People In Brief
This article was originally published in The Gray Sheet
Executive Summary
Post-Gutman OIVD: Steve Gutman will leave FDA for academia at year-end after 17 years with the agency, including 14 years leading the device center's in vitro diagnostics oversight efforts. In 1993, Gutman took over the now-defunct clinical laboratory devices division in CDRH's Office of Device Evaluation. In 2002, he was the founding director of the Office of In Vitro Diagnostic Device Evaluation and Safety, which has jurisdiction over both pre-market and post-market activity for test kits. Product waivers under the Clinical Laboratory Improvement Amendments and regulation of analyte specific reagents were among hot-topic policy issues he addressed during his tenure. Moving forward policies on the oversight of genetic, genomic and pharmacogenomic tests has also been a major focus. Gutman's last working day at FDA will be Dec. 9. He will join the faculty at the University of Central Florida early next year and may also do some consulting, he says. Don St. Pierre, OIVD's associate director for policy and operations, will serve as acting director until a replacement is found
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People In Brief
Medtronic's DeMane goes VC: Former Medtronic Chief Operating Officer Michael DeMane joins health care venture capital firm Thomas, McNerney & Partners April 3. Thomas, McNerney's device portfolio includes atrial fibrillation firm Atritech and continuous glucose monitor developer ArKal Medical. DeMane, who had served in various executive roles with Medtronic since 2000, left the device giant last year when the firm elected to remove the COO position (1"The Gray Sheet" May 5, 2008, p. 4). He is the second big device company COO to move to the venture capital sector in the past three months, with Paul LaViolette leaving Boston Scientific for SV Life Sciences in January (2"The Gray Sheet" Dec. 22, 2008, p. 21)
More Musical Chairs For Device Center’s Higher-Ups
During the final months under former FDA Commissioner Andrew von Eschenbach's leadership, the device center continued to tinker with its upper management, with more than 30 staffers either changing roles or leaving the agency since August (see chart: "1CDRH In Flux").