Getting Revolutionary Devices onto the Market with Regulatory Logic

While the FDA and regulatory bodies are constantly evolving, medical device technology is destined to evolve at a faster clip than regulatory code. What should medical device companies do?

Brian Buntz

The current regulatory structure of FDA or other regulatory bodies was not initially designed to accommodate personalized medicine in general or 3-D printing in particular. That doesn't mean that device developers should wait until FDA has formulated clear guidelines for such products before they start developing them, declares Mike Drues, president at Vascular Sciences (Boston). Some regulatory consultants have already developed proven regulatory blueprints for getting such next-gen products on the market.

In fact, the same approach can be used for vastly different products. "The regulatory strategy to bring the first 3-D printed knee to market in 2014 was exactly same as the strategy as bringing the first 3-D printed drug to market last year," Drues declares. "From a regulatory perspective, this is all personalized medicine."

Drues, who is speaking on this subject at MD&M West, recommends prioritizing regulatory logic over the current regulatory structure, which was not developed with 3-D printing or personalized medicine in mind. Nevertheless, there are already proven regulatory best practices for 3-D printed medical devices and there are in fact already roughly 85 3-D printed medical devices that have been cleared by FDA.

So how is the strategy for clearing 3-D printed devices essentially the same as the one used to clear the first 3-D printed drug in August of last year--known as Spritam from Aprecia Pharmaceuticals? "The was not a new drug. The manufacturer could show that the drug that the  active pharmaceutical ingredient (API) in the pill coming off the 3-D printer is the same as the API in the traditional manufacturing process?" Drues asks. "If I do that, I can just focus on the process and remove the drug from the equation entirely. I can limit the dosage of the drug in the 3D printer to correspond to the dosage to the drugs that are commercially manufacturing and then do a label expansion and then tell the printer to put into the pill whatever the patient needs," Drues says. "Bottom line, the regulatory strategy for the drug and the 3-D printed knee is the same."

"If we want to bring a medical device like a 3-D printed knee to the market using an existing pathway like the 510(k), how do we do that?" he asks. "What if I could show the knee is substantially equivalent as the knee coming off the traditional manufacturing process?" If you can do that, you can essentially remove the knee from the equation and focus on validating the manufacturing process.

"I can further hedge my regulatory risk initially limiting the sizes of the knees I can print to sizes that are already on the market in the traditional manufacturing process," Drues says. If the traditional knee is available in increments of 25, 50, and 75 mm, the manufacturer can limit the printer to make the same size devices. This will help the manufacturer get on the market as simply as possible.Later on, the manufacturer could remove that criteria by expanding the label, eventually enabling the physician to print any size between the smallest to the largest knee that are on the market.

Drues says that this strategy draws inspiration from baseball. "It is like aiming to get a single instead of trying to hit a homerun," he says. "Ultimately we take this to the n^th degree and do a second label expansion to allow a physician to print any size knee he or she wants."

Nevertheless, it can be difficult to get a revolutionary device onto the market using the current model, which was designed for a one-size-fits-all approach. "With personalized medicine, when your intended patient population is one patient, how do you do a clinical trial?" Drues asks. "I believe there is a solution to that problem. When I look at a clinical trial as an engineer, I see nothing other than a validation," he says. "You can validate the product or you can validate the process. And so this goes back to the 3-D printed knee. If I can show the 3-D knee is the same as the traditional knee, I just need to validate the process."

The most important message for device companies boils down to this, Drues says: "Whether we are talking about 3-D printing of a medical device or a drug or nanotechnology, if we wait for regulation to catch up to what we do, we will be waiting until the sun burns out," he says. "My approach is to focus on the regulatory logic rather than the current regulatory approach. It is not FDA's job to tell us how to do it; it is our job." He recommends being a leader when approaching FDA. "It is a company's job to say: 'based on the engineering and the biology, this is what we want to do," Drues says. "It is FDA's job to be devil's advocate; to make sure we can substantiate it."