Positioning innovation and governance for 3D printing in clinical care: an Australian case

Author:

Heemsbergen Luke1ORCID,Fordyce Robbie2

Affiliation:

1. Deakin University, Member Alfred Deakin Institute for Citizenship & Globalisation, 221 Burwood Highway, Burwood VIC 3125, Melbourne, Australia

2. Monash University, 900 Dandenong Road, Caulfield East VIC 3145, Melbourne, Australia

Abstract

Aim: To position medical 3D printing practices, risk and governance as more complex than mere manufacturing so to consider the contextual network-enabled dilemmas from remediating and remanufacturing the body in professional clinical and pedagogical practice; to suggest the current regulatory logics of risk and innovation do not sufficiently acknowledge shifts to network-enabled practitioner collaborations, exemplified here via ‘chilling effects’ of closed intellectual property regimes. Methods & framework: Anonymous practitioner workshop (n:12), socio-legal critique. Results: Communicated need to acknowledge practices of medical 3D printing under socio-legal constraints. Conclusion: Consider 3D printing as communication models to sustain medical research-practice in a digital–physical age, including consideration of novel governance mechanisms such as practitioner licensing and building a medical commons with network-friendly intellectual property regime.

Publisher

Future Medicine Ltd

Subject

General Medicine

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5. Therapeutic Goods Administration. Proposed regulatory changes related to personalised and 3D printed medical devices. Consultation Paper Version 1.0 (2017). https://www.tga.gov.au/sites/default/files/consultation-proposed-regulatory-changes-related-personalised-and-3d-printed-medical-devices.pdf

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