturing business.
You'll also realise if the working hours suit your lifestyle. For many entrepreneurs, this can be a "make or break" situation, especially if they have children to look after.
First-hand experience will not only ensure that this is the right business opportunity for you, but will also enable you to meet valuable contacts and gain a better understanding of customer expectations and key success factors which will likely prove advantageous when launching your own medical device manufacturing business.
Participate in a training course
Undertaking training within your chosen industry is another way to get a feel for how a medical device manufacturing business works before deciding to pursue a new venture.
Whichever approach you go for to gain insights before starting your medical device manufacturing business, make sure you familiarise yourself with:
- The expertise needed to run the business successfully (do you have the skills required?)
- How a week of running a medical device manufacturing business might look like (does this fit with your personal situation?)
- The potential turnover of your medical device manufacturing business and long-term growth prospects (does this match your ambition?)
- The likely course of action if you decide to sell the company or retire (it's never too early to consider your exit)
At the end of this stage, you should be able to decide whether opening a medical device manufacturing business is the right business idea for you given your current personal situation (skills, desires, money, family, etc.).
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Assemble your medical device manufacturing business's founding team
The next step to start your medical device manufacturing business is to think about the ideal founding team, or to go in alone (which is always an option).
Setting up a business with several partners is a way of reducing the (high) risk of launching a medical device manufacturing business since it allows the financial risk of the project to be shared between the co-founders.
This also allows the company to benefit from a greater diversity of profiles in the management team and to spread the burden of decision-making over several shoulders.
But, running a business with multiple co-founders brings its own challenges. Disagreements between co-founders are quite common, and these can pose risks to the business. That's why it's crucial to consider all aspects before starting your business.
To make an informed decision, we suggest asking yourself these questions:
- How many co-founders would increase the project's chances of success?
- Do you and your potential partners share the same aspirations for the project?
- What is your plan B in case of failure?
Let's examine each of these questions in detail.
How many co-founders would increase the project's chances of success?
The answer to this question will depend on a number of factors, including:
- Your savings compared with the amount of initial capital needed to launch the medical device manufacturing business
- The skills you have compared with those needed to make a success of such a project
- How you want key decisions to be taken in the business (an odd number of partners or a majority partner is generally recommended to avoid deadlock)
Put simply, your partners contribute money and/or skills, and increasing the number of partners is often a good idea when one of these resources is in short supply.
Do you and your potential partners share the same aspirations for the project?
One of the key questions when selecting your potential partners will be their expectations. Do you want to create a small or large business? What are your ambitions for the next 10 or 15 years?
It's better to agree from the outset on what you want to create to avoid disagreements, and to check that you stay on the same wavelength as the project progresses to avoid frustration.
What is your plan B in case of failure?
Of course, we wish you every success, but it's wise to have a plan B when setting up a business.
How you handle the possibility of things not working out can depend a lot on the kind of relationship you have with your co-founders (like being a close friend, spouse, former colleague, etc.) and each person's individual situation.
Take, for instance, launching a business with your spouse. It may seem like a great plan, but if the business doesn't succeed, you could find yourself losing the entire household income at once, and that could be quite a nerve-wracking situation.
Similarly, starting a business partnership with a friend has its challenges. If the business doesn't work out or if tough decisions need to be made, it could strain the friendship.
It's essential to carefully evaluate your options before starting up to ensure you're well-prepared for any potential outcomes.
Undertake market research for a medical device manufacturing business
The next step to start your medical device manufacturing business is to use market research to check that there is indeed an opportunity to be seized. Let's take a look at what this involves.
The objectives of market research
In a nutshell, doing market research enables you to verify that there is a business opportunity for your company to seize, and to size the opportunity precisely.
First of all, market research enables you to assess whether the market you're targeting is large enough to withstand the arrival of a new competitor: your medical device manufacturing business.
The market analysis will also help you define the product and service offering of your medical device manufacturing business, and transcribe it into a market positioning and concept that will strike a chord with your target customers.
Finally, your market research will provide you with the data you need to draw up your sales and marketing plan and estimate the revenue potential of your medical device manufacturing business.
Analyse key trends in the industry
Market research for a medical device manufacturing business must always begin with a thorough investigation of consumer habits and current industry trends.
Normally, medical device manufacturing business market research begins with a sectorial analysis which will provide you with a better understanding of how the industry is organized, who the major players are, and what are the current market trends.
Assess the demand
A demand analysis enables you to accurately assess the expectations of your medical device manufacturing business's future customers.
Your analysis will focus on the following questions:
- How many potential customers are present in the geographical areas served by your company?
- What are their expectations and purchasing behaviors?
- How much are they willing to spend?
- Are there different customer segments with distinct characteristics?
- How to communicate and where to promote your business to reach your target market?
The main goal of your demand analysis is to identify potential customer segments that your medical device manufacturing business could target and what products or services would meet these customers' expectations.
Supply side
Supply-side analysis looks at the products and services offered by your competitors on the market.
You should focus here on the following questions:
- Who will your competitors be?
- Are they any good?
- Where are they located?
- Who do they target?
- What range of products and services do they offer?
- Are they small independent players?
- What prices do they charge?
- How do they sell their products and services?
- Do their concepts appeal to customers?
One of the aims of your supply-side analysis will be to gather the elements that will enable you to define a market positioning that will set you apart from what is already being done on the market, so as to avoid direct confrontation with competitors already established (more on that below).
Regulations
Market research is also an opportunity to look at the regulations and conditions required to do business.
You should ask yourself the following questions:
- Does it take a specific degree to open a medical device manufacturing business?
- Do you need specific licences or business permits?
- What are the main regulations applicable to your future business?
Given that your project is still in its early stages, your analysis of the regulation can be carried out at a high level for the time being. You just want to identify the main laws applicable and check that you meet the conditions for running this type of business before going any further.
Once your project is more advanced, you can come back to the regulation in greater detail with your lawyer.
Concluding your market research
Your market research should lead you to draw a clear conclusion about your chances of commercial success of your business idea:
- Either the market is saturated, and you'd better look into another business idea.
- Or there's an opportunity to be seized in the geographical area you're considering, and you can go ahead with your project to open a medical device manufacturing business.
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Choosing the right concept and positioning for your medical device manufacturing business
Once your market research is completed, it's time to consider the type of medical device manufacturing business you want to open and define precisely your company's market positioning in order to capitalise on the opportunity you identified during your market research.
Market positioning refers to the place your product and service offering occupies in customers' minds and how they differ from competing products and services. Being perceived as the premium solution, for example.
There are four questions you need to consider:
- How will you compete with and differentiate yourself from competitors already on the market?
- Is it better to start or buy a medical device manufacturing business already in operation?
- How will you validate your concept and market positioning?
Let's look at each of these in a little more detail.
How will you compete with and differentiate yourself from competitors already on the market?
When you choose to start up a medical device manufacturing business, you are at a disadvantage compared to your rivals who have an established presence on the market.
Your competitors have a reputation, a loyal customer base and a solid team already in place, whereas you're starting from scratch...
Entering the market and taking market share from your competitors won't happen automatically, so it's important to carefully consider how you plan to establish your presence.
There are four questions to consider here:
- Can you avoid direct competition by targeting a customer segment that is currently poorly served by other players in the market?
- Can you offer something unique or complementary to what is already available on the market?
- How will you build a sustainable competitive advantage for your medical device manufacturing business?
- Do you have the resources to compete with well-established competitors on your own, or would it be wiser to explore alternative options?
Also, think about how your competitors will react to your arrival in their market.
Is it better to start or buy a medical device manufacturing business already in operation?
An alternative to opening a new business is to take over a medical device manufacturing business already trading.
Purchasing an existing medical device manufacturing business means you get a loyal customer base and an efficient team. It also avoids disrupting the equilibrium in the market by introducing a new player.
A takeover hugely reduces the risk of the business failing compared to starting a new business, whilst giving you the freedom to change the market positioning of the business taken over if you wish.
This makes buying an existing medical device manufacturing business a solid alternative to opening your own.
However, buying a business requires more capital compared to starting a medical device manufacturing business from scratch, as you will need to purchase the business from its current owner.
How will you validate your concept and market positioning?
Regardless of how you choose to establish your business, it's crucial to make sure that the way you position your company aligns with the expectations of your target market.
To achieve this, you'll have to meet with your potential customers to showcase your products or services and get their feedback.
Deciding where to base your medical device manufacturing business
The next step to opening a medical device manufacturing business is deciding where you want to set up your business.
Choosing the right location for your business is like finding the perfect stage for a play. Without it, your business may lack the spotlight it deserves.
Whilst there is no “perfect” location for your medical device manufacturing business, one that meets as many of the following factors as possible could be ideal:
- Visibility and foot traffic: This is important for a medical device manufacturing business as it can help attract potential customers and create brand awareness. A visible location with high foot traffic can also make it easier for clients to find and access the business.
- Availability of skilled labor: Medical device manufacturing requires a highly skilled workforce, so a location with a pool of skilled labor can be beneficial. This can also help with recruitment and training processes.
- Efficient logistics: As medical devices may need to be shipped to different locations, a location with efficient logistics and good transportation infrastructure can help reduce costs and ensure timely delivery.
- Proximity to target customers: Being close to hospitals, clinics, and other healthcare facilities can be advantageous for a medical device manufacturing business. It allows for easier access to potential customers and can also facilitate collaboration and partnerships.
This list is obviously not exhaustive and will have to be adapted to the particularities of your project.
Once you’ve considered the factors above, it’s important to think about the budget that your startup has at its disposal. You’ll need to find a location that meets your business requirements but is affordable enough, especially short-term.
If you opt for renting instead of buying your premises, make sure to take into account the terms of the lease, including aspects such as the duration, rent increase, renewal, and so on.
The lease contractual terms vary greatly from country to country, so be sure to check the terms applicable to your situation and have your lease reviewed by your lawyer before signing.
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What legal form should I choose for my medical device manufacturing business?
The next step to start a medical device manufacturing business is to choose the legal form of your business.
The legal form of a business simply means the legal structure it operates under. This structure outlines how the business is set up and defines its legal obligations and responsibilities.
Why is your medical device manufacturing business's legal form important?
Choosing the right legal form for your medical device manufacturing business is important because this will affect:
- Taxation: your tax obligations depend on the legal structure you choose, and this principle applies to both personal income tax and business taxes.
- Risk exposure: some legal structures have a legal personality (also known as corporate personality) and limited liability, which separates them from the owners running the business. This means that the business would be liable rather than the owners if things were to go wrong (lawsuit, debt owed in case of bankruptcy, etc.).
- Decision-making and governance: how you make key decisions varies based on the legal form of your business. In some cases you might need to have a board of directors and organise general assemblies to enable shareholders to influence major decisions with their voting rights.
- Financing: securing funding from investors requires you to have a company and they will expect limited liability and corporate personality to protect them legally.
- Paperwork and legal formalities: the legal structure you select determines whether certain obligations are necessary, such as producing annual accounts, or getting your books audited.
Popular business legal forms
The specific names of legal structures vary from country to country, but they usually fall within the two main categories below:
- Individual businesses
- Companies
Individual businesses
Individual businesses, like sole traders or sole proprietorships, are made for self-employed entrepreneurs and freelancers rather than businesses which employ staff.
They benefit from straightforward administrative requirements, minimal paperwork to start, simpler tax calculations, and streamlined accounting procedures.
However, the downside is that there's typically no legal distinction between the business and the person responsible for day-to-day operations. This means the owner's personal assets are at risk if the business faces problems or goes bankrupt.
There is also no share capital in such a structure, meaning that individual businesses cannot raise equity from investors which seriously limits funding options.
Companies
Companies are versatile structures suited to projects of all sizes in terms of number of founders, number of employees and amount of capital.
They are a bit more complex to operate than individual businesses with more formalities, stringent accounting requirements, more complex tax implications, etc.
In return, they offer stronger protections to their shareholders. They usually benefit from having their own legal identity and limited liability, meaning co-founders and investors can only ever lose the amount of money they have put into the company.
For instance, if things were to go south (the company files for bankruptcy or there is a legal issue), the company would take the hit, safeguarding the personal assets of the founders and investors.
How should I choose my medical device manufacturing business's legal structure?
Deciding on a legal form is easy once you've estimated your sales, decided whether or not you need employees and figured out the number of co-founders joining you.
It's essential to remember that a solid business idea will succeed no matter which legal structure you pick. Tax laws change regularly, so you can't rely on specific tax advantages tied to a particular structure when starting a business.
A proven approach is to look at what legal structures your top competitors are using, and go with the most common option as a working assumption. Once your idea is mature enough, and you're getting closer to officially registering your business, you can get advice from a lawyer and an accountant to confirm your choice.
Can I switch my medical device manufacturing business's legal structure if I get it wrong?
Yes, changing your legal structure later is possible, though it may involve selling the old entity to a new entity in some cases, which adds further expenses. If you want to save on such costs, it makes sense to pick the correct legal form for your business the first time around.
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Assess the startup costs for a medical device manufacturing business
The next step in creating a medical device manufacturing business involves thinking about the equipment and staff needed for the business to operate.
After figuring out what you need for your business, your financial plan will reveal how much money you'll need to start and how much you might make (check below for more details).
Because every venture is distinctive, providing a reliable one-size-fits-all budget for launching a medical device manufacturing business without knowing the specifics of your project is not feasible.
Each project has its own particularities (size, concept, location), and only a forecast can show the exact amount required for the initial investment.
The first thing you'll need to consider is the equipment and investments you'll need to get your business up and running.
Startup costs and investments to launch your medical device manufacturing business
For a medical device manufacturing business, the initial working capital requirements (WCR) and investments could include the following elements:
- Machinery and Equipment: This includes items such as production machines, assembly equipment, and quality control tools that are essential for the manufacturing process of medical devices.
- Facility Expansion: As your business grows, you may need to expand your facility to accommodate increased production and storage needs. This could include purchasing or leasing additional space, renovating existing space, or building new facilities.
- Research and Development: As a medical device manufacturer, it is important to constantly innovate and improve your products. This may require investing in research and development activities, such as hiring specialized staff, purchasing lab equipment, and conducting clinical trials.
- Intellectual Property Protection: Obtaining patents and trademarks for your medical devices is crucial for protecting your business and products from competitors. This may involve legal fees, registration fees, and other related expenses.
- Software and Technology: In today's digital age, technology plays a significant role in the manufacturing process. This could include purchasing software for product design and development, quality control, and inventory management.
Of course, you will need to adapt this list to your business specificities.
Staffing plan of a medical device manufacturing business
In addition to equipment, you'll also need to consider the human resources required to run the medical device manufacturing business on a day-to-day basis.
The number of recruitments you need to plan will depend mainly on the size of your company.
Once again, this list is only indicative and will need to be adjusted according to the specifics of your medical device manufacturing business.
Other operating expenses for a medical device manufacturing business
While you're thinking about the resources you'll need, it's also a good time to start listing the operating costs you'll need to anticipate for your business.
The main operating costs for a medical device manufacturing business may include:
- Staff salaries and wages, including healthcare benefits and payroll taxes
- Accountancy fees for financial reporting and tax preparation
- Insurance costs for liability, workers' compensation, and product liability
- Software licenses for design and manufacturing software, as well as enterprise resource planning (ERP) systems
- Banking fees for merchant services, wire transfers, and overdraft protection
- Raw materials and supplies for production
- Rent or lease payments for manufacturing facilities
- Utilities, such as electricity, water, and gas
- Maintenance and repair costs for equipment and machinery
- Research and development expenses for new product development
- Marketing and advertising expenses for promoting the business and its products
- Travel and transportation costs for sales representatives and executives
- Professional fees for legal and consulting services
- Quality control and testing expenses for ensuring product safety and efficacy
- Employee training and development costs for maintaining expertise and compliance
Like for the other examples included in this guide, this list will need to be tailored to your business but should be a good starting point for your budget.
Creating a sales & marketing plan for your medical device manufacturing business
The next step to start a medical device manufacturing business is to think about how you are going to attract and retain customers.
You need to ask yourself the following questions:
- What actions can be leveraged to attract as many customers as possible?
- How will you then retain customers?
- What resources do you need to allocate for each initiative (human and financial)?
- How many sales and what turnover can you expect to generate in return?
How you will attract and retain customers depends on your ambition, the size of your startup and the nature of your exact concept, but you could consider the following initiatives.
Your sales forecast may also be influenced by seasonality related to your business type, such as fluctuations during busy holiday periods, and your competitive environment.
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Building your medical device manufacturing business's financial forecast
The next step to opening a medical device manufacturing business is to create your financial forecast.
What is a medical device manufacturing business financial forecast?
A medical device manufacturing business financial forecast is a forward-looking tool that projects the financial performance of your business over a specific period (usually 3 years for start-ups).
A forecast looks at your business finances in detail - from income to operating costs and investments - to evaluate its expected profitability and future cash flows.
Building a financial forecast enables you to determine the precise amount of initial financing required to start your medical device manufacturing business.
There are many promising business ideas but very few are actually viable and making a financial forecast is the only way to ensure that your project holds up economically and financially.
Your financial forecast will also be part of your overall business plan (which we will detail in a later step), which is the document you will need to secure financing.
Financial forecasts are used to drive your medical device manufacturing business and make key decisions, both in the pre and post-launch phases:
- Should we go ahead with the business or scrap the idea?
- Should we hire staff or use an external service provider?
- Which development project offers the best growth prospects?
- Etc.
Creating a financial forecast for starting a medical device manufacturing business is an iterative process as you will need to refine your numbers as your business idea matures.
As your medical device manufacturing business grows, your forecasts will become more accurate. You will also need to test different scenarios to ensure that your business model holds true even if economic conditions deteriorate (lower sales than expected, difficulties in recruiting, sudden cost increases or equipment failure problems, for example).
Once you’ve launched your business, it will also be important to regularly compare your accounting data to your financial projections in order to keep your forecast up-to-date and maintain visibility on future cash flows.
What does a financial projection look like?
Your medical device manufacturing business forecast will be presented using the following financial tables.
The projected P&L statement
The projected P&L statement for a medical device manufacturing business shows how much revenue and profits your business is expected to generate in the future.
The projected balance sheet of your medical device manufacturing business
Your medical device manufacturing business's projected balance sheet provides a snapshot of your business’s financial position at year-end.
The cash flow forecast
A projected cash flow statement for a medical device manufacturing business is used to show how much cash the business is expected to consume or generate in the years to come.
What is the best financial forecasting tool for starting your medical device manufacturing business?
The simplest and easiest way to create your medical device manufacturing business's projections is to use professional online financial forecasting software such as the one we offer at The Business Plan Shop.
There are several advantages to using specialised software:
- You can easily create your financial forecast by letting the software take care of the financial calculations for you without errors
- You have access to complete financial forecast templates
- You get a complete financial forecast ready to be sent to your bank or investors
- The software helps you identify and correct any inconsistencies in your figures
- You can create scenarios to stress-test your forecast's main assumptions to stress-test the robustness of your business model
- After you start trading, you can easily track your actual financial performance against your financial forecast, and recalibrate your forecast to maintain visibility on your future cash flows
- You have a friendly support team on standby to assist you when you are stuck
If you are interested in this type of solution, you can try our forecasting software for free by signing up here.
Finding a name and registering your medical device manufacturing business
The next step in starting a medical device manufacturing business is to decide on a name for your entity.
For starters, you cannot take a name similar to a name already registered by a competitor or protected by a trademark without inevitably risking getting sued. So you’ll need to find a name available, and reserve it before others can.
In addition, you will probably want to use the same name for:
- Your company’s legal name - Example LTD or Example Inc
- Your trading name - Example
- A trademark - Example ®
- Your company’s domain name - Example.com
The issue is that you’ll need to register your name in three different places almost simultaneously, but with each place having its own timeframes:
- Registering a domain name is instantaneous
- Registering a trademark takes at least 3 months (if your application is accepted)
- Registering a company depends on the country, but it's generally fairly quick
You will therefore be faced with the choice of either registering everything at once in the hope that your name will be accepted everywhere, or proceeding step by step in order to minimise costs, but taking the risk that someone else will register one of the names you wanted in the meantime.
Our advice is to discuss the strategy with your legal counsel (see further down in this guide) and to give priority to your domain names and your registered trademark. You'll always have the option of using a trading name that's different from your company's legal name, and that's not a big deal.
To check that the name you want is not already in use, you should consult:
- Your country's business register
- The register of trademarks where you wish to obtain protection
- Your preferred search engine
- A domain name reservation company (such as GoDaddy)
If the name you want is available, you can go ahead and register it.
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Deciding upon the corporate identity of your medical device manufacturing business
The next step in opening a medical device manufacturing business is to look at your company's visual identity.
Your company's “visual identity” plays a crucial role in shaping your brand image. It helps you to be recognizable and to stand out from your competitors.
Although you can define your visual identity yourself, it is generally advisable to call on the services of a designer or marketing agency to achieve a professional result.
At a minimum, you will need to define the following elements:
- Logo
- Brand guidelines
- Business cards
- Website theme
Logo
Your medical device manufacturing business's logo allows others to quickly identify your company. It will be used on all your communication media (website, social networks, business cards, etc.) and official documents (invoices, contracts, etc.).
In addition to its design, it's important that your logo is available in a variety of colors, so that it can be seen on all media (white, dark background, etc.).
Brand guidelines
Having brand guidelines enables you to maintain consistency in formatting across all your communications media and official documents.
Brand guidelines define the font (family and size), design and colours used by your brand.
In terms of fonts, for example, you may use Roboto in size 20 for your titles and Lato in size 14 for your texts.
The colours used to represent your brand should generally be limited to five:
- The main colour,
- A secondary colour (the accent),
- A dark background colour (blue or black),
- A grey background colour (to vary from white),
- Possibly another secondary colour.
Business cards
Designing business cards for your medical device manufacturing business is a must, as they will allow you to communicate your contact details to your customers, suppliers, partners, potential recruits, etc.
In principle, they will include your logo and the brand guidelines that we mentioned above.
Website theme
In the same way, the theme of your medical device manufacturing business website will be based on your logo and the brand guidelines we mentioned above.
This involves defining the look and feel of your site's main graphic elements:
- Buttons,
- Menus,
- Forms,
- Banners,
- Etc.
Understanding the legal and regulatory steps involved in opening a medical device manufacturing business
The next step in opening a medical device manufacturing business is to take the necessary legal and regulatory steps.
We recommend that you be accompanied by a law firm for all of the steps outlined below.
Registering a trademark and protecting the intellectual property of your medical device manufacturing business
The first step is to protect your company's intellectual property.
As mentioned earlier in this guide, you have the option to register a trademark. Your lawyer can assist you with a thorough search to ensure your chosen trademark is unique and doesn't conflict with existing ones and help select the classes (economic activities) and jurisdictions in which to register your trademark.
Your lawyer will also be able to advise you on other steps you could take to protect your company's other intellectual property assets.
Drafting the contractual documents for your medical device manufacturing business
Your medical device manufacturing business will rely on a set of contracts and legal documents for day-to-day operations.
Once again, we strongly recommend that you have these documents drawn up by a lawyer.
Your exact needs will depend on the country in which you are launching your medical device manufacturing business and the size of the company you are planning.
However, you may wish to consider the following documents at a minimum:
- Employment contracts
- General terms and conditions of sale
- General terms and conditions of use for your website
- Privacy Policy for your website
- Cookie Policy for your website
- Invoices
- Etc.
Applying for licences and permits and registering for various taxes
The licenses and permits needed for your business will depend on the country where you are establishing it. Your lawyer can guide you on the regulations relevant to your activity.
Similarly, your chartered accountant will be able to help you register for taxes and take the necessary steps to comply with the tax authorities.
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Create a business plan for your medical device manufacturing business
The next step to open a medical device manufacturing business: put together your business plan.
What is a business plan?
To keep it simple, a business plan comprises two crucial components:
- Firstly, a numerical part, the financial forecast (which we mentioned earlier), which highlights the initial financing requirements and profitability potential of the medical device manufacturing business,
- And a written, well-argued section that presents your project in detail, aims to convince the reader of its chances of success, and provides the context needed to assess whether the forecast is realistic or not.
The business plan will enable you to verify the coherence of your project, and ensure that the company can be profitable before incurring further costs. It will also help you convince business and financial partners.
As you can see, your business plan must be convincing and error-free.
How to write a business plan for a medical device manufacturing business?
Nowadays, the modern and most efficient way to write a medical device manufacturer business plan is to use startup business plan software like the one we offer at The Business Plan Shop.
Using The Business Plan Shop to create a business plan for amedical device manufacturing business has several advantages :
- 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 startup 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 create scenarios to stress test your forecast's main assumptions
- You can easily track your actual financial performance against your financial forecast by importing accounting data
- 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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Raise the financing needed to launch your medical device manufacturing business
With your business plan in hand, you can tackle one of the final steps to open a medical device manufacturing business business: the search for financing.
Raising the capital needed to launch your business will probably require a combination of equity and debt, which are the two types of financing available to companies.
Equity funding
Equity is the sum of money invested in a medical device manufacturing business by both founders and investors.
Equity is a key factor in business start-ups. Should the project fail, the sums invested in equity are likely to be lost; these sums therefore enable the founders to send a strong signal to their commercial and financial partners as to their conviction in the project's chances of success.
In terms of return on investment, equity investors can either receive dividends from the company (provided it is profitable) or realize capital gains by selling their shares (provided a buyer is interested in the company).
Equity providers are therefore in a very risky position. They can lose everything in the event of bankruptcy, and will only see a return on their investment if the company is profitable or resold. On the other hand, they can generate a very high return if the project is a success.
Given their position, equity investors look for start-up projects with sufficient growth and profitability potential to offset their risk.
From a technical standpoint, equity includes:
- Share capital and premiums: which represent the amount invested by the shareholders. This capital is considered permanent as it is non-refundable. In return for their investment, shareholders receive shares that entitle them to information, decision-making power (voting in general assembly), and the potential to receive a portion of any dividends distributed by the company.
- Director loans: these are examples of non-permanent capital advanced to the company by the shareholders. This is a more flexible way of injecting some liquidity into your company as you can repay director loans at any time.
- Reserves: these represent the share of profits set aside to strengthen the company's equity. Allocating a percentage of your profits to the reserves can be mandatory in certain cases (legal or statutory requirement depending on the legal form of your company). Once allocated in reserves, these profits can no longer be distributed as dividends.
- Investment grants: which represent any non-refundable amounts received by the company to help it invest in long-term assets.
- Other equity: which includes the equity items which don't fit in the other categories. Mostly convertible or derivative instruments. For a small business, it is likely that you won't have any other equity items.
The main sources of equity are as follows:
- Contributions made by the owners.
- Private investors: business angels, friends and family.
- Crowdfunding: raising funds by involving a group of people through campaigns where they contribute money or make donations, often getting something in return for their support.
- Start-up aid, e.g. government loans to help founders build up their start-up capital.
Debt financing
Debt is the other way of financing companies. Unlike equity, debt offers lenders a limited, contractually guaranteed return on their investment.
Your medical device manufacturing business undertakes to pay lenders' interest and repay the capital borrowed according to a pre-agreed schedule. Lenders are therefore making money whether or not your company makes a profit.
As a result, the only risk lenders take is that of your medical device manufacturing business going bankrupt, so they're extremely conservative and will want to see prudent, hands-on management of the company's finances.
From the point of view of the company and all its stakeholders (workforce, customers, suppliers, etc.), the company's contractual obligation to repay lenders increases the risk for all. As a result, there is a certain caution towards companies which are too heavily indebted.
Businesses can borrow debt in two main ways:
- Against assets: this is the most common way of borrowing. The bank funds a percentage of the price of an asset (a vehicle or a building, for example) and takes the asset as collateral. If the business cannot repay the loan, the bank takes the asset and sells it to reduce losses.
- Against cash flows: the bank looks at how much profit and cash flow the business expects to make in the future. Based on these projections, it assigns a credit risk to the business and decides how much the business can borrow and under what terms (amount, interest rate, and duration of the loan).
It's difficult to borrow against future cash flows when you're starting a medical device manufacturing business, because the business doesn't yet have historical data to reassure about the credibility of cash flow forecast.
Borrowing to finance a portion of equipment purchases is therefore often the only option available to founders. The assets that can be financed with this option must also be easy to resell, in the unfortunate event that the bank is forced to seize them, which could limit your options even further.
As far as possible sources of borrowing are concerned, the main ones here are banks and credit institutions. Bear in mind, however, that each institution is different, in terms of the risk it is prepared to accept, what it is willing to finance, and how the risk of your project will be perceived.
In some countries, it is also possible to borrow from private investors (directly or via crowdfunding platforms) or other companies, but not everywhere.
Key points about financing your medical device manufacturing business
Multiple solutions are available to help you raise the initial financing you need to open your medical device manufacturing business. A minimum amount of equity will be needed to give the project credibility, and bank financing can be sought to complete the financing.
Launching your medical device manufacturing business and monitoring progress against your forecast
Once you’ve secured financing, you will finally be ready to launch your medical device manufacturing business. Congratulations!
Celebrate the launch of your business and acknowledge the hard work that brought you here, but remember, this is where the real work begins.
As you know, 50% of business start-ups do not pass the five-year mark. Your priority will be to do everything to secure your business's future.
To do this, it is key to keep an eye on your business plan to ensure that you are on track to achieve your goals.
No one can predict the future with certainty, so it’s likely that your medical device manufacturing business's financial performance will differ from what you predicted in your forecast.
This is why it is recommended to make several forecasts:
- A base case (most likely)
- An optimistic scenario
- And a pessimistic scenario to test the robustness of your financial model
If you follow this approach, your numbers will hopefully be better than your optimistic case and you can consider accelerating your expansion plans. That’s what we wish you anyway!
If, unfortunately, your figures are below your base case (or worse than your pessimistic case), you will need to quickly put in place corrective actions, or consider stopping the activity.
The key, in terms of decision-making, is to regularly compare your real accounting data to your medical device manufacturing business's forecast to:
- Measure the discrepancies and promptly identify where the variances with your base case come from
- Adjust your financial forecast as the year progresses to maintain visibility on future cash flow and cash position
There is nothing worse than waiting for your accountant to prepare your year-end accounts, which can take several months after the end of your financial year (up to nine months in the UK for example), to realise that the performance over the past year was well below the your base case and that your medical device manufacturing business will not have enough cash to keep running over the next twelve months.
This is why using a financial forecasting solution that integrates with accounting software and offers actuals vs. forecast tracking out of the box, like the financial dashboards we offer at The Business Plan Shop, greatly facilitates the task and significantly reduces the risk associated with starting a business.
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Key takeaways
- There are 15 key steps to opening a medical device manufacturing business.
- Your financial forecast will enable you to accurately assess your initial financing requirements and the potential profitability of your project.
- Your business plan will give your financial partners the context they need to be able to judge the consistency and relevance of your forecast before deciding whether or not to finance the creation of your medical device manufacturing business.
- Post-launch, it's essential to have an up-to-date forecast to maintain visibility of your business's future cash flows.
- Using a financial planning and analysis platform that integrates forecasts, business plans and actual performance monitoring, such as The Business Plan Shop, makes the process easier and reduces the risks involved in starting a business.
We hope this guide has helped you understand how to open a medical device manufacturing business. Please don't hesitate to contact us if you have any questions or want to share your experience as an entrepreneur.
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Founder & CEO at The Business Plan Shop Ltd
