Tag Archives: regulation

New report: Mass customisation governance

We’re pleased to be able to share the final project report from the feasibility study led by Dr Phoebe Li at University of Sussex. “Mass customisation governance: regulation, liability, and intellectual property of re-distributed manufacturing in 3D bioprinting” describes results of their work undertaken during the 2016 round of 3DP-RDM feasibility studies. The results of this project were presented at the 3DP-RDM event 3D Printing Where and How on 31st January 2017 at the IfM in Cambridge.


Phoebe Li, Alex Faulkner, James Griffin and Nick Medcalf

The feasibility study assesses the impacts of existing legal regimes on re-distributed manufacturing (RDM) in 3D printing (3DP). It investigates the viability of an embedded watermarking system into mass customisation governance of RDM as part of the potential impact of the three most important regimes on 3DP – regulation, liability, and intellectual property (IP) – in order to secure safety, quality control, surveillance, and traceability.

Download the report

[Image source]

Introducing the 3DP-RDM Feasibility Studies: A feasibility study of mass customisation governance

Following the recent feasibility study competition, the 3DP-RDM network is funding four projects in 2016. In this series of blog posts we introduce the four studies. Today we introduce the second study, “A feasibility study of mass customisation governance: regulation, liability, and intellectual property of re-distributed manufacturing in 3D printing”, which is being led by Dr Phoebe Li at the University of Sussex.

Decentralisation, localisation, and democratisation of 3D printing (3DP) technologies provide accessibility and efficiency to customised product development by enabling consumers to take part in re-distributive manufacturing (RDM). Grass-roots open innovation platforms are accelerating the uptake of 3DP and RDM by connecting and transforming consumers into active ‘prosumers’ via project crowdsourcing. Yet in so doing RDM decentralises design and manufacture and localises unprecedented risks throughout the ‘mass customisation’ production chain as well as blurring the lines in standardisation and classification in the regulatory landscape.

In the health sector, RDM disrupts social and legal norms. Stakeholders are facing an undefined, evolving regulatory landscape. The lack of a regulatory framework would delay wide acceptance of 3DP and create barriers to market. A robust regulatory roadmap would reduce unrealistic expectation and hype, provide clear signposts for R&D, secure quality and traceability, and enhance accessibility.

This study aims to map the scope and to identify the main issues arising from ‘mass customisation governance’, taking the health sector as a case study. The feasibility study will assess the impacts of existing legal regimes on RDM in 3DP. This work will define the research agenda needed for RDM in 3DP by interpreting the current and potential impact of regulation, liability, and intellectual property (IP). The research will assess how new governance models might emerge, identify new challenges for regulation, and assess implications for responsible innovation. It will investigate the viability of an embedded watermarking system into mass customisation governance of RDM, in order to secure safety, quality control, surveillance and traceability.

This comparative study will look at the issues in both China and the UK.

This feasibility study will be conducted by fieldwork and documents and regulatory policy analysis. We will conduct five interviews in China and elicit diverse views in a focus group in the UK. Selected interviews in China will provide a comparative study for assessing UK’s global competitive advantage in the field.

This study will be conducted by partners at Sussex Law School and the Centre for Global Health Policy at the University of Sussex, the Law and the Computer Science departments at the Exeter University, the EPSRC Centre for Innovative Manufacturing in Regenerative Medicine at Loughborough University, and 3Dynamic Systems Ltd.

This project is led by Dr Phoebe Li, a Lecturer in Law at the University of Sussex in the UK. Her research interests revolve around the regulation of science and technology, intellectual property (IP), development, and international trade. She is particularly interested in exploring the convergence and divergence of risk regulation and IP in relation to emerging technologies. Her current research interests lie in the regulatory and IP implications of 3D printing and bioprinting technologies, following from an interdisciplinary project on 3D chocolate printing.  In addition to the EPSRC/Cambridge feasibility study, Dr Li is currently working on an international collaborative project on 3D printing licensing in China at the AHRC Centre for Digital Copyright and IP Research in China (funded by AHRC/Newton Fund), and on another project on medical 3D printing and patent policy in China (funded by BILETA). She has been invited to speak on the topic at national and international institutions. She is an Advisor to the 3D Bioprinting Pioneering project for the Taiwan Food and Drug Administration (TFDA). For further information about this project or to engage in the feasibility study please contact her.

Dr Phoebe Li talking at a recent conference in Changsha, China.

[Images source: Phoebe Li]