Shawn M. Schmitt
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Shawn M. Schmitt
Medtech Insight’s Shawn M. Schmitt talks about Part 4 of “Medtech’s Next Top Maturity Model,” his feature series on the appraisal of device-makers’ manufacturing capability and maturity. This episode focuses on appraisers affiliated with Pittsburgh's CMMI Institute and describes the hurdles they must clear to be part of a US FDA pilot program that uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework.
Assessing A Device-Maker's Manufacturing Capability Is Serious Business For These 2 Longtime CMMI Appraisers. Here’s Their Story
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.
FDA Staffers, Device Firm Employees Are Training As Appraisal Team Members For CMMI Maturity Model Pilot
US FDA's ongoing Voluntary Medical Device Manufacturing and Product Quality Pilot Program, which assesses device-makers' manufacturing maturity and capability, has become so popular that both the agency and manufacturers are sending their own employees to CMMI Institute to be trained as Appraisal Team Members, or ATMs, to assist in device-related Capability Maturity Model Integration (CMMI) appraisals.
The maker of wound-dressing product Omiderm was cited for quality systems violations in the only device-related warning letter released by US FDA this week.
Two Medtronic facilities that make cardiac rhythm management devices were sent warning letters by US FDA because of quality systems issues. The sites were inspected by the agency after the firm initiated high-risk class I recalls for an array of CRM products earlier this year.
Medtronic is the recipient of two warning letters following unfavorable FDA inspections at its Minnesota and Puerto Rico facilities. The missives were the only device-related letters released by the US agency this week.