After a somewhat mixed performance in 2017, medical device manufacturers have scaled back their expectations for anticipated growth in 2018, according to a recent survey by The Emergo Group.
Released in February, the company’s 10th annual “Outlook for the Medical Device Industry” polled more than 4000 medical industry professionals, who appear to be a bit less optimistic than a year ago. At that time, Emergo’s annual survey found that more than 90 percent of companies saw some increase in their business in 2016, with fully one-third of companies seeing an increase of more than 10 percent. But in 2017, about 60 percent of survey respondents saw growth of 10 percent or less.
2017’s results have dampened expectations for 2018 in every market around the globe. While respondents are still optimistic on growth in both the U.S. and European markets, projected increases are off for both markets from 2017 projections (41% in the EU for 2018 versus 51% for 2017, and 43% in the U.S. for 2018 versus 60% for 2017). And growth expectations for countries such as China, Brazil and India are off significantly from 2017 projections (23% in China for 2018 versus 33% for 2017, 12% in Brazil for 2018 versus 17% for 2017, and 12% in India for 2018 versus 18% for 2017).
The Emergo Group report notes that the changing regulatory landscape continues to challenge companies of all sizes. In the EU, the transition to the new Medical Device Regulation (MDR) and InVitro Diagnostic Regulation (IVDR) is expected to make market access more difficult. And, in the U.S., the ongoing debate on the scope of the Affordable Care Act overshadows efforts by the U.S. Food and Drug Administration (FDA) to streamline the regulatory process for medical devices.