Company insight
Personalised implants require a 3D solution
Additive manufacturing, also known as 3D printing, has found its way into industries of all kinds, but healthcare has been slow to adopt, until now. New hardware and software, as well as regulatory changes, are bringing it to the fore. Jim Banks talks to Gautam Gupta, senior VP and general manager for medical devices at 3D Systems, about these changing times.
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he fabrication of physical objects from a 3D digital model by laying down and bonding successive layers of material has proved revolutionary in many industry sectors. New 3D printing technologies make manufacturing quicker and more cost-efficient, and open up a new era of design innovation. Now, faster printers, software powered by artificial intelligence (AI) and the changing stance of regulators are expanding applications of additive manufacturing in the medical device sector. The demand for 3D-printed devices is finally heating up, but why has it taken so long?
“I’ve been in the industry for 20 years and the way devices are manufactured did not really evolve from the 1980s,” says Gautam Gupta, general manager and SVP for medical devices at 3D Systems. “If something works and there is great clinical data around it, then it becomes difficult to move away from it. Now, products have been copied and everything is commoditised, so it is hard to differentiate between companies and solutions. “That is where additive manufacturing makes inroads,” he remarks. “The technology supports premium products, allows companies to innovate faster, shrinks the size of the factory and allows devices to be personalised. Products don’t require much machining, and manufacturers don’t need to buy expensive moulds.”
Made to measure
One of additive manufacturing’s greatest strengths is its ability to increase the level of personalisation. The customisation of devices for individual patients is now far simpler.
Manufacturers are bound by guardrails put in place by the FDA and other
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regulators that limit the materials that can be used in the human body. Their stance on new materials is very conservative, but existing alloys and plastics offer great scope for more bespoke configurations.
3D Systems is a leader in printing titanium cages for spinal column support and is moving towards cobalt chrome (CoCr) products for articulating joints. It recently announced clearances for nylon surgical guides to pair with two total ankle implant solutions, which is a fast-growing area in orthopaedics.
and doing it in an innovative way, so we can provide PEEK implants with the right biocompatibility and stability.”
Empowered by AI
The ability to innovate is partly driven by new 3D printing hardware, and partly by AI-powered software, which can help expedite the design of personalised implants from a patient’s CT scans. Now, the company is looking at ways in which AI can read the same level of data from X-rays, as CT scans involve a much higher dose of radiation, are more
“Products don’t require much machining, and manufacturers don’t need to buy expensive moulds.”
Recently, the company obtained clearances to create the world’s first 3D-printed patient-specific polyether ether ketone (PEEK) cranial plate. The first surgery using this solution involved a 55-year-old male in Switzerland who was seeking to correct a huge cranial defect he had suffered since childhood.
“The defect, which had a major aesthetic and psychological impact, could not be corrected using a traditional implant because the weight would be so great that he would not be able to keep his head steady,” Gupta explains. “Using our additive technology, we could create hollow spaces within the implant based on the optimal weight for him to keep his head upright. “We took a CT scan of his skull and created an implant with hollow spaces between the two walls to achieve the target weight,” he adds. “Everything worked out perfectly. We can customise implants to the gramme. We are taking an existing process
expensive and, in some jurisdictions, are hard to get. “We are trying to move towards using X-ray data as the initiating point where AI can help us to link that data to other available images,” says Gupta. “It is progressing well but AI feeds on data, so we need to generate data that is reliable and repeatable without much noise to help the software learn quickly.
“More and more we are seeing a tremendous focus on personalisation,” he adds. “AI plays a key role in that, as you can’t do personalisation without advanced software that can adapt to scan data and provide a solution for each individual patient.”
At 3D Systems, the accent is clearly on innovation, and the opportunities for additive manufacturing in the medical sector are only just starting to emerge. ●
www.3dsystems.com Medical Device Developments /
www.nsmedicaldevices.com
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