Personalisation is the future, particularly when it comes to assistive technology.
Rehabilitation engineering has always been a small community in Australia, but it is soon set to grow, with the rollout of the National Disability Insurance Scheme’s Assistive Technology (AT) strategy providing both investment opportunities and increased awareness around the provision of AT.
As healthcare becomes increasingly personalised – with the government recently investing $500.1 million in genomic research to improve disease diagnosis and treatment options – it makes sense that custom assistive technology is also growing in prominence.
Iain Brown MIEAust CPEng(Biomedical), Chair of the National Committee on Rehabilitation Engineering (NCRE), sat down with create to discuss the different types of personalised medical devices, how they are brought to market, and the increasingly important role they play in rehabilitation.
What are personalised medical devices?
Personalised medical devices are configured specifically to suit individual users, with the design reflecting the user’s specific anatomy, physiology or pathology in order to be effective and appropriate.
Rehabilitation engineers, working across various areas of practice, then translate this need for personalisation into devices for their own client group.
“Devices which are personalised in this way are better suited to the needs of the individual and facilitate the rehabilitation journey,” Brown said.
“Equipment that fits poorly or doesn’t suit the individual, by contrast, can severely undermine the effectiveness of rehabilitation – detrimentally impacting an individual’s independence and overall quality of life.”
For more information about what a rehabilitation engineer does for work, read this article.
What are some of the newest innovations?
From more sophisticated wheelchairs and exoskeletons to personalised bone-replacement implants and digital twins, the possibilities presented by personalised medical innovations are endless.
“Wheelchairs now have increased range, better handling and suspension, increased actuation including seat tilt, articulated standing, sophisticated control mechanisms, and power assist options,” Brown explained.
With digital twins now used in many areas of engineering, it’s no surprise they are gaining popularity in rehabilitation engineering.
“In this case, it’s [about] building a digital twin of people for the purposes of understanding physiological functions, or how the biomechanics of the anatomy interact with certain activities – combined with real-time sensing and feedback to that system,” Brown said.
“The benefits are the ability to simulate, predict and test different ideas on digital twins and have some degree of confidence about what the impact would be on a real-world person.”
Meanwhile, exoskeletons are an emerging technology comprising electro-mechanical systems that coordinate with the human body, and augment existing action to enable greater functionality and independence.
“Some of the most striking exoskeletons go over the lower limbs of the individual, providing electromechanical support to a person who can’t walk,” he said.
As they are designed to restore gait function, exoskeletons are most appropriate for conditions that affect the gait, such as spinal cord injuries.
“There’s also some exploration happening around exoskeleton systems for high muscle tone conditions such as cerebral palsy,” Brown said.
However, while exoskeletons have been around for a while, the price points are prohibitive.
“One of the difficulties in the rehabilitation engineering space is that what’s technically feasible and what’s financially viable are not the same,” he explained.
How are personalised medical devices defined and regulated?
Regulations around medical devices were updated in 2021 by the Therapeutic Goods Administration (TGA), the Australian government’s medicine and therapeutic regulatory agency.
In this update, the previous definition of a “custom-made medical device” was replaced with the term “personalised medical device”.
The personalised medical devices group consists of four device types:
- Adaptable medical devices
- Patient-matched medical devices
- Custom-made medical devices (a revised and narrower definition than before)
- Medical device production systems
Although each of the device types are personalised in nature, how this personalisation is achieved is what determines the type, Brown said.
“Medical devices produced with the intention of being configured to the user on supply, typically by adjusting the dimensions or other parameters within a range of options defined by the manufacturer, are referred to as adaptable medical devices,” he said. “These devices are manufactured with the scope for reconfiguration built in.”
On the other hand, the design of a patient-matched medical device is adjusted prior to manufacture.
“The configuration is often specified in conjunction with a healthcare professional to ensure the design meets the needs of the intended user,” Brown said.
Patient-matched medical devices derived from a common design base are grouped together by Specified Design Envelopes (SDEs), which detail how relevant input parameters translate into resultant device configurations.
“That means two devices for different users with similar clinical needs might be quite distinct, but both be products of the same SDE, and considered part of the same patient-matched device family,” he said.
The new definition of custom-made medical devices is much narrower than before the 2021 regulatory update, with these types of personalised medical devices needing to be conceptually distinct from other medical devices.
“Devices that are sufficiently unique as to be considered custom address novel anatomical, physiological or pathological presentations, or achieve the intended therapeutic intent using novel techniques,” Brown said.
“Many devices that begin as custom but are then found to have broader applicability will transition from custom-made to patient-matched as subsequent devices are fabricated.”
What’s the journey to get personalised medical devices on the market?
Before dipping a toe in the personalised medical device pool, designers should first confirm there’s a demand for the solution they are looking to develop.
Next steps include engaging with potential users of the device to understand the environment and any design considerations that are relevant.
“Once this information is in hand, the design brief will be more clearly specified and be much more likely to succeed,” Brown said. “The most commercially successful AT is something that has broader application than the original intended group it was designed for. And once they become broader in their application, you see more of them being developed and sold.”
But as rehabilitation engineers will know full well, health technology rapidly outpaces regulation – so bringing a personalised medical device to market is no mean feat.
“The device manufacturer must capture all the relevant processes and aspects of the device design to demonstrate the proposed medical device achieves its stated therapeutic intent in a manner that’s safe, effective and reliable,” he said.