Incentive-Based Regulation: Is it possible?

As some who know me would tell you, my mind happens to wander at times about a variety of topics. The subject of this mental galavant happened to be the current regulatory landscape in the United States - specifically the FDA's new outlook of regulation and greater enforcement.

Certainly, I acknowledge why the FDA is looking to enforce further control upon the medical device industry. Many manufacturers are ignorant to what requirements apply, may not fully understand or appreciate the regulations or, heaven forbid, may even purposely de-value them. It is FDA's job to ensure the safety of the patient and operator of the device.

With that said, a tweet (yes, we are on Twitter @raqasolutions. Look us up!) led me to a thought: "What if there were incentive-based regulations alongside the consequence-based regulation to encourage manufacturers to follow regs rather than just discouragement of violating the law?" I'll admit - the thought is infantile in its development. I wish I could post my full proposal of how it might work and apply to the industry. Alas, my thought has yet to develop that far; however, the idea seems appealing.

One of my greatest frustrations is the lack of full acceptance of a quality system and its implementation because a piece of regulation requires a company to adopt one. There are many, very successful companies that adopt ISO 9001 compliant systems simply to better their business. But when law forces companies to adopt one, often times it presents a different atmosphere, one of eye-rolling and obligation. If incentive-based regulations were implemented, could that single-handedly shift this type of culture? Would it drive employees to want to enact quality system regulations?

I know that the idea has short comings: Where are the resources to provide such incentives? How can you ensure objectivity in rewarding such incentives? What type of measurement system would be enacted to control this? But, do we, as humans, react better when we are afraid of consequence, or when driving to achieve a goal?

With the uproar from the medical device industry about how the new FDA regulations are going to stifle innovation, maybe incentive-based regulation is a topic for discussion.

-RTK