EXPOFYBI Conference. 3D Technologies

Development of customized solutions: Applications. Regulatory Aspect. 3D Technologies. Project management.

Tuesday, August 08, 7:15 p.m.

Summary of the presentation

The generation of solutions in medical devices has historically been conditioned by the limitations of production processes and their need for standardization. As a consequence, the gap between the solution required by a particular patient and the delivery of the medical device had been accepted as a technical feasibility limit.

Today, the meeting between the flexibility of 3d technologies and the medical world, is expanding the possibility of personalizing the solution that medical devices provide, impacting the entire product life cycle: generation and analysis of information, project of Development, prototyping, production, implementation, monitoring and subsequent monitoring.

The growth of the field of customized solutions requires the development of its regulatory framework for which FDA has already issued a draft. For its part, ANMAT establishes certain requirements for products made to measure.

In this context, the projects of personalization of medical solutions require a new role to the medical professional consultant and a fluid dialogue between this and the medical device development team. In order to reduce communication risks and their possible impact on the project, it becomes essential to be aware of the differences between the Operations and Projects dynamics.

The approach of these issues and the elaboration of strategies for their implementation, will allow to obtain the benefits that these new technologies can offer to the medical world.