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.

Recent changes made in the Mexican regulatory framework have the potential to significantly ease Mexican approval process going forward.

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?

The safety assurance case approach helps more reliably design safety into products at an early stage, and communicate the safety arguments in an easier format. However, the burdensome pathway is growing longer and more arduous, and the 510(k) process is migrating closer to a premarket approval. Few understand what an assurance case is or how to construct one, even, some aver, among the CDRH review staff.

FDA 21 CFR Part 11 provides, in particular, regulations that enable device manufacturers to use electronic records and signatures in a manner equivalent to paper-based records and hand signatures. However, FDA does not specify how companies must address these requirements, but rather provides a set of guidelines based on common sense and good workflow processes. This paper describes how an ideal enterprise software solution can enable device makers to fulfill these demands.

Total product lifecycle management must become more than an FDA-, compliance-focused initiative. To reap the cost, quality and regulatory benefits presented by TPLC, companies must adopt new ways of conducting business. With consistently applied processes and systems, companies will be able to predict and prevent quality issues that affect compliance and cost. 

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.

The 2011 Medical Device Industry Outlook survey, conducted by Emergo Group and Medical Device Summit, has revealed cautious optimism. In terms of indicators such as expansion into new markets, expected sales trajectories and salary outlooks, the medical device industry expects to see a healthy rate of growth this year. More than three quarters of respondents expect overall sales to increase, with many seeing significant increases in international orders, and planning to expand into emerging international markets. More than half of respondents plan on hiring more in 2011.