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.

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.

The concept of CoQ models and their effectiveness has been evolving since the late 1940s and today, there are a number of different CoQ models employed by industry. However, most CoQ models and their derivatives are premised on the Prevention-Appraisal-Failure Model. To ensure an accurate determination of total CoQ is achieved, an organization must evaluate all costs influencing quality.

Biocompatibility testing is common in the medical device industry, but with 24 categories under which a device could qualify, biocompatibility testing can be intimidating. The majority of biocompatibility failures are not catastrophic and can be solved without significant delays, cost or recalls. Having a plan in place will expedite that process and get the product to market in a timely manner. Always anticipate a failure and be prepared with options before they happen.

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. 

Supplier control issues will remain high on the list of FDA’s Center for Devices and Radiological Health and Office of Regulatory Affairs targets for inspection and enforcement activity this year. Unique issues in medical device supplier management include the diversity of supplied products and services, the varying complexity of materials and components, and the wide range of risk from different products – even from different products provided by the same supplier to the same customer. MedicalDeviceSummit’s conference on this topic highlighted some key issues.

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.

The medical devices sector faces a host of problems including pricing concerns, procedural volume pressure, fallout of the healthcare reform, and increasing regulatory uncertainty. These pressures are prompting device companies to expand into lucrative emerging markets. We present excerpts from recent market research released by Zacks Investment Research describing major opportunities and weaknesses for the device sector in the U.S. market.