Executives from Leading Medical Device Organizations Drive Research on Total Product Lifecycle

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Directors and VPs of Regulatory Affairs, Quality, Information Services, Innovation, and Operations form the Industry Council for a new study being conducted by Axendia, Cambashi, and FDAnews. The participating executives represent several of the largest and most respected companies in the medical device industry, and are providing input and direction to the research team on a new survey about current industry challenges, practices, systems, and opportunities.

Axendia, Cambashi, and FDAnews today announced that executives from a group of leading medical device manufacturers have joined the industry council for the Total Product Lifecycle (TPLC) management study. The council will provide critical guidance and insight on the industry's transition to more collaborative approaches and their impact on increased product quality and lower costs.

The industry council members for this project are directors and VPs of regulatory affairs, quality, information services, innovation, and operations. These executives represent several of the largest and most respected companies in the medical device industry. This select group of industry practitioners has provided input and direction to the research team on a new survey about current industry challenges, practices, systems, and opportunities.

Industry Council members provide executive perspective to ensure that this research focuses on critical innovation, quality, safety and profitability issues that will deliver real gains in understanding and insight for the industry. This distinguished group of industry executives will oversee and review findings, and provide guidance to frame the presentation of results in ways that will be most meaningful to the industry. The research team would welcome other executives to join this prestigious group of people in the Industry Council and review the TPLC study results prior to their release.

To obtain the broadest possible input from industry practitioners, the research team is seeking responses to both an on-line and a follow-on telephone survey from all medical device manufacturing companies through April 16. Survey responses will be aggregated and individual responses will remain strictly confidential.

To participate in this important research study, complete the online survey available at: http://www.surveymethods.com/EndUser.aspx?E6C2AEB0E0A6B0BD or through http://www.fdanews.com, http://www.axendia.com or http://www.cambashi.com.

The results of this study will be released at the Sixth Annual Medical Device Quality Congress June 3-5 in Cambridge, MA, in a special session on the research, Total Product Lifecycle Management: Lowering Costs while Increasing Quality. This research ties in closely with the conference theme, Leading the Way to Better Performance With Quality Systems Compliance.

All respondents will receive a copy of the final report a few weeks after the conference to help them gauge their own progress toward a coherent approach to total product lifecycle management. In addition, survey respondents receive two free reports, one on risk management, and one on troubleshooting medical device quality systems for worldwide markets.

About Axendia
Axendia is a leading analyst and strategic advisory firm focused on the Life-Sciences and Healthcare markets. We provide trusted advice to Life-Science Executives on Business, Regulatory and Technology issues. Axendia professionals offer a unique combination of deep hands-on industry experience coupled with strategic vision. Axendia serves the complete Life-Science Eco-System including Life-Science Organizations, Technology & Service Providers and the Investment community. Our clients range from startups to Fortune 100. We contribute to our client's success by providing long-range visibility and helping them navigate the ever-changing landscape in the Life-Sciences and Healthcare markets. For more information, visit http://www.axendia.com or contact us at info(at)axendia.com. To stay informed on Industry trends, read Axendia's Life-Science Panorama, a Journal for Industry Executives, at http://lsp.axendia.com.

About Cambashi
Cambashi, based in Cambridge, UK, and Cummaquid, MA, USA, provides independent research and analysis of the business reasons to use IT in industry worldwide. It specializes in engineering, enterprise, plant and supply chain applications and the infrastructure to enable industrial firms to use IT effectively. Cambashi publishes market size estimates in the engineering applications Market Observatory and industry issue research studies in the Cambashi Reports Industry Directions series. Its clients vary in size from small to large and include most of the leading software vendors and many pioneering IT users. Cambashi is a member of CATN, an international association of consultants. To learn more, visit: http://www.cambashi.com.

About FDAnews
FDAnews publishes domestic and international regulatory, legislative and business news and information for executives in industries regulated by the U.S. Food and Drug Administration. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books, management reports and conferences to stay in compliance with international standards and FDA's complex and ever-changing regulations to get their products to market faster and boost profits. FDAnews brings you the knowledge you need, when you need it. To learn more, visit: http://www.fdanews.com.


Daniel R. Matlis
(267) 352-4801

Matt Salt
(703) 538-7600

Julie Fraser
(508) 362-3480

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