A clarion call for understanding regulatory processes for additive manufacturing in the health sector

ABSTRACT

Introduction: As Additive Manufacturing (AM) in the health sector evolves to the point where products can be translated into the clinic, these manufactured goods need to be assessed by regulators in order for such products to be manufactured, sold, and used in accordance with the law. In this article, the authors argue that if AM products in the health sector are to be regulated in the near future, stakeholders involved in translational research need to understand the challenges faced by both regulators and industry. We portray different points of possible dissonance for AM medical products with existing regulatory frameworks. Hence, we advocate for stakeholders to proactively provide solutions for regulatory processes for products emerging from AM in the health sector.

Areas covered: The publication discusses the need for clear definitions and standards to enable translation of AM research into the health sector. Key literature around legal and regulatory challenges applicable to this topic was synthesized.

Expert opinion: We argue that stakeholders need to develop regulatory-rooted risk profiles of the respective AM medical products. The terminology must be defined clearly and used consistently. Standards need to be designed for the purpose of advancing regulatory processes.

KEYWORDS:

• Medical products
• regulation
• definitions
• harmonization
• standards
• additive manufacturing
• 3D printing
• bioprinting
• personalized devices
• health care

Declaration of interest

A Horst is a scholarship recipient of the ARC ITTC in Additive Biomanufacturing (PhD Scholarship & Tuition Fee Waver). F McDonald is a principal investigator of the ARC ITTC in Additive Biomanufacturing. DW Hutmacher is a training centre director of the ARC ITTC in Additive Biomanufacturing. DW Hutmacher is a founder and shareholder of both BellaSeno GmbH and Osteopore International Pte Ltd. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was funded by the Australian Research Council Industry Transformation Training Centre in Additive Biomanufacturing. The Project ID for this Grant is [IC 160100026].