Category Archives: Webinar


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:


Designing for Manufacturability; Closing the Loop Between Design and Manufacturing

By Daniel R. Matlis

I recently finished writing a whitepaper on the benefits of Designing for Manufacturability and Quality by Design in the Medical Device Industry.

With the dawn of personalized healthcare, we are seeing the increasing the tempo of innovation. Examples include the development of targeted therapies, combination products and mass customization.  This individualized approach to healthcare requires the development, manufacture and commercialization of ever more complex products.

Contact lenses provide a good example of things to come. Today’s contact lens prescription specifies power, base curve, diameter, color (pretty much any shade in the rainbow) and for those patients with an astigmatism, cylinder and axis.  In the not too distant future, joint replacements will be customized based on the patient’s individual anatomy and lifestyle needs. Drug eluted stents will be coated with specific compounds targeted to a patients genetic makeup.  “Have it your way” has a whole new meaning in Medical devices.

To stay ahead of this wave of change, Medical Device manufacturers must:

  • Increase the rate of product innovation
  • Increase product quality by reducing variability
  • Raise product safety and effectiveness
  • Decrease time to market and time to volume 
  • Reduce costs

Meeting these objectives pose a significant challenge as innovation, by its very nature, induces variability. This challenge is exacerbated by the organizational structure and technological state of many medical device manufacturers.

To address these challenges, medical device organizations should consider the following roadmap:

  • Enable rapid innovation cycles to out run the Innovation Gap
  • Shift from a reactive to proactive stands
  • Move their organization from silos to seamless 
  • Tackle variability through operational excellent and robust design 
  • Fully integrate DMR, DHF and DHR systems to support continuous improvement

The integration of Product Lifecycle Management (PLM) and Manufacturing Execution Systems (MES) can enable Medical Device Manufactures to close the loop between manufacturing and design, enabling rapid innovation cycles while at the same time managing the risk, hard-wiring compliance, increasing product quality, maximizing production yields and decreasing costs.

Please join us for a webinar on July 25, 2007 at 1:00pm EDT, to learn how these innovative strategies can help Device Manufacturers decrease new product introduction cycles and speed time to volume, increase product quality and lower production costs. This webinar is presented in cooperation with Camstar and PTC.

During this Webinar, we will cover the benefits of Designing for Manufacturability and Quality by Design.

To register for the webinar, please click on this link


The Challenges of Making Life-Science from Life

by Daniel R. Matlis

I recently wrote a whitepaper discussing how Biological product manufacturers seek to achieve two seemingly contradictory objectives:

    1. Implement tight controls over every step in the manufacturing processes to increase product yield and quality. 
    2. Provide for a flexible manufacturing process allowing for maximum equipment reconfiguration and utilization lowering capital investments.

In the paper we examine technologies which can enable the transformation required to simultaneously achieve the objectives thereby reducing process variability and costs, while increasing product yields and quality.

The folks at Camstar, the white-paper’s underwriter, have asked me to participate in a 3 part webinar series based on the research findings.

The webinars will address key business regulatory and technology challenges facing the Biotechnology industry, as well as provide practical and proven approaches firms can use to address them.

The topics to be covered in the series include:

Making Life-Science from Life – The State of the Biotech Industry

This webinar will focus on the current state of the industry and provide framework for tools and techniques Bio-Technology and Bio-Diagnostics products manufacturers can take advantage of to address challenges and opportunities.

Pursuing the Golden Batch (From Data to Truth)

This session will discuss a variety of tools and techniques which can be used to identify key parameters responsible for making a Golden Batch, and the means of translating the analysis into repeatable and controllable processes.

The Future is Now –Manufacturing Personalized Medicines Today

Manufacturing approaches in Biotech are as varied as the products being manufactured. They range from outsourcing and factory-less manufacturing, to dedicated equipment and flexible manufacturing for quick facility reconfiguration. This webinar will cover need for a flexible, configurable and adaptable manufacturing system of record.

If you would like to attend one of these Webinars on the entire series please click here to register.