Regulatory challenges top list of concerns of medtech professionals in annual survey

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February 23, 2018

The survey of medtech professionals that regulatory consultancy Emergo (Austin, TX) conducts each year is a good gauge of the mood of the global medical device industry as it heads into a new year. Typically, there are no dramatic shifts in attitudes and perceptions from one year to the next—progress and change tend to be incremental in the medtech sector—but there is movement on the margins that can be instructive. From that perspective, key takeaways from the Global Medical Device Industry Outlook for 2018 include tempered growth expectations in all markets compared with 2017 and a broad consensus that a “changing regulatory environment” is the biggest challenge that industry faces in 2018.

“Overall, it appears as though 2017 was more good than great,” writes Emergo Senior Regulatory Analyst Stewart Eisenhart in the executive summary of the survey report. “These more modest performance results help explain lower growth expectations for all markets heading into 2018,” he added.

Reflecting on 2017 results, 63% of companies responding to the survey reported an increase in sales between 1 and 10%; 11% said sales increased by 11%; and 19% had a 15%+ sales increase. Only 7% said that sales declined in 2017.

In 2018, as in past years, survey respondents expect to see the strongest sales growth in the United States (43%) and Europe (41%). China comes in a distant third, getting 23% of the votes. Once the darlings of industry analysts, the BRIC countries—Brazil, Russia, India and China—continue their downward spiral, although at “less dramatic rates” than in the past, writes Eisenhart. The chart below from Emergo shows the most noteworthy changes in expectations of growth between the 2017 and 2018 surveys.

Emergo chart
Image courtesy Emergo.

Asia remains the favorite in terms of long-term growth prospects, notes the report—52% of respondents pegged it as having “high growth potential”—while the United States and Europe scored “average growth potential” with a plurality of respondents.

When asked how they thought their company and the medical device industry at large would fare in 2018, respondents interestingly “expressed significantly more optimism for their 2018 prospects than for the industry as a whole—40% of respondents have a very positive outlook for their own firms versus 23% for the entire device industry,” notes the report.

The next rendezvous for plastics professionals and the medical device supply chain happens in Cleveland, OH, on March 7 and 8, 2018. UBM America’s newest design and manufacturing trade show and conference, Advanced Design & Manufacturing (ADM) Expo showcases five zones—medical manufacturing, plastics, packaging, automation and robotics, and design and manufacturing. A full slate of conference sessions will explore innovations in advanced manufacturing. Go to the ADM Cleveland website to learn more and to register to attend.

In terms of the biggest challenges industry faces, 68% pointed to a changing regulatory environment. This is driven largely by the European Union’s transition to the new, more stringent Medical Device Regulation, which begins to go into effect in 2020. The United States is not entirely off the hook: While the Trump administration has made some attempts to streamline FDA’s regulatory process, “ongoing attempts to repeal or reduce the scope of the Affordable Care Act and related federal healthcare programs have added uncertainty for market registrants,” writes Eisenhart in the executive summary. Other things keeping medtech professionals awake at night, according to the survey, include new product development (47%) and financing/funding and pricing pressures, both at 35%.

A total of 4282 medical device industry professionals participated in the survey, 40% of whom are based in Europe and 38% in North America, reports Emergo.

The report is available as a free download on the Emergo website.

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