Smid, Tom (2026) Navigating the Regulatory Disabler: A Configurational Analysis of FDA Clearance Among Healthcare AI Startups. Research Project, Industrial Engineering and Management.
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Abstract
Healthcare AI startups face a persistent implementation gap: despite technological promise and substantial investment, few successfully integrate into routine clinical practice. This re- search extends the "External Disabler" framework by examining which configurations of startup characteristics enable the navigation of regulatory barriers, specifically FDA clearance. Using fsQCA on a sample of 86 US startups, with a focused sufficiency analysis on 30 high-autonomy companies where FDA clearance is a relevant milestone. Five conditions are examined: AI autonomy level, company maturity, funding level, clinical founder presence, and clinical trial activity. The analysis identifies one robust configuration associated with success: the absence of clin- ical founders combined with clinical trial activity, organizational maturity, and substantial funding. Negated outcome analysis demonstrates asymmetry, identifying two distinct path- ways to regulatory failure. The highest failure risk occurs when clinical founders lack supporting resources, suggesting that clinical expertise without trial activity, maturity, and funding associated with stagnation. A second failure path shows that maturity alone is insufficient; without clinical founders, mature companies still fail when lacking both trials and funding. These findings suggest that clinical domain expertise is a complement to, rather than a substitute for, the organizational infrastructure required for FDA clearance.
| Item Type: | Thesis (Research Project) |
|---|---|
| Supervisor name: | Groen, A.J. and Belousova, O. |
| Degree programme: | Industrial Engineering and Management |
| Thesis type: | Research Project |
| Language: | English |
| Date Deposited: | 13 Mar 2026 09:31 |
| Last Modified: | 13 Mar 2026 09:31 |
| URI: | https://fse.studenttheses.ub.rug.nl/id/eprint/37253 |
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