title: Adapting the IDEAL Framework and Recommendations for medical device evaluation: A modified Delphi survey.
abstract: BACKGROUND
  Current regulatory systems for medical device marketing approval lack adequate requirements for evidence of safety and efficacy. The Total Product Life Cycle (TPLC) concept, with clinical use and marketing expanding as evidence develops, has won support, but lacks a template to define evidence requirements at different stages. The IDEAL Framework & Recommendations, originally developed for new surgical procedures, might provide such a template, but may require modification.
  
  
  METHODS
  We conducted a Delphi expert consensus exercise to determine how IDEAL might be modified to accommodate the needs of device regulation. 34 experts were invited to participate in 3 rounds of questioning, with feedback of the results of each round to participants before the next.
  
  
  RESULTS
  27 of 34 experts responded in at least one survey round. Experts agreed that, after appropriate modifications, IDEAL could form an evidence template for a TPLC-based regulatory system. Necessary modifications include a new Stage 0 should guide reporting of pre-clinical studies, expansion of registries to all stages, and omission of IDEAL stages 2 and 3 for "successor" devices under certain conditions.
  
  
  CONCLUSIONS
  A standard approach to TPLC evaluation of medical devices does not currently exist. The IDEAL Framework, if modified appropriately, could fill such a void and improve the safety of new medical devices.
authors.affiliation: Department of Surgery, Maimonides Medical Center, 4802 10th Ave, Brooklyn, NY, 11219, USA.
authors.forename: Christopher P
authors.initials: CP
authors.lastname: Pennell
authors.affiliation: IDEAL Collaboration, University of Oxford, Nuffield Department of Surgical Sciences, John Radcliffe Hospital, Headley Way, Oxford, OX3 9LA, UK.
authors.forename: Allison
authors.initials: A
authors.lastname: Hirst
authors.affiliation: New York Presbyterian Hospital, Weill Cornell Medical College, 402 East 67th Street, LA 223, New York, NY, 10067, USA.
authors.forename: Art
authors.initials: A
authors.lastname: Sedrakyan
authors.affiliation: IDEAL Collaboration, University of Oxford, Nuffield Department of Surgical Sciences, John Radcliffe Hospital, Headley Way, Oxford, OX3 9LA, UK. Electronic address: peter.mcculloch@nds.ox.ac.uk.
authors.forename: Peter G
authors.initials: PG
authors.lastname: McCulloch
mesh_terms: D003697:Delphi Technique; D004864:Equipment and Supplies / Q000009:adverse effects; D006801:Humans; D007258:Informed Consent; D011795:Surveys and Questionnaires
keywords: Delphi survey; IDEAL Framework; IDEAL Recommendations; Medical device; Medical device safety