On this week's podcast, Shawn M. Schmitt talks about his first story in a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry. An ongoing US FDA pilot program – which uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method – is discussed.

A follow-up inspection evaluating Zimmer Biomet’s progress in remediating issues documented in a 2016 FDA Form-483 uncovered 11 observations, eight of them repeats.

Now that US FDA's "program alignment" inspection paradigm is in full swing, does your device firm know where to send an FDA-483 response? How to alert the agency about a recall? Who to contact if there is a problem with an FDA investigator? If not, then check out the answers to those questions – and seven more – in this updated feature article.

More medical devices were recalled by manufacturers in the first quarter of 2018 than in any quarter since at least 2005, with 343 initiated. Moreover, there were 208.4 million units recalled in Q1 '18 – more units than in all of 2017. Check out our Q1 recalls infographic.

Scott Gottlieb wrote in a May 9 blog post that the agency will propose a new rule that will blend its Quality System Regulation with international quality systems standard ISO 13485. Gottlieb claims the new rule would "harmonize domestic and international requirements, and modernize the regulation," while making sure that device-makers "adhere to high, internationally accepted quality systems."

Former longtime US FDA official Kim Trautman, now with NSF International, sat down with Medtech Insight at MedCon 2018 for a podcast interview to discuss an array of industry issues, including the burgeoning Medical Device Single Audit Program, international regulatory convergence, FDA's percolating plan to replace the Quality System Regulation with ISO 13485, what keeps her up at night (hint: it's EU's new Medical Device and IVD Regulations), and other important issues that device-makers need to keep a sharp eye on.

Baxter Healthcare's Elizabeth Zybczynski was excited when she first heard that her company would join a US FDA pilot program to measure the capability and maturity of medical device manufacturing sites. Having worked in the aerospace and defense industries before moving to the health-care arena, Zybczynski knew that the tried-and-true Capability Maturity Model Integration (CMMI) approach could elevate quality in the device industry. CMMI Institute's Kimberly Kaplan and CMMI appraisers Becky Fitzgerald and George Zack explain the maturity model process that Baxter – and 13 other manufacturers – have gone through, from initial intake phone calls to the unveiling of final appraisal results.

The second 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.

The pursuit of quality can be a daunting task for device-makers. One wrong step can cause costly product recalls affecting patient health – among other troubles tied to poor quality products and processes. To help firms move toward a goal of best-in-industry quality, US FDA, through its Case for Quality initiative, has convened a pilot program to measure a manufacturer's capability and maturity to help put it on a path to continuous improvement. The pilot uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method, developed jointly by FDA, industry and CMMI Institute.

The first 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.

The US agency's 22-year-old bedrock rule for making safe and effective medical devices to be sold in the United States will likely be replaced with international quality systems standard ISO 13485, FDA official Sean Boyd said at MedCon 2018. But the author of the Quality System Regulation, Kim Trautman, told Medtech Insight that it would be a thorny, years-long chore for the agency.