Brad Osborne, Director of Supply Chain, Cogmedix
Recently Cogmedix had the pleasure of seeing first-hand what the future of medical device compliance holds for organizations such as our own…and we’re happy to say the future is so bright, we should have worn our shades!
The “future of medical device compliance” I am referring to is the leadership in whose hands the reins of organizations like Cogmedix will be held. We had the pleasure of hosting a group of future leaders, a Regulatory Affairs class (taught by Prof. Mike Leal, an FDA inspector himself) of mostly graduate-level students from WPI for a tour of Cogmedix. The course they are involved in is one that we live each day as an organization whose motto is “Cogmedix = Compliance”. We view compliance as the number one value-added activity that we bring to our customers…it is THE differentiating factor between a “time to market medical device services company” and a “medical device contract manufacturer”.
The students we hosted were introduced to our organization and provided an overview by Pete Rizzo, Manager of Positive Client Relations for Cogmedix. We then introduced them to our compliance leader, Scott Cook, Sr. Vice President of Corporate Quality and Compliance for Coghlin Companies. Scott discussed with them his unique path into quality and compliance (I won’t spoil the surprise for those of you who haven’t heard the story), as well as the unique challenges and costs involved in ensuring a constant state of readiness when it comes to compliance in the medical device industry.
The students were then taken on the “Grade A Tour” (after all, he does no other type of tour) by our Vice President of Manufacturing Operations, Chad Burdick. It was a fantastic time as Chad discussed our various lean initiatives and how those tie into compliance efforts (e.g., the value in having a deep understanding of our processes that comes with Value Stream Mapping, the organization and discipline that come with 6S initiatives). The students were asking a lot of great questions from, “what exactly is EOED?” to, “who was W. Edwards Deming?”
The day ended with a nice luncheon where we continued to discuss what was seen during the tour, what sort of interests the individual students had, and even what opportunities existed within our organization for such bright graduates! As a follow-up to the tour, Scott and Chad will soon be speaking to the entire Regulatory Affairs class at WPI!