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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

'An Unnecessary Editorial Revision': In Letter, MDSAP Council Rails Against ISO's Push To Change 13485 Quality Standard

The chair of the Medical Device Single Audit Program (MDSAP) Regulatory Authority Council is warning of "instability" in industry if the International Organization for Standardization (ISO) Technical Management Board has its way and makes changes now to international quality systems standard ISO 13485.

International Standards

ISO Wants To Tinker With Quality Systems Standard 13485:2016. Let ISO Know What You Think By Nov. 9

Device firms don't have to conform to the latest version of ISO 13485 until March 2019, yet the International Organization for Standardization (ISO) Technical Management Board is champing at the bit to open up the quality systems standard for a rewrite. In response, ISO Technical Committee 210 has developed a survey to determine how changing the standard will affect device-makers and other stakeholders. TC210 wants to "gather opinions from the users [of ISO 13485] to justify why no immediate revision is desired, especially in light of all the regulatory changes that are coming," TC210 delegate Kim Trautman says. The survey closes Nov. 9.

International Standards

Breathing Easy: ALung CEO Talks Novel Hemolung Device, FDA's Breakthrough Pathway, Landmark US/UK Clinical Trials

In a deep-dive sit-down interview with Medtech Insight, ALung Technologies CEO Pete DeComo dishes on US FDA's Breakthrough Devices Program and explains why his firm's novel artificial lung device, Hemolung, is worthy of traveling the expedited pathway to agency approval. DeComo also details two pivotal Hemolung clinical trials in the US and UK, and explains why Hemolung isn't marketing the device for commercial use despite being approved in 36 countries outside the US. He also talks about a future portable version of Hemolung, but noted that's not where ALung is focused right now. "Our first task is that first-generation technology – to get it to market, make it the standard-of-care, and then, if you are successful with all of that, you can do all of those wonderful other things as it relates to portability and wearability," DeComo says.

Respiratory Innovation

Life Sciences Greenhouse Plants Medtech Seeds In Pittsburgh

ALung CEO Pete DeComo says the start-up's novel Hemolung device might never have seen the light of day if it weren't for the support of the company's local community and, in particular, investment firm Pittsburgh Life Sciences Greenhouse. And ALung isn't the only Pittsburgh medtech firm the Greenhouse is aiding – there are currently 25 device and diagnostics start-ups in its portfolio.

Innovation StartUps and SMEs

Warning Letter Roundup & Recap – Oct. 30, 2018

Four US FDA warning letters addressed to overseas device-makers were posted online by the agency this week, including one to a firm that stored sub-assemblies and final assembled units on the manufacturing floor without proper documentation, and another to a company that sold its catheter tip pressure transducers without FDA pre-market approval.

Device Warning Letters FDA

Compliance Corner: 8 Handy Tips From An MDSAP Auditor To Help You Ace Your Next Audit

NSF International's Brian Ludovico offers up advice for device-makers facing an audit under the Medical Device Single Audit Program.

Compliance Corner International
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