I started my career in device regulatory affairs in the early 90s, with a PMA supported by multiple, multicenter clinical trials, all conducted outside the US. I sometimes joke that I've spent my entire career waiting for the industry to catch up with me. It's been slow going, but I've been pleased to see more companies adhering to design controls in product development, and more thinking globally in the pre-market phase. And I rarely hear people say that "FDA won't approve a medical device based on foreign data" any more.
In light of the industry's long-standing aversion to higher risk devices and clinical trials, I feel fortunate to have had the opportunity to work on several PMAs, and, in light of the low success rate of medical device startups, to see some of these devices make to the market. I myself made my career more difficult by having a long-standing aversion to living anywhere but North Carolina, which in the 1990s and 2000s was not exactly a hotbed of medical device development, and virtually no one was working virtually. There, too, things are changing now. It looks like the industry might finally be ready for me a decade or two after I retire, lol. Ah well...timing is everything, and I've always been ahead of mine. Happily, in the 90s my area became the CRO capital of the world, and I was still able to pay the bills doing GCP compliance and IDE work when I didn't have device regulatory work to keep me entertained.
I was drawn to Regulatory Affairs by the intellectual challenge of getting regulatory approval for novel devices. Regulatory Affairs, as I know it, is a complex discipline that sits at the intersection of Business, Government, Law, Medicine, Science, and Technology, all of which are in a constant state of evolution. I was drawn to the challenge of keeping up, and to the fascinating intellectual exercise of taking a totally novel medical device, learning everything I could about it, its intended use, and its market, and figuring out the best regulatory path to meet business goals and also how to present the device to regulators in a way that would expedite approval, while keeping costs at a level appropriate to the post-market value of the product. As an MBA, I'm keenly aware of the business side of new product development, and always keep business goals and constraints in mind when laying out a regulatory strategy.
I prefer to take on a device early in development, when I can provide useful input into the design control process and develop a good regulatory plan, preferably a global plan. Once I have a plan, I usually hope to be involved in its implementation, but some of it may not be a good fit for me. In that case, I like to help clients find other competent professionals who can carry out whatever part of the plan I'm not prepared to take on. Sometimes I can provide a start-up with enough guidance that they can implement some of the plan themselves.
Today I'm excited about the new De Novo path at FDA, which takes the same approach as pre-market approval, but is tailored to lower risk devices. It's potentially a great solution for companies that are developing a novel device, i.e., one for which there is no suitable predicate, and that presents lower risk than a Class III device. I think it could have a significant impact on the industry over the next decade, hopefully encouraging more development of novel devices, rather than mostly "me too's." I think it could have an impact on my profession as well, since it requires a different skill set than a 510(k). I expect some growing pains in the interim, but, in the end, I think it can be a very good thing for the industry, for my profession, and for patients.
Julie Omohundro, MBA
Durham, North Carolina