I recently received a phone call from a doctor with an idea for a new medical device. He asked if Creo Quality could provide a proposal for a FDA submission. After a brief, initial conversation, I had the sense that quite a bit of work was required before putting together a 510(k) submission. I provided a brief questionnaire to the doctor so that I could better assess what had been done. The questionnaire included questions like:
- Have you defined the user needs?
- Do you have design input requirements?
- Do you have design outputs defined, including drawings, specifications, etc.?
- Did your design verification activities meet acceptance criteria?
- Have you documented risk management activities?
The doctor’s responses indicated that very little of the FDA Design Control regulations had been met. After receiving his response, I told the doctor that he was not ready for a 510(k). I indicated that to get his product ready for submission, it could easily cost $1M or more and take several months.
The doctor was not happy to hear this. He indicated that he had received proposals from others for putting together a FDA submission and that the cost would be in the tens of thousands. He just didn’t understand where I was coming from. I realize that part of the frustration is that the doctor has been working on his idea for years. He couldn’t fathom spending six figures and more time getting it ready. But, unfortunately, the doctor doesn”t understand the premise behind a 510(k). A 510(k) clearance means the FDA is granting market clearance. The purpose of the 510(k) submission is to demonstrate the product meets design controls, is safe and effective, and is substantially equivalent to an already cleared 510(k) medical device.
Nothing I could say or do was going to change the doctor’s mind. He was not willing to listen or understand the reasoning. I wish him luck.
Do you have an idea for a new medical device or technology? If so, where do you go for help? Are you willing to accept that you don’t know what you don’t know? Are you willing to go to experts for help? Do you realize that medical device product development can be an expensive, time-consuming process?
If you have an idea for a new medical device, I’d love for you to contact Creo Quality. We will provide you with a simple questionnaire and are avaialbe for FREE consultations.
But even if you don’t contact us, PLEASE address the following ASAP and consult experts before you spend too much time and money:
- Be sure your idea meets an unmet clinical need
- Determine a regulatory strategy. How is the device classified? Determine predicate devices.
- Estimate timeline and financial requirements.