The Surgeon and the 510(k): Why Great Inventions Get Stuck

Medical Patents Broker Inc.
By Kenneth Pearce, President

"I am a Surgeon Inventor and this 510(k) Thing is Impossible"

This is a sentiment echoed in scrub sinks and surgeons' lounges across the country. The invention that saves lives gets buried under a wall of bureaucracy. The FDA is about safety and efficacy; it is a process diametrically opposed to the robotic microsecond incision - all of which can be frustrating.

The Dilemma

Many times, the invention provides better treatment for the patient, but the FDA looks at the mechanical evidence. For 510(k) status, the later invention’s structure must be “piggy-backed” on a previous invention that has already been cleared by the FDA. And sometimes, there is no piggy-back available. But that’s another blog.

For a 510(k), the Medical Treatment can be Irrelevant while the Stress Tests can be Everything

1. The Predicate Selection: When filing the 510(k) Submission, one must select a "legally marketed device" to compare against. Experience of what does not work is helpful in finding what does work. Pick the wrong “piggy-back,” and it’s a time-consuming mess to unravel.
2. Design Controls: Surgeons are used to documenting patient outcomes, not "Design Inputs" and "Risk Mitigations" in a 21 CFR Part 820-compliant format. This is not the OR world of microsecond decisions of life and death.
3. Concise Communication: For those used to writing publications for professional journals, it is often better for the FDA to keep the information simple and short.

An Option to Relieve the Headache

For the surgeon-inventor, the most efficient pathway to market is a strategic hand-off via a sale or license to a third party with deep FDA experience. Depending on many market variables, MPB can facilitate a “meeting of the minds” between that third party and the surgeon.

Patent Maestro® – Orchestrating Technology To The Patient℠

Medical Patents Broker Inc.

By Kenneth Pearce, President