14Jul/14
From left to right:  Dan Matlis, Jim Robinson, Matt Scott, Mark Lincoln

Med-Tech Industry Outlook: Prognosis from Proactive Leaders

By Daniel R. Matlis

Earlier this year, I had the opportunity to attend Camstar’s 2014 Global Conference. The theme of the event was “The Global Ready Enterprise.” The Conference provided attendees with the unique opportunity to share and learn strategies and techniques to evolve into true Enterprise Manufacturing companies leveraging MES across the world. The conference brought together leading medical device manufacturers, service providers and Camstar experts to exchange ideas, hear real-world experiences, and get a glimpse of the future in the Med-Tech world.

I had the privilege to moderate a panel entitled: “Outlook for the Medical Device Industry 2014 and Beyond: Advice from Proactive Leaders”. The panel included the Vice Presidents of Operations of three Med-Tech companies who use Camstar’s MES software to automate process enforcement, prevent quality issues, improve patient safety and reduce operational costs. Continue reading

07Jul/14
Living-heart-project

Hovering Through the Human Heart

By Daniel R. Matlis

Last month, I had the opportunity to attend Dassault Systèmes’ analyst conference at the company’s headquarters in Vélizy, France, just outside Paris. There, I was briefed by company executives on Dassault’s Life Sciences strategy.

My most memorable experience at the conference was that of hovering through the human heart.  While Dassault scientists have not yet devised a way to miniaturize matter by shrinking individual atoms, like in Fantastic Voyage, they have achieved the next best thing. Continue reading

20Jun/14
Global-Transformation

FDA Continues Global Transformation

By Ellyn McMullin

In June of 2011 I published an article “FDA Wants to Transform into a Global Agency” after the Food and Drug Administration unveiled a new global strategy to help ensure safety and quality of imported products.

Recently, Howard Sklamburg, FDA’s Deputy Commissioner for Global Regulatory Operations & Policy posted a blog entitled “Ensuring Pharmaceutical Quality Through International Engagement” to provide an update on the Agency’s pursuit of global participation.

Continue reading

14Apr/14
obctacle

Is Compliance an Obstacle to Quality?

By: Daniel R Matlis

Can you distribute poor quality products while complying with regulatory requirements?  Sure, after all, you can conduct a recall of poor quality products in compliance with all applicable regulations.

Regulatory Compliance and Quality are NOT the same.  In fact, the industry’s hyper-focus on compliance is often an obstacle to quality.

This distinction seems to be the renewed focus at the FDA, from the Commissioner on down…  Continue reading