Step-by-step digitization of a medical device manufacturer
Strict MDR and IVDR rules greatly increase documentation in medical tech, tying up resources, delaying time-to-market, and raising error risk. Step-by-step digitization of product lifecycle processes adds structure, cuts media breaks, and speeds up approvals efficiently.
Industry / Customer
Manufacturer of active medical devices in the dermatological field.
Initial situation / Challenge
With the introduction of the Medical Device Regulation (MDR) and the In-vitro Diagnostic Medical Device Regulation (IVDR) in the EU, the documentation requirements for manufacturers of medical devices have increased significantly. This leads to a significant additional burden on all areas involved in the product life cycle, ties up numerous resources, and noticeably extends the time to market. The increasing complexity of the products and frequent changes further increase the susceptibility to errors.
Objective of the consultation
The gradual digitization of life cycle processes offers a way out of this situation. It enables smooth processes, a clear information basis (single source of truth), and saves time on documentation and approval-related issues.As part of the digitization roadmap and implementation concept, a so-called use case factory is used to identify the processes that bring the greatest and fastest benefits. A pilot project lays the foundation for the successful digitization of processes, departments, or the entire company. Methods are tested, employees are trained, management is convinced, and enthusiasm for change is created.
Consulting services from SEQLY
The starting point was a concept workshop to analyze the digitization status. The short- and long-term goals of the process owners and management were recorded.In the subsequent concept phase, the “pains and gains” of the individual process owners were identified and used to develop concrete use cases – i.e., the areas in which timely digitization would have the greatest effect. Based on this, a digitization roadmap and concepts for the selection, introduction, and optimization of digital tools were developed. In the pilot project, a tool for the Requirements & Test Engineering department was specified, selected, and successfully introduced.
Results / Added value
The company now has a digitization roadmap with short-, medium-, and long-term goals and a clear implementation plan. The first use case impressively demonstrated the advantages of digitizing a complex area – both for the teams directly affected (development) and for closely related areas such as quality management, regulatory affairs, and production engineering.
Lessons learned
In the SME environment of medical technology, investment funds are limited. Therefore, quick wins through small, agile pilot projects are crucial for the overall success of digitalization. The pilot project demonstrated the advantages in everyday work and delivered initial economic benefits. Essential to the project's success were the early involvement of the employees affected, the consideration of their experiences and input, and strong support from management.
Next steps/follow-up projects
In upcoming projects, further stages of the product life cycle processes are to be optimized with the help of digital tools. A central element here is digital data management. Media breaks caused by frequent tool changes must be avoided in order to ensure consistent digitalization.
