Sector
Medical devices
In medical devices, R&D must prove clinical efficacy, satisfy the regulator and be manufacturable at a controlled cost. Calsoï helps companies in this sector align these three constraints.
What Calsoï brings to this sector
Jean-Christophe Simon served as R&D Director of Thuasne Group, a global player in compression and orthopaedic medical devices. He understands the constraints specific to the sector: long development cycles, clinical requirements, certification challenges, and trade-offs between disruptive innovation and range improvement.
Calsoï can help to:
- Define or restructure the R&D strategy of a medical device manufacturer
- Prepare a technical file for CE marking (MDR) or FDA clearance
- Support a fundraising round or divestiture by making R&D assets legible
- Provide fractional R&D leadership during a transition or growth phase
Key challenges in the sector
The EU MDR regulation has tightened clinical and documentary requirements for all medical devices placed on the European market. Smaller manufacturers are often caught between limited R&D resources and compliance requirements that demand a robust organisation.
The goal is not merely compliance. It is building an R&D whose rigour becomes a competitive advantage: solid technical files strengthen discussions with hospital purchasers, distributors and investors.
Engagement formats
Depending on the company's stage: innovation strategy advisory, fractional R&D leadership, or technology company divestiture mandate.