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 peopleunderstand 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.