Personalised medical devices consumer survey

The Therapeutic Goods Administration (TGA) invited feedback from consumers of personalised medical devices through a survey from 16 March to 26 April 2026.

The survey was open to people who had used a personalised device and those without direct experience. We asked about:

• how people accessed personalised devices
• what information they received about their device
• experiences with safety, performance and use
• barriers to accessing devices
• views on trust, responsibility and regulatory oversight by the TGA

A total of 128 survey responses were received: 105 (82%) were from people with direct experience using a personalised device, 11 (9%) were from people involved in someone else’s experience, and 12 (9%) were from people without direct experience. Responses from those without direct experience were broadly consistent with the views of those who had used one.

Consumers reported experience with a wide range of personalised devices. The most commonly reported devices were dental devices (such as crowns, aligners) and orthotic devices (such as splints), while other device types such as implants were reported less frequently.

Health professionals played a central role in how most (95%) respondents accessed and chose personalised devices. Their recommendation was a key reason for choosing a personalised rather than mass-produced device. Most devices were reported to have been made at the point of care (85%), including in hospitals, clinics and laboratories, rather than industrial manufacturing facilities (9%). Over half of respondents (55%) said they were not offered alternative device options by their health professional.

Most respondents reported long-term use, with 75% using their device for more than one year. Over half (55%) reported no issues. Where issues occurred, they most commonly related to fit or discomfort, and were typically managed through health professionals or clinical settings.

Most information about devices was provided by health professionals (90%), often verbally (52%), rather than in writing (7%) or in both formats (38%). Respondents commonly received information about benefits and risks and who to contact if something went wrong. However, fewer reported receiving information about how the device was made or about warranty and repairs. Some respondents said this information was limited, unclear or difficult to access later, particularly when provided verbally.

Over half of respondents (55%) reported no barriers to accessing personalised devices. Where barriers were identified, they most commonly related to cost (31%) and wait times (14%). Devices were most often funded out of pocket or through a gap payment (57%), or through private health insurance (48%).

Respondents generally expressed confidence in personalised devices and in the health professionals recommending them. Most agreed that health professionals recommend safe and effective devices (70%), and that devices are made by skilled and trained practitioners (78%). Around two-thirds (63%) said they would like to be able to check whether a device meets TGA requirements before use. At the same time, confidence was lower in relation to transparency, particularly around how decisions are made and what factors influence device selection. Around half (49%) agreed that TGA regulation increases their confidence, and a similar proportion (55%) also agreed that over- regulation could limit innovation and access. Responsibility for device safety was most often attributed to manufacturers (95%), health professionals (88%), and hospitals or clinics (86%).

Insights from this survey will help inform potential refinements to the regulation of personalised devices, including patient-matched medical devices (PMMDs). This work aims to support a proportionate, risk-based approach that maintains safety and performance while improving transparency, accountability and timely access for consumers.