Intended for healthcare professionals


Regulating incremental innovation in medical devices

BMJ 2014; 349 doi: (Published 09 September 2014) Cite this as: BMJ 2014;349:g5303
  1. Aaron S Kesselheim, associate professor of medicine,
  2. Prashant V Rajan, medical student
  1. 1Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, and Harvard Medical School, Boston MA 02120, USA
  1. akesselheim{at}

Patients need active regulatory oversight, linked to compulsory post-marketing research

As therapeutic options, medical devices differ from prescription drugs in many ways, but one of the most important is their potential for rapid evolution in basic design or technology. In the context of prescription drugs, it would be completely unreasonable to take a basic chemical structure, add another methyl group to it, and presume the drug would work the same (or better) without subjecting the new molecule to additional clinical testing. Medical devices, by contrast, change often. In a study published earlier this year, we found that cardiac implantable electronic devices approved in the US had a median of 50 applications to the Food and Drug Administration (FDA) for big and small changes over their median 15 year regulatory lifespans.1

In a linked paper (doi:10.1136/bmj.g5133), Nieuwenhuijse and colleagues provide important insights into the evidence base supporting new versions of hip and knee replacement devices.2 After conducting a systematic review of the literature and registry data, they found no good evidence of improved clinical outcomes for five widely used and marketed “advances” in hip and knee replacement technology, but they …

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