Lessons from innovation in drug-device combination products
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Lessons form Innovation Cuoto et al 2011.pdf
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Author(s)
Couto, Daniela S.
Perez-Breva, Luis
Saraiva, Pedro M.
Cooney, Charles L
Date Issued
November 2011
Journal
Advanced Drug Delivery Reviews
Publisher
Elsevier
Citation
Couto, Daniela S.; Perez-Breva, Luis; Saraiva, Pedro and Cooney, Charles L. “Lessons from Innovation in Drug-Device Combination Products.” Advanced Drug Delivery Reviews 64, no. 1 (January 2012): 69–77. © 2011 Elsevier B.V.
Version
Author's final manuscript
Abstract
Drug-device combination products introduced a new dynamic on medical product development, regulatory approval, and corporate interaction that provide valuable lessons for the development of new generations of combination products. This paper examines the case studies of drug-eluting stents and transdermal patches to facilitate a detailed understanding of the challenges and opportunities introduced by combination products when compared to previous generations of traditional medical or drug delivery devices. Our analysis indicates that the largest barrier to introduce a new kind of combination products is the determination of the regulatory center that is to oversee its approval. The first product of a new class of combination products offers a learning opportunity for the regulator and the sponsor. Once that first product is approved, the leading regulatory center is determined, and the uncertainty about the entire class of combination products is drastically reduced. The sponsor pioneering a new class of combination products assumes a central role in reducing this uncertainty by advising the decision on the primary function of the combination product. Our analysis also suggests that this decision influences the nature (pharmaceutical, biotechnology, or medical devices) of the companies that will lead the introduction of these products into the market, and guide the structure of corporate interaction thereon.
MIT Department
Massachusetts Institute of Technology. Department of Chemical Engineering
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Creative Commons Attribution-NonCommercial-NoDerivs License
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DOI of Published Version
https://doi.org/10.1016/j.addr.2011.10.008
