Things are looking rosy in 2013 for the majority of respondents in a medical device industry survey, which aimed to capture attitudes about the year ahead.
Of the more than 3,000 survey participants, most said they were either "somewhat" or "very positive" about the general business environment the industry in 2013, and even more were optimistic about their own companies’ prospects for the year.
The most significant challenge facing device makers in the year ahead was the regulatory environment, although new product development and challenges in accessing capital and financing were a close 2nd and 3rd, according to the Emergo Group survey.
When asked about the general outlook for 2013, nearly half of participants said they were "somewhat positive," taking a more cautious stance than the 21% who said they were "very positive." The upbeat mood appears to have increased since last year, when 67% of survey-takers said they were somewhat or very positive about 2012.
The trend spanned continents, with respondents from all regions largely reporting optimistic expectations for 2013.
"Despite global economic uncertainty, results suggest that medical device firms expect growth opportunities driven by aging populations and growing middle classes in emerging markets including Brazil, India and China," according to Emergo.
About 14% of survey-takers were neutral about the industry’s 2013 and prospects, and 12% said they were "somewhat" or "very negative," with the remainder checking "not sure."
Medical device makers in general were ambivalent about the obstacles they may face in the year ahead, but for the subset of respondents with President, CEO, COO or Managing Director titles, the regulatory environment took the top spot.
Other concerns followed close behind, with new product development and access to capital each affecting more than 40% of respondents. Pricing pressure and increased competition rounded out the top 5.
Environmental obstacles varied when accounting for company size, with organizations of less than 10 individuals far more worried about access to capital and those with more than 249 workers focused more on regulation and product development. Reimbursement concerns were evenly distributed among most groups, and competition and pricing pressures weighed more heavily on the larger companies.
Dealing with regulation
The respondents generally agreed that regulatory environments across a variety of markets hadn’t gotten any easier to navigate. Device makers were torn about the U.S. approval process, with 41.8% voting that things had grown more difficult and 41.7% voting that things had stayed the same. Only about 3.5% said things had improved, and 13% said they didn’t know.
About half of survey respondents agreed that the FDA is "taking positive steps toward making the regulatory process easier and more transparent," although 32% voted "no" and 20% weren’t sure or had no opinion on the matter.
In terms of difficulty, the Canadian regulatory system seemed the same for 59% of survey-takers and more difficult to 14.3%, and the European environment looked the same to 57% and harsher to 42.7%, according to the survey results.
About 34% said things had grown more challenging in Brazil, 43% said the same of China and nearly 20% reported a more challenging regulatory environment in Japan.
Nearly 75% of the survey respondents came form the medical device or IVC manufacturing industry, with the remainder comprised of distribution/logistics, professional services, government/academia and miscellaneous other areas.
About 35% came from companies of 250 or more employees and 20% worked with 9 or fewer employees. Just over half were from the U.S., 31% were from Europe, the Middle East or Africa, and the remainder participated from the Asia Pacific region.
Nearly 60% of survey respondents were primarily responsible for regulatory, quality or clinical roles, about 16% were in senior management positions and the rest were comprised of sales, marketing, engineering and others.