Successful commercialization of medical technologies increasingly requires developers and manufacturers to think early-on about regulatory approval and reimbursement strategies for their new devices. This can be particularly challenging in the case of monitoring devices, where demonstrating the effectiveness and finding the coding and coverage can often be a complicated and lengthy process, particularly with the given current reimbursement policy. In this paper, we use three technology case studies to examine how firms are navigating the status quo and illustrate the importance of incorporating a comprehensive understanding of current market and regulatory constraints into the development and commercialization process. The case studies suggest that viable approaches can include pairing a monitoring technology with a therapy, or relying on hospital-pay or patient-pay models that are based on demonstration of direct benefits or cost-savings to these parties. The results emphasize that successful innovation in monitoring technologies increasingly requires a very closely aligned engineering, business, and health-economic strategy. Developing a comprehensive understanding of the specific value drivers and policy-induced constraints can contribute substantially to achieving the true benefits of monitoring technologies.
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June 2009
Technical Briefs
Policy-Induced Constraints in the Design and Commercialization of Monitoring Devices: An Assessment of Three Technologies’ Reimbursement Models
Sunil K. Rao,
Sunil K. Rao
Department of Management Science and Engineering,
Stanford University
, 380 Panama Way, Stanford, CA 94305-4026
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Jan B. Pietzsch
Jan B. Pietzsch
Department of Management Science and Engineering,
Stanford University
, 380 Panama Way, Stanford, CA 94305-4026; Wing Tech Inc.
, 9916 Newhall Road, Potomac, MD 20854
Search for other works by this author on:
Sunil K. Rao
Department of Management Science and Engineering,
Stanford University
, 380 Panama Way, Stanford, CA 94305-4026
Jan B. Pietzsch
Department of Management Science and Engineering,
Stanford University
, 380 Panama Way, Stanford, CA 94305-4026; Wing Tech Inc.
, 9916 Newhall Road, Potomac, MD 20854J. Med. Devices. Jun 2009, 3(2): 024502 (4 pages)
Published Online: June 8, 2009
Article history
Received:
November 4, 2007
Revised:
December 9, 2008
Published:
June 8, 2009
Citation
Rao, S. K., and Pietzsch, J. B. (June 8, 2009). "Policy-Induced Constraints in the Design and Commercialization of Monitoring Devices: An Assessment of Three Technologies’ Reimbursement Models." ASME. J. Med. Devices. June 2009; 3(2): 024502. https://doi.org/10.1115/1.3148837
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