In all of our years of product development and manufacturing, we’ve seen many mistakes that people make when developing a medical device. More often than not, we see the same common set of pitfalls repeated across different companies. Here we’ve come up with a list of common pitfalls that we see repeatedly happening in the medical device development industry. Read on as we describe mistakes to avoid when developing a medical device so that you can set yourself up for success.
The Worst Mistake You Can Make When Developing A Medical Device and How To Avoid Them
We’ve used our years of professional experience to create this list of mistakes to avoid developing a medical device. Keep reading if you want to set yourself apart and ahead of the competition.
Design A Product No One Needs
Are you designed a product that is necessary on the market? If the market you’re building for isn’t big enough, then you won’t find a financial path to the market. Building a product like this results from focusing too much on the technology rather than conducting market research and creating something the market is searching for. Often we see our clients getting far into a project developing something that they find out later isn’t meeting market demand.
Design A Piece of Technology Instead Of A Product
Similarly to mistake number one, remember that even the best technology in the world will go to waste without the right market. Make sure you’re thinking about the impact of your medical device on the workflow of the technicians, physicians, and patients who will use it. Think about how to integrate into medical practices and the income stream that comes with that. If your device is tied to a loss of income for medical procedures, without a concrete gain to make up for that loss, then it simply won’t be adopted by practices.
One of the top mistakes to avoid when developing a medical device is to ignore the ROI. Even if your product is incredible, your efforts will have been in vain if no one has the money to pay for it.
Don’t Consider Regulatory Strategies
Avoid a colossal mistake by looking up regulatory strategies first. Even if your device is revolutionary, it’s no good to anyone if you can’t get it cleared. Make sure you have a proposed intended use and indications for you, as this dictates the design and the regulations that apply to that design.
We give this piece of advice to remind you to look at the big picture, which includes purpose, design input, and risk analysis.
A huge piece of advice we give to our clients is to stay focused on the most important thing. Trying to build multiple devices at once is a mistake, especially if you don’t have tons of funding at your disposal. Specifically, we advise against trying to create one product with several different applications - it’s not cost-effective or helpful when budgeting, especially when the cost of building multiplies for each application.
Don’t Consider The Risks
Make sure you identify the key risks that could come up during the development phase. Not properly informing investors of even minor technical things that need to get worked out could cause them to kill the project and dilute your equity.
On the flip side of that, you might be at risk of diluting way too much if you can’t drive an early high valuation. It’s good to be comprehensive early, but make sure it’s in ways that investors will recognize. Make sure you’re setting reasonable goals and are able to adapt when risks are identified later on in your project, which might change or derail your project. Maintain open communication, and be prepared to handle challenges as they arise.
Underestimate The Scope
A huge problem that companies face when developing a new product is underestimating the scope. They get pretty far into the project and even go as far as to make commitments to other people and get stuck with no time and no money. They make very specific and impossible promises to investors about ROI and time projections and then have to somehow get themselves out of the hole they dug for themselves.
Set realistic expectations for yourself and your product from the get-go.
Forget To Look Up Non-Medical Device Regulations
We think that you shouldn’t ignore non-medical device regulations like chemical regulations, as ignoring them might prevent you from marketing specific products. Even if they aren’t medical regulations, most likely, they will still apply to medical devices.
Don’t Do Enough Testing
A big mistake that a lot of developers and manufacturers make is not doing enough testing. Whether that’s clinical, performance, markets, people, human factors, etc., you need to include at least a couple of testing cycles in your planning. Ensure that you include making changes as a result of your testing, and don’t expect everything to be perfect.
Focusing Too Much On The End Product
Another on our list of mistakes to avoid when developing a medical device is to focus too much on the end result and not doing the due diligence necessary during development. Instead, we think you should be doing a series of focused experiments to tackle the risks. Don’t waste your money on pushing test results on things that are really risky or unimportant just for the sake of moving forward. Instead, make sure you’re staying aligned with the concept and work out the kinks throughout the process.
Let Outer Reef Help
At the end of the day, you need to focus on the big picture and build the right product that meets the market’s needs. Did we miss any mistakes you’ve seen while being in the industry?
At Outer Reef Technologies, we take pride in providing engineering and technology solutions that are responsive to our clients’ needs. Each of our medical device development projects is innovative, cost-effective, professional, and high-quality. We’ve tailored our approach to combine exceptional design, verified results, and proven performance. From medical device development to robotics and mechanical design, and more, we’d love to offer our engineering consulting services so that you can avoid some of the mistakes we’ve mentioned above.
We operate under a quality management system and are ISO 13485 compliant,so give us a call today!