According to a new survey of more than 2,600 medical device industry participants by medical device regulatory consulting firm Emergo Group, more than 53% of respondents reported increased international sales in 2011, compared to nearly 42% of respondents reporting growth in domestic sales.
BRIC markets command highest interest
As more medical device companies pursue global business development strategies, more and more of them are focusing on BRIC markets-Brazil, Russia, India and China. More than 65% of survey participants saw China as the market with the biggest five-year growth potential, with Brazilian and Indian markets also ranking highly among firms.
US versus EU: Preferences Emerge
Another key finding in the survey examines claims that a more cumbersome FDA registration process has led more and more manufacturers to commercialize their devices first in Europe. Although nearly 22% of participants indicated that the European CE Marking process for medical devices became more difficult in 2011 due partly to stricter clinical data requirements, more than half of participants have found the US FDA registration process to be more difficult since 2010.
While most North American participants still prefer to launch products in the US first-and most European firms prefer to launch in Europe first-nearly 40% of North American participants stated theyd choose Europe as their first path to market. Only 17% of European firms would consider launching products in the US first. "These results seem to validate industry perceptions that the US regulatory process has grown more complicated since 2010, and that European registration is in comparison more transparent and predictable for manufacturers," according to Stewart Eisenhart, Regulatory Editor for Emergo Group.
Full results of Emergo Groups 2012 Medical Device Industry Survey are available at: http://www.emergogroup.com/research
About Emergo Group
Emergo Group is a global medical device regulatory consulting firm providing a wide range of services for device registration, QMS compliance, clinical trial management, in-country representation, reimbursement and distributor search consulting.