Regulatory changes a top concern for medtech companies in 2018


Changing regulatory environments are a top concern for medtech industry professionals in 2018, according to a recent survey from Emergo Group (Austin, Texas).

According to the survey, 68% of industry senior managers and executives said that changing regulatory environments is one of the biggest challenges their companies face. Europe is currently going through major regulatory changes, which is a contributing factor to increased challenges. Up 11% from last year, 56% of firms with less than 10 employees expressed regulatory challenges being a major concern for 2018. About 79% of respondents from companies that employ more than 1,000 employees also expressed regulatory changes being a challenge for 2018.

challenges by employee numbers

2018 challenges by company size [Image from Emergo]

Since regulatory changes are a major concern for companies, understanding new developments is key. Only 29% of respondents reported tracking the developments closely and having a full understanding of the proposed regulations. About 55% said they only have a basic understanding of the changes, having not studied them closely. Another 15% reported that they were aware of upcoming changed, but didn’t know much about them. The remaining 1% was unaware of any regulatory changes.

About 47% of respondents said that new product development would be the second biggest challenge for this year. The third biggest challenges are pricing or profitability pressures and funding, capital, credit and financing with 35% of industry senior managers and executives reporting their projections.

Keeping pace with technological changes and changing reimbursement environments are also what 18% of respondents believe to be a challenge for 2018.

regulatory approval

Difficulty of entering each market [Image from Emergo]

Respondents also reported that it is getting more difficult to get CE Mark approval in Europe, while the Chinese market is also expected to be more challenging going forward. 72% of quality assurance and research analysts thought that the process of getting regulatory approval for a medical device or IVD in Europe will be more difficult this year while 26% said it’ll be about the same difficulty and 2% reported it getting easier. It will be more difficult to get regulatory approval in the Chinese market, according to 65% of respondents. Another 28% reported it being the same difficulty and 7% said it will get easier.

Global medical device consulting company Emergo surveyed 4,282 medical device industry professionals to gauge the industry’s current and prospective climate over 2018.

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