New Research on Medical Device Total Product Lifecycle Practices: Cambashi, Axendia and FDAnews Request Input on Practices and Outcomes in Industry Survey

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Cambashi, Axendia, and FDAnews today announced a major research project designed to determine how far medical device companies have moved toward the Total Product Lifecycle approach recommended by the FDA. This study, Managing the Total Product Lifecycle: Lowering Costs While Increasing Quality, will examine the transformation from waterfall processes to more concurrent and collaborative processes. Medical device manufacturers are invited to respond to a new survey on current practices plus the challenges and benefits of that transformation.

A major research project announced today by Cambashi, Axendia, and FDAnews is designed to determine how far medical device companies have moved toward the Total Product Life Cycle approach recommended by the FDA. This study, Managing the Total Product Lifecycle: Lowering Costs While Increasing Quality, will examine the transformation from waterfall processes to more concurrent and collaborative processes. Medical device manufacturers are invited to respond to a new survey on current practices plus the challenges and benefits of that transformation.

This study will:

  • identify major challenges associated with managing the Total Product Lifecycle
  • uncover the transitional issues facing medical device organizations and their ecosystem, including globally distributed production, outsourced operations, suppliers, distributors and trading partners
  • describe innovative strategies, best practices, and technologies that medical device companies should consider to achieve quality and cost benefits
  • characterize the current state of the medical device industry and provide insight into how industry leaders are meeting today's challenges

Survey respondents will receive the final report as an aid to enable their transformation from disconnected "silo" processes to holistic end-to-end product approaches, plus valuable related reports. The research team is seeking responses representing the broad spectrum of companies in the medical device industry - organizations of all sizes, all classes of devices, and in every geographic region. The initial online survey is open for industry response from April 2 until April 14th. All responses will be aggregated to formulate report findings. Individual responses will remain strictly confidential.

The online survey is 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 research is co-sponsored by five companies - all of which are active in the Medical Device industry. These companies provide deep and diverse expertise in medical devices practices and provide design, product lifecycle management, production, quality, and related software and services to the industry as well as management consulting services to leverage applications appropriately. Working together, these underwriting sponsors hope to increase the medical device market's understanding of how to reduce risks and improve compliance and profitability. Research Sponsors for the study are: management and technology consulting firm BearingPoint (http://www.bearingpoint.com), enterprise manufacturing and quality software provider Camstar Systems (http://www.camstar.com ), product lifecycle management (PLM) software innovator Dassault Systèmes Enovia (http://www.3ds.com) with its medical device industry PLM partner Integware (http://www.integware.com), and PLM and enterprise content management software provider PTC (http://www.ptc.com).

The analysis and report will be prepared by Cambashi and Axendia, which retain full editorial control. The results of this survey will be released at the Sixth Annual Medical Device Quality Congress June 3-5 in Cambridge, MA in a special session on the research, Managing the Total Product Lifecycle: Lowering Costs while Increasing Quality. This research ties in closely with this year's conference theme, Leading the Way to Better Performance With Quality Systems Compliance.

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 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: 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: fdanews.com

Contacts:
Axendia
Daniel R. Matlis
(267) 352-4801

FDAnews
Matt Salt
(703) 538-7600

Cambashi
Julie Fraser
(508) 362-3480

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NANCY HODGMAN

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