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Orthotics, which include braces and splints, are used by about 2.5 million people in the UK to correct the function of movable parts of the body, which may be compromised by conditions such as spina bifida and cerebral palsy.
But the traditional manufacturing process for orthotic devices can be time-consuming, labour-intensive and error-prone, leaving the users of these devices, many of whom are severely disabled children, without the biomechanical support they need to go about their daily lives.
“We need something that fits perfectly in order to have the biomechanical function to either realign or prevent movement,” says Jonathan Bell, a clinical specialist orthotist at Bell Orthotics, who has 12 years’ experience in this field of medicine.
“To do that, we need to capture the shape of the body, and the only way we could do that for years was by using traditional plaster casts – like the stuff you would have if you had a broken arm – or polyester.”
According to Bell, using traditional manufacturing processes means it takes about 24 hours’ manual labour to produce one splint that would go from the knee to foot.
This process includes creating negative and positive casts of the relevant body part, “rectifying” them – whereby plaster is added or removed based on the patient’s anatomy – and sending them off to a remote workshop facility to be made.
For Bell, at least one-fifth of all the devices he receives back from the workshops need significant alterations to fit the patient properly, further increasing the work involved.
The problem of ill-fitting orthoses is also highlighted by Chris Cody, clinical lead and head of regional orthotics services at Guy’s and St Thomas’ NHS Foundation Trust, who says the need for alterations puts extra pressure on time-strapped clinicians. “Alterations take time,” he says. “And coming from an NHS background, time is something we all need more of.”
The Andiamo effect
However, medical technology (medtech) startup Andiamo claims to have the answer to both Bell’s and Cody’s woes, in that its use of artificial intelligence (AI), coupled with 3D scanning and 3D printing techniques, can cut the time it takes to deliver orthotic devices to children from six months to just a week.
Established in 2014, Andiamo spent four years on research and development (R&D) before entering the market in 2018, with a technological setup that it claims can increase the accuracy of orthotic devices to 1mm.
Since then, it has been applying its R&D to real-world clinical settings, serving 80 patients with about 500 wearables, in an attempt to improve the product and scale of its orthotic service.
According to Bell and Cody, Andiamo has hugely reduced the need for orthotic alterations because of its use of a hand-held scanner, which can make the process of creating casts for patients much easier and more comfortable.
“A lot of our children who have additional needs are very much not fans of being cast – hot, gooey plaster being wrapped on your limb while you don’t understand why you are forcibly being held, and then having it cut off is tricky at the best of times,” says Bell. “So the idea of a direct scan is far better from a patient experience perspective.”
Naveed Parvez, Andiamo
Cody says the mixture of AI and 3D printing also opens up a world of possibility for orthotists, who can now control every aspect of the manufacturing process, from the material used and the shape of it, to the exact thickness and flexibility of the device.
“The level of detail, research and engineering that’s gone into [Andiamo] optimising the design is paying dividends in that you don’t have to make as many changes [to the finished devices],” he says.
Using the AI component of Andiamo, clinicians can also create a mock-up of how the device will function, eliminating the trial and error of the traditional manufacturing process and ensuring that the device fits first time.
“If I do a mock-up, I am very confident that it is going to function exactly as I want it to – there’s no guesswork,” says Bell.
With the increased accuracy and control, clinicians now spend less time taking casts and making alterations, and more time understanding the needs of their patients.
Cody adds: “It gives me more time to assess the impact of that device on the child, to assess my prescription – which is gold time to me – and then it gives me more time with the parents and the child to explain what this device is that I’m fitting to them.”
Scaling up the manufacturing process
Although most traditionally made orthoses are sent to a remote workshop for production, some clinics have on-site facilities that allow greater collaboration between engineers, technicians and orthotists during the manufacturing process.
“Unfortunately, that infrastructure is not commonplace in a lot of orthotic centres and hospitals,” says Cody. “Orthotists will go in, do a clinic and send off their casts to a remote workshop facility where they haven’t got everything on hand. That disconnect can sometimes introduce problems, although it has got better over the years.”
Although the level of control that clinicians get from the Andiamo platform helps to bridge this disconnect, the lack of orthotic specialists is an ongoing problem.
Andiamo founder and CEO Naveed Parvez says there are about 300 qualified orthotists in the UK, who collectively care for two million people with orthotic needs.
“There are only two universities in the UK that can train these people and they can maybe train 30 people a year, maybe about a third of whom actually work in the UK when they finish studying,” he says.
“The group of new clinicians coming through is not enough to deal with the problem, and that’s where technology is part of the solution.”
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Parvez says that taking a “system-level” approach, whereby the prescription, design, manufacturing, data and more are all wrapped up into one platform, can ease some of the pressure.
“When you aggregate a problem into a platform approach, you can bring not only a whole new scale, but you can start to approach problems from a different perspective,” he says, pointing to the example of an autistic child who needed a two-hour appointment because of his needs, rather than the standard 20-minute slot.
“That’s not a technical fix, but the technology enables us to do it,” says Parvez. “If we can save enough time elsewhere, then we have the ability to schedule two-hour appointments. A big part of what we do with the technology is to scale empathy.”
But while the Andiamo platform can help clinicians to increase their productivity through its speed and accuracy, the technology is still ultimately reliant on orthotists to be successful.
“You still need the orthotists to feed the right information in to the right assessment,” says Parvez. “You need to get that right. If you put something good in, something good will come out, but if your assessment is poor, if your clinical reasoning is poor, then your chances of failing on the prescription are going to be very high, no matter what technology is employed.”
How cloud powers Andiamo
Described by Parvez as a platform-as-a-service (PaaS) business, Andiamo receives money through monthly subscriptions that gives its clients access to its latest data, its standardised prescriptions and its third-party printing facilities. Andiamo also charges a fee for each orthotic device created.
Parvez says there was no incentive for traditional companies to move into 3D-printed orthoses because the cost of the printers is too high.
“The business case doesn’t necessarily add up if you look at it from a manufacturing perspective because these printers can cost £500,000,” he says.
By aggregating the problem and building an end-to-end platform for orthotic delivery, Andiamo is also much easier to scale than if it were a traditional manufacturer tied to specific physical assets, he points out.
Lee Provoost, co-founder and chief technology officer at Andiamo, says: “The key problem with existing business models in the industry is that they’re not very scalable.
“It only scales by hiring more people to manufacture these devices, and even if you turn that into a digital process by hiring engineers or technicians, you can still only scale by hiring more.”
Instead of scaling in this way, Andiamo will remain reliant on Amazon Web Services (AWS) for its processing, data storage and security needs, while it will continue to use third-party printing bureaux to produce its physical devices.
“Building globally, you have two choices,” says Parvez. “Either you go and build all the machines yourself, which is obviously quite a slow and costly process, or you rely on third-party printing bureaux, which is what we do.
“In terms of plugging into their capacity, it gives us a much more flexible and robust manufacturing base, and that means we can set up in a new country relatively quickly.”
Provoost and Parvez both point out that the low cost, yet reliable outcomes, of these third-party services make the choice a “no-brainer”.