Feb 27, 2017


  • Regulatory issues continue to be the biggest business challenge for medical device companies of all sizes.
  • Managers at smaller firms report greater concern for funding and capital issues, while largest firms are more challenged by pricing and competition pressures.
  • Medium- and large-sized firms cite product development as a significant challenge, as well.

Changing regulatory environments continue to present the biggest business challenge for a majority of medical device company senior managers, according to an annual Emergo industry survey.

Asked to identify the biggest business challenge they face as part of Emergo’s 2017 Global Medical Device Industry Outlook, nearly 70% of more than 500 senior managers of medical device companies surveyed cited changing regulatory environments as their top issue. But depending on respondents’ size, other challenges such as product development, profitability and funding were also identified.

Medical device regulatory challenges: still number one

Regulatory issues perennially top the list of business challenges in Emergo’s industry surveys, and this year was no different. But while 66% of senior managers identified regulatory changes generally as their biggest challenge, managers of larger firms were more likely to cite regulatory changes as their top concern.

Funding, product development bigger challenge for smaller medical device companies

For small and start-up firms with fewer than 10 employees, on the other hand, regulatory changes were still cited as a big challenge—45% of these respondents said so—but an understandably bigger challenge for these firms is funding and capital (56% of firms).

Product development also represented a significant business challenge for respondents of all sizes; 57% of managers at mid-sized firms with between 50 and 250 employees listed product development as their second largest challenge, and half of all larger firms with more than 250 employees cited product development as second only to regulatory issues as their biggest challenge, as well.

Pricing and competition concerns for largest players

Finally, managers at the largest respondents were most likely to cite pricing and competition pressures as major business challenges.

More than 50% of managers at companies with more than 1,000 employees indicated increased competition as a key challenge; 46% of these managers also cited pricing pressures as a major concern. Among smallest respondents, on the other hand, only 15% and 28% of managers listed competition and pricing, respectively, as major challenges. 


  • Stewart Eisenhart