The pandemic has largely fixed the FDA’s focus on emergency use authorizations (EUAs), leaving more typical device approvals waiting. At this time, the regulatory agency has granted 84 EUAs since Feb. 4 and has approved only 10 non-coronavirus-related devices this year — the last one on March 18. In comparison, the FDA approved 16 devices by May in 2019 and 46 during all of last year.
The slowdown in premarket approvals could even stretch into next year, according to Debbie Wang, a senior analyst at Morningstar.
“Considering how busy the FDA will be with COVID-19 diagnostic testing oversight (not to mention trials for COVID-19 treatments and vaccines), we wouldn’t be surprised to see the pace of new device approvals slow through 2020 and into 2021,” Wang told Medical Design & Outsourcing.
Some medtech companies have devices in the research and development pipeline for this fiscal year, but a few companies have publicly announced temporary holds on trials and studies of devices: Edwards Lifesciences paused enrollments in its active pivotal clinical trials of transcatheter mitral and tricuspid therapies on March 28; three weeks later, Medtronic put a temporary hold on clinical trial enrollment.
“Timelines are likely going to get stretched due to most trials being put on hold for a period of time as well as delays in review,” Raj Denhoy, a Jefferies analyst, told MDO.
COVID-19 has also caused companies to re-evaluate their financial guidance for the fiscal year:
- Medtronic reported in April that its weekly revenue in the U.S. was down 60% because of the pandemic. The Fridley, Minn.-based company said products from its cardiac and vascular group, minimally invasive therapies group and diabetes group are in high demand, but that it expects COVID-19 to negatively affect its fourth-quarter performance.
- Boston Scientific said that business trends through the first two months of the year were in line with financial expectations, but now expects first-quarter revenue growth on a GAAP basis to be flat to up slightly compared to 2019. “We are continually assessing shifting market dynamics related to the pandemic and will disclose any updates to our timelines in accordance with SEC regulations,” Boston Scientific spokeswoman Kate Haranis said.
- Edwards Lifesciences lowered its outlook, saying it couldn’t accurately predict the progression of COVID-19 or the disruption to hospital procedures that would use Edwards devices. The company said second-quarter sales will be severely affected, followed by a gradual recovery in the third quarter and a Q4 that better matches its original sales expectations. Edwards now expects 2020 sales in the range of $4 billion to $4.5 billion, down from the previous range of $4.6 billion to $5 billion.
“As for COVID-19, we suspect the device makers will be loath to reduce their R&D resources,” Wang said. “Even if they reduce R&D spending in the near term, we would expect they’ll try to hang onto as many engineers as possible. During the Great Recession, the device makers managed to preserve their R&D capabilities.”
Despite the challenges gaining timely approval, the medical device pipeline is full of devices ranging in applications from renal denervation to single-use scopes. Here are seven devices whose manufacturers expect to gain approval during this fiscal year.