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Shawn M. Schmitt

Deputy Editor

Cape Coral, FL
Shawn M. Schmitt, deputy editor for regulatory and policy, lives and works in Cape Coral, 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, 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, Dec. 6, 2017 – How Investigator Familiarity Breeds Recalls, Poor Quality

On this week’s podcast, we highlight an eye-opening study that shows that the chummier a device-maker is with US FDA investigators, the more likely it is that those firms will experience quality system troubles and face costly product recalls.

Device Week Quality Control

Warning Letter Roundup & Recap – Dec. 5, 2017

US FDA addressed quality systems and Medical Device Reporting violations at a manufacturer of bone fixation fastener systems in the only device-related warning letter posted this week.

Device Warning Letters Regulation

BFFs With FDA? Repeat Visits From Investigators Can Lead To Poor Device Quality, Recalls, Study Suggests

When a US FDA investigator is overly familiar with a company and its people, it can lead to a weaker facility inspection that might not uncover quality system problems – which in turn could lead to troublesome devices and recalls. So says a study conducted by professors at the University of Wisconsin, Indiana University and the University of Minnesota, which found that a device-maker's recall hazard increases 21% when it's inspected a second time by the same investigator. Even more concerning: The recall hazard shoots up 57% after an investigator's third audit of a firm. Might rotating investigator assignments help? And how might the agency's new "program alignment" inspectional scheme affect how often an investigator visits a particular firm?

Quality Control Recalls

A Helping Hand: 'MedTech Color' Aims To Move Minorities From Shop Floor To Executive Suite

Industry veteran Kwame Ulmer has cobbled together a new group to help address perceived racial disparities at device firms. "MedTech Color" has already attracted attention from heavy-hitters Johnson & Johnson, Medtronic, 3M and Danaher, as well as industry advocacy group AdvaMed.

Leadership Human Capital

5 Ongoing US FDA Device Center Pilot Programs: A Listing

Having trouble keeping track of the many pilot programs offered by US FDA's device center? Then this handy listing of ongoing pilots should help.

FDA Quality Control

US FDA Approves Device To Aid Cataract Patients

Approved by US FDA on Nov. 22, a new intraocular lens from RxSight is designed to correct residual refractive errors after cataract surgery and enable clearer vision.

Ophthalmology Approvals
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