Australian Regulatory Updates for 3D Printed Medical Devices and Implants

Category: Blog
Jan 19, 2020

3D printing is continually proving to have enormous advantages and opportunities to revolutionize the medical industry. The technology is offering exciting new ways to provide personalized care in various sectors and create better-performing medical devices. Key applications of medical 3D printing can include orthopedic implants, personalized surgery and a range of medical devices.

Orthopedic implants are used to surgically replace a missing joint or bone enabling medical professionals to create better-fitting, longer-lasting, and higher-performing implants. One of the factors driving the demand for 3D printed implants is the potential for enhanced implant performance, owing to generative design flexibility and topology optimization. Implants can be designed with porous surface structures, facilitating faster integration between a living bone and the artificial implant. 3D printing is increasingly being utilized to develop patient-specific anatomical models for education, pre-surgical planning and bespoke surgical tools using the patient’s own medical imaging data. The accessibility of medical CAD/CAM software and lower-cost desktop 3D printers is increasing, enabling hospitals to establish more 3D printing labs like the Melbourne based 3DMedLab at Austin Health or the EPIC Lab at Westmead Children’s Hospital. Medical and dental devices like prosthetics, biodegradable stents, braces, dentures, and clear aligners can also significantly benefit from 3D printing advances. According to a recent report by market research firm, SmarTech Analysis, the market for medical 3D printing is currently estimated to be worth $1.25 billion. By 2027, the market value is set to grow to $6.08 billion.

However, unlocking the full potential of 3D printing for healthcare is not without its challenges. The rapid advances of this technology are allowing more complex and, in some cases, higher risk medical devices to be manufactured for an individual patient and are also allowing point of care manufacturing of these personalized medical devices. The fact that developments evolve so quickly means that there is a lack of comprehensive regulatory frameworks and hence is proving to be one of the industry’s biggest barriers moving forward. Several regulatory bodies around the world are working on developing standards for 3D printing in healthcare. Most notably, the U.S Food and Drug Administration (FDA), issued a guidance “Technical Considerations for Additive Manufactured Devices” in December 2017. The guidance highlights the technical considerations and recommendations for the design, manufacturing, and testing of 3D printed medical devices. For an easy to understand the classification of FDA approved medical devices with examples of each, visit AMFG and for an excellent summary of an international comparison of regulatory body updates check out this previous 3DHeals Expert Corner blog written by Dr. Khalid Rafi titled “A world of Regulation: Updates on 3D Printed Medical Devices”. Patient-specific devices are definitely the most complicated cases to regulate. Traditionally manufactured medical devices are a standardized, one-size-fits-all approach. However, with a product that is customized, it can be difficult to test each and every single device that is custom-made. Looking ahead, to produce more opportunities for personalization, regulatory bodies need to find ways of how to pre-approve custom devices. Currently, it’s challenging because the requirements for approval are developed to certify off the shelf implants and instruments. Therefore, regulatory bodies need to focus on how they can address the differences between people rather than only similarities to enable this level of personalized care. Organizations like the FDA are trying to overcome this issue by setting maximum and minimum sizes or features for custom-created devices.

Now, where does Australia fit in with the rest of the world? The Australian Government is undertaking a significant program of reform to the regulation of medicines and medical devices in Australia. As part of the Australian Government Depart of Health, the Therapeutic Goods Administration (TGA) regulates these products, and it’s responsible for implementing the governments’ reforms. In February 2019 the TGA hosted a consultation for the “Proposed regulatory scheme for personalized medical devices, including 3D-printed devices” which follows on from earlier public forums in 2017 and 2018 with the aim to understand the impact that the proposed changes will have on the medical device industry, health care professionals and patients. The previous consultation undertaken in 2017 confirmed that the public supports the efforts to reform the current regulatory requirements for personalized medical devices, which were recognized as being too broad and no longer fit for purpose under the current provisions for custom-made medical devices. Two areas from the previous consultation required further clarification and are addressed in last year’s update. First, updated definitions for personalized medical devices and second the concept of a medical device production system.

This consult was focused on regulatory reforms for medical devices that are manufactured for particular patients and the impact of these reforms. These are devices that are currently captured under the custom-made medical device definition shown above, and their corresponding exemptions, as well as devices that are referred to in the definition of the manufacturer as devices already supplied but intended to be assembled or adapted to suit an individual. It does not cover the technical considerations for designing, manufacturing and testing such devices. The term personalized medical devices include 3D-printed medical devices manufactured for a particular patient, but it also applies to such devices manufactured through other methods as well.

Today, ever-growing numbers of patients are receiving higher-risk classification medical devices to meet particular needs, under custom-made medical device exemptions. High-risk implantable devices are generally manufactured under strictly controlled conditions and are subject to rigorous premarket testing and regulatory oversight to ensure that they comply with the essential principles for safety and performance. However, strict regulatory oversight does not apply to the majority of similarly high-risk 3D-printed implants in Australia, which are currently captured under the exemptions for custom-made medical devices. It is proposed to introduce appropriate regulatory controls for this emerging field of personalized medical devices and with that, a summary of proposed changes & timeline for the next steps involved is highlighted below.

About the Author:

William Harley graduated with honors in medical biotechnology from the University of New South Wales. Currently, he is undertaking a Ph.D. at the University of Melbourne in acoustophoretic bioprinting. Stemming from his research experience in biomaterials, stem cells, and nanofabrication, he is driven by the clinical translation of personalized regenerative medicine. He is passionate about the innovation of 3D printing in healthcare and is determined to orchestrate a series of 3D HEALS events to engage in the Australian community.

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