Dean Kamen: Don't Blame Regulators for Stalling Medtech Innovation

Posted in Regulatory and Compliance by Jamie Hartford on July 22, 2014

Medtech inventor and entrepreneur Dean Kamen says the public needs to get a more realistic idea of what it takes to bring innovative medical devices to market.

The medical device industry loves to beat up on FDA, but one person you won’t find lining up to take a shot at the agency is medtech inventor and entrepreneur Dean Kamen.

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At the recent keynote address at the MD&M East exposition in New York City, Kamen urged the audience not to blame regulators for hampering medtech innovation. Instead, he said, it’s the public that needs to shift its attitude about what’s required to bring new medical technologies to market.

Hear his call to action to the industry in the video below: 

Didn't make it to MD&M East this year? Head to MD&M Minneapolis this fall.

Jamie Hartford, managing editor, MD+DI




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People like Dean are the problem

Dean's never ending inaccurate hype in the media has caused more damage to his message than anything the FDA or politician's could do. Fraudulent claims of meaningful medical innovation come around to bite eventually.

The FDA drags it's feet for years delaying critical well designed US studies that companies are ready to do. The way the agency rewards internal performance and the lack of oversight contributes greatly to delays that ruin US medical device startup companies and the space in general.

This is a big contributing factor as to why US venture capital managers see this whole area as a looser for investment. Only easy incremental small change devices that require 510(k)'s can get funding.

Dean needs to go back to developing self propelled self balancing motor scooters and leave real medical innovation and industry messaging to Med Device professionals.

Medical Developement

As a former employee, Dean i can tell you medical device Developement would go a lot quicker if you treated your employees better. It is hard to develop medical devices when you are worried about having other employees stick guns in your face . It is even harder when you are punished for reporting the incident. DEKA is the definition of hostile work environment. Until you do something about that you have no right to say anything!