Applying S.P.E.L. standard to patient matched devices: The need for a transparent regulatory matrix to qualify new manufacturing methods and technologies.

In the field of personalized medicine, in connection with "smart implants" and in the interaction of various industries, new solutions are constantly being researched to give implant materials special properties and enhanced characteristics. On several levels and multiple medtech market segments, there is a need for implant materials and manufacturing methods that match ideally the patient’s needs, fit and heal optimally within the patient's anatomy and remaining stable anchored as well as free of any adverse effects.

To provide implants, implant materials and geometries with such improved mechanical or biological properties, the industry offers a wide variety of solution methods, ranging from coating processes to novel composite materials[1] on the material side and new manufacturing methods such as additive manufacturing including 3D-printing, which may offer completely new possibilities2.

But often research projects and innovative industrial applications have one thing in common: a lack of transparent, cross-industry and generally valid systems and procedures for objective quality evaluations but also safety and performance characteristics, of these individual developed and manufactured devices.