Today we have Kristin Benokraitis, Director of Quality and Operations with EG-GILERO sharing her thoughts on the five biggest pitfalls of medical device startups. In my day-to-day job at EG-GILERO, I have had the opportunity to work on hundreds of projects with a wide range of clients who are looking to develop the next big idea in the medical device industry. We are able to provide full contract design and manufacturing services to each client based on their individual needs and therefore we see a lot of different types of “personas” who include the following:
- “The Clinician” – Healthcare professionals who are frustrated with existing products and have an idea for a new or improved product.
- “The Entrepreneur” – Funded startup companies who may or may not have experience in the medical device space, but have the financial backing to move their big idea forward.
- “The Corporation” – Fortune 500 medical device companies who have established product development processes but are looking for an extension to their R&D team to improve their ability to be more agile and innovative.
- “The Drug Expert” – Pharmaceutical companies who understand the world of drug regulations but need support in developing a medical device to deliver their drug.
Developing a medical device is not easy. There – someone said it. It doesn’t matter if you are a seasoned industry veteran or a motivated entrepreneur. If it was easy, someone would have already done what you are trying to do. Blame it on FDA regulations, corporate red tape, lack of funding, etc. It takes a special team to execute on developing a new product idea and then successfully bringing it to market. When you see a product advertised on TV and think to yourself, “why didn’t I think of that,” maybe subconsciously you did but piecing together the steps that translate that bright idea into something that is commercially viable is completely different.
Funded startups have a particularly challenging road to success as not only do they have the standard hurdles one may encounter during product development, but investors are constantly looking over their shoulder to ensure the project is hitting all milestones and commitments within the agreed upon funding strategy and timeline. I’ve experienced funded startups encounter some common pitfalls first hand along the way, and the following are the top five that cause the most harm in medical device product development:
/pərˈfekSH(ə)n/ – the action or process of improving something until it is faultless or as faultless as possible
There are people in this world who strive to design the perfect product. Unfortunately, perfection (in the true definition of the word) can never be reached. It is important to honestly assess what design inputs are “must haves” versus “nice to haves.” Focus on understanding who the end user is and what their needs really are. This may require putting aside your own opinions on what you think the product should look like or do, and truly design and develop with as little bias as possible. In other words, don’t design a Ferrari when all the end user is telling you that all they need is a 10-speed bicycle. Of course, there are examples of products that we, as consumers, didn’t know we needed or wanted until they were flashed before our eyes (thank you Steve Jobs). But most people aren’t Steve Jobs. Focus on the end user and their must haves so you don’t end up with a warehouse full of Ferraris and an empty piggy bank.
Do not procrastinate in following Design Controls
If you are building a new house from the ground up, would you start construction without any architectural drawings? How about not bothering to tell the builder what finishes you want (cabinets? flooring?). Would you feel comfortable skipping a pre-drywall meeting where you would get a sneak peek behind the walls that are about to go up? If you skipped these steps during the construction process, you may end up with a house, but it will probably not be the kind of house you were expecting.
Similar to building controls followed during new home construction, FDA requires following Design Controls for many types of medical devices. Design Controls are procedures that guide the design of medical devices to ensure specified design requirements are met. Sometimes it is difficult to determine when to initiate Design Controls during the development process. FDA recommends that you start when research ends and design begins, or after you have completed feasibility or a proof of concept.
The potential pitfall is when a company avoids Design Controls and continues to play in the “feasibility” sandbox (beyond where the real point of feasibility ended). Be careful, because before you know it, you are actually in the launch phase. Bypassing Design Controls and thinking that it can all be done at the end is a common misconception for startups who are crunched for time and money. However, being in situations where elements of Design Controls are generated after their expected time is not only ill-advised, it is risky and delays the overall development timeline. It is most efficient to utilize the elements of Design Controls to drive the design itself to assess and mitigate risk along the way. The further your company is in the development process, the more expensive it is to circle back and revise the design to address an unanticipated requirement or failure mode.
If you do not have a Quality System or Design Controls procedure in place during medical device development, it’s recommended you work with a contract design and manufacturer, like EG-GILERO (who does).
FDA is not a big, scary monster
To make a splash in the market with your big idea, you want a novel product that generates intellectual property. However, if you are trying to mitigate or simplify a regulatory path to get your medical device into the market, you want a “like-me” product where you can claim substantial equivalence to something that is already cleared by FDA. Spoiler alert: Those strategies may contradict each other. However, it’s important to know that FDA and medical device regulations are not intended to be scary. FDA are very helpful if you understand what tools and processes they have in place for small businesses. That being said, FDA regulations are intentionally vague with gray areas for interpretation. It would be practically impossible for regulations to be descriptive in detail for every type of medical device being developed. This is where the fear, uncertainty, and doubt often occurs because it requires understanding and interpreting the intent behind the regulation. Document regulatory strategies, justification and decisions in case they need to be defended in the future.
Know what you don’t know
We have worked with entrepreneurs who are “business smart” and have history of successful product launches and acquisitions, but lack clinical and regulatory experience. Conversely, we have worked with academic researchers or healthcare professionals who excel in the clinical space, but fail to understand the regulatory requirements or realize what it takes to run a business. It’s a good reminder to be honest with yourself and identify what you don’t know. Pick a balanced team with complementary experiences. Realize where there are gaps, and then determine if it would be beneficial to involve consultants with medical device experience to fill in the unknowns. Not all consultants are equal. Find the right team for you and your needs.
Expect the unexpected
R&D is an iterative process, and while there has been substantial growth in areas that help speed up the development process (3D printing, rapid injection molding, etc.), sometimes you just don’t know where all of the speed bumps are until you hit them in real time. Be prepared to encounter forks in the road during the development process and make the best decision with the information in-hand at the time so that you can learn from mistakes along the way. Understand that just because you have a workable prototype doesn’t mean you are ready for product launch. Building ten prototypes by hand in the lab is completely different than designing a cost-sensitive medical device for high-volume production.
In the end, understand your strengths and weaknesses and know when it’s time to ask for help. Be true to yourself and find a consultant that can be a complementary extension of your team.