I always look forward to the annual medical device industry outlook published by Emergo by UL, a global regulatory consulting firm specializing in the medical device and IVD sectors headquartered in Austin, TX. The company has released its “high-level snapshot of the industry’s current climate, as well as its prospects over the coming year,” and the report paints a largely positive picture of the medtech industry going into 2019, although there are also some glimpses of furrowed brows in the C suite.
A total of 2,327 medical device industry professionals from around the world participated in the survey. Here are some key takeaways from my perspective. The full report, Global Medical Device Industry Outlook for 2019, is available as a free download (registration required) at the Emergo by UL website.
- Slightly more companies reported low to moderate sales increases but fewer companies reported increases of more than 15% in 2018 than in the previous survey. See chart below for the full breakdown. “So, fewer firms missed their sales targets in 2018, but higher-rate increases proved more elusive,” writes Stewart Eisenhart, Senior Regulatory Analyst, in the report.
- Companies anticipate the strongest growth in sales/turnover for 2019 in the United States and Europe—42% and 36%, respectively, of respondents—but long-term prospects for high-growth potential favor Asia/Pacific. Sixty-four percent of respondents pegged Asia/Pacific as the long-term growth leader, compared with 30% for North America and 16% for Europe. For the latter two markets, a majority of respondents anticipate average growth.
- Survey participants were more optimistic about their own company’s prospects in 2019 than they were of the industry as a whole, but both numbers took a dip compared with the 2018 survey. “The number of firms expressing very positive outlooks for themselves declined from 40% in 2018 to 33% this year, while those with very positive outlooks for the industry fell from 23% last year to 18% this year,” writes Eisenhart.
- The biggest challenge medical device manufacturers face, by far, is a changing regulatory environment, which was cited by 72% of respondents. Coming in at number 2 is new product development, which garnered 46% of the votes. (This question was posed only to senior managers and executives, notes Emergo.) Not surprisingly, most firms citing regulatory matters as the top issue are based in Europe, where the new Medical Device Regulations will come into force next year. On a related note, the survey also revealed that nearly half of respondents still have only a basic understanding of the regulation. So, there’s that, and then there’s Brexit.
- Almost half of all respondents indicated “no major adjustments to deal with Brexit, despite the ramifications of a potential no-deal Brexit on manufacturers’ Notified Body and Authorized Representative relationships in the UK and Europe,” writes Eisenhart. A significant percentage of survey participants said that they did not know or could not disclose how their company planned to deal with Brexit . . . much like the UK government at this point.
Graphics courtesy Emergo by UL.