Jeffrey Shuren, M.D., J.D., Director, Center for Devices & Radiological Health spoke at the public workshop “Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology.” Dr. Shuren provided an overview of the Health IT Report released in April jointly by the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC). Continue reading
The Cloud… everyone is talking about it, technology companies are embracing it, while Life-Science companies are wrestling with “how to validate it”.
This trend was evident during my discussions with QAD’s executive management team at company’s Explore conference.
QAD is making a significant investment in migrating customers to its Cloud based ERP offerings. “One very interesting and exciting thing is that our Cloud revenue has increased about 35 to 40% a year over the last few years” said Karl Lopker, CEO at QAD. “ Our Cloud revenue is now about 10% of the company’s revenue and is increasing at such a rate that it will be a major portion of our revenue in the future, he added”
The push to the Cloud was also evident in the many sessions dealing with this topic. Continue reading
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
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
When we discuss the Cloud with Life-Science executives we often get this question: “Do you know when FDA will issue new regulation to deal with Cloud solutions?”
Our answer: “Do you really want more regulation?” Continue reading