Medical Design Briefs - November 2021 - 4

FROM
THE EDITOR
Report: 2021 an 'Average Year'
for Medtech with Strong M&A and
an Active FDA
Anew 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 outpaced
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.
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" 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. "
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.
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4
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ToC
Sherrie Trigg
Editor and Director of Medical Content
For a copy of the report, go to
https://bit.ly/evaluate-2021-in-review.
Medical Design Briefs, November 2021
http://info.hotims.com/79419-760 https://www.bit.ly/evaluate-2021-in-review
Medical Design Briefs - November 2021

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