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Early-stage firms urged to run trials on 510(k) devices

This article was originally published in The Gray Sheet

Executive Summary

To boost sales and reimbursement, startups are "going to have to do the big clinical trial whether it's a 510(k) or a PMA, because you have got to prove to the market, in addition to the FDA, that the technology is valuable," Piper Jaffray Ventures Managing Director Buzz Benson asserts at the recent IBF/Medical Alley Medtech Investing Conference in Minneapolis. Startup firms also should focus on the appropriate setting for device use - be it inpatient, outpatient, home or ambulatory surgical centers. At a March meeting, venture capitalists urged startups to pursue reimbursement as early as possible (1"The Gray Sheet" March 8, 2004, p. 8)...
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