#1 – They underestimate the amount of work the FDA will require.
The FDA’s primary concern is that your product is safe and effective, and its approval process requires a lot of documentation to show it. It requires medical device startup companies like The Clinician eXchange to undergo a rigorous testing and verification process that is done by a strict set of guidelines.
If the FDA sees potential mistakes in your submission package, it will be rejected, costing time and money. And more importantly, you do not want your medical device startup company to end up in the news because your device hurt someone, or worse.
Our advice: Submit an airtight submission package to the FDA with expert advice guiding the process.
#2 – They listen to only what they want to hear.
Leadership in medical device startup companies often consists of experts in their field of medical specialty. It can be difficult to seek or follow the advice of outsiders. Instead, they rely on those who are telling them only what they want to hear.
Our advice: Listen to the people who know this space, and who have years of experience. Seek the counsel of those with the experience you lack.
#3 –They want to hand off the work and get it back when it is done.
Medical device startup companies make the mistake of thinking they can provide their design for development and get it back once it is FDA approved and ready to generate revenue. That positions you to be disappointed if your vision is not realized the way you wanted.
Our advice: Trust the process, understand what it will take to get to the end. The process cannot work if the medical device startup company is not an active partner.