MAE Group

Top Mistakes Made by Medical Device Startups

Preventable mistakes help

Truth be told, medical device startups make preventable mistakes. Learn first how to avoid the common mistakes mitigating disaster, saving time, and preventing costly delays. This article breaks down why medical device startups make these mistakes. Then, we’ll outline how to prevent and mitigate them. In short, this article outlines the top mistakes made by medical device startups to help you bring your life-saving device to market.

Top Mistakes Made by Medical Startups

Above all, starting a business is complex, and even more so in the medical device industry. Most startups are experts in their own field, extremely knowledgable and educated. However, expertise in medicine or engineering only carries you so far in getting a device manufactured, approved, and placed on the market. Therefore, the 3 most common and preventable mistakes outlined below lessens your chance of making the same avoidable errors during the device development processes.

Mistake #1: Rushing the Process

Assuming or wishing the FDA approval process took less time leads to rushed work and submission rejections. Many start-ups underestimate both the time and amount of documentation required for FDA clearance. Above all, the FDA functions to ensure safe and effective products. Safety requires extensive testing and verification conducted within a set of strict guidelines.

In short, he FDA will reject your submission package until all the problems have been addressed, costing your company more time and money than you likely anticipated.

How to Avoid Mistake #1

Essentially, when you submit your FDA package, make sure it is close to flawless. (Flawless is impossible but you can get very close!) Trust expert, experienced advice.

What to Do:  When you submit your FDA package, make sure it is close to flawless. (Flawless is impossible but you can get very close!) Trust expert, experienced advice.

Preventable Mistake #2 Hand Off Too Early

Lots of start-ups try to hand-off the device design to a contact manufacturing firm (CMO), and only “come back” after it’s ready. However, design and manufacturing require a teamwork approach to avoid eleventh hour failure. As such, start-ups should remain really involved and fully part of the process of design transfer. Therefore, they can see whether the development of the manufacturing processes fulfills their design’s key requirements.

How to Avoid Mistake #2

Trust the manufacturing process design that your CMO uses and contribute. Most importantly, know ahead of time what it takes to get you to the end, with products in hand that meet all your internal and external requirements. In short, trust experts to guide you (and your CMO) along with your valuable input away from common manufacturing risks. Learn how MAE Group can help.

Preventable Mistakes #3 Not Listening

By far the most common mistake is not listening to experts. Start-ups have expertise in their field, but rarely (if ever) does a start-up have wide-ranging expertise in medical device design, testing, regulatory standards, and manufacturing. Many small companies only listen to others who tell them what they want to hear. Such listen to others who tell them what they want to hear. Such confirmation bias will end up costing everyone valuable time and money.

How much? Here are some real statistics that are not for the faint of heart:

  • The average cost to bring a medical device to US market through the 510(k) pathway is $31 million, and the PMA pathway is $94 million.
  • At least 60% of early-stage med-tech companies fail, with 75% of those failures due to lack of knowledge in the commercialization process

In other words: it’s not the technology that lets the company down, it’s the lack of wide-ranging managerial experience.

What to Do: Listen to people who know this industry, who have years of experience. At MAE Group, we have the experience you need, so you can avoid falling into that quagmire described above. We can you help you develop the product, get it through the FDA clearance process, and get it on the market, providing innovative value to your customers and potential partners.

Conclusion

In short, the top mistakes made by medical device are absolutely preventable. No doubt many medical device startups make mistakes, costly mistakes. However, medical device startups often provide the most promising and innovative devices in the market. In fact, large corporations depend on startups to take much of the risk out of the development process.

Let MAE Group be part of your approach to avoiding the top mistakes medical startups make. Isn’t your company and life-saving product worth it?

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