Characterising uncertainty in the assessment of medical devices and determining future research needs

Claire Rothery, Karl Claxton, Stephen Palmer, David Epstein, Rosanna Tarricone, Mark Sculpher

Research output: Contribution to journalArticlepeer-review


Decisions about the adoption of medical interventions are informed by evidence on their costs and effects. For a range of reasons, evidence relating to medical devices may be limited. The decision to adopt a device early in its life cycle when the evidence base is least mature may impact on the prospects of acquiring further evidence to reduce uncertainties. Equally, rejecting a device will result in no uptake in practice and hence no chance to learn about performance. Decision options such as ‘only in research’ or ‘approval with research’ can overcome these issues by allowing patients early access to promising new technologies
while limiting the risks associated with making incorrect decisions until more evidence or learning is established. In this paper, we set out the issues relating to uncertainty and the value of research specific to devices: learning curve effects, incremental device innovation, investment and irrecoverable costs, and dynamic pricing. We show the circumstances under which an only in research or approval with research scheme may be an appropriate policy choice. We also consider how the value of additional research might be shared between the manufacturer and health sector to help inform who might reasonably be
expected to conduct the research needed.
Original languageEnglish
Pages (from-to)109-123
Number of pages15
JournalHealth Economics
Issue number(Suppl. 1)
Early online date31 Jan 2017
Publication statusPublished - 31 Jan 2017

Bibliographical note

© 2017, the Authors.


  • MedtecHTA
  • cost-effectiveness
  • health technology assessment
  • medical devices
  • only in research
  • uncertainty

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