by
sterling1
on
Jun 14, 2010 • Comments Closed
For years and years, big technology companies have been walking in to major industry analyst firms and ordering up some research. Still, it never ceases to amaze me just how often the research results favor the company footing the bill. Now I’m not saying that is how or why a recent article got written by an...
by
sterling1
on
Jun 3, 2010 • Comments Closed
Just the other day, an online site called Today’s Medical Developments ran a story about a U.S.-focused medical device market report being made available (for a price). It sounds like it may be worth it although it was written before the passage of the healthcare bill. We, of course,
by
sterling1
on
Jun 1, 2010 • Comments Closed
Thanks to a recent article in The Massachusetts Medical Devices Journal, which is a very fine online site that covers the medical devices industry in Massachusetts and New England, I was alerted to an upcoming FDA public workshop to be held on June 24th in Gaithersburg, Maryland. The theme of the gathering is: Identifying Unmet Public Health Needs...
by
sterling1
on
May 17, 2010 • Comments Closed
Writing for Logistics Viewpoints, Steve banker poses an interesting point based on a common assertion among supply chain professionals. Here’s how he puts it: Supply chain managers often bemoan increasing regulation, and how new regulations or overly stringent oversight increases supply chain costs and makes their day-to-day jobs more complex. Sound familiar? But is it...
by
sterling1
on
Mar 24, 2010 • Comments Closed
Opinions about the recently passed healthcare reform legislation are all over the place. One recent article in particular demonstrates this with specific reference to device manufacturers, manufacturers in general, and pharmaceutical manufacturers. The National Association of Manufacturers and the Medical Device Manufacturers Association say the new healthcare reform legislation signed into law today will negatively hinder business...
by
sterling1
on
Mar 23, 2010 • Comments Closed
Maybe you’ve heard the name Joshua Makower? According to a recent story out of Minneapolis, he’s a medical doctor with an MBA from Columbia University and an engineering degree from the Massachusetts Institute of Technology who has founded — and successfully spun off — three med-tech companies, most recently Acclarent Inc., which was sold to Johnson...
by
sterling1
on
Mar 11, 2010 • Comments Closed
This is an important update to the Food and Drug Administration’s (FDA) timelines for UDI (Unique Device Identification) implementation deadlines. It comes by way of a recently published article entitled, “The FDA’s Take on Unique Device Identification,” authored by Jay Crowley who is senior advisor for patient safety for the Food and Drug Administration’s Center for Devices...
by
sterling1
on
Mar 9, 2010 • Comments Closed
We have a brand new and very compelling White Paper just out. Compliance with UDI Labeling Mandates: A Proven Methodology, was produced because, as the introduction states: There has never been a better or more urgent time for manufacturers of healthcare products to make a close examination of their product labeling systems. If you read...
by
sterling1
on
Dec 14, 2009 • Comments Closed
This is very interesting. At the FDA News web site you’ll see a brief item entitled, “Devicemakers Question Data Requests for FDA’s Prototype UDI Database.” The first sentence seems to imply there may be much work ahead to finalize a UDI approach that satisfies everyone. The sentence is: Devicemakers testing a unique device identifier (UDI)...