A novel maturity index for assessing medical device startups
Abstract Background: Startup companies in the healthcare sector often fail because they lack sufficient entrepreneurial, regulatory, and business development expertise. Maturity models provide useful frameworks to assess the state of business elements more systematically than heuristic assessments...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2022-01-01
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| Series: | Journal of Clinical and Translational Science |
| Subjects: | |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866122004368/type/journal_article |
| _version_ | 1811156493189251072 |
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| author | Frances J. Richmond Grzegorz Zapotoczny Brian Green Sowmya Lokappa Katy Rudnick Juan Espinoza the ICRS-CTIP Collaborative for Regulatory Research |
| author_facet | Frances J. Richmond Grzegorz Zapotoczny Brian Green Sowmya Lokappa Katy Rudnick Juan Espinoza the ICRS-CTIP Collaborative for Regulatory Research |
| author_sort | Frances J. Richmond |
| collection | DOAJ |
| description |
Abstract
Background:
Startup companies in the healthcare sector often fail because they lack sufficient entrepreneurial, regulatory, and business development expertise. Maturity models provide useful frameworks to assess the state of business elements more systematically than heuristic assessments. However, previous models were developed primarily to characterize the business state of larger nonmedical companies. A maturity index designed specifically for startup companies in the medical product sector could help to identify areas in which targeted interventions could assist business development.
Methods:
A novel MedTech Startup Maturity Index (SMI) was developed by a collaborative team of academic and industry experts and refined through feedback from external stakeholders. Pediatric medical device startups associated with the West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) were scored and ranked according to the SMI following semi-structured interviews. The CTIP executive team independently ranked the maturity of each company based on their extensive experiences with the same companies.
Results:
SMI scores for 16 companies ranged from 1.2 to 3.8 out of 4. These scores were well aligned with heuristic CTIP rankings for 14 out of 16 companies, reflected by strong correlations between the two datasets (Spearman’s rho = 0.721, P = 0.002, and Kendall’s tau-b = 0.526, P = 0.006).
Conclusions:
The SMI yields maturity scores that correlate well with expert rankings but can be assessed without prior company knowledge and can identify specific areas of concern more systematically. Further research is required to generalize and validate the SMI as a pre-/post-evaluation tool.
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| first_indexed | 2024-04-10T04:52:40Z |
| format | Article |
| id | doaj.art-6f4c52397ad748938f51838066f62923 |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-10T04:52:40Z |
| publishDate | 2022-01-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-6f4c52397ad748938f51838066f629232023-03-09T12:31:05ZengCambridge University PressJournal of Clinical and Translational Science2059-86612022-01-01610.1017/cts.2022.436A novel maturity index for assessing medical device startupsFrances J. Richmond0Grzegorz Zapotoczny1https://orcid.org/0000-0003-2036-2992Brian Green2Sowmya Lokappa3Katy Rudnick4Juan Espinoza5the ICRS-CTIP Collaborative for Regulatory ResearchDepartment of Regulatory and Quality Sciences, School of Pharmacy, University of Southern California, Los Angeles, CA, USADepartment of Regulatory and Quality Sciences, School of Pharmacy, University of Southern California, Los Angeles, CA, USADepartment of Regulatory and Quality Sciences, School of Pharmacy, University of Southern California, Los Angeles, CA, USADepartment of Regulatory and Quality Sciences, School of Pharmacy, University of Southern California, Los Angeles, CA, USADepartment of Regulatory and Quality Sciences, School of Pharmacy, University of Southern California, Los Angeles, CA, USADepartment of Pediatrics, Children’s Hospital Los Angeles, Los Angeles, CA, USA Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA Abstract Background: Startup companies in the healthcare sector often fail because they lack sufficient entrepreneurial, regulatory, and business development expertise. Maturity models provide useful frameworks to assess the state of business elements more systematically than heuristic assessments. However, previous models were developed primarily to characterize the business state of larger nonmedical companies. A maturity index designed specifically for startup companies in the medical product sector could help to identify areas in which targeted interventions could assist business development. Methods: A novel MedTech Startup Maturity Index (SMI) was developed by a collaborative team of academic and industry experts and refined through feedback from external stakeholders. Pediatric medical device startups associated with the West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) were scored and ranked according to the SMI following semi-structured interviews. The CTIP executive team independently ranked the maturity of each company based on their extensive experiences with the same companies. Results: SMI scores for 16 companies ranged from 1.2 to 3.8 out of 4. These scores were well aligned with heuristic CTIP rankings for 14 out of 16 companies, reflected by strong correlations between the two datasets (Spearman’s rho = 0.721, P = 0.002, and Kendall’s tau-b = 0.526, P = 0.006). Conclusions: The SMI yields maturity scores that correlate well with expert rankings but can be assessed without prior company knowledge and can identify specific areas of concern more systematically. Further research is required to generalize and validate the SMI as a pre-/post-evaluation tool. https://www.cambridge.org/core/product/identifier/S2059866122004368/type/journal_articlePediatricsmedical devicesregulatory sciencebusiness maturitystartupsclinical readinesssmall- and medium-sized enterprises |
| spellingShingle | Frances J. Richmond Grzegorz Zapotoczny Brian Green Sowmya Lokappa Katy Rudnick Juan Espinoza the ICRS-CTIP Collaborative for Regulatory Research A novel maturity index for assessing medical device startups Journal of Clinical and Translational Science Pediatrics medical devices regulatory science business maturity startups clinical readiness small- and medium-sized enterprises |
| title | A novel maturity index for assessing medical device startups |
| title_full | A novel maturity index for assessing medical device startups |
| title_fullStr | A novel maturity index for assessing medical device startups |
| title_full_unstemmed | A novel maturity index for assessing medical device startups |
| title_short | A novel maturity index for assessing medical device startups |
| title_sort | novel maturity index for assessing medical device startups |
| topic | Pediatrics medical devices regulatory science business maturity startups clinical readiness small- and medium-sized enterprises |
| url | https://www.cambridge.org/core/product/identifier/S2059866122004368/type/journal_article |
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