Mitigating Regulatory Uncertainty through AI-Assisted Information Processing: Evidence from Medical Device Development

Sammanfattning

Abstract: The purpose of this thesis is to understand how Artificial Intelligence (AI) can support a healthcare company in mitigating the regulatory uncertainties in the early-stage development of medical devices. The study investigates how AI can be used to interpret regulatory requirements and identify viable regulatory pathways. Medical device companies developing novel technologies face a structural pioneer disadvantage, spending significantly longer in regulatory approval, driven not by technological weakness but by procedural ambiguity about what information regulators require. This uncertainty is particularly acute at the FFE of innovation, where conceptual decisions with major downstream regulatory implications are made before formal regulatory assessment is structurally present. This study uses a qualitative research design using Atos Medical as the case company. Data is collected through 11 exploratory interviews, including 7 semi-structured interviews with key personnel from the case company involved in early concept development, and 4 external experts in medical device regulation and innovation processes. The data was analyzed to identify patterns related to regulatory uncertainty and AI-assisted information processing at the FFE of medical device development. This study contributes empirically grounded insights into how AI-assisted information processing can support the mitigation of regulatory uncertainty at the FFE and identifies four boundary conditions under which it remains effective. The findings identified 3 types of uncertainty at the FFE and their driving factors. AI-assisted information processing has the potential to mitigate these gaps, constrained by boundary conditions. The findings also provide the case company with actionable insights on how AI-assisted information processing can support early-stage development workflows and how regulatory intelligence and compliance requirements can be embedded early in the FFE before major resources are committed. Ultimately, the thesis offers both theoretical and practical contributions, supporting medical device companies in designing more informed and regulatory-aware FFE development processes.