There's no doubt that starting a prosthetic 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.
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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!
Before thinking about starting a prosthetic 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 prosthetic device manufacturing business works are to:
Talking to seasoned entrepreneurs who have also set up a prosthetic 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.
Gaining hands-on experience in a prosthetic 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 prosthetic 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 prosthetic device manufacturing business.
Undertaking training within your chosen industry is another way to get a feel for how a prosthetic device manufacturing business works before deciding to pursue a new venture.
Whichever approach you go for to gain insights before starting your prosthetic device manufacturing business, make sure you familiarise yourself with:
At the end of this stage, you should be able to decide whether opening a prosthetic device manufacturing business is the right business idea for you given your current personal situation (skills, desires, money, family, etc.).
The next step to opening your prosthetic device manufacturing business, is to decide whether to assemble an ideal team or venture solo.
The failure rate for business start-ups is high: almost half don't make it past the five-year mark, and setting up a prosthetic device manufacturing business is no exception.
Starting with a group of co-founders helps reduce this risk as each of you brings complementary skills and enables the financial risk to be spread on multiple shoulders.
However, managing a business with multiple partners comes with its own set of challenges. Disagreements among co-founders are quite prevalent, and they can pose risks to the business. That's why it's essential to carefully weigh all aspects before launching a business.
To help you think things through, we recommend that you ask yourself the following questions:
Let's look at these issues in more detail.
To answer this question you will need to consider the following:
In simple terms, co-founders bring skills, money, or both to the table. Having more partners is beneficial when there's a lack of either of these resources.
One of the main sources of conflict between co-founders comes from a lack of alignment on the long-term vision.
To avoid any risk of disagreement, it is advisable to agree on ambitions from the outset and to provide an exit mechanism for one of the partners in the event of disagreement.
We hope your prosthetic device manufacturing business takes off and thrives, but it's smart to have a "plan B" just in case things don't go as expected.
How you tackle potential failure can vary broadly depending on the type of co-founders (close friend, spouse, ex-colleague, etc.) and the personal circumstances of each of them.
For example, launching a family business with your spouse might seem exciting, but if it fails, you risk losing all of your household income at once, which might be stressful.
Likewise, starting a business with a friend might strain the friendship if things go wrong or if tough decisions need to be made.
Before diving in, make sure to thoroughly think about your choices. This way, you'll be ready for whatever might come your way when starting up.
The next step in starting a prosthetic device manufacturing business is to undertake market research. Now, let's delve into what this entails.
The goal here is straightforward: evaluate the demand for your business and determine if there's an opportunity to be seized.
One of the key points of your market analysis will be to ensure that the market is not saturated by competing offers.
The market research to open your prosthetic device manufacturing business will also help you to define a concept and market positioning likely to appeal to your target clientele.
Finally, your analysis will provide you with the data you need to assess the revenue potential of your future business.
Let's take a look at how to carry out your market research.
Market research for a prosthetic device manufacturing business usually begins with an analysis of the sector in order to develop a solid understanding of its key players, and recent trends.
After the sector analysis comes demand analysis. Demand for a prosthetic device manufacturing business refers to customers likely to consume the products and services offered by your company or its competitors.
Looking at the demand will enable you to gain insights into the desires and needs expressed by your future customers and their observed purchasing habits.
To be relevant, your demand analysis must be targeted to the geographic area(s) served by your company.
Your demand analysis should highlight the following points:
Analyzing demand helps pinpoint customer segments your prosthetic device manufacturing business could target and determines the products or services that will meet their expectations.
For example, your target market might include healthcare facilities such as hospitals and rehabilitation centers that are in need of high-quality prosthetic devices for their patients. These facilities are looking for durable, customizable and cost-effective solutions to improve the quality of life for their patients. They value innovation and advanced technology in the prosthetic devices they purchase and are willing to invest in top-notch products. Additionally, your target market could also include individual amputees who are looking for a personalized and comfortable prosthetic device that will help them regain their mobility and independence. These individuals prioritize functionality, comfort, and aesthetics in their prosthetic devices and are willing to pay for high-quality options.Once you have a clear vision of who your potential customers are and what they want, the next step is to look at your competitors.
Amongst other things, you’ll need to ask yourself:
The aim of your competitive analysis will be to identify who is likely to overshadow you, and to find a way to differentiate yourself (more on this see below).
Market research is also an opportunity to look at the regulations and conditions required to do business.
Ask yourself the following questions:
At this stage, your analysis of the regulations should be carried out at a high level, to familiarize yourself with any rules and procedures, and above all to ensure that you meet the necessary conditions for carrying out the activity before going any further.
You will have the opportunity to come back to the regulation afterwards with your lawyer when your project is at a more advanced stage.
Market research should give you a definitive idea of your business idea's chances of commercial success.
Ideally, the conclusion is that there is a market opportunity because one or more customer segments are currently underserved by the competition.
On the other hand, the conclusion may be that the market is already taken. In this case, don't panic: the first piece of good news is that you're not going to spend several years working hard on a project that has no chance of succeeding. The second is that there's no shortage of ideas out there: at The Business Plan Shop, we've identified over 1,300 business start-up ideas, so you're bound to find something that will work.
The next step to start your prosthetic device manufacturing business is to define precisely the market positioning your company will adopt in order to capitalise on the opportunity 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 the competition. Being perceived as a low-cost solution, for example.
To find a concept and a market positioning that will resonate with your customers, you need to address the following issues:
Let's look at these aspects in more detail.
Opening a prosthetic device manufacturing business means starting with a major disadvantage compared with competitors already active on the market.
While you will have to create everything from scratch, your competitors already have everything in place.
Your competitors' teams know the business well, whereas yours has only just been recruited, their customers are loyal and they benefit from word of mouth that you don't yet have.
So you're going to need a solid plan to succeed in taking market share from your competitors and making your mark.
There are a number of aspects to consider in order to try to avoid direct confrontation if possible:
The alternative to setting up a new independent business is to buy out and take over a prosthetic device manufacturing business already in operation.
A takeover is a good way of reducing the risk of your project compared with a pure start-up.
Taking over a business has two enormous advantages over setting up a new one: you start out on an equal footing with your competitors since you take over the team and the customer base, and you don't increase the supply on the market enabling you to maintain the existing balance on the market where the business operates.
However, the capital requirements for a takeover are higher because the business will have to be bought from its previous owners.
However you decide to set up your business, you will need to ensure that there is a good fit between what you sell and what customers are looking to buy.
To do this, you'll need to meet your target customers to present your products or services and check that they meet their expectations.
The next step in our guide on starting a prosthetic device manufacturing business involves making a key choice about where you want your business to be located.
Picking the ideal location for your business is like selecting the perfect canvas for a painting. Without it, your business might not showcase its true colors.
We recommend that you take the following factors into account when making your decision:
This list is not comprehensive and will have to be adjusted based on the details of your project.
The parameters to be taken into account will also depend on whether you opt to rent premises or buy them. If you are a tenant, you will need to consider the conditions attached to the lease: duration, rent increase, renewal conditions, etc.
Lease agreements differ widely from country to country, so it's essential to review the terms that apply to your situation. Before putting pen to paper, consider having your lawyer look carefully at the lease.
It's now time to think about the legal structure for your prosthetic device manufacturing 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.
Naturally, the names and intricacies of business structures differ by country. However, they typically fit into two main categories:
Individual businesses are usually a good fit for self-employed individuals and freelancers who want limited administrative work. These types of entrepreneurs are commonly referred to as sole traders or sole proprietorships.
As mentioned above, the main benefit of being a sole trader is that minimal paperwork is required to launch and operate the business. Tax calculations are also relatively simple and annual accounts are not always required (and when they are, usually don't need to be audited) which saves a bit of time and money on bookkeeping and accounting fees.
Decision-making is also easy as the final decision is fully dependent on the sole trader (even if employees are hired).
However, being a sole trader also has drawbacks. The main disadvantage is that there is no separation between the individual running day-to-day operations and the business.
This means that if the business were to file for bankruptcy or legal disputes were to arise, the individual would be liable for any debts and their personal assets subsequently at risk. In essence, sole traders have unlimited liability.
This also means that profits earned by the business are usually taxed under the personal income tax category of the sole trader.
Another drawback is that sole traders might find it harder to finance their business. Debt (bank loan for example) is likely to be the only source of external financing given that the business doesn't have a share capital (effectively preventing equity investors from investing in their business).
Companies are more flexible and more robust than individual businesses. They are suitable for projects of all sizes and can be formed by one or more individuals, working on their own or with employees.
Unlike individual businesses, companies are recognised as distinct entities that have their own legal personality. Usually, there is also a limited liability which means that founders and investors cannot lose more than the capital they have invested into the business.
This means that there is a clear legal separation between the company and its owners (co-founders and investors), which protects the latter's personal assets in the event of legal disputes or bankruptcy.
Entrepreneurs using companies also gain the advantage of being able to attract equity investment by selling shares in the business.
As you can see companies offer better protection and more financing options, but this comes at a trade-off in terms of red-tape and complexity.
From a taxation perspective, companies are usually liable for corporation tax on their profits, and the income received by the owners running the business is taxed separately (like normal employees).
Normally, companies also have to produce annual accounts, which might have to be audited, and hold general assemblies, among other formalities.
Choosing the right legal setup is often simple once you figure out things like how many partners you'll have, if you hire employees, and how much money you expect to make.
Remember, a great business idea can work well no matter which legal structure you pick. Tax laws change often, so you shouldn't rely too much on getting specific tax benefits from a certain structure when getting started.
You could start by looking at the legal structures most commonly utilised by your competitors. As your idea evolves and you're ready to officially register your business, it's a good idea to confirm your choice using inputs from a lawyer and an accountant.
Yes, you have the flexibility to change your legal setup later, which might include selling the existing one and adopting a new structure in certain situations. Keep in mind, though, that this restructuring comes with additional expenses, so making the right choice from the start is usually more cost-effective.
To answer this key question, we first need to look at the resources you'll need to launch your prosthetic device manufacturing business and keep it running on a daily basis. Let's take a look at what that entails.
Since each venture is distinct, providing an average budget for starting a prosthetic device manufacturing business is impossible.
We strongly advise careful consideration when reading estimates on the web. It’s best to ask yourself the following questions:
Your thinking behind the investments and human resources required to launch and operate the business will then enable you to cost each item and include them in your financial forecast (which we'll look at later in this guide).
Once complete, the forecast will give you a precise idea of the initial investment required and profitability potential for your business idea.
Let's start with the investments. To set up a prosthetic device manufacturing business, initial working capital and investments can include the following items:
Of course, you will need to adapt this list to your company's specific needs.
You'll also need to think about the staff required to run the business on a day-to-day basis.
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The human resources required will vary according to the size of your company.
For example, you could recruit a production manager to oversee the manufacturing process and ensure efficient production of prosthetic devices. Additionally, you may want to consider hiring a quality control specialist to ensure that all products meet industry standards and regulations. Another valuable addition to your team could be a sales representative to promote your products and establish relationships with potential clients. These staff members would play crucial roles in the day-to-day operations of your prosthetic device manufacturing business, helping to drive growth and success. Other potential positions to consider could include a human resources manager, an accountant, and a marketing specialist.Once again, this list is only indicative and will need to be adjusted according to the specifics of your prosthetic device manufacturing business.
The final point to consider when analyzing the resources required is the question of operating costs.
Operating expenses for a prosthetic device manufacturing business may include:
Here also, this list will need to be tailored to the specifics of your prosthetic device manufacturing business but should be a good starting point for your budget.
The next step to launching your prosthetic device manufacturing business is to think about the actions you need to take to promote your products and services and build customer loyalty.
Here, you'll be looking at the following issues:
The precise sales and marketing levers to activate will depend on the size of your prosthetic device manufacturing business. But you could potentially leverage some of the initiatives below.
For example, your prosthetic device manufacturing business might consider implementing a targeted marketing campaign to reach potential clients. By creating a database of contacts at hospitals, rehabilitation centers, and other medical facilities, you can send personalized emails highlighting the benefits and features of your prosthetic devices. You could also offer special promotions or discounts to incentivize them to try your products. Additionally, you could attend industry conferences and trade shows to network with potential clients and showcase your products. By actively promoting your business and building relationships with key decision-makers, you can increase brand awareness and ultimately grow your sales.Besides your sales and marketing plan, your sales forecast will be affected by seasonal patterns related to the nature of your business, such as fluctuations during the holiday season, and your competitive landscape.
The next step to start your prosthetic device manufacturing business: putting your financial projections together.
A forecast is a quantified decision-making document that shows the initial investment required to open a prosthetic device manufacturing business and the company's potential profitability and cash flow generation over the next 3 to 5 years.
As you think about your prosthetic device manufacturing business idea, the main role of financial projections will be to help you decide whether it makes sense to create the company.
Building a financial forecast helps determine the amount of initial financing required to start your prosthetic device manufacturing business.
In fact, creating financial projections is the only way to assess the amount of initial financing you'll need to open your prosthetic device manufacturing business, and to make sure your project makes economic and financial sense.
Keep in mind that very few business ideas are financially viable. At The Business Plan Shop, we've seen nearly a million business start-up ideas, and we estimate that less than one in four is economically viable.
Your forecast will therefore require your full attention and constant revision, as your project matures. It's also a good idea to simulate different scenarios to anticipate several possibilities (what happens if your sales take longer than expected to ramp up, for example), so you're ready for all eventualities.
When seeking financing, your forecast will be incorporated into your business plan, which is the document you will use to present your business idea to financial partners. We'll come back to the business plan in more detail later in this guide.
Creating and updating your prosthetic device manufacturing business's forecast is an ongoing process. Indeed, having up-to-date financial projections is the only way to maintain visibility over your company's future cash flow and cash position.
Forecasting is, therefore, the financial management tool that will be with you throughout the life of your company. Once you've started trading, you'll need to regularly compare the difference between your actual accounts and your forecasts, and then adjust them to maintain visibility over your future cash flows.
Your prosthetic device manufacturing business forecast will be presented using the following financial tables.
The projected P&L statement for a prosthetic device manufacturing business shows how much revenue and profits your business is expected to generate in the future.
Your prosthetic device manufacturing business's projected balance sheet provides a snapshot of your business’s financial position at year-end.
A projected cash flow statement for a prosthetic device manufacturing business is used to show how much cash the business is expected to consume or generate in the years to come.
The easiest and safest way to create your prosthetic device manufacturing business forecasts is to use an online financial forecasting software, like the one we offer at The Business Plan Shop.
There are several advantages to using professional software:
If you are interested in this type of solution, you can try our forecasting software for free by signing up here.
The next phase in launching your prosthetic device manufacturing business involves selecting a name for your company.
This stage is trickier than it seems. Finding the name itself is quite fun; the difficulty lies in finding one that is available and being the first to reserve it.
You cannot take a name that is similar to a name already used by a competitor or protected by a registered trademark without inevitably risking legal action.
So you need to find a name that is available, and be able to register it before someone else can.
In addition, you will probably want to use the same name for:
The problem is that the procedures for registering these different names are carried out in different places, each with their own deadlines:
You will therefore be faced with the choice of: either registering everything at once and hoping 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 strategy with your legal counsel (see further down in this guide) and prioritise your domain names and registered trademarks. You'll always have the option of using a trade 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:
In this area too, your legal counsel will be able to help with the research and formalities.
The following step to start a prosthetic device manufacturing business is to define your company's visual identity.
Visual identity is part of the DNA of your prosthetic device manufacturing business: it makes you recognizable and recognized by your customers, and helps you stand out from the competition. It also helps convey your values, notably through the choice of colors that identify the company.
Creating your business's visual identity yourself is entirely possible: there are several online tools that let you generate color palettes, choose typography and even generate logos.
However, we advise you to delegate this task to a designer or a communications agency for a professional result.
Your corporate identity will include the following elements:
Your prosthetic device manufacturing business's logo serves as a quick identifier for your company. It will be featured on all your communication platforms (website, social networks, business cards, etc.) and official documents (invoices, contracts, etc.).
Beyond its appearance, your logo should be easy to use on any type of support and background (white, black, gray, colored, etc.). Ideally, it should be easy to use in a variety of colors.
One of the challenges when starting a prosthetic device manufacturing business is to ensure a consistent brand image wherever your company is visible.
This is the role of your company's brand guidelines, which defines the typography and colors used by your brand and thus acts as the protector of your brand image.
Typography refers to the fonts used (family and size). For example, Trebuchet in size 22 for your titles and Times New Roman in size 13 for your texts.
The colors chosen to represent your brand should typically be limited to five (or fewer):
Classic but a must-have, your business cards will be at your side to help you easily communicate your contact details to your founders, customers, suppliers, recruitment candidates, etc.
In essence, they should feature your logo and adhere to the brand guidelines mentioned earlier.
Likewise, the theme of your prosthetic device manufacturing business website will integrate your logo and follow the brand guidelines we talked about earlier.
This will also define the look and feel of all your site's graphic elements:
The next step in opening a prosthetic device manufacturing business is to look in detail at the legal and regulatory formalities.
Although it is possible to do the formalities yourself and draft some of the documents detailed here, The Business Plan Shop recommends that you seek advice on these aspects from a law firm.
One of the first things you need to do here is to protect your company's current and future intellectual property.
One way of doing this is to register a trade mark, as mentioned earlier in this guide. Your lawyer will be in a position to do the formalities for you and to help you select the classes (economic activities) and jurisdictions in which you have an interest in obtaining protection.
Your law firm can also advise you on other ways of protecting your company's intellectual property.
Your prosthetic device manufacturing business will need a set of legal and contractual documents to operate on a daily basis.
Your exact needs in this respect will depend on the country in which you are launching your prosthetic device manufacturing business and the size and legal form envisaged for the company. Once again, we highly recommend having these documents prepared by your lawyer.
As a minimum, we recommend that you have the following documents prepared:
Here too, the list of licences and business permits required for your business to operate legally will depend on the country in which you have decided to start your prosthetic device manufacturing business.
Your law firm will be able to advise you on all the regulations applicable to your business.
Likewise, your accountant will be able to assist you and take care of the formalities involved in complying with the tax authorities.
Once you've completed all the above steps, you can start writing the business plan for your prosthetic device manufacturing business.
The business plan is a document containing:
The business plan is particularly important: it will help you validate your business idea and ensure its coherence and financial viability.
But it's also the document you'll send to your bank and potential investors to present your plan to open a prosthetic device manufacturing business and make them want to support you.
So it's best to draw up a professional, reliable and error-free business plan.
If you're not used to writing business plans, or if you want to save time, a good solution is to use an online business plan software for startups like the one we offer at The Business Plan Shop.
Using The Business Plan Shop to create a business plan for a prosthetic device manufacturing business has several advantages:
Interested? If so, you can try The Business Plan Shop for free by signing up here.
With your business plan in hand, you can tackle one of the final steps to open a prosthetic 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 is the sum of money invested in a prosthetic 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:
The main sources of equity are as follows:
Debt is the other way of financing companies. Unlike equity, debt offers lenders a limited, contractually guaranteed return on their investment.
Your prosthetic 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 prosthetic 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:
It's difficult to borrow against future cash flows when you're starting a prosthetic 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.
Multiple solutions are available to help you raise the initial financing you need to open your prosthetic 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 prosthetic device manufacturing business is the beginning of an exciting entrepreneurial adventure, and the culmination of your efforts to turn your idea into a reality. But this is also when the real work begins.
As you know, nearly half of all new businesses fail, so you'll need to do everything you can to make your business sustainable right from the start.
Estimating the future financial performance of a prosthetic device manufacturing business inevitably involves a degree of uncertainty. That's why we recommend simulating several scenarios: a central case with the most likely scenario, an optimistic case, and a pessimistic case designed to test the limits of your business model.
Normally, your company's actual financial performance, observed after you start trading, should fall somewhere between your pessimistic and optimistic cases.
The important thing will be to quickly measure and compare this actual performance with the figures in your forecast to see where you stand, then update the forecast to re-estimate the future cash flows and cash position of your prosthetic device manufacturing business.
This forward-looking financial management exercise is the only way to know where you stand and where you're going. And, when your figures fall short of expectations, to quickly implement actions to turn things around before the company runs out of cash.
There's nothing more dangerous than waiting until you have your accounts, which takes up to nine months after the end of your financial year (if you are in the UK, abroad your mileage will vary), to then realize that you're not on the right track and that your prosthetic device manufacturing business won't have enough cash to operate over the next twelve months.
This is where using a forecasting solution that integrates actuals vs. forecast tracking, like The Business Plan Shop's financial dashboards do, can simplify the financial management of your business and help reduce the risk associated with your start-up project.
We hope this practical guide has given you a better understanding of how to open a prosthetic device manufacturing business. Please do not hesitate to contact our team if you have any questions or if you would like to share your experience of setting up your own business.
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