Lessons from innovation in drug-device combination products
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 trans...
| Main Authors: | , , , |
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| Other Authors: | |
| Format: | Article |
| Language: | en_US |
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Elsevier
2017
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| Online Access: | http://hdl.handle.net/1721.1/108142 https://orcid.org/0000-0002-0828-535X |
| _version_ | 1826214443778834432 |
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| author | Couto, Daniela S. Perez-Breva, Luis Saraiva, Pedro M. Cooney, Charles L |
| author2 | Massachusetts Institute of Technology. Department of Chemical Engineering |
| author_facet | Massachusetts Institute of Technology. Department of Chemical Engineering Couto, Daniela S. Perez-Breva, Luis Saraiva, Pedro M. Cooney, Charles L |
| author_sort | Couto, Daniela S. |
| collection | MIT |
| description | 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. |
| first_indexed | 2024-09-23T16:05:27Z |
| format | Article |
| id | mit-1721.1/108142 |
| institution | Massachusetts Institute of Technology |
| language | en_US |
| last_indexed | 2024-09-23T16:05:27Z |
| publishDate | 2017 |
| publisher | Elsevier |
| record_format | dspace |
| spelling | mit-1721.1/1081422022-09-29T18:10:38Z Lessons from innovation in drug-device combination products Couto, Daniela S. Perez-Breva, Luis Saraiva, Pedro M. Cooney, Charles L Massachusetts Institute of Technology. Department of Chemical Engineering Cooney, Charles L. Perez-Breva, Luis Saraiva, Pedro M. Cooney, Charles L 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-Portugal Doctoral Program. Bioengineering (SFRH/BD/39444/2007) MIT Portugal Program 2017-04-13T19:43:12Z 2017-04-13T19:43:12Z 2011-11 2011-06 Article http://purl.org/eprint/type/JournalArticle 0169-409X http://hdl.handle.net/1721.1/108142 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. https://orcid.org/0000-0002-0828-535X en_US http://dx.doi.org/10.1016/j.addr.2011.10.008 Advanced Drug Delivery Reviews Creative Commons Attribution-NonCommercial-NoDerivs License http://creativecommons.org/licenses/by-nc-nd/4.0/ application/pdf Elsevier Prof. Cooney via Erja Kajosalo |
| spellingShingle | Couto, Daniela S. Perez-Breva, Luis Saraiva, Pedro M. Cooney, Charles L Lessons from innovation in drug-device combination products |
| title | Lessons from innovation in drug-device combination products |
| title_full | Lessons from innovation in drug-device combination products |
| title_fullStr | Lessons from innovation in drug-device combination products |
| title_full_unstemmed | Lessons from innovation in drug-device combination products |
| title_short | Lessons from innovation in drug-device combination products |
| title_sort | lessons from innovation in drug device combination products |
| url | http://hdl.handle.net/1721.1/108142 https://orcid.org/0000-0002-0828-535X |
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