Apr 13, 2021

Medical device and IVD manufacturers report healthy performance over the course of 2020, but also faced significant operational and regulatory challenges related to the coronavirus pandemic.

Emergo by UL’s Global Medical Device Industry Outlook for 2021,  which surveyed more than 1,600 manufacturers, showed companies performing at levels similar to those reported in our 2020 and 2019 industry surveys. (Only 10% of respondents reported sales decreases this year, up only two percent from our 2020 report.)

Disparate impact on different manufacturers

Despite their overall healthy performance numbers, more than half (56%) of our 2021 respondents indicated slight or significant business decreases attributable to the coronavirus pandemic. Effects of the COVID-19 public health emergency on the medical device and IVD industries were far from uniform, furthermore, with more than 20% of larger manufacturers actually indicating business increases last year due to the pandemic.

Mid-sized survey respondents with between 250 and 1,000 employees reported business decreases at the highest rate (nearly 65% of these firms), while almost 30% of smaller companies with fewer than 50 employees reported significant business decreases during the pandemic year.

Some survey respondents provided specific examples of how the coronavirus pandemic challenged business as usual for them:

  • Delayed regulatory reviews and increased time to market as US FDA and other regulators focused on emergency authorization pathways for medical devices and equipment related to the COVID-19 emergency;
  • Difficulty sourcing and obtaining device component and raw materials
  • Delayed clinical trial executions due to social distancing and lockdown requirements in various jurisdictions and countries
  • Challenging international sales environments

Regulatory challenges still dominate—but less so

The business challenge posed to manufacturers by the coronavirus pandemic in 2020 also affected longstanding issues such as changing regulatory environments, new product development and pricing pressures cited by companies in previous Emergo by UL annual surveys.

Every year, for example, strong majorities of survey respondents identify changing regulatory environments as their biggest challenge, as was the case for our 2021 results—but only 65% of firms did so this year, compared to 74% in 2020. As the COVID-19 emergency took hold globally, companies appear to have refocused on addressing acute pandemic-related challenges. Whether or not these percentages revert back to more typical form for our 2022 survey depends on how comprehensively the COVID-19 emergency is brought under control this year.

Learn more about COVID-19 and related medical device regulatory resources:

  • COVID-19 regulatory resource center for medical device and IVD companies
  • US FDA Emergency Use Authorization (EUA) consulting for medical device and IVD manufacturers
  • Medical device and IVD emergency use pathways in the European Union

Author

  • Stewart Eisenhart

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