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Shawn M. Schmitt

Executive Editor

Miami, FL
Executive Editor Shawn M. Schmitt lives and works in Miami. 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

Device Week, 6 December 2019 – Oh No, EtO!

Over the past year a number of medical device sterilization facilities that use ethylene oxide, or EtO, have shut down as state regulators have raised concerns about their potential environmental impact. On this week’s podcast, executive editor Shawn M. Schmitt chats with senior reporter Danny Al-Faruque about what’s happened to date, as well as where this EtO issue is headed in the future.

Device Week Safety

Analyzing Quality Data Is Essential. Here’s What One Expert Says Your Firm Should Do To Stay In FDA’s Good Graces

Device makers should make sure they have adequate resources to analyze quality data they take in so they can prevent the recurrence of nonconforming products, processes and procedures. That’s just one nugget of advice from former FDA investigations branch director Ricki Chase, who explains why collecting and properly handling such data is critical to complying with agency expectations in this Medtech Insight Q&A interview.

Quality FDA

US Regulatory Roundup, November 2019: EtO Woes Concern Industry; FDA Pushes Back Deadline For Blended QSR/ISO 13485 Rule; And More

Concerns expressed by stakeholders during a two-day FDA meeting on the use of ethylene oxide (EtO) to sterilize medical devices was of most interest our online readers last month. EtO was also the focus of several other highly read stories – including worries by industry about device shortages and news that device maker Teleflex expects to lose millions because an EtO facility shut down. Meanwhile, the FDA’s announcement that it would push back its deadline for delivering a draft version of a new rule that will harmonize its Quality System Regulation with ISO 13485 also garnered significant interest. Here are November’s 10 most popular US regulation and policy stories from Medtech Insight.

United States Regulation

Warning Letter Roundup & Recap – 3 December 2019

In the only device-related warning letter released by the US FDA this week, a manufacturer of surgical trays and kits was cited for quality systems violations.

Device Warning Letters FDA

How Your Medtech Company Can Build Trust With FDA Investigators – And The Agency At Large

Device makers that build bridges with US FDA investigators will have an easier go of things during facility inspections, says Ricki Chase, a former FDA investigations branch director. By doing this, firms can extend that trust to the agency as a whole. Check out our full Q&A with Chase here.

FDA Compliance

Device Week, 22 November 2019 – False Claims Act Takes Center Stage

Enforcement of the False Claims Act is always a hot-button topic for industry. That’s because fines for FCA violations can be costly, reaching into the billions of dollars. On this week’s podcast, executive editor Shawn M. Schmitt chats with senior reporter Elizabeth Orr about some of the more important FCA cases from 2019.

Device Week Legal Issues
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