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Lightning Workshop: Congratulations, You’ve Received Your 510(k). So, Is Your Product Really Successful?

Walter Cecka (Senior Director, Drug Delivery Practice, Triple Ring Technologies)

Siddharth Desai (Technical Leader, and President, Health Care Evolution Inc.)

Location: 210D

Date: Thursday, February 13

Time: 10:45am - 12:15pm

Vault Recording: TBD

Too often it seems, especially with entrepreneurs and investors new to Medtech, the 510(k) is interpreted as the grand milestone, the validation of years of work, of all-consuming fundraising, of late nights with cold dinners. They've made it! Right? Well, have they? Does it really work? Can you build it? Is quantity within acceptable yields? Will someone pay for it? In other words, are you really done? In this session you’ll hear from industry veteran about the rush to overemphasize regulatory clearance...the press release of all press releases...relative to the more important achievement of developing medical device solutions that actually work, that can be manufactured, and that someone will pay for.

Topics covered include:

  • Examining products that didn't work as expected, devices that worked well but couldn't be manufactured, or devices that weren't studied with the rigor needed to attract payers
  • Using case studies from personal and industry experiences to look at both the outcomes and root causes behind product failures
  • The staggering costs, both to the companies and to the patients in need of solutions, behind product failures.
  • Best practices to improve the chances that the 510(k) is indeed a celebratory event, with the patient being the big winner