Copenhagen, Denmark—5 November 2019—ISPOR, the professional society for health economics and outcomes research—explored the issue of medical devices and the evolving demands for evidence requirements and assessments in the session, “The Evolving Demands for Medical Device Evidence Development: What the Future Holds.” [SP3]. The session was held this afternoon at ISPOR Europe 2019 in Copenhagen, Denmark.
The medtech industry has seen a flurry of recent changes around the globe. New developments include replacement of the Canadian Medical Devices Conformity Assessment System with the Medical Device Single Audit Program, the movement towards implementation of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation, the deadline for transition to ISO 13485:2016, advancement in the work of the International Medical Device Regulators Forum, modernization of the US Food and Drug Administration’s (FDAs) 510(k) program, and release of dozens of new FDA guidances, and many more. These changes have been instituted to ensure product safety and effectiveness, as well as to enhance the efficiency of regulatory processes. In many cases this has resulted in an increase in the evidence necessary for attainment of regulatory approval/clearance/certification of medical devices.
Historically, the types of evidence required for medical device regulatory and coverage/reimbursement decision-making processes have differed and have been collected at different time points in the medical device lifecycle. Regulatory evidence has typically been collected in early phases and focused on safety and effectiveness studies. Coverage/reimbursement evidence has most often been collected in later phases (sometimes after product launch) and focused on reasonable and necessary clinical criteria; with many countries also conducting value assessments/health technology assessments (HTA).
This special spotlight session examined these recent changes and looked at the future of the medical device regulatory and reimbursement landscapes.
- Rossana Alessandrello, MSc, Agency for Health Quality and Assessment of Catalonia, Barcelona, Spain
- Lindsay Bockstedt, PhD, Medtronic, Minneapolis, MN, USA
- Meike Bomhof, Hull Associates, LLC, Valencia, Spain
- Rachele Busca, PharmD, MSc, MBA, W.L. Gore, Verona, Italy
- Giorgio Colombo, MSc, PhD, University of Pavia, Pavia, Italy
- Hedi Schelleman, PhD, The National Healthcare Institute, Diemen, Netherlands
With the new regulations and associated increases in evidence requirements, the dynamic of evidence collection for these different decision-making processes may change. Experts in the medical device field have been considering a number of issues, including how the additional regulatory evidence will be used to increase the efficiency of coverage/reimbursement decision-making processes, if the evidence needs for regulatory and value assessment/HTA processes will be more aligned, if this will lead to shortened timeframes for devices to reach the market and the patient, how medical device companies will be affected, and what effect this will have on patients? These and other issues were debated amongst the spotlight panelists.
ISPOR is recognized globally as the leading professional society for health economics and outcomes research and its role in improving healthcare decisions. ISPOR Europe 2019 expects to draw more than 5000 healthcare stakeholders with an interest in HEOR, including researchers and academicians, assessors and regulators, payers and policymakers, the life sciences industry, healthcare providers, and patient engagement organizations.
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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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