IDEAL Collaboration

The IDEAL Framework was developed by an expert consensus and defines five stages of innovation and its evaluation (Ideas, Development, Exploration, Assessment, Long-term study). This framework 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 a less rigorous process and market release for innovative devices. On the other hand, a continuous evaluation process using IDEAL allows graded, responsible and early 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. As a leading international framework since 2012, IDEAL collaboration has facilitated the organization of two major regulation application think tanks and the publication of a major framework paper in The British Medical Journal (BMJ). Furthermore, on April 7, 2016, the IDEAL collaboration facilitated the organization of a major conference in Oxford, UK, to discuss rapid cycle device innovation and evaluation methodologies. The inaugural IDEAL conference, at the New York Academy of Medicine, May 4-5, 2017, was followed by the annual Food and Drug Administration (FDA) Medical Device Epidemiology Network (MDEpiNet) conference, October 19-20, 2017.

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