Folks,
This past week I attended a Medical Device Manufacturing Conference put on by Q1 productions. I had the honor of being the kick off speaker and the chair for the second day of the conference. The thrust of the conference was how to select and work with subcontract manufacturers in a world of FDA regulations. There were talks on the legal aspects, prototyping, clean rooms, cost of quality, etc of building medical products, through subcontractors, that must comply with FDA regulations.
One of the talks was on what I would call "total data automation." The talk, by folks from Camstar discussed how "enterprise" type software can now control and report all data pertinent to quality and compliance in one system with simplified data summation. I see this as a wave of the future for all types of assembly and manufacturing. Imagine have SPC, yield, rework, downtime, product throughput, inventory turns, etc in one system where the data could be analyzed for total process optimization and productivity maximization.
The final talk was by Steve Neidelman, a chap with over 30 years with the FDA and now a consultant. He discussed the challenges of auditing and assuring FDA conformance when dealing with subcontractors. It struck me at the end of his talk, that we who deal mostly with standard electronic assembly have been troubled by WEEE and RoHS regulations and compliance. We can probably learn a lot for our friends in the medical device business. They have been doing compliant manufacturing for generations…..I wonder if they complain about the FDA as much as we have about WEEE and RoHS?
Cheers,
Dr. Ron
The photo? A Yorkshire Terrier's (Five year old Nina, 15 pounds (7 kg)) of umbridled fury when she sees one of our local deer or turkeys) view of the snow at my home in Woodstock, VT on March 1, 2008. There is about 3 feet (1 meter) of packed snow on the ground, the snow falling off of our garage's snow roof is about 8 feet (2.5 meters) high. Looks like my plans to be golfing by March 15 will have to be put off a bit!