How a division within an international MedTech company consolidated its tool landscape, leveraged group-wide synergies, and integrated regulatory requirements significantly more efficiently using AI.
Initial situation: rising regulatory requirements meet a fragmented system landscape
The division of an internationally active MedTech company faced a strategic realignment: the introduction of a PLM system was intended to consolidate a fragmented system landscape, structurally integrate regulatory requirements into product development, and harmonize working methods across the group to leverage synergies across departments.
The initial situation was characterized by high complexity. Since 2015, regulatory requirements had increased by 260%. Information was distributed across 137 tools, documentation was primarily created manually, and a consistent “Single Source of Truth” was missing. Differing process models between divisions and group initiatives hindered transparency and consistent management.
Structured PLM implementation as a foundation
The focus was on introducing a PLM platform as a connecting backbone across development and regulatory affairs. 3DSE Management Consultants utilized a capability-based strategy and transformation approach. To this end, technical handovers between the involved departments were systematically analyzed and transferred into stable functional clusters. Based on this, a prioritized roadmap was developed that establishes PLM step-by-step along central end-to-end capabilities – including, for example, (regulatory) requirements management, test management, and dossier and registration management.
In parallel, processes and data models were defined so that regulatory evidence is no longer created separately but can be derived from ongoing development. Governance involving line management anchored decisions and accelerated implementation. To increase acceptance, employees from all functional areas were able to test the target vision using specific use cases during a PLM Experience Week, thereby helping to shape the system’s design.
Measurable results after 12 months
After approximately 12 months, over 100 employees in the division are working productively on the new PLM platform, and two products are already being developed there. At the same time, transparency regarding the tool landscape was achieved for the first time – with identified consolidation potential from 137 to fewer than 30 applications.
A key lever for increasing efficiency was the introduction of an AI-based solution for the automated derivation of regulatory requirements from legal specifications. Requirements can now be extracted up to 95% faster and transferred into PLM processes in a structured manner. Additionally, automated reporting enables time savings of up to 42.5 hours per case – corresponding to a reduction in effort of up to 90%. Combined with the introduction of the IMDRF structure and standardized templates, auditability was significantly increased.
It was crucial not to treat PLM as an IT rollout, but as a binding framework across processes, data models, and responsibilities – so that regulatory affairs became an integral part of the solution and efficiency gains became effective in day-to-day operations.
