Start-Up FDA? CDRH Seeks Entrepreneurial Spirit With New “In-Residence” Program
This article was originally published in The Gray Sheet
Executive SummaryCDRH is hoping to inject a dose of start-up-firm mentality into its processes with the official launch last week of the entrepreneurs-in-residence pilot program as part of a broader FDA push to highlight its “innovation” bona fides.
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Variability runs high in FDA’s process for approving new device trials, but the agency is open to recommendations for improvements coming out of its entrepreneurs-in-residence program, says Chip Hance, a former Abbott executive participating in the program.
FDA’s device center launched the second round of its entrepreneurs-in-residence program, bringing in outside experts to the center to focus on streamlining data collection and the approval-to-reimbursement pathway.
FDA’s device center hopes the effort, which is intended to model a quicker-turnaround “Silicon Valley” approach to system development, will help reduce time-to-market for new devices, and simplify some post-market surveillance efforts.