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Shawn M. Schmitt

Deputy Editor

Miami Beach, FL
Shawn M. Schmitt, deputy editor for regulatory and policy, lives and works in Miami Beach, Florida. For more than two decades he has written and edited for various high-profile media outlets, including The New Republic and London's Independent Television News (ITN). Since 2005 he has reported on medical device quality control, compliance and post-market issues. A spirited, creative journalist, Shawn reported from the White House Rose Garden for Counseling Today, met with medical device experts in Costa Rica for Medtech Insight, traveled the US to get the scoop on Medicare funding for DecisionHealth, and wrote about the proliferation of nuclear weapons for National Journal's Global Security Newswire. Shawn holds a Master of Arts in Communication: Journalism and Public Affairs from American University in Washington, D.C. (2004), and a Bachelor of Arts in Journalism and Communications from Point Park University in Pittsburgh (1997).
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Latest From Shawn M. Schmitt

Compliance Corner: Follow These 4 Tips From FDA's Maisel For A Better Pre-Market Experience

Bill Maisel – the director of the Office of Device Evaluation within US FDA's Center for Devices and Radiological Health (among other titles) – says there are four things device-makers should do to make sure they succeed during the product-review process.

Compliance Corner FDA

Device Week, July 13, 2018 – Medtech’s Next Top Maturity Model, Part 3

Part 3 of Medtech Insight’s feature series on the appraisal of manufacturing capability and maturity – “Medtech’s Next Top Maturity Model” – is discussed on this week’s podcast. Author Shawn M. Schmitt gives details on how Baxter Healthcare, Edwards Lifesciences and other firms weathered their appraisals using the Capability Maturity Model Integration (CMMI) model and method.

Device Week FDA

Inside Toyota's 'Cult': Car-Maker's Quality VP Tells Device-Makers How They Can Adopt 4-Pronged Quality Strategy

Toyota Motor North America's Kristen Tabar told a roomful of medical device quality and regulatory professionals at a Case for Quality forum that they can infuse quality concepts into every nook and cranny of their firms by adopting the car-maker's quality strategy of reflection, education, celebration and planning. "I don’t want to make it sound like it’s sort of cult-y, but it’s kind of cult-y," Tabar quipped.

Quality Safety

With New Initiatives, Case For Quality Embarks On Mission To Create 'Safe Space,' Engage CEOs, #makeCAPAcool

Quality and regulatory officials from Medtronic, Hologic, Baxter Healthcare and Boston Scientific – among others – are working with the joint US FDA/MDIC Case for Quality to fully realize a two-year strategic plan that targets corrective and preventive action (CAPA), CEO engagement in quality activities, career paths in device quality, and more.

Quality Control Manufacturing

New 'Quality Culture Playbook' Aims To Drive An Organization-Wide Quality Mindset, AdvaMed Says

The device industry advocacy group is putting the final touches on its free playbook, which draws from proven quality culture work conducted at high-profile companies like Medtronic and Covidien, among others.

Quality Quality Control

Boston Scientific, Edwards Lifesciences, Baxter Used CMMI To Measure Their Manufacturing Capability. Here's What They Said About The Experience

Quality, compliance and regulatory officials at the three large device firms – along with their peers at Steris and CVRx – open up about appraisals conducted at their facilities under a voluntary US FDA pilot program that uses Capability Maturity Model Integration (CMMI) to measure the capability and maturity of their manufacturing sites. Along with providing a step-by-step walk-through of the assessments, the officials explain how a CMMI appraisal is nothing like a typical regulatory audit. They also talk about the types of benefits they're seeing (hint: cost-savings, and better manufacturing capability and quality), and how they network via monthly conference calls linked to the pilot. Also: Baxter Healthcare explains why it made its own maturity model, and how it plans to eventually replace the homemade tool with CMMI at all its facilities.

The third 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.

Quality Control FDA
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