Leadership in IDEAL collaboration

 

Dr. Sedrakyan is currently the Vice-Chair of the IDEAL collaboration. The IDEAL Framework was developed by an expert consensus and defines five stages of innovation and its evaluation (Idea, Development, Exploration, Assessment, Long-term study). The IDEAL for devices framework developed by Dr. Sedrakyan represents a potential paradigm shift in regulatory evidence. The current pre/post-market system, in which most rigorous evaluation occurs at the pre-market level, encourages less rigorous process and less rigorous market release for some innovative devices. On the other hand, a continuous evaluation process using IDEAL-D allows graded, responsible and earlier patient access.

The IDEAL proposal offers the potential for better, safer and faster regulatory evidence gathering for new devices, but cannot guarantee improved surveillance without appropriate adaptation of regulatory structures and procedures. The IDEAL collaboration has become a leading framework internationally. Since 2012, the collaboration has organized two major think tanks related to IDEAL application in regulation and published a major framework paper in the high impact medical journal, The BMJ. Furthermore, on April 7, 2016 the collaboration organized a major conference in Oxford, UK, to discuss methodologies for rapid cycle device innovation and evaluation. The collaboration also organized its first inaugural IDEAL-D annual conference at the New York Academy of Medicine On May 4-5, 2017, followed by the MDEpiNet Annual Conference at the FDA on October 19-20, 2017.


CONTACT US

  • Dr. Art Sedrakyan
    Department of Healthcare Policy & Research
    402 East 67th Street New York, NY 10065
    (646) 962-8072
    ars2013@med.cornell.edu
  • Courtney Baird
    Department of Healthcare Policy & Research
    402 East 67th Street
    New York, NY 10065
    (646) 962-8099
    ceb3003@med.cornell.edu
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