2011 Pro-Dex Blogs
December
- Negotiating MPO Agreements
Pros and cons to the contract manufacturing agreement process Byline: Joe Rotino Who’s responsible for device problems if things go wrong? Is it the OEM? The supplier? If a supplier puts a $.05 part in a $1,000 device, and that $1,000 device causes harm, should the onus fall on the supplier? Answers to these tough questions were attempted at the “Negotiating Medical Product Outsourcing Agreements” panel at AdvaMed 2011. But not all were satisfied with the answers. Here are some highlights and lowlights …
Posted: Wednesday, December 14, 2011 By: Prodex
October
- Emerging Trends At AdvaMed 2011 - Healthcare Reform
To say that there’ve been sleepless nights over The Affordable Care Act of 2010 would probably be the understatement of the year. Something that complex and expansive has left many expressing—sometimes vehemently—concern over what it will mean for medical device innovation, quality, and profitability. Four panelists at AdvaMed 2011(Caroll Neubauer of B.Braun Medical, Inc., John Bishop of Cepheid, Michael Mussallem of Edward Lifesciences Corporation, and Patrick Morrisey of King & Spaulding) weighed in on what health care reform looks like one year later—and what aspects keep them up at night.
Posted: Thursday, October 06, 2011 By: Prodex - Medtech 3.0: Paradigm Shifts in the MedTech Business Model
Innovation is alive and well at this year’s AdvaMed conference. While it’s clear that medical device innovation in the U.S. has taken a hit, there’s important advancement happening around the development of new business models. The next evolution of the medical technology industry—MedTech 3.0—focuses on collaborative, non-traditional partnerships and a changing customer base.
Posted: Wednesday, October 12, 2011 By: Prodex - CEO's Unplugged: Tech and Regulatory
Solution-focused approach key to FDA-MedTech future You’d expect there to be finger pointing and an undertone of hostility at a “CEO’s Unplugged” panel at AdvaMed 2011—especially on the topic of technology and regulation. But instead of talking about what’s not working and what’s not happening, the CEO panelists used the opportunity to tone down the rhetoric and acknowledge what is working.
Posted: Thursday, October 20, 2011 By: Prodex - Uncertainty in MedTech
One thing’s for certain: There’s a lot of uncertainty in today’s MedTech industry Byline: Tricia Rodewald “Uncertainty” is a main theme coming out of this year’s AdvaMed convention. Uncertainty about 510(k) process reforms. Uncertainty about FDA and healthcare reform. Uncertainty about the future of medical device innovation.
Posted: Wednesday, October 26, 2011 By: Prodex
