Industry Professionals Guide FDAnews & Industry Directions Study -- eVent Medical, Gaymar, Osmetech, Roche Contribute Insights to Risk Management: Best Practices for Medical Device Profitability

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FDAnews and Industry Directions Inc., in close association with research analysis partner Cambashi Ltd, today announced that executives from a group of medical device manufacturers have helped guide the research effort into multiple aspects of risk management and how they contribute to increased profits and business success.

FDAnews and Industry Directions Inc., in close association with research analysis partner Cambashi Ltd, today announced that executives from a group of medical device manufacturers have helped guide the research effort into multiple aspects of risk management and how they contribute to increased profits and business success. The industry council members for this project include Bob Lundberg, VP Regulatory Affairs and Quality for eVent Medical; Patti Burandt, Project Manager for Gaymar Industries; independent Consultant Linda Lovett; Robert Dicheck, VP of Quality and Regulatory Affairs for Osmetech Molecular Diagnostics; and, John Dzelme, IT Systems Integration Analyst for Roche Diagnostics, and executives from other major medical device companies.

This select group of people has helped draft the new survey on current industry challenges, practices, systems, and opportunities. The Industry Council represents a broad cross-section of the medical device industry, both large companies and emerging growth players making relatively simple to very complex products. During meetings and one-on-one exchanges with the research team, the members of the Industry Council have ensured that the research focuses on issues critical to the business success of medical device manufacturers.

The research team is seeking responses from all medical device manufacturing companies through May 6. All responses will be aggregated and individual responses will remain strictly confidential. The online survey is open at: http://www.fdanews.com , http://www.industrydirections.com , or directly at http://www.surveymethods.com/EndUser.aspx?F4D0BCA5F6BEA6A6 .

"These Industry Council members' contributions are pivotal to the success of this project," said Julie Fraser, principal of Industry Directions Inc. and project leader. "Their varied viewpoints have helped refine our thinking and aligned the research more closely with what medical devices companies must consider to mitigate risk and improve profitability."

"Without the participation of these industry participants, we would certainly have missed some of the nuances of what makes medical devices such a challenging industry, such as the many facets of risk management and the magnitude of the perceived tradeoff between profits and risk," said Matt Salt, publisher of FDAnews.

The results of this survey will be released at the Fifth Annual Medical Device Quality Congress June 25-27 in Cambridge, MA in a special session on the research, Risk Management: Best Practices for Medical Device Profitability. This research ties in closely with this year's conference theme, Leading the Way to Better Performance With Quality Systems Compliance.

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

About Industry Directions
Industry Directions is an industry analyst firm that conducts research on the business processes and enabling technologies used in manufacturing value networks in specific vertical industries. Areas of focus include supply chain, business-to-business, production, lean and other improvement initiatives, enterprise management, product life-cycle management and performance management. To learn more, visit: http://www.industrydirections.com

About Cambashi Ltd.
Cambashi, based in Cambridge UK, provides independent research and analysis of the business reasons to use IT in industry worldwide. It specializes in engineering and enterprise applications and the infrastructure to enable industrial firms to use IT effectively. Cambashi publishes market size estimates in the engineering applications market observatory. 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

Contacts:
FDAnews
Matt Salt
(703) 538-7600
msalt(at)fdanews.com    

Industry Directions
Julie Fraser
(508) 362-3480
jfraser(at)industrydirections.com

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NANCY HODGMAN

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FDAnews
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