Monthly Archives: April 2009


QMS Implementations Lack Visibility in Global and Outsourced Environments

By Daniel R. Matlis

The lack of visibility most Quality Management System (QMS) implementations provide in Global and Outsourced environments is one of the key findings from Axendia’s “Quality Management System trends in Life Sciences” research study. 

The study gathered input from over 125 companies, covering small, mid-size, and Fortune 100 Life-Science organizations representing the full spectrum of medical device, pharmaceutical, biotech and diagnostic organizations.

According to our analysis, most QMS implementations in Life-Science companies are fragmented and lack real-time visibility outside the organization’s 4-walls. While typical QMS implementations provide a reasonable view at the local or site level, they fall short on delivering visibility across the enterprise. This is especially significant, given that 75% of respondents belong to multi-site organizations. For those companies that have multiple sites the survey shows that:

  • 34% can roll up QMS data from multiple locations in real time
  • 37% need to aggregate the data from multiple locations
  • 29% say it is not possible to rollup data from multiple locations.

This lack of real-time visibility can be a barrier to in-depth root analysis. This may be a key factor in promoting corrective, rather than preventive approaches to managing non-conformances. In today’s increasingly Global and Outsourced Life-Science value chains, real-time visibility across organizational boundaries, as well as supplier and external partner networks, are no longer a nicety but a competitive necessity.

To learn more, join me in a webinar sponsored by Camstar on May 5th, 2009 at 1:00 PM EDT. In this webinar, we will be sharing in-depth analysis and recommendations on the need to shift from a fragmented approach to QMS implementations in light of our industry’s increasingly Global and Outsourced Environments.

To register for this webinar visit:

For additional information on the “Quality Management System Trends in Life Sciences” research visit:


New Research on Medical Device TPLC Practices Launched

By Daniel R. Matlis

Innovation is the lifeblood of the medical device industry. Managing the Total Product Life Cycle (TPLC) could enable medical device manufactures to lower costs while increasing quality. 

To determine the industry’s adoption of a Total Product Life Cycle approach, as advocated by FDA, Axendia ™ , in cooperation with Cambashi and FDAnews launched a major research project.
This study entitled, Managing the Total Product Lifecycle: Lowering Costs While Increasing Quality, will examine the transformation from waterfall processes to more concurrent and collaborative processes. 

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

 To be a part of this important industry research and share your perspectives on Medical Device trends, complete the survey by clicking on the link below:  The survey will be open from April 2 until April 14th. 

Note: Individual responses will remain strictly confidential.

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 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”. 

To learn more about this research visit:

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 (, enterprise manufacturing and quality software provider Camstar Systems ( ), product lifecycle management (PLM) software innovator Dassault Systèmes Enovia ( with its medical device industry PLM partner Integware (, and PLM and enterprise content management software provider PTC (

The analysis and report will be prepared by Axendia and Cambashi, which retain full editorial control.