The Nemedio Blog:  Demystifying Compliance

your guide to product development and compliance for medical technology

I’m building a medical device. Do I *need* to do a clinical study?

May 12, 2022

This question comes to any medical device company leader’s mind as they set out to create the next big product. 

How do we show the world that our product works? 

How do we show it works better than the product we are improving on or disrupting? 

The second question answers a big first step. If you set out to improve a device, or have a device that is similar to the other device, chances are you are seeking substantial equivalence from the FDA for the purposes of clearing your device. 

We get it - you are better than what you are comparing yourself to, but the FDA created a mechanism to get you to the market with minimal stumbling blocks before you can improve on it.

The 510(k) clause you may have heard of requires you to:

  • find a product similar to what you are making
  • show how your device is similar for the critical aspects that affect patient safety and product effectiveness
  • then clear it for market use. 

At this point, there is a business decision to make: you can either use this route and get to the market, after which you can run in-use studies to make more claims you couldn’t substantiate, or run a clinical study before the submissions to make those claims with the filing. 

Most startups don’t have the luxury of time and cash flows to run studies prior to a launch, especially if the product is not a big disruption or solution to the existing problems. Most startups use a route referred to as IRB (Institutional Review Board) approved studies. These are studies that permit a product in development to be tried out in its clinical application to gather data that can be used in design stages. The downside of this study is that the findings are only useful for design iterations, and are not admissible for the FDA or other regulatory body filing. The clinical studies, with finished product, a Quality System, and protocols are the only means to generate data that can be submitted for marketing claims such as ‘superior to x company’, ‘able to fix y problem’.


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