From training classes to onsite observations, two lead appraisers affiliated with Pittsburgh's CMMI Institute describe the high hurdles they jumped to be part of a flourishing US FDA pilot program that aims to elevate product, manufacturing and process quality at device firms. The pilot uses an industry-tailored version of the tried-and-true Capability Maturity Model Integration (CMMI) framework that's been around for decades. Beth Layman, an appraiser who has assessed more than a hundred companies in a variety of industries, says appraisers can't just be book-smart – rather, they must also possess a select set of personal skills, including flexibility and open-mindedness. Her fellow appraiser Thayne Hill, who "was there in the early days" of the Capability Maturity Model, says device-makers are often leery of appraisers because of past negative interactions with regulators, which can make his job challenging. The fourth of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry.
[Editor's note:This is the fourth of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry. Check out Part 1 at https://bit.ly/2jGPlL1, Part 2 at https://bit.ly/2K6TWRV, and Part 3 at https://bit.ly/2K69U34.]
A few decades ago, as a civilian electronic engineer working in the US Air Force, Thayne Hill became part of a project that would turn out to be so game-changing...