Medtech: Regulations can be a competitive advantage

Feb. 5, 2014
The process of jumping through regulatory hoops in getting medical products to market can be more than just an exercise in tedium. Smart manufacturers use regulations as a means of getting a leg up on their competitors.

Manufacturers of medical equipment often look at the regulatory process accompanying medical products as a major pain in the behind. That's wrong, says Michael Drues, Ph.D., President of Vascular Sciences, a Grafton, Mass. company that consults with medical device makers. in actuality, the regulatory process can provide a leg-up over competitors for companies that know how to approach regulations properly.

Drues will be speaking at next week's MD&M West 2014 conference in Anaheim, Calif. In his talk on Monday afternoon, called Competitive regulatory strategy: Acting as a barrier to entry for your competitors, he plans to make the point that few people understand that regulations can actually help make manufacturers competitive. "Anybody can design a regulatory strategy to get something through the FDA," he says. "The challenge is to get a product on the market while simultaneously making it more difficult for your competitors to get their product on the market. I've found most regulatory folks don't even think in those terms."

Drues gives an example from the drug world: Orphan drug designations typically bring to mind the image of a drug with few customers. But that's not necessarily true, says Drues.

"One of the requirements of the orphan designation is that you have to identify a group of fewer than 200,000 patients annually for the drug. But nowhere does the regulation put a limit on the number of indications. So if you can bring to market an orphan drug for 32 indications, multiple 32 by 200,000 to get a pretty respectible number," Drues says. "Several drugs have gotten to market under the orphan drug designation and have gone on to be block busters. Who would have guessed?"

And he says there are regulations for medical devices that closely resemble orphan drug rules. One in particular is the humanitarian device exception, HDE. There are similar opportunities for medical device makers that arise from the HDE, he claims.

About the Author

Leland Teschler

Lee Teschler served as Editor-in-Chief of Machine Design until 2014. He holds a B.S. Engineering from the University of Michigan; a B.S. Electrical Engineering from the University of Michigan; and an MBA from Cleveland State University. Prior to joining Penton, Lee worked as a Communications design engineer for the U.S. Government.

Sponsored Recommendations

Pumps Push the Boundaries of Low Temperature Technology

June 14, 2024
As an integral part of cryotechnology, KNF pumps facilitate scientific advances in cryostats, allowing them to push temperature boundaries and approach absolute zero.

The entire spectrum of drive technology

June 5, 2024
Read exciting stories about all aspects of maxon drive technology in our magazine.


May 15, 2024
Production equipment is expensive and needs to be protected against input abnormalities such as voltage, current, frequency, and phase to stay online and in operation for the ...

Solenoid Valve Mechanics: Understanding Force Balance Equations

May 13, 2024
When evaluating a solenoid valve for a particular application, it is important to ensure that the valve can both remain in state and transition between its de-energized and fully...

Voice your opinion!

To join the conversation, and become an exclusive member of Machine Design, create an account today!