Part of the mission of the CDRH is to ensure medical devices are safe and effective. Based on the risk of the device and the agency’s familiarity with the device type, different levels of evidence are required to convince the FDA that a device is safe and effective.

The most common route to demonstrate is by showing your device is substantially equivalent to a predicate via the 510(k) pathway. The main things the FDA reviews when determining substantial equivalence is the intended use, and technological characteristics such as design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.

This analysis includes a detailed side by side comparison of a new device to predicate. The predicate may be anything that is legally marketed - either a competitor’s product, or one of your previously cleared products in your pipeline.

The FDA explicitly states, “A claim of substantial equivalence does not mean the new and predicate devices must be identical.” Let’s think of substantial equivalence like a family. They don’t have to be identical twins, they can probably be fraternal to share a lot of the same features. They may even be able to be cousins…but your aunt’s second cousin’s neighbor’s pizza boy probably won’t make the cut. The more degrees of separation from the predicate device, the less likely you are to be able to use substantial equivalence. You may have to go another route (PMA, de novo, etc.)

You can see how important it becomes to have a good predicate device that matches yours in every way possible. However, I mentioned in my last post that in order to get a patent, your invention has to be novel and unobvious. Patenting assumes your product differs from the prior art. The fine line is in analyzing what those differences are. The product you patent could very well be different than the prior art while at the same time not raising new questions of safety and efficacy.

How do you balance these opposing forces? One good way to handle this is to have two different groups of people involved at the design concept and ideation stage. Some of those people can work independently from outside influences to come up with a solution to a problem, while others can brainstorm new ideas based on competitors’ products and other prior art. Bringing those groups together for strategic conversations will make sure you have both of the pieces of the puzzle – uninhibited innovation and feasibility for a marketable product.

How do you manage IP vs. Regulatory in your organization?

- Sherri

Check out my original post on the struggles of innovation here - http://rqteam.com/2012/09/standing-out-vs-fitting-in/

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