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.

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.”

By leveraging features such as material chemistry, and maximizing interconnected porosity in a biostable elastomeric scaffold, it is possible to produce desirable clinical outcomes, i.e., stable tissue in-growth, while at the same time limiting the extent of the foreign body response to prevent encapsulation or scar formation.

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.

For the past decade “translational science” and “translational medicine” have been cherished buzzwords, raising the prospect of faster, better, more seamless transfer of discoveries from bench to bedside. Too often, though, it doesn’t work. Differences in the cultures of academia and medical manufacturing, and a poor grasp of regulatory and reimbursement issues, or of what makes a bright idea into a clinically useful, commercially viable product have scuttled more than one promising innovation.

The relationship between the end use of the device, the substrates specified, the adhesive chemistry, and the actual design of the bond joint can all impact the strength of the final assembly, yielding different results for each device. To ensure a robust device design, engineers must thoroughly test the assembly under both manufacturing and sterilization conditions.  

Medical device manufacturers’ business needs have changed significantly over the past several years, evolving the roles that technology plays within their manufacturing process. Two key technologies—Enterprise Resource Planning (ERP) and Product Lifecycle Management (PLM)—have developed into critical success factors for these manufacturers. Each technology brings unique value to the enterprise, and when combined, ERP and PLM provide a wholly collaborative environment that has a major impact on successful product development performance and the ability to maintain a competitive advantage.

Surface tension keeps pond-skating insects from sinking and soap bubbles from popping. However, in other areas of life, it can cause adhesive contact surfaces to fail, medical tubing to block – and worse. Determining the surface energy of a polymer surface is critical to ensuring proper coating quality, as well as the adhesion properties – especially with the growing popularity of water-based inks, coatings, and adhesives.

Human Factors Engineering (HFE), also known as usability engineering or ergonomics, is the study of how humans interact with machines and complex systems.  HFE entails overt consideration for all aspects of user interaction with a device and is assessed continuously during the product development process using usability testing.  As medical devices are becoming more complex – due, in part, to greater availability of technology and the sophisticated tasks asked of them; human factors considerations are increasingly critical.  This is particularly true for medical devices intended to be used directly by patients.