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Emergo Group surveyed more than 5,400 medical device industry professionals around the world to gauge the industry’s climate in 2015. Survey respondents were asked to pinpoint their biggest challenges, the most challenging markets for regulatory approval/compliance and effects of the U.S. medical device tax.
Survey results indicated a mostly positive outlook going into 2015, especially for U.S. companies. Not surprisingly, challenges remained in the areas of pricing, regulatory issues and reimbursement.
Challenging global markets for regulatory approval indicated by survey participants were China, Japan, Russia and Brazil. That said, many companies predict strong growth in Asian markets in the next five years.
Also, many U.S. companies reported that they did not make many changes in 2014 in response to the medical device tax.
What follows is greater detail on these key findings.
75% of the 5,400+ survey respondents are positive about the medical device industry in 2015
Companies from North/South American and Asia are more optimistic than those located in Europe, due to weakened economic conditions in Europe.
China, Japan, Russia and Brazil have become more difficult in the area of regulatory approval
The survey asked quality assurance and regulatory affairs professionals whether obtaining regulatory approval in various markets is more difficult today than it was last year. Here’s what the numbers look like, based on responses from 2,248 professionals.
Percent of respondents (from all over the world) who indicated obtaining regulatory approval in this country was more difficult today vs. last year:
- Canada – 15%
- Taiwan – 25%
- Mexico – 25%
- Europe – 31%
- South Korea – 32%
- Japan – 33%
- United States – 35%
- Brazil – 42%
- Russia – 52%
- China – 63%
New regulations released in China in 2014, as well as uncertainties about which products require clinical trials, have made regulatory compliance in that country more difficult. Similarly, new regulations by the Pharmaceutical and Medical Device Agency (PMDA) went into effect in Japan in late 2014, impacting the regulatory pathway. In Russia, a lack of transparency challenges RA professionals. Long review times and Brazilian Good Manufacturing Practice (BGMP) audit queues by Agência Nacional de Vigilância Sanitária (ANVISA) challenge regulatory approval in Brazil.
Respondents from Asia (mostly Japan and China) reported difficulty in complying with Chinese CFDA regulations and U.S. FDA regulations.
- 51% of respondents in Asia reported China as a difficult market for regulatory compliance
- 49% of respondents in Asia reported the U.S. as a difficult market for regulatory compliance
North and South American respondents reported China and Japan as challenging markets.
- 40% of respondents in North and South America reported Japan as a difficult market for regulatory compliance
- 46% respondents in North and South America reported China as a difficult market for regulatory compliance
Despite regulatory challenges in China, most companies expect the Chinese market to experience strong growth in 2015
334 responses from senior medical device executives (throughout the world) in companies with 250+ employees were asked what geographic regions they expected to have the strongest growth in 2015. Here’s how they reported:
- China – 44%
- U.S. – 43%
- Europe – 37%
- Brazil – 29%
- India – 25%
Many U.S. companies did not make major changes in response to the medical device tax
Based upon responses from 685 medical device executives in the U.S.:
- 57% of companies made no significant changes
- 29% raised prices
- 18% invested less in R&D
- 14% reduced staff
- 8% lowered production costs without reducing staff
Larger companies were more likely to raise prices, cut R&D budgets and reduce staff.
