Research, Regulation, and Reimbursement in Surgery and Technologies
Promoting innovation and evaluation in modern surgery and other invasive technologies including implants is one of the main challenges in healthcare. IDEAL is a development of Evidence Based Medicine approach designed to provide practical solutions to the real problems of surgery, devices and other complex therapies where randomised trials are often problematic.
The second IDEAL international conference of over one hundred participants focussed on the hottest topics in surgical/interventional care in various clinical areas and celebrated the continuing work of the IDEAL Collaboration. The conference provided real-world context and a wide variety of perspectives from surgeons, methodologists, professional societies, industry, regulators, ethicists, and payers. Plenary lectures were intermixed with parallel educational sessions and discussion opportunities for surgeons and scientists.
Presentations
Plenary Session 1: IDEAL Surgical Innovation/Evaluation: current developments
- IDEAL Template and specific opportunities – Peter McCulloch, NDS Oxford
- Introduction to IDEAL-D – Art Sedrakyan, Weill Cornell Medical College, NY
- IDEAL and Innovation at the FDA – Murray Sheldon/Danica Marinac-Dabic, FDA
- IDEAL is a continuously improving work in progress – Jane Blazeby, University of Bristol
Clinical Think-Tanks using IDEAL to reflect on case studies
- Cardiovascular Session – Bruce Campbell, NICE/MHRA, UK
- Orthopaedic Session – David Beard, SITU, NDORMS, University of Oxford
Plenary Session 2: IDEAL Stakeholder Engagement in Education
- Education and current surgical research training – Ajit Sachdeva, American College of Surgeons
- UK perspective: NICE, the MHRA and IDEAL – Bruce Campbell, MHRA
- Industry exposure to IDEAL: education and outreach – Jesse Berlin, Johnson & Johnson
Publishing IDEAL – A Conversation with Journal Editors
- Perspectives from a general medical journal – Elizabeth Loder, British Medical Journal
- An update on the Research Registry and IDEAL studies – Riaz Agha, Intl Journal of Surgery
- Surgical journals and IDEAL – style reporting – Justin Dimick, Annals of Surgery and JAMA Surgery
Plenary Session 3: Health Technology Assessment and IDEAL
- IDEAL and HTA – Sean Tunis, Center for Medical Technology Policy (CMTP)
- Advancing methods of Health Technology Assessment for medical devices: the EU MedTechHTA Project – Tammy Clifford – CADTH/MedTechHTA
- International Society for Pharmacoeconomics and Outcomes Research – Medical devices – Bruce Gingles – Cook Medical/ISPOR
- HTA and IDEAL (a “NICE” perspective) – Bruce Campbell – MHRA/NICE
MDEpiNet and NEST Session
- The history of MDEpiNet and device life-cycle evaluations – Danica Marinac-Dabic, FDA
- Creating coordinated registry networks & utilising routine data for device research – Art Sedrakyan, Weill Cornell
- More efficient evaluation using registries and Bayesian approaches – Marion Campbell, University of Aberdeen
- UDI database interoperability and registries: vascular device examples – Behnaz Minaei, FDA and Phil Goodney, Dartmouth
- Introduction to National Evaluation System for Devices/Technology (NEST) and IDEAL – Bill Murray, MDIC
Partners
- Weill Cornell Medicine
- Maimonides Medical Center
- Medical Device Epidemiology Network
Supporters
- Institute for Surgical Excellence
- The MedTech Strategist
- Johnson & Johnson