IDEAL framework for surgical innovation 1: the idea and development stages

Peter McCulloch, Jonathan A Cook, Douglas G Altman, Carl Heneghan, Markus K Diener, IDEAL Group, Doug Altman, Jeff Aronson, David Beard, Jane Blazeby, Bruce Campbell, Andrew Carr, Tammy Clifford, Jonathan Cook, Pierre Dagenais, Philipp Dahm, Peter Davidson, Hugh Davies, Markus K Diener, Jonothan Earnshaw, Patrick Ergina, Shamiram Feinglass, Trish Groves, Sion Glyn-Jones, Muir Gray, Alison Halliday, Judith Hargreaves, Carl Heneghan, Jo Carol Hiatt, Sean Kehoe, Nicola Lennard, Georgios Lyratzopoulos, Guy Maddern, Danica Marinac-Dabic, Peter McCulloch, Jon Nicholl, Markus Ott, Art Sedrakyan, Dan Schaber, Frank Schuller, Bill Summerskill, Peter McCulloch, Jonathan A Cook, Douglas G Altman, Carl Heneghan, Markus K Diener, IDEAL Group, Doug Altman, Jeff Aronson, David Beard, Jane Blazeby, Bruce Campbell, Andrew Carr, Tammy Clifford, Jonathan Cook, Pierre Dagenais, Philipp Dahm, Peter Davidson, Hugh Davies, Markus K Diener, Jonothan Earnshaw, Patrick Ergina, Shamiram Feinglass, Trish Groves, Sion Glyn-Jones, Muir Gray, Alison Halliday, Judith Hargreaves, Carl Heneghan, Jo Carol Hiatt, Sean Kehoe, Nicola Lennard, Georgios Lyratzopoulos, Guy Maddern, Danica Marinac-Dabic, Peter McCulloch, Jon Nicholl, Markus Ott, Art Sedrakyan, Dan Schaber, Frank Schuller, Bill Summerskill

Abstract

IDEAL is a framework for evaluations of surgical innovations, which follow a distinct development pathway differing from the approach developed for pharmacological interventions. Many pathway and evaluation challenges are shared by other interventional therapies, requiring individual therapist skills and customisation of treatment to the individual, partly through medical devices. This paper provides an overview of the IDEAL framework and recommendations, and focuses on the first two stages: idea and development.

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: PM received financial support from the National Institute for Health Research’s Health Technology Assessment programme, Johnson & Johnson, Medtronic, and Zimmer for the IDEAL collaboration and for a workshop; PM and JC received support for travel to the US from the FDA to attend a seminar on IDEAL; no other financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

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