title: Dynamics of device innovation: implications for assessing value.
abstract: BACKGROUND
  In recent years, there has been growing interest in evaluating the health and economic impact of medical devices. Payers increasingly rely on cost-effectiveness analyses in making their coverage decisions, and are adopting value-based purchasing initiatives. These analytic approaches, however, have been shaped heavily by their use in the pharmaceutical realm, and are ill-adapted to the medical device context.
  
  
  METHODS
  This study focuses on the development and evaluation of left ventricular assist devices (LVADs) to highlight the unique challenges involved in the design and conduct of device trials compared with pharmaceuticals.
  
  
  RESULTS
  Devices are moving targets characterized by a much higher degree of post-introduction innovation and "learning by using" than pharmaceuticals. The cost effectiveness ratio of left ventricular assist devices for destination therapy, for example, decreased from around $600,000 per life year saved based on results from the pivotal trial to around $100,000 within a relatively short time period.
  
  
  CONCLUSIONS
  These dynamics pose fundamental challenges to the evaluation enterprise as well as the policy-making world, which this paper addresses.
authors.affiliation: Icahn School of Medicine at Mount Sinai.
authors.forename: Annetine C
authors.initials: AC
authors.lastname: Gelijns
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Russo
authors.forename: Kimberly N
authors.initials: KN
authors.lastname: Hong
authors.forename: Lawrence D
authors.initials: LD
authors.lastname: Brown
authors.forename: Deborah D
authors.initials: DD
authors.lastname: Ascheim
authors.forename: Alan J
authors.initials: AJ
authors.lastname: Moskowitz
mesh_terms: D018795:Device Approval; D006353:Heart-Assist Devices / Q000191:economics*; D062069:Inventions; D013673:Technology Assessment, Biomedical / Q000379:methods*; D062505:Value-Based Purchasing; D018487:Ventricular Dysfunction, Left / Q000628:therapy