"Regenerative implants are most ideally suited for individualized production using additive manufacturing. For regulatory market access, if not containing cells or tissue compounds making them ATMP’s, the choice is between serially produced scaffolds, patient-adapted designs or custom-made devices that require a prescription. While it seems helpful that custom-made products do not get a CE mark and leave much of the risk with the surgeon, the procedure is cumbersome to the clinical staff and reimbursement often prone to discussion. This might be the reason why entire sets of prefabricated size-ranges are still taken into the sterile area every day. In other regulatory spheres like Australia and USA, more practical approaches towards medical product registration of AM implants exist, while the MDR relies on the freshly enhanced custom-made path. A more viable solution for the European regenerative implant market that fits into reimbursement seamlessly might unleash the potential of AM in modern medicine, a field in which Europe is struggling to maintain its leading position.
With the current situation, and despite all the hype, AM regenerative implant manufacturers have to feel rather exotic and miss a secure embedding in the daily clinical routine, despite all the magic they can produce especially in cooperation with the right clinical partner, usually a university hospital. The discrepancy stems from traditional CE marking as medical product registration path, simultaneously creating clinical evidence or at least acceptance and thus the base for reimbursement by public and private health plans. Individually manufactured implants do not fit into this registration scheme, making it necessary to defend their application from case to case. However, it appears that, by copying from software medical product registration, and proving efficacy and safety similar to patient-adapted implants, a more pragmatic regulatory approach would be possible. Today, the development of AM production chains has come to a point where an individual implant, designed by constraints from the treating medical authority, can be produced and delivered on the push of a button. It seems possible that reimbursement, be it for operational models, implants or tissue engineering constructs, can be equally integrated into daily clinical practice – making the magic regulated and risk controlled.
An important aspect remains data handling and privacy in the light of the GDPR. First mobile solutions for something as simple as CT data transfer are emerging. A standardization of data handling, respecting the patient’s private sphere and at the same time gathering information important for AM on gender, personal heritage and behavioral patterns in a modern way might even be the base for a sound regulatory scheme, if integrated into intelligent information management as integral part of AM regenerative implant design."