A new report from research firm Evaluate gives the medtech industry a fair grade for its performance in 2021. It notes that much of the industry benefited from relaxed rules that had banned nonurgent healthcare visits and elective procedures in 2020. Robotic surgery, imaging, and hearing aid developers fared the best, according to the report.

“Biopharma and Medtech Half-Year Review 2021,” grades the overall outlook for the industry at “steadfastly average,” but adds that this is an improvement over a year ago and may indicate “a belief among investors that the sector is returning to normal after a turbulent 18 months.”

Some good news is that M&A activity for just the first six months of 2021 out-paced all of 2020. The report’s analysts attribute the deals — worth $31 billion — to a “pent-up demand owing to the deals put on hold last year,” at the height of the pandemic.

The top five deals (in the first half of the year) included:

  • Siemens Healthineers purchase of Varian Medical Systems ($16.4 billion)

  • Steris acquisition of Cantel Medical ($4.6 billion)

  • Philips purchase of Biotelemetry ($2.8 billion)

  • Exact Sciences acquisition of Thrive Earlier Detection ($2.2 billion)

  • Hologic acquisition of Mobidiag ($795 million)

VC investment was also healthy, and the analysts say this was due primarily to the pandemic.

“As with the greatest share price moves among listed medtechs, the pandemic has driven much of the action. Some of the biggest rounds have gone to companies active in telehealth, digital therapies, and home treatment, all of which have seen increased uptake under lockdown.”

The 2021 report notes that much of the industry benefited from relaxed rules that had banned nonurgent healthcare visits and elective procedures in 2020.

COVID-19 diagnostics developers also did well. The report points to a very different trend for low-risk novel devices, noting that 14 de novo 510(k) clearances were awarded in the first half of 2021; that number had reached 22 as of mid-October, compared with a total of 26 in 2020.

FDA, of course, had a starring role in medtech’s success as it pushed muchneeded diagnostics and devices to the market via emergency use authorization to combat COVID-19. But that flurry of activity has slowed down.

“Now it seems that burnout might have hit the agency. During the first six months of 2021 the FDA awarded just 12 first-time premarket approvals and one humanitarian device exemption,” the analysts note.

The agency’s focus on responding to COVID-19–related products began to significantly strain CDRH’s resources.

Naming a new FDA commissioner is likely to have a significant impact on the industry in 2022. “The appointment of a new permanent commissioner could mean the pace of approvals picks up again — or it could go the other way, with more thorough scrutiny, particularly of higher-risk devices, driving approvals down,” notes the report.

Sherrie Trigg

Editor and Director of Medical Content

For a copy of the report, visit here .