The first high-risk medical device in a given category--such as a coronary stent or transaortic valve replacement--takes 34% longer to be approved than a follow-on version from a competitor, finds a Harvard Business School study.
"There is a huge delay associated with being the first product to enter a new device market," concludes the study author, Ariel Dora Stern. "As you can imagine, that results in a big cost for folks trying to bring new products to market."
She estimates that delay costs the industry $6.7 million, in addition to the $94 million average cost of getting a high-risk PMA device to the market. It also deters smaller players. Stern discovered that non-public companies with revenues under $500 million account for 14% of follow-on devices, but just 7% of truly new ones.
That stands in contrast to the pharma industry, where follow-on drugs take slightly longer to be approved than their predecessors.
"It wasn't 'wow, we've never seen this kind of product' that led to the longest delays. Rather, we observed many big regulatory delays for devices that are put in new product categories, but built on technologies the FDA is already familiar with," Stern said in a summary of her study on the Harvard Business School website. "That suggests there is something more administrative in the delays--something in the classification process that matters."
The FDA likes to boast that it approved the latest generation of TAVRs made by Medtronic ($MDT) and Edwards Lifesciences ($EW) just a few months later than its European counterparts. But those were follow-ons to the original TAVRs.
Edward's first-generation Sapien was approved in Europe four years prior to getting the FDA's go-ahead. And similarly, additional TAVRs from companies like Boston Scientific ($BSX) and St. Jude Medical ($STJ), as well as smaller players, are now on the market in Europe, but their devices are still awaiting FDA approval.
"Our mission is to protect public health and to promote public health. We've done a good job on the protect side," CDRH head Dr. Jeffrey Shuren said at the May meeting of the Medical Device Manufacturers Association. "We have not done so well on the promote side, by facilitating innovation and speeding patient access to safe and effective devices," he admitted.
Shuren acknowledged that the FDA approved the first TAVR years after it received a CE mark, but said the agency doesn't plan to be slow to get the next wave of technologies to market: "We have now approved three early feasibility studies for transcutaneous mitral valve replacement. The first patient just got an implant last week, and the rest of the world is in exactly the same place, so we are now starting to see companies say, 'you know what we are going to do an early feasibility study here.'"
While industry is happy to see faster approval of next-generation TAVRs, and other FDA moves to increase patient access like the Expedited Access Pathway, Stern's study makes clear that timely (or untimely) approval of the first version of a paradigm-shifting device, such as a transcutaneous mitral valve replacement, will be the true test of the FDA's recently stated commitment to speed.