An exclusive blog, sponsored by Loftware, devoted to labeling issues that affect your business in an ever-changing global economy.
Posts tagged "Medical Devices"

Industry Analyst Says UDI a High Cost, Low Return Initiative

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...

The Global Leadership of U.S.-Based Medical Device Manufacturers

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,

Medical Device Development the Focus of FDA Public Workshop in June

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...

Will Looming FDA UDI Mandates in Healthcare Lower Supply Chain Risks?

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...

The Medical Device Manufacturers Association Weighs in on Healthcare Reform

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...

The Future of Medical Device 'Game Changers'

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...

UDI Perspectives and Timetables Explained by FDA Senior Advisor in Recent Article

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...

A ground-breaking white paper: Compliance with UDI Labeling Mandates: A Proven Methodology

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...

Report on FDA's Prototype UDI Database Apt to Spur Questions at our Jan. 12th Webinar

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)...