Make or Buy: How to Choose Your MedTech Product Components?
Choosing the right MedTech product components is one of the toughest decisions you face during medical device development. It is a choice that dictates your product’s entire lifecycle, regulatory path and budget.
At first sourcing components might not seem as a life-or-death choice. But dig a little deeper and you uncover difficulties that can emerge during mass production, often compelling you to completely redesign your device.
Whether you are an engineer with a brilliant prototype or a developer tackling complex production logistics, sooner or later, you will face this exact question:
How to choose your MedTech product components?
What Kind of MedTech Product Components Do You Need?
Knowing exactly what components your product needs is based on how well you define its intended use. To do so, you must ask yourself these 4 crucial questions:
- What specific problem does it solve?
- Where will it be used?
- Who will be using it?
- What is your production scale and lifecycle?
Is it a single-use disposable device or will it be sterilized with harsh chemicals several times a day?
Is it going to have direct contact with body fluids or just the skin? Will it be used in a controlled, sterile hospital environment or in a patient’s house?
An elderly patient who needs a large interface or a constantly moving child? If doctors will use it while wearing gloves, they cannot rely on a simple touchscreen.
Design for tens of units requires a completely different approach than for thousands. Are you building a small batch to test the market or preparing for mass production? Do you aim to be on the market for 10 or 5 years?
These are only examples, but answering the questions gives you a clear roadmap of what MedTech product components you need.
MedTech Product Components in Terms of Risk
After defining your medical device’s intended use and scale, you must now evaluate components in terms of their supply chain risk. Whether you source hardware (electrical, mechanical, material) or software, you must know what happens if a supplier suddenly discontinues your parts.
Lower risk comes with passive parts like housing, screws or standard electronics. As long as you use standard elements, they are relatively easy to swap without causing regulatory difficulties. Avoid parts with non-typical, exotic values.
Higher risk appears in case of specific measurement integrated circuits and other unique, complex parts. Finding a substitute often forces a complete redesign of your medical device.
The Decision Triangle: It’s Never Just “Make or Buy”
Never trivialize any stage of medical devices development. Sourcing your MedTech product components rarely simplifies to a zero-one “make or buy” question. There are often times that point out another option to consider – if the device can be designed differently? For example, instead of debating whether to buy standard screws or manufacture custom, can you redesign the housing to use snap-fits?
To make a proper call, you need a holistic view of the problem. Assessing this may seem overwhelming, but you can break it down into one decision triangle. If you take into account each of these three pillars, you will not miss any crucial information.
The Decision Triangle Development Cost, Unit Cost, Lifecycle Risks.
- Development Cost
- Unit Cost
- Lifecycle Risks
It is crucial to focus on the initial capital needed just to get your device to the manufacturing line. Here, you calculate the exact costs of the research and development process, specialized testing tools or expensive custom injection molds. Summarize every single expense required to prepare the device for mass production.
This pillar may seem obvious, but developers often miscalculate it. When calculating a single unit cost, you must look far beyond the basic bill of materials and delivery fees. Correctly done unit cost includes the assembly time, human resources, specific testing per unit and scrap rate. You must calculate the exact cost of manufacturing one unit so that the final sale price actually generates a profit.
Calculating an exact amount of time a product will survive on the market is undeniably hard, but it is critical. You need to make an objective prognosis: after these years dedicated to regulatory approvals and market launch, will this device still have buyers? Moreover, this pillar evaluates the lifespan of your components – do not be afraid to reach out directly to the supplier!
Only after thoroughly analyzing all three pillars of the decision triangle it is possible to declare whether you should make or buy your MedTech product components.
Team “Buy”: Is It Really Easier and Cheaper?
If you are getting off the shelf, ready components, you should consider the not-so-obvious advantages and disadvantages. Remember: it always comes down to a manufacturing scale and the device’s expected lifecycle. After defining your medical device’s intended use and analyzing it through the decision triangle, use this final checklist to confirm if buying is your best choice.
The Pros of Buying
Do you need a quick solution?
If you are manufacturing a small first series (e.g. 30-50 units) to test the market or if your clock is ticking, you should definitely consider getting your MedTech product components off the shelf. Even at this small rate, manual assembly is still costly and time-consuming, so buying can save you crucial development time.
Do you need only standard elements?
If your design consists of standard components that are easily achievable and replaceable (like passive electronics), then buying them is the most logical conclusion. You do not risk disappearing these kinds of components from the market.
The Cons of Buying
Are you ready for supply chain shocks?
With each off-the-shelf component comes a risk of market shifts. When you buy, you lose control over the supply chain. A sudden global change can heavily impact your manufacturing, even if it is a small medical device – it still relies on the same big techs.
Do you want to avoid expensive testing with “Medical Grade” components?
Be aware of this trap that many developers fall for: buying components with an assigned “Medical Grade” label does not free you from testing the whole device. It is easy to overpay for these specific parts, only to realize you still need a full system certification. Usually the same component parameters, you are able to achieve with simple ones, without any fancy label.
Do you want perfectly copyable parameters?
Even if you buy exactly the same component, with the same series and batch number, from the same manufacturer, there is always a hidden hazard – storage variables. Distributors’ differences in warehouse temperature or humidity can subtly affect a component’s parameters for example even an electrical conductivity. In mass production, especially for highly sensitive diagnostic products, this tiny change might be the reason a whole batch fails quality control.
Making Your MedTech Product Components From Scratch can be a long-term Investment.
Team “Make”: Is It Worth Your Investment?
Whether you cannot find an existing solution on the market or you want something more personalized, choosing to make something from scratch always requires upfront cost and overload. However, you should treat it as an investment in your long-term goals, so to know if it is worth it – answer the questions stated below.
The Pros of Making
Do you aim for a long-term product?
If your medical device is designed to exist on the market for a decade, then you should definitely consider making your own medtech components. The initial investment in custom testers or injection molds might seem scary at first, but in a 10-year perspective it becomes profitable.
Do you want a guarantee of existing components?
As mentioned before, bought components always carry a hazard of end-of-life discontinuation or unannounced design changes. With self-made ones you control their existence, longevity and manufacturing methods. You are no longer at the mercy of global supply chain shifts.
Are you producing at a massive scale?
When your production volume scales into thousands, manual assembly becomes physically and financially impossible. At that scale, investing in automated custom parts is the only logical path. Injection molding companies are eager to maintain custom molds for clients who aim to consistently manufacture thousands of units year after year.
The Cons of Making
Can you survive high initial costs?
If you lack the funding for an initial investment, getting MedTech product components off the shelf might be your only available option. Making from scratch burns through your finances long before the first unit is sold. However, keep in mind that having a fully personalized, market-secured product can attract sponsors and investors.
Are you prepared for the scaling trap?
The scaling trap is common among medical devices’ development. You rely on manual assembly, because of small batches and your technician successfully makes 500 units per year. But imagine the sudden spike to 1000 units. You must hire new technicians, who are not able to make an exact copy – because they are humans. If you choose to make, you must also invest heavy amounts of time into standardizing and automating your manufacturing processes.
The Final Choice
Choosing the right MedTech product components is barely the beginning. Even with a perfectly structured strategy, a mistake founders make is mismatching their subcontractors to their actual production scale. A provider that assemblies your 50 prototypes is willing to reject an order for 5000 units, and the other way around. Before you sign any contracts, ensure your manufacturer aligns with your specific volume and product’s lifecycle.
Remember – you do not have to navigate this complex process alone. Instead of relying on costly trial and error, leave the logistics, risk analysis and scaling strategy to the experts.
