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It's no mean feat to win over industry experts who live and breathe the regulations, science, and art of monitoring medical devices on the market. Safety, quality, and risk management veterans typically exude a healthy skepticism about any proposed adjustments to well-known and well-honed-but considerably challenging- postmarket surveillance activities.
Now, though, industry experts are expressing cautious optimism about the broad intent of a plan by the U.S. Food and Drug Administration (FDA) to leverage big data and broad partnerships to enhance postmarket activities and improve patient safety.
If the plan becomes a reality over the next decade, it would unleash an unprecedented era of research, discovery, and innovation that would benefit patients, clinicians, manufacturers, regulators, and payers with safer and more effective devices, according to its supporters.
Moreover, postmarket vigilance could become less of a burdensome chore focused on regulatory compliance and enforcement and more of an ecosystem that supports better, faster, cheaper-and value-added-practices for improving the full life cycle of medical devices.
"Big data is where you can really see signals in device use and performance. If companies are able to get to this data, it will provide a wealth of information," said Lina Alzate, senior director of medical safety operations at Johnson & Johnson Medical Devices.
Patrick Caines, director of quality and postmarket surveillance at Baxter Healthcare, agreed.
"The initiative that the FDA has laid out and its partnership with industry are good things," he said. "Compliance is a minimum entry point for being in this game. The next question is, how do you turn it into a competitive advantage? Progressive companies already view postmarket activities with a life cycle approach-a closed-loop system of feeding information back into risk management and design to improve the safety and effectiveness of the process and products. Once people really understand the benefits to business if it's done in this fashion, I think you will see more ready adoption."
Hallmarks of the Plan
The FDA plan, which has been in the works for at least three years, is laid out in a 141-page draftreport, Recommendations for a National Medical Device Evaluation System: Strategically Coordinated Registry Networks to Bridge Clinical Care and Research.1 The plan was released in August; public comments were solicited through Oct. 26.
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