Oct 29, 2015 | By Alec

While most surgical applications of 3D printing technology we report on involve unique or very rare cases and strange deformities or injuries, some startups are also hard at work standardizing this customization process for hospitals everywhere. One of the most successful is the British startup Embody Orthopaedic of Dr Susannah Clarke, which has used 3D printing to develop a system for manufacturing custom 3D printed instruments and surgical models to be used in knee and hip surgeries. Having extensively tested them in hundreds of surgeries in the Charing Cross Hospital in London, Clarke and Embody Orthopaedic are now ready to expand their services to hospitals across Britain.

That’s very good news, as knee and hip replacement surgeries are becoming increasingly common. An estimated 160,000 of these surgeries take place in England and Wales every year, featuring one-size-fits-all tools that don’t always fit. ‘I first noticed an opportunity to improve this approach while I was studying for a PhD in orthopaedics at Imperial College London. I saw the ways hip implants fail due to being poorly positioned in patients,’ the 34-year-old bioengineer Clarke explains, who received a PhD at Imperial College London. ‘I decided that 3D printing, a method just gaining ground at the time, would be an ideal way to customise joint replacement procedures cheaply and at the touch of a button,’ she tells The Guardian.

Setting up Embody Orthopaedics in 2012 together with Professor Justin Cobb from the Imperial College London, she and her team have since developed 3D printed instruments that have been specifically designed for a single surgical intervention. 3D printed in nylon, they are low cost tools that are easily sterilized and are minimally invasive. ‘[These] devices assist surgeons to position joint replacements precisely, and improve recovery times,’ she explains. The system has been extensively tested at Charing Cross Hospital in London over the last year– in more than 400 surgeries – and the results have been excellent.

Each of these instruments is based on CAT scan data to make custom models for each patients, while the same software is used to rehearse the operation on the computer and planning incisions and bone alignment before the actual surgery takes place. ‘It's better to make these decisions, especially in complex cases, before the patient is anaesthetised and on the oeprating table,’ Dr Clarke tells The Telegraph. ‘Bone shape and size can vary widely between individuals and we provide the 3D-printed parts that are an exact fit. This reduces costs and inefficiencies.’

The 3D printer used.

The same team is currently looking into 3D printing the joint implants too, but this first success is already going to be implemented in hospitals across Britain over the coming year. This does mean challenging existing medical practices and manufacturing companies, but Clarke insists that Embody Orthopaedics will work alongside, rather than against them. Their biggest advantage in the marketing field? Costs. ‘The cost of our technology is in the hundreds of pounds not the thousands, per operation, and will be less than the sterilisation and haulage costs of the current system,’ the bioengineer claims.

But it also makes the lives of surgeons much easier, making the learning process itself so much shorter. ‘We embed rules in the guide and then any surgeon can access the level of skill and precision held by the leading surgeon. Everyone can have a Justin Cobb knee,’ she explains. With the help of these visual models, bones are more clearly seen than in any other operation, and instruments suiting that particular situation are immediately and automatically 3D printed. ‘This automation process is one of the most novel things that Embody is doing, Clarke explains, ‘because of the huge impact it has on the turnaround time.’ A grasshopper algorithm is used for each 3D model, taking minutes, rather than hours, to make. While not all instruments look fancy, they are certainly fitting and disposable.

Yet that marketing process wasn’t easy, she reveals. ‘Healthcare is very tightly regulated and getting approval for your products or services can be considerably more difficult in healthcare than in standard consumer technologies,’ she tells The Guardian. ‘It is notoriously difficult to successfully develop and market a new medical technology.’ In fact, to make ends meet in her medical 3D printing business, Clarke actually sold 3D printing time to medical practioners, who used it to make surgical models. ‘This allowed us to bring money in before the core product was ready. At the same time, we were able to raise our profile among our intended customer base,’ she adds.

Clarke.

Embody Orthopaedics has also been fortunate enough to receive a series of grants and business support over the years. In 2012, they received a Royal Academy of Engineering Enterprise Fellowship, which gave Clarke & co access to training, mentorship, funding and support from the Enterprise Hub. Despite this assistance, she found Britain’s decades-old healthcare system NHS difficult to navigate through. ‘Even when you have a business model you are confident with, you still have to actively sell your product or service. The medical industry has long sales cycles, and selling into a hospital can take more than 12 months,’ she says. ‘Healthcare professionals are sometimes considered technology-averse, so influencing them to buy into new medical technologies requires entrepreneurs to communicate the benefits in terms they are concerned with: tangible health outcomes, financial impact, process and resourcing efficiency.’ Fortunately, the NHS is increasingly opening up to new initiatives, enabling successes like that of Embody Orthopaedics.

Posted in 3D Printing Application

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