Intended for healthcare professionals


IDEAL-D: a rational framework for evaluating and regulating the use of medical devices

BMJ 2016; 353 doi: (Published 09 June 2016) Cite this as: BMJ 2016;353:i2372
  1. Art Sedrakyan, professor1,
  2. Bruce Campbell, professor2,
  3. Jose G Merino, clinical research editor3,
  4. Richard Kuntz, chief scientific, clinical, and regulatory officer4,
  5. Allison Hirst, researcher5,
  6. Peter McCulloch, professor5
  1. 1Department of Healthcare Policy and Research and Medical Device Epidemiology Network (MDEpiNet) Science and Infrastructure Center, Weill Medical College of Cornell University, New York, NY, USA
  2. 2Interventional Procedures Programme, National Institute for Health and Care Excellence, London, UK
  3. 3The BMJ and Johns Hopkins Community Physicians, Bethesda, MD, USA
  4. 4Medtronic, Minneapolis, MN, USA
  5. 5Nuffield Department of Surgical Science, University of Oxford, Oxford, UK
  1. Correspondence to: P McCulloch peter.mcculloch{at}
  • Accepted 29 March 2016

High profile device failures have highlighted the inadequacies of current regulation. Art Sedrakyan and colleagues call for a move to a graduated model of approval and suggest a framework to achieve this goal

Implantable devices such as pacemakers and hip implants have transformed many lives, but there have also been high profile instances of harm.1 2 3 4 5 Unlike the system for drugs, marketing approval for devices in the European Union and the United States has historically focused on proof of safety as a minimum requirement, and approval could be granted based on preclinical evidence alone, with no randomised clinical trials (fig 1). In both jurisdictions, recent years have seen some tightening of requirements. In the US, more invasive devices now generally require a rigorous “pivotal” clinical trial either through the FDA’s pre-market approval (PMA) pathway or within the 510k pathway. In the EU, the CE mark requirements are being moved in a similar direction by the evolving medical device reform (MDR) programme.

Fig 1 Simplified flowcharts showing approval process for invasive medical devices in the European Union and United States

Despite these improvements, both systems dichotomise device status as either pre-market (not yet approved) or post-market (approved), so removing incentives for fuller evaluation and reporting at both early and later stages in the evolution of the device. A system in which data requirements for device approval and surveillance can be matched to the device’s stage of development, known as total product life cycle evaluation,6 would encourage better evidence development and reporting both before and after a pivotal trial, in much the same way that the Kefauver-Harris Amendment 1962 did for medicines after thalidomide.7

While the total product life cycle idea is attractive in principle, there has been little guidance on implementation. The IDEAL (Idea, …

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