A manufacturer of dental implants engaged the interim manager to support the introduction of a development process adapted to new EU legislation (MDR). In particular, he was to help accelerate the new R&D process. The pilot project was the development of a new dental implant.
MDR: New EU law makes medical device manufacturers more accountable
New regulations for the development and approval of medical devices have been in force in the EU since 2017: Primarily in response to the scandals surrounding unsafe silicone breast implants, this European regulation on medical devices, the Medical Device Regulation (MDR), is intended to make medical devices safer. Among other things, the MDR obliges manufacturers to provide extensive and complex documentation - from the initial development steps through to approval.
Clients had underestimated the complexity of EU law and workflows
The new EU law for medical devices places much higher demands on manufacturers in terms of documentation for development and approval. Soon after the start of the mandate, the interim manager realized that the client had significantly underestimated the complexity of the required coordination of documents and their interlinking in document management.
After intensive discussions with the management, the interim manager added urgently needed skills to the project team. These included two design engineers and an experienced product manager. The next step was to gather all the necessary information and use this as the basis for coordinating a new project plan.
Agile project management makes the complexity of the project manageable
The interim manager's agile project management made a significant contribution to better presenting and gradually reducing the complexity of the project. The workflow is now organized and the templates have been developed in such a way that they are also suitable for future projects.
Project successful - but targeted acceleration of processes not achievable
Both the new appointment of the project team and the agile project management were ultimately not enough to significantly accelerate the R&D process as originally planned. The complexity of the task was too great for this. After a total of twelve months, the interim manager was able to hand over the project to the employed project manager with clearly defined interfaces, an orderly workflow and transparent documentation. The product was transferred to the validation phase and prepared for the production phase.
