FDA and to a slightly less extent, AdvaMed, are not effectively representing industry concerns over the 510(k) product review process. The FDA's CDRH (Center for Devices and Radiological Health) federally funded budget of $272 million should be decreased. And the time and money spent to gain US approvals hurts America in terms of having the latest medical technology available vs. the rest of the world. These are some of the findings of this past year�'s MedicalDesign.com Reader Polls.

Though I'll be the first to admit that the polls aren�'t exactly scientific, they represent shared opinions expressed by readers of Medical Design, Medical Edge e-News and MedicalDesign.com. Here�'s a sampling of what readers told us in 2011:

• �Industry concerns over the 510(k) process are being mishandled. When asked, �"Is FDA effectively addressing industry concerns over 510(k)?�" 74% answered no, while only 25% answered yes. When the same question was posed with AdvaMed, instead of FDA, as the lightning rod, 56% answered no and 43% said yes, AdvaMed is effectively addressing industry concerns surrounding 510(k).
• FDA needs to bet better, not richer. Following a Congressional hearing last February during which Jeffrey Shuren, director of FDA's Center for Device and Radiological Health (CDRH), made a case for increased funding, our Reader Poll asked respondents to �"Please indicate whether the FDA�'s CDRH federally funded budget of $272 million should increase, decrease, or remain the same.�" Seventy-one percent said the CDRH budget should decrease, while just 18% said it should increase. Ten percent said it should remain the same. For more on the hearing, see the Feb 22 Perspectives blog, �"Hearing addresses FDA funding, industry accountability," at www.MedicalDesign.com.
• US medtech is being hurt by approval process. This past year saw the industry discussing two studies on how the FDA review process is impacting US medtech. The studies, one of which was co-authored by Stanford Consulting Professor Josh Makower in late 2010 and the other by Northwestern University researchers and funded by InHealth (Institute for Health Technology) in May 2011, highlighted some recurring themes having to do with costs, delays, and inconsistencies. So we asked readers, �"Does the time and money spent to gain US approvals hurt or help America in terms of having the latest medical technology available vs. the rest of the developed world?�" Seventy-five percent said it hurts, 15% said it helps; and 8% said it has no effect at all.

While the MedicalDesign.com readers shared concerns, there was also a shared optimism as shown in the following:

• �Companies look forward to adding jobs. When asked, �"For 2011, please indicate whether your company's workforce will increase, decrease, or remain the same,�" 39% said increase; 25% said decrease; and 35% said remain the same.
• Industrial design ranks high. When asked, �"For its industrial design efforts, is your company using industrial designers,�" 79% answered in the affirmative, with 38% saying they use both inhouse and outside industrial designers; 26% said inhouse only; and 15% reported using outside industrial designers only.

This month�'s poll asks, �"For 2012, will your company�'s research and development expenditures increase, decrease, or remain the same?�" I hope you�'ll weigh in with your response.

Merry Christmas and Happy Holidays!