Abstract

Commercialising Customised Living Implants: Lessons from Franchised Manufacturing

Nicholas Medcalf, , Loughborough University

Bioprinting offers the potential to manufacture living implants to support, or replace, diseased or missing structures in the body. The manufacturing process must be customised, personalised and is best carried out close to the patient and in coordination with administration of the product. There are advantages to ‘fresh preservation’ and avoidance of the changes that may occur with cryopreservation of the product. The regulatory status of such products is unusual and the basis of assurance of quality will be demanding to achieve given the de-centralised operation. Lessons can be learned from unrelated service-rich industries that rely on tight control of operator training, proactive management of suppliers and raw material quality and reduced discretion by the operators for making process changes. Typically this is managed by special legal arrangements that grant licenses to the distributed manufacturing units. Regular re-training and quality oversight at a central facility, that is identical in equipment and operation to the distributed manufacturing units, is used to maintain quality and to control the comparability of product from site to site in a franchise arrangement. The central facility is thus a ‘franchise prototype’ and this business model offers a channel for academic centres to act as the management resource for commercialising bioprinted goods.