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.
Additional information on the conference can be found
at:
Conference Information | Program | Registration | Short Course Program | Sponsors | Exhibitors | Press
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and outcomes research (HEOR), is an international, multistakeholder, nonprofit
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globally. The Society is the leading source for scientific conferences,
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