Point-of-care 3D printing becomes more and more popular, and the range of clinical applications continuously grows. With this new variety of possibilities, physicians and hospital managers face the growing challenge to deal with regulatory requirements.
This trend is clearly visible in a survey by the American Society of Mechanical Engineers (ASME) for its “Year In Review 19-20” on Medical 3D Printing (see p 21). The responses to the “greatest challenges” question given by more than 300 members of the medical 3D printing community confirm that stakeholders in medical 3D printing request clarity on regulatory frameworks, processes and quality management.
Kumovis has developed an application-specific solution to meet these challenges and proudly introduces the manufacturing of PEEK cranial implants at the point of care. Medical technology companies and hospitals that apply this new cranial plate manufacturing framework will benefit from high patient satisfaction, gained efficiencies and cost savings, despite regulatory challenges and increasing cost pressure.
4 Cornerstones of Point-of-Care Manufacturing for Cranial Implants
The following cornerstones summarize the four major topics of 3D printing individualized implants for cranioplasty at the point of care.