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.”

As novel devices are being designed with newer materials and several heat-sensitive components, there is increased interest in cold EO sterilization, in which sterilization is effected at body temperatures. But while successful cold EO sterilization has been demonstrated, it is not without downsides, and many contract EO sterilizers do not yet have the capability to run at such low temperatures.

Taking a medical device product to market is a road trip in the fast lane through perilous mountain passes. Using a project management process can help products travel more securely from conception to commercialization and prevent costly detours during the product development process. This could translate to less money wasted on dead ends, safer trips through regulatory review and faster launches.

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.

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.

Medical device manufacturers have long marketed their products with limited concern for costs. But today, an aging population and skyrocketing medical costs are prompting private insurers and government payers worldwide to limit reimbursements for medical devices. Medical device manufacturers are responding in two ways, by one, justifying product price points by carefully documenting their value in improving patient outcomes; and two, reducing costs throughout their operations by rethinking how they sell and market their products, outsourcing operations, and implementing Lean manufacturing principles. Enterprise software enables medical device manufacturers to more successfully implement these price justification and cost cutting initiatives.

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.

The compact design of medical devices has many benefits including the availability of patient home care devices such as portable blood pressure and other vital-sign monitoring devices. Electronic component sizes are becoming smaller and smaller and the latest packaging technology, Package-on-Package, enables miniature designs that will allow designers and developers to add more technological features to products within the same limited space. PoP will thus play an important role in component reliability and compact design for medical devices in the years to come.