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Emergo Survey: Regulatory Challenges Having Bigger Impact on Smaller Medical Device Companies


  • Regulatory challenges are affecting larger percentages of both large and small medical device companies heading into 2018, according to a new Emergo survey.
  • In previous years, small and startup companies were more concerned with funding and capital issues than regulatory challenges.
  • Product development, pricing pressure and funding challenges also ranked highly in our 2018 survey.

Medical device manufacturers of all sizes cite changing regulatory requirements as their top business challenge heading into 2018, according to a new survey.

Emergo’s 2018 Outlook for the Medical Device Industry, which queried more than 4,200 medical device and IVD companies based in North America, Europe and Asia on market, compliance and related issues, also asked respondents who were senior managers at their firms to identify their top business challenges.

Changing medical device regulatory environment

Changing regulatory requirements have been the biggest challenge identified by companies every year the Emergo survey has been conducted, but our 2018 results show more companies of all sizes citing this issue.

First, 68% of senior managers and executives indicated changing regulatory environments as their biggest challenge for 2018, an increase from 66% of managers last year. However, a majority (55%) of even small firms with less than 10 employees cited regulations as their biggest challenge; in 2017, substantially more small companies identified funding and capital challenges (56%) as a bigger obstacle than regulatory changes (45%).

Larger survey respondents (firms with 250 or more employees) have historically named regulatory requirements as bigger operational challenges than smaller companies have. This trends make sense given that larger firms have registered devices for sale in multiple markets, and thus must deal with multiple regulators.

In 2018, though, it appears that even smaller companies are feeling the effects—particularly of massive medical device and IVD regulatory overhauls underway in Europe. Given the size of the European healthcare market, more and more device manufacturers both large and small have felt the impact of the Medical Devices Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR) in terms of CE Mark certification requirements, Notified Body partnerships and related issues.

Other key business challenges for 2018

Although regulatory issues once again dominated our survey’s “biggest challenges” category, other significant issues companies identified include:

  • Product development: This was the second biggest challenge in our 2018 survey, selected by 47% of respondents. Larger companies were more likely to cite this challenge than smaller firms.
  • Funding and capital: As in previous years, more than half of small and startup companies (54%) deal with this issue, while mid-sized and larger firms do not.
  • Pricing pressure: 35% of this year’s respondents indicated pricing pressure as a key challenge, up one percent from our 2017 survey. This was a bigger concern for larger companies, with more devices commercialized in more markets, than their smaller competitors.

Related global medical device regulatory resources from Emergo:

  • European CE Marking strategy consulting
  • US FDA 510(k) consulting for medical device and IVD companies
  • Whitepaper: European MDR transition timelines and strategies
  • Whitepaper: Preparing a US FDA 510(k) submission

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