EMERGO SUMMARY OF KEY POINTS:

• One third of all 2017 Global Medical Device Industry Outlook respondents reported sales increases of 10% or more over the last year.
• Many medical device companies are expecting more growth from established markets in the US and Europe than in developing markets in 2017.
• Regulatory changes continue to represent the biggest business challenge for most survey respondents.

Emergo's latest survey of more than 3,000 medical device industry participants finds renewed focus among companies on US and European markets, as well as more bearish expectations for BRIC markets and greater challenges addressing regulatory compliance.

The 2017 Global Medical Device Industry Outlook examines issues including 2016 sales performance, worldwide market growth projections, preparations for the new ISO 13485:2016 quality standard and reactions to new medical device and IVD regulations soon to impact the European Union.

Below, we cover five major findings of our 2017 survey. In the coming weeks, we will provide more in-depth analysis of particular findings of the survey.

Substantial sales growth for most respondents

More than 20% of our latest survey respondents reported sales increases of 15% or higher last year, and nearly 30% of firms reported increases of between six and 10 percent. Only 10% of firms indicated decreased sales for 2016.

The highest percentages of sales increases came from smaller firms—34% of firms with nine or fewer employees and 31% of firms with 50 or fewer employees grew sales by 15% or more. Larger respondents with 250 or more employees indicated more modest sales growth of 10% or less.

Market outlook: Higher hopes for US, Europe

Emergo surveys from previous years found relatively bullish growth expectations for BRIC (Brazil, Russia, India and China) medical device markets. Our 2017 results, however, reflect a significant shift in such expectations away from developing BRIC markets toward the US and Europe.

Positive growth expectations for the US jumped nine percent between 2016 (51% of respondents) and 2017 (60%), while such expectations for Europe increased from 40% in 2016 to 51% in our latest survey.

Emerging markets, on the other hand, saw declines in growth expectations between 2016 and 2016, due to various factors including economic slowdowns, regulatory challenges and increased costs of market entry.

Guarded optimism for 2017

More than 80% of 2017 survey respondents anticipate very or somewhat positive performance for the coming year for their own part, but do not show quite the same level of optimism for their industry as a whole.

Although more than 40% of firms expressed a very positive 2017 outlook for themselves, only 22% of those respondents are equally as optimistic about the medical device industry's overall prospects.

Levels of optimism varied according to region, as well. More respondents based in Asia (31%) reported very positive 2017 outlooks for themselves, while about half of firms based in North America and Europe reported only a somewhat positive outlook.

Regulatory challenges affecting firms of all sizes

As was the case in our 2016 survey, most senior managers (66%) identified regulatory changes as their biggest business challenge this year. Firms with as few as 10 employees and as many as 1,000 cited regulatory issues as their biggest challenge for 2017; larger firms identified these issues as their top concern more so than smaller firms, which also cited funding and capital as key challenges.

Europe's MDR: More studying to do

Europe's pending Medical Device Regulations (MDR) represent a massive change to how devices are regulated in one of the world's largest markets, but based on our 2017 survey responses, industry participants have yet to fully understand how the MDR will impact their compliance efforts.

More than half of all 2017 respondents reported a basic understanding of the MDR, but that they still need to examine the new regulations more closely to determine how their European operations will be affected.

Larger firms—with larger regulatory affairs departments—were more likely to report better understanding of the MDR's ramifications.