PARIS – One week before regulations governing the CE mark for medical devices formally takes the force of law, makers of cardiovascular devices have already turned their backs on Europe and are headed to the U.S. for first-to-market approvals.
In reforming its law, the European Union has made the new Medical Device Regulation (MDR) so onerous, so complex and so uncertain that the formidable formalities of the U.S. FDA now seem user-friendly, according to discussions during several panel sessions at EuroPCR 2017, Europe's largest congress for interventional cardiology.
"The pendulum has swung. The early feasibility route is getting more efficient in the United States. Europe is just too complicated," said Peter Fitzgerald, managing partner at Triventures, a venture capital firm in Menlo Park, Calif.
Jeffrey Jump, the former chairman at Biosensors Europe SA based in Morges, Switzerland, said, "Other regulatory authorities have issued new regulations creating expedited access for bringing new and innovative products to market. Europe is headed in the opposite direction."
"Europe's notified bodies need to get their act together," said Chas Taylor, a serial entrepreneur for three companies specializing in interventional vascular products who told Medical Device Daily he would take a fourth company to the U.S. first.
Jack Eadie with London-based Eight Roads Ventures, an arm of Boston-based Fidelity Investments, asks if Europe has raised the bar, or if it has built a wall so high that small companies won't have enough money to get over it.
Vice President and General Manager for Heart Valve Therapies at Dublin-based Medtronic plc, Rhonda Robb, explained why she designed a speed to market strategy for the next-generation Evolut Pro that started in the United States, saying, "Europe has multiple requirements that vary from one country to another where the U.S. has one set of requirements."
She noted that the Evolut Pro was approved by the FDA in March 2017 and that Medtronic is still waiting for CE mark approval.
"I never would have imagined going for a first-in-human in the U.S.," said Semih Oktay the founder of Cardiomed Device Consultants, who worked six years as an expert scientific reviewer in the FDA's Interventional Cardiology Devices branch.
ONE-THIRD OF DEVICES TO DISAPPEAR
After leaving Biosensors, Jefferey Jump took a seat on the board of directors for half a dozen startup companies with medical devices. At EuroPCR he was charged with setting a perspective on the MDR during a session titled, "Changes in medical device regulation in Europe: What you need to know."
Quickly he sketched the landscape, saying there are 26,000 medical device companies in Europe where 90 percent have fewer than 250 employees. There are more than 500,000 medical products. In 2015 an estimated 4,500 devices received a CE mark, and 10 percent of those were class III devices.
Europe's decentralized system depends on product review by notified bodies, independent companies. Thanks to the new requirements, he said, "there will be fewer of them, they will be harder to find, they will take longer in the review process and CE mark approval time is going to be longer. And we will have different interpretations of the MDR between different notified bodies."
Citing the newly released, "Compendium of the New European Medical Device Regulation," he said, "Thirty percent of all medical devices will disappear, and manufacturers will cut their product portfolios by 50 percent because they will not pay to have unprofitable products recertified. The number of innovative medical devices receiving a CE mark will go down by 30 percent. CE mark approval time will double. Estimated additional cost to manufacturers will be from $12 billion to $17 billion. There will be a huge impact on health care costs in Europe."
According to Jump, "Uncertainty of MDR implementation and interpretation, increased cost of compliance, fragmented distribution and divergent reimbursement policies will lead to a re-evaluation of where to seek approval first. The 40-year-old model of go to Europe first will be challenged. Europe may need to wait for innovative medical devices to be proven safe and effective in other markets before European patients can benefit. Physicians, payers and patients will all have less choice and higher costs."
"Innovators will follow the path of least resistance and vote with their feet," he said.
MORE MONEY, LONGER TIMELINES
"Six years ago, we would always have gone to Europe first, and to the U.S. second. Today it is a 50-50 call every time," said Daniel O'Mahony, a partner at Seroba Life Science based in Dublin with €200 million under management that is focused on investing in health care technologies.
"Our view of the MDR is that it is going to add time and cost to any clinical pathway leading to approval. For a company embarking on a CE mark, previously we would have scheduled two to three years. We probably need to add another year to that process with the notified bodies and competent authorities. Our experience is that they are getting slower."
"This creates uncertainty, making it difficult for any investor," said O'Mahony. "On the U.S. side, our experience has been that it is more collaborative and embracing, more supportive for bringing products through clinical trials. Granted that in the U.S. it may be a bigger study, but there is more certainty in dealing with a single authority, and not the issues of dealing with 27 different competent authorities."
Taylor said that with three companies for three different regulatory strategies, "My experience with the FDA has been consistently positive. The hand-overs for multiple reviews has been seamless, the advice has been impartial, helpful and consistent. The experience with Europe's notified bodies has been inconsistent. Those [NBs] where I had poor experiences brought in external clinical experts who do not understand the regulations, and now there are more new rules coming up for med tech."
"When you have a certain amount of cash to spend on your regulatory pathway the question is where are you going to spend it," he said. "In Europe, the notified bodies need to get their act together. The U.S. market is where you are going to have your company acquired and are going to make the big bucks."