Medical Devices: Generating and Using Real-World Observational Data for Decision-Making on Value

Panellists: Dr. Tammy Clifford, Vice-President, Medical Devices and Rapid Response Programs, CADTH; Dr. Jessica Jalbert, Director of Pharmacoepidemiology US and Adjunct Professor, LA-SER Group and Weill Cornell Medical College; Dr. Laura Hatfield, Assistant Professor in the Department of Health Care Policy, Harvard Medical School; Dr. Patricia Trbovich, Academic Research Lead, Centre for Global eHealth Innovation and Assistant Professor of Clinical Engineering in the Institute of Biomaterials and Biomedical Engineering, University Health Network and University of Toronto; Mark Campbell, Associate Director - Medical Technologies Evaluation Programme, National Institute for Health and Care Excellence (NICE)

Background: The US Food and Drug Administration defines medical devices as instruments used to diagnose, treat, or prevent a medical condition without any chemical action in the body. Unlike drug therapies, the permission to market a medical device may not be based on the evaluation of efficacy and safety data from randomized controlled trials. Post-market surveillance and epidemiology programs, therefore, are complementary to the pre-market process because they can identify durability and rare serious adverse events from long-term use of the medical device. As there are unique methodological challenges associated with the evidence synthesis and assessment of medical devices, research initiatives to address them will be presented.

Panel session description and objectives: Four panellists will present the challenges associated with medical device evidence synthesis and health technology assessment, and recent developments for improvement.

  1. Dr. Jalbert will outline a conceptual framework for evidence evaluation of implantable medical devices (IMDs). Important methodological issues that require consideration when assessing the comparative effectiveness of IMDs will also be discussed.
  2. Dr. Hatfield will discuss recent developments in methodologies applied to assess the effectiveness and safety of medical devices in pre- and post-market settings.
  3. Dr. Trbovich will present how environments, workflow processes, and human characteristics can impact the effectiveness and safety of medical devices and equipment.
  4. Mark Campbell will describe the development and use of observational data to support decision-making on recommendations for health system-–wide adoption of new and novel devices and diagnostics in the National Institute for Health and Care Excellence’s (NICE) non-drug technology programs.