A new model for manufacturing regenerative medicine and tissue engineered products.

Project title: “Mass customisation governance: regulation, liability, and intellectual property of re-distributed manufacturing in 3D bioprinting” 

Funded by: EPSRC, £45, 922, July 2016 to January 2017.

Grantholders: Prof. Alex Faulkner (Centre for Global Health Policy), Dr Phoebe Li (PI) (Sussex, Law), Dr James Griffin (Exeter University, Law), Prof. Nick Medcalf  (Loughborough University, EPSRC Centre for Innovative Manufacturing in Regenerative Medicine).

3D bioprinting adapts 3D printing (also known as additive manufacturing) to the techniques of cell therapy, tissue engineering and regenerative medicine. It is likely that this innovation will mean that some hospitals in essence become manufacturers of biomedical products, challenging the conventional models of pharmaceutical  and medical innovation and supply chains, and with enormous implications for issues of liability, medicinal and medical device regulation and intellectual property. Because software is involved in the customised/personalised ‘design’ and manufacturing process, issues of e-health regulation, data protection and commercial secrets also arise. This project investigates and analyses these issues as they are being highlighted by 3D bioprinting and redistributed manufacturing innovations.

The research involved interviews, documentary analysis, legal and regulatory analysis,  a high-level stakeholder workshop, and proposals for a watermarking approach to IP protection. The research was carried out in the UK and China.

The project is one of a suite of projects about redistributed manufacturing, you can read about this here. 

Read the final report here.

A new ESRC social science and law project is continuing to develop this area of research, you can read about this here.