Agile Transformation in Medical Device R&D
Project thesis for my continuing education as a systemic consultant — a change strategy for merging two R&D departments into an agile, product-focused organization in a regulated medical device company.
As part of my education as a systemic consultant for organizational development and change management, I wrote a project thesis based on a real-world consulting engagement at a mid-sized medical device company. The engagement covers the merger of two R&D departments into a new department, and the cultural shift towards agile ways of working.
The core tension: strict regulatory requirements for Class III medical devices (MDR) versus the desired agility of modern software development. The thesis designs a change architecture and combines systemic tools (triangle contracts, stakeholder carousel, informal org chart analysis) with concrete team-level interventions — from workshops to a lightweight agile handbook grown from actual retrospectives rather than written top-down. The thesis argues that agile transformation in regulated industries is possible, but only if it is designed as an evolutionary, iterative process rather than a purely structural measure.
