title: Making the Leap: the Translation of Innovative Surgical Devices From the Laboratory to the Operating Room.
abstract: OBJECTIVE
  To determine the rate and extent of translation of innovative surgical devices from the laboratory to first-in-human studies, and to evaluate the factors influencing such translation.
  
  
  BACKGROUND
  Innovative surgical devices have preceded many of the major advances in surgical practice. However, the process by which devices arising from academia find their way to translation remains poorly understood.
  
  
  METHODS
  All biomedical engineering journals, and the 5 basic science journals with the highest impact factor, were searched between January 1993 and January 2000 using the Boolean search term "surgery OR surgeon OR surgical". Articles were included if they described the development of a new device and a surgical application was described. A recursive search of all citations to the article was performed using the Web of Science (Thompson-Reuters, New York, NY) to identify any associated first-in-human studies published by January 2015. Kaplan-Meier curves were constructed for the time to first-in-human studies. Factors influencing translation were evaluated using log-rank and Cox proportional hazards models.
  
  
  RESULTS
  A total of 8297 articles were screened, and 205 publications describing unique devices were identified. The probability of a first-in-human at 10 years was 9.8%. Clinical involvement was a significant predictor of a first-in-human study (P = 0.02); devices developed with early clinical collaboration were over 6 times more likely to be translated than those without [RR 6.5 (95% confidence interval 0.9-48)].
  
  
  CONCLUSIONS
  These findings support initiatives to increase clinical translation through improved interactions between basic, translational, and clinical researchers.
authors.affiliation: The Hamlyn Centre, Institute of Global Health Innovation, Imperial College London, London, UK.|Department of Neurosurgery, Imperial College Healthcare NHS Trust, London, UK.
authors.forename: Hani J
authors.initials: HJ
authors.lastname: Marcus
authors.affiliation: The Hamlyn Centre, Institute of Global Health Innovation, Imperial College London, London, UK.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Payne
authors.affiliation: The Hamlyn Centre, Institute of Global Health Innovation, Imperial College London, London, UK.
authors.forename: Archie
authors.initials: A
authors.lastname: Hughes-Hallett
authors.affiliation: The Hamlyn Centre, Institute of Global Health Innovation, Imperial College London, London, UK.
authors.forename: Gauthier
authors.initials: G
authors.lastname: Gras
authors.affiliation: The Hamlyn Centre, Institute of Global Health Innovation, Imperial College London, London, UK.
authors.forename: Konrad
authors.initials: K
authors.lastname: Leibrandt
authors.affiliation: Department of Neurosurgery, Imperial College Healthcare NHS Trust, London, UK.
authors.forename: Dipankar
authors.initials: D
authors.lastname: Nandi
authors.affiliation: The Hamlyn Centre, Institute of Global Health Innovation, Imperial College London, London, UK.
authors.forename: Guang-Zhong
authors.initials: GZ
authors.lastname: Yang
mesh_terms: D000818:Animals; D001698:Biomedical Engineering; D004059:Diffusion of Innovation; D006801:Humans; D010506:Periodicals as Topic; D013525:Surgical Instruments; D057170:Translational Research, Biomedical