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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

Yardley, PA, July 17, 2007, Axendia, Inc. a trusted advisor to Life-Science Executives on Business, Regulatory and Technology strategies, today announced that it has been selected by Drexel University’s School of Biomedical Engineering, Science and Health Systems (Drexel University) to provide advisory services on Technology Commercialization.

Drexel University has received the Translational Research Partnership Award in Biomedical Engineering from the Coulter Foundation, a private, nonprofit foundation dedicated to supporting biomedical engineering translational research that addresses unmet health care needs.

“Our goal is to promote and develop translational research activities to increase effective collaborations between biomedical engineers and clinicians, increase the conversion of promising technologies into commercialized products and clinical applications” commented Dr. Robert Loring, Drexel University’s Senior Entrepreneur in Residence. “Axendia’s 50 plus years of combined Life-Science experience will enhance Drexel’s strong Biomedical Technology Transfer and Commercialization efforts” added Dr. Loring.

“There are significant healthcare benefits in bringing promising technologies into commercialized products and clinical applications by enabling the collaboration between leading Biomedical Academic Institutions, and the private sector”, commented Daniel R. Matlis, founder and President of Axendia. “We are very pleased to have been selected by Drexel University’s Biomedical Department to provide advisory services on this important initiative.” Matlis added.

About Drexel School of Biomedical Engineering, Science and Health Systems
The Drexel University School of Biomedical Engineering, Science and Health Systems’ technology platforms encompass the translation of multiple clinical or personal health-care applications, from cardiovascular engineering to neurology and from skin bioengineering to pediatric technologies. The School’s strategic academic specializations include biosensing, bioimaging, drug delivery, cellular tissue engineering, neuroengineering and integrated bioinformatics, enabled by bionanotechnologies, biomedical ultrasound and optics and information engineering.

About Axendia
Axendia, Inc. is the leading analysis and strategic advisory firm focused on the Life-Sciences and Healthcare markets. Our Mission is to be the most trusted advisor to Life-Science Executives on Business, Regulatory and Technology issues. With over 50 years experience in the Life-Sciences and Healthcare industries, Axendia provides a unique combination of hands on experience coupled with strategic vision. This enables us to successfully identify, create and execute strategies which provide lasting business value for our clients. Additional information on Axendia’s can be found at www.Axendia.com

By Daniel R. Matlis

In 2005, I had the opportunity to visit Pfizer’s Groton, CT, facility to learn about the company’s implementation of its smart card Identity Management and Digital Signature system. The system uses SAFE-BioPharma Association’s Public Key Infrastructure (PKI) standard.  SAFE is a coalition of pharmaceutical companies responsible for establishing a common digital identity and signature standard and trust model for the pharmaceutical industry,

During our visit we had the privilege of interviewing Tony Gazikas and Scott Potter from Pfizer. Portions of our interviews were published in a SAFE whitepaper entitled “Meeting the Need for a Global Identity Management System in the Life Sciences Industry”

This week’s CIO Magazine, includes an article by Laurianne McLaughlin entitled “How Pfizer Did ID Management Right”.

I was delighted to see that the CIO article highlighted some of the same points we address in the SAFE whitepaper. More importantly, I was pleased to see that the hard work done by members of the SAFE-BioPharma association is getting the recognition it deserves not only in Life-Sciences, but across the CIO community.

By Daniel R. Matlis

Last week Google Announced the formation of a high powered Google Health Advisory Council. The mission of the council is to help Google better understand the problems consumers and providers face every day and offer feedback on product ideas and development.

According to the Wall Street Journals Health Blog “the company (Google) has been making noises about health care for a while, and there was some recent speculation that Google might be working on a way for people to store their medical records online.”

Google is great at finding things, but does not have a track record hiding them. Try Googling your home phone number or your name, and you’ll see what I mean. As a result, I would not feel comfortable storing my Medical Records on Google.

My solution for keeping medical records secure yet portable would be an n-Tegrity fingerprint secured, AES 256 bit encrypted USB drive.

Full disclosure, I’ve been working with n-Trance, the maker of the n-Tegrity device and have been impressed by its capabilities.

The convergence of technology in the fingerprint secured, AES 256 bit encrypted USB drive addresses the security and privacy issues associated with making Medical Record electronic and portable.

The owner’s fingerprint would unlock the device and would decrypt the medical record contained in the USB drive. Unlike password devices, even if the patient is unconscious, medical personnel could unlock and view the patient’s health records to be able to make timely and effective decisions.

I carry an n-Tegrity device and use it daily to keep sensitive data protected and secured. I would not hesitate to load my Medical Records if my doctor made them available.

Even if the device was lost or stolen, the records contained in the drive would be secure, and unreachable. In this event, or if the device was damaged, a backup utility would make it possible for me, and only me, to restore the contents of the drive onto a new one securely.