Into 2019: Digital Leads US Policy Innovations, But Public Medtech Scrutiny Grows
Scott Gottlieb's FDA continues to push out policy reforms and experiments at a rapid pace, with special focus on digital and AI technologies. In parallel, US Medicare officials are more publicly signaling plans to roll out policies for a quicker path to reimbursement for new devices. However, public scrutiny of whether device regulations properly protect patient safety is growing, and it could have an impact.
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Investigative journalists, tort lawyers, the judicial system and public opinion all provide checks and balances on medical research, industrial innovation and commercial exploitation of health-care technologies. Whether those affected like it or not, these well-intentioned elements of society demand accountability of an industry that has a profound effect on all our lives. The "Implant Files" episode is a reminder for medtech stakeholders across the world that nothing can be taken for granted, says medtech industry and regulatory consultant Trevor Lewis in this guest column for Medtech Insight.
The Implant Files: EU Blamed For Regulatory Inadequacies The World Over While 'Wrath'-Behrendt Fumes
All over the world, the medtech industry woke up Monday morning to read highly critical reports of the way the medtech industry is regulated. Investigative pieces accuse the medtech industry of putting profits before safety, of sabotaging the EU's best efforts toward more appropriate regulation, and treating patients as guinea pigs. This is a first look at the International Consortium of Investigative Journalists' Implant Files investigation from an EU perspective.
In an interview at The MedTech Conference in Philadelphia this week, US FDA device-center Director Jeff Shuren spoke to Medtech Insight about what is happening with the pending total product lifecycle office and the larger-than-expected response to the Breakthrough Devices Program. He also makes the point that supporting innovation and protecting safety are not opposing goals, and more.