From Recalls To Clinical Trials, Medtronic’s Developing A ‘Systematic Approach’ To Capturing Patient Input
The medtech behemoth is putting in place a company-wide framework to make sure the voice of the patient is heard across the firm’s premarket and postmarket activities.
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Medtronic on 5 October widened its 2019 recall of MiniMed pump models 630G and 670G because there’s a chance they can over- or under-dose patients. It also expanded an unrelated 2018 recall of remote controllers used with specific MiniMed pumps due to cybersecurity concerns.
The medtech giant yanked from shelves in July its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology. The recall was labeled high-risk class I by the US FDA on 20 September. It’s the company’s ninth class I this year.
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?