Ann Surg 2021 Apr 7. Epub 2021 Apr 7.
Wellcome EPSRC centre for Interventional and Surgical Sciences, University College London, UK Department of Neurosurgery, National Hospital for Neurology and Neurosurgery, UCLH Foundation Trust, London, UK Orthox Ltd., Oxford, UK Department of Neurosurgery, Great Ormond Street Hospital, London, UK Institute of Child Health, University College London, UK OrganOx Ltd., Oxford, UK Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, Oxford, UK Department of Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK Surgery Theme, Cambridge Clinical Trials Unit, Cambridge University Hospitals, Cambridge, UK Department of Surgery and Cancer, Imperial College London, UK Western University, Ontario, Canada Departments of Health Evidence and Operating Rooms, Radboud University Medical Center, Nijmegen, The Netherlands Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK.
Objective: To extend the IDEAL Framework for device innovation, IDEAL-D, to include the preclinical stage of development (Stage 0).
Background: In previous work, the IDEAL collaboration has proposed frameworks for new surgical techniques and complex therapeutic technologies, the central tenet being that development and evaluation can and should proceed together in an ordered and logical manner that balances innovation and safety.
Methods: Following agreement at the IDEAL Collaboration Council, a multidisciplinary working group was formed comprising 12 representatives from healthcare, academia, industry, and a patient advocate. Read More