How to Conquer Medtech & #039;s Over-Documentation Problem

Ever wonder why startups seem to develop new products so much faster than large, established medical device companies? One reason, according to a product development expert who spoke at BIOMEDevice Boston, is that startups only submit the minimum amount of quality management system (QMS) documentation. Medical device development is 70% to 80% documentation, said Tom Waddell, CEO of the Waddell Group. He used one company as an example, which he described only as a large medical device company based in the Minneapolis, MN area, that required roughly 1,000 to 1,300 documents to submit a class III device to FDA for a clinical trial even though the agency's requirements for such was really in the range of 350 documents, Waddell said. "If you're in the company doing 1,000 documents to turn in to FDA and you actually figure out how to do just 350 you go from 15 months of documentation down into the range of two to three months of documentation," Waddell said. That's just to take the device into the clinical trial phase though. "First thing I look at is what's the objective of the project? Is it through a limited clinical study? Then you can start reducing your full-blown manufacturing documentation up front. Your QMS system, if it's designed to be flexible, will allow for that," Waddell said. That's not to say that it's okay to shortcut the QMS system requirements when the product reaches the manufacturing phase, he clarified. "Obviously, if the project comes back and it's a succes...
Source: MDDI - Category: Medical Devices Authors: Tags: BIOMEDevice Boston R & Source Type: news