The 2012 Medical Device Industry Outlook survey, conducted by Emergo Group in cooperation with Medical Device Summit, has revealed tempered enthusiasm. Results show that many companies performed well last year, but are bracing for challenges and uncertainties in various markets in the coming year, such as the device approval process, the device tax, and growth in emerging markets.

Unlike some other emerging markets, China has a medical device regulatory system in place that is both substantial and challenging.

Adhesives offer a number of advantages over other fastening systems. Today, a number of adhesive are available and there is no such thing as “one adhesive fits all.”

Is the 510(k) process ideal? Far from it. But it generally does a very good job at what it’s supposed to do: make a risk-based assessment of new or modified products before permitting them on the market, while keeping the evidentiary burden on companies at realistic levels, and rely on postmarket surveillance to capture problems.

Thinking of marketing your product in China, India or Brazil? What do you need to know?

It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedicalDeviceSummit presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.