How Should Regulators Ensure High-Levels of Safety While Supporting Innovation of Medical Devices?
New Orleans, LA, USA—May 21, 2019—ISPOR, the professional society for health economics and outcomes research (HEOR), started the day with the second plenary session of its ISPOR 2019 annual conference with, “Medical Device Innovation and Regulation: Turbocharged for Success?”
The medical device market is undergoing fast growth while also facing increasing calls for regulation and oversight. The new European Union (EU) Medical Devices Regulation (EU 2017/745) will begin in May 26, 2020 and is intended to “ensure a high level of safety and health while supporting innovation.” Other regulators, such as the US Food and Drug Administration (FDA), are also instituting major changes to their medical device regulations.
The panel explored ways that regulators can ensure a high level of health protection while also allowing for research and growth in the sector. Panelists also discussed the implications and opportunities for the HEOR community. Laurie Burke, MPH with LORA Group LLC and University of Maryland School of Pharmacy; Royal Oak, MD, USA moderated the session. Speakers included Stephanie Christopher, MA, Medical Device Innovation Consortium, Arlington, VA, USA; Paul Coplan, ScD, MBA, Johnson and Johnson, New Brunswick, NJ, USA; Stephen A. Hull, MHS, Hull Associates LLC, Rockland, MA, USA; and Harindra Wijeysundera, MD, PhD, Canadian Agency for Drugs and Technologies in Health, Ottawa, ON, Canada.
Mr Hull pointed out that most global device evidence approaches are oriented toward US Food and Drug Administration device requirements and that the vast majority of US medical devices are cleared through the 510(k) program. He noted that there is a disconnect between what the 510(k) process requires and the evidence payers want to approve coverage. Medical devices that receive clearance often face significant difficulty gaining coverage by payers.
Dr Coplan spoke about the importance of real-world evidence (RWE) for medical devices. He noted that clinical trials of medical devices face a number of challenges, including difficulty in blinding, variability in surgeon skill and hospital processes, the rapid innovation cycle for devices, the long-term follow-up required, and small patient pools that pose enrollment challenges. He also discussed the FDA’s National Evaluation System for health Technology (NEST) initiative that seeks to more efficiently generate better evidence for medical device evaluation and regulatory decision making.
Ms Christopher spoke about the work of the Medical Device Innovation Consortium (MDIC), a public/private partnership with the goal of transforming the industry through research and engagement. MDIC is working to advance patient preference assessment in the medical device sector. This will require a culture shift toward continuous quality improvement.
Dr Wijeysundera provided a health technology assessment (HTA) and clinician’s perspective on the issue. He defined HTA using the World Health Organization definition that emphasizes that the main purpose of HTA is to inform policy decision making. He contrasted the regulatory approach that asks if the product is safe and technically sound with the HTA approach that makes a determination on value.
In closing, Ms Burke asked each panelist to sum up their one message on this issue. Mr Hull felt it was most important for device manufacturers to dialogue with payers early in the development/clearance process. Dr Coplan encouraged viewing regulatory and HTA bodies as partners in the process. Ms Christopher agreed that beginning dialogue early in the process was key in addition to having he willingness to “give and take a bit.” Dr Wijeysundera reinforced the theme of early dialogue with payers saying that “open dialogue with a bit of humility” can go a long way.
ISPOR is recognized globally as the leading professional society for health economics and outcomes research and its role in improving healthcare decisions. ISPOR 2019 is the leading global HEOR conference and draws nearly 4000 healthcare thought leaders and stakeholders, including researchers and academicians, assessors and regulators, payers and policy makers, the life sciences industry, healthcare providers, and patient engagement organizations.
ISPOR, the professional society for health economics and outcomes research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE®-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.
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