Additive manufacturing of biomechanically personalized medical devices

Efficiency-driven personalized therapy

For therapy approaches focused on efficiency and individualization, it is essential to establish a clear link between product functionality and patient-specific pathology. This requires objective biomechanical and structural analyses that provide a solid basis for tailoring medical technology to the individual in ways that demonstrably support the patient’s therapeutic journey. Achieving such personalized adaptation of product functions demands advanced digital personalization capabilities, made possible only through computer-aided design and digital manufacturing processes.

The resulting complexity—spanning product functionality, design, production, and digital integration—necessitates strategic frameworks that enable more evidence-based medical technology. At the same time, the sustainability of product life cycles is becoming an increasingly important factor in market acceptance. Bio-based materials are gaining traction in this context, offering new opportunities for sustainable solutions through bio-inspired functional integration in personalized products.

However, adopting a personalized, digitally driven product development strategy remains challenging for many companies, as it requires the integration of diverse, cutting-edge technologies from multiple specialized fields.

 

Additive manufacturing as a production technology

Additive manufacturing processes, first developed in the 1980s, make it possible to produce complex, customized products in quantities as low as a single unit, while remaining both cost-effective and sustainable. These processes can employ innovative bio-based and biodegradable plastics, incorporating them into a closed-loop circular economy.

Despite its potential, this relatively young production technology still requires significant advancement to achieve consistent reproducibility between print jobs and seamless transferability across different systems. For medical technology applications, component properties must be analyzed with regard to the raw materials used and specific process parameters, ensuring compliance with regulatory standards.

Moreover, robust production chains must be established that enable efficient, reliable manufacturing and allow for validated quality assessments of printed components.

Fraunhofer IPA – Interface competence in In Silico Human Modeling and additive manufacturing

Fraunhofer IPA brings together leading expertise in In Silico Human Modeling and additive manufacturing, working to minimize risks and overcome innovation barriers in support of Germany’s position as a competitive business hub.

Function, design, and layout

  • Development of virtual testing and analysis methods for medical devices based on human–device interaction
  • Evaluation and optimization of biomechanical product functions to improve clinical effectiveness
  • Enhancement of medical device comfort for optimal anatomical fit
  • Load-optimized structural design integrated into the digital manufacturing workflow

Quality-assured additive production

  • Application-specific system and process development
  • Feasibility studies on suitable materials and the fabrication of prototype components
  • Collection and analysis of material and process data before and during production to support validated quality assessments
  • Development of scalable approaches for series production

Material and component qualification

  • Raw material analysis of polymers prior to processing
  • Experimental and numerical evaluation of both conventional and additively manufactured polymer products
  • Assessment of variation in material properties introduced during manufacturing to ensure safe and reliable product design