Using 3D printing to make implants smart
Back in the 16th century, broken bones were physically manipulated back to the correct orientation by a bone setter. Failing that, the local blacksmith would step in.
Thankfully, advances in medical treatments since the early 1900s have allowed surgeons to use metal implants in healthcare, typically to treat bone diseases including osteoarthritis and inflammatory rheumatoid arthritis, as well as in reconstruction therapy. Though a well-established technology, traditional implants often cause challenges for patients and surgeons. One area currently being developed is that of smart implants, which improve patient outcomes, bringing the technology into the modern age.
“Implants can be smart in two ways, either by being additively manufactured to produce patient specific implants (PSIs) from computed tomography (CT) data, or by incorporating sensors,” explains Matt Parkes, Senior Medical Development Engineer at Renishaw, a company at the forefront of new engineering technologies utilised across sectors in everything from jet engines to dentistry. “Still in the early phases of development, inbuilt sensors could collect patient-specific data, enabling surgeons and other healthcare professionals to tailor treatment to the needs of individual patients.”
What patient challenges can PSIs help overcome? “One of the key issues that traditional implants present is loosening,” explains Parkes. “Particularly common following joint replacement procedures, loosening can be a result of poor osseointegration – the structural and functional connection of the implant with the patient’s bone. This can occur due to wearing over time and is exacerbated by factors including infection and poor compliance with advised physiotherapy regimes.”
Parkes notes this can be exacerbated by the limitations of traditional metal implants, which are only manufactured in a discrete number of shapes and sizes. “It is unlikely patients will receive an implant that fits them accurately,” he concedes. “This can cause poor physical function and contribute to loosening. Poor physical function can also occur because of stress shielding – the process whereby metal implants remove stress from the patient’s bone. The bone responds by reducing in density and therefore becomes weaker.”
Parkes also highlights the increasing incidence of obesity as one of the reasons why joint replacements are becoming more common in young people. “This poses longevity issues as implants can reach their maximum lifespan and need replacing several times during the patient’s lifetime,” he says. “To combat these issues, researchers and engineers have been developing implants in new ways, using techniques such as additive manufacturing (AM). The technology aims to improve the form, fit and function of implants.”
AM, also known as 3D printing, offers exciting opportunities to develop new technologies across industry sectors. It can remove many of the constraints seen in more traditional manufacturing methods such as milling, casting or fabrication. This opens up new possibilities for complex geometries and mass customisation of parts, at a commercially viable cost, that were previously unfeasible. 3D printing is highly suited to the production of medical devices in both cobalt chrome and titanium, and capable of producing complex features and accurate parts.
Renishaw is working to apply additive manufacturing to custom medical device production for craniomaxillofacial implants and guides, and is keen to work with its customers to improve existing custom devices and develop new applications that are yet to be exploited. “Renishaw's laser melting is a pioneering additive manufacturing process capable of producing fully dense metal parts direct from 3D CAD files using a high-powered fibre laser,” explains Parkes. “Parts are built from a range of fine metal powders that are fully melted in a tightly controlled atmosphere layer by layer in thicknesses ranging from 20 to 100 microns.”
AM has been used as a manufacturing method in the medical field for over 10 years, but Parkes believes the technology is yet to reach its full potential in this industry. “Because AM builds an implant layer by layer, it’s possible to produce PSIs that are a more accurate fit for the patient. The manufacturing method also has fewer geometric constraints than subtractive manufacturing. PSIs designed and manufactured according to a patient’s CT scan encourages the implant to integrate with the patient’s bone, reducing the risk of loosening.”
As a result, patients are less likely to suffer pain or require revision surgeries. “As well as being able to manufacture an exact shape, AM enables surgeons to control additional properties of the material,” he adds. “They can design implants that mimic the patient’s bone stiffness, density and trabecular structure, which can reduce stress shielding and improve osseointegration and physical function further.”
Implants can also be made smarter by adding sensors. This allows clinicians to accurately measure patient data – a key to evidence-based medicine, notes Parkes: “One parameter a sensor could measure is temperature, as a raised temperature can indicate an infection before symptoms appear. This could benefit both patients and doctors by enabling treatment before the infection becomes complicated and expensive to treat.”
Parkes believes sensors could also be incorporated into bone reinforcement implants, which are used to help fractures heal. “In this example, sensors can measure the strain exerted on the implant, which indicates the extent the fracture has healed. From this information, surgeons can determine the best time to progress the patient to the next stage of therapy and could also identify healing problems earlier than currently possible,” he argues. “As implant loosening can be affected by non-compliance with physiotherapy, technology has been developed to overcome this issue. Incorporating accelerometers to monitor the movement of patients would allow healthcare professionals to remotely obtain data. These could be used to determine whether a patient is complying with their prescribed physiotherapy and rest regime.”
One institute developing technology in this field is a collaboration between Renishaw and Western University in Ontario, Canada, which has set up the Additive Design in Surgical Solutions (ADEISS) Centre to bring together clinicians and academics to generate novel 3D printed medical devices. “ADEISS recently showcased the smart hip concept, which uses temperature sensors and accelerometers to collect patient data that can be communicated to a remote device,” reveals Parkes. “By making use of advanced sensor technology, there is now potential for the development of implants that can detect an infection and subsequently secrete the appropriate dose of antibiotic to treat it before it becomes symptomatic. This could reduce the number of patients admitted to hospital.”
The ultimate driving force for developing smart implants is the potential to considerably improve patient outcomes. Parkes believes AM offers several benefits, one major advantage being that the fit time schedule is reduced – a benefit to both patients and surgeons.
The benefits smart implants have over traditional metal implants could mean patients would suffer less pain and discomfort and be less likely to become seriously ill due to infection while at lower risk of needing revision surgeries – critical for younger patients. However, Parkes maintains that for widespread clinical adoption of smart implants, there are still challenges to overcome. “Clinicians must run clinical studies to collect data on the safety and performance the implants offer to patients,” he says. “This must all be done in line with regulations such as the EU regulations on medical devices. A further key consideration is the processing of personal data in smart implants and how that data is used by the industry and clinicians.”
The treatment of bone diseases and injuries has come a long way since the days of bone setters and blacksmiths, with patients now able to receive metal implants specifically designed to their individual requirements. Parkes expects that trend to develop further as new technology is enhanced: “Pioneering research institutes are overcoming the hurdles and improving the technology, so the uptake of additively manufactured and data-driven implants is set to rise, improving outcomes for patients and hospitals.”
How UiPath robots are helping with the NHS backlog
The COVID-19 pandemic has caused many hospitals to have logistical nightmares, as backlogs of surgeries built up as a result of cancellations. The BMJ has estimated it will take the UK's National Health Service (NHS) a year and a half to recover.
However software robots can help, by automating computer-based processes such as replenishing inventory, managing patient bookings, and digitising patient files. Mark O’Connor, Public Sector Director for Ireland at UiPath, tells us how they deployed robots at Mater Hospital in Dublin, saving clinicians valuable time.
When Did Mater Hospital implement the software robots - was it specifically to address the challenges of the pandemic?
The need for automation at Mater Hospital pre-existed the pandemic but it was the onset of COVID-19 that got the team to turn to the technology and start introducing software robots into the workflow of doctors and nurses.
The pandemic placed an increased administrative strain on the Infection Prevention and Control (IPC) department at Mater Hospital in Dublin. To combat the problem and ensure that nurses could spend more time with their patients and less time on admin, the IPC deployed its first software robots in March 2020.
The IPC at Mater plans to continue using robots to manage data around drug resistant microbes such as MRSA once the COVID-19 crisis subsides.
What tasks do they perform?
In the IPC at Mater Hospital, software robots have taken the task of reporting COVID-19 test results. Pre-automation, the process created during the 2003 SARS outbreak required a clinician to log into the laboratory system, extract a disease code and then manually enter the results into a data platform. This was hugely time consuming, taking up to three hours of a nurse’s day.
UiPath software robots are now responsible for this task. They process the data in a fraction of the time, distributing patient results in minutes and consequently freeing up to 18 hours of each IPC nurse’s time each week, and up to 936 hours over the course of a year. As a result, the healthcare professionals can spend more time caring for their patients and less time on repetitive tasks and admin work.
Is there any possibility of error with software robots, compared to humans?
By nature, humans are prone to make mistakes, especially when working under pressure, under strict deadlines and while handling a large volume of data while performing repetitive tasks.
Once taught the process, software robots, on the other hand, will follow the same steps every time without the risk of the inevitable human error. Simply speaking, robots can perform data-intensive tasks more quickly and accurately than humans can.
Which members of staff benefit the most, and what can they do with the time saved?
In the case of Mater Hospital, the IPC unit has adopted a robot for every nurse approach. This means that every nurse in the department has access to a robot to help reduce the burden of their admin work. Rather than spending time entering test results, they can focus on the work that requires their human ingenuity, empathy and skill – taking care of their patients.
In other sectors, the story is no different. Every job will have some repetitive nature to it. Whether that be a finance department processing thousands of invoices a day or simply having to send one daily email. If a task is repetitive and data-intensive, the chances are that a software robot can help. Just like with the nurses in the IPC, these employees can then focus on handling exceptions and on work that requires decision making or creativity - the work that people enjoy doing.
How can software robots most benefit healthcare providers both during a pandemic and beyond?
When the COVID-19 outbreak hit, software robots were deployed to lessen the administrative strain healthcare professionals were facing and give them more time to care for an increased number of patients. With hospitals around the world at capacity, every moment with a patient counted.
Now, the NHS and other healthcare providers face a huge backlog of routine surgeries and procedures following cancellations during the pandemic. In the UK alone, 5 million people are waiting for treatment and it’s estimated that this could cause 6,400 excess deaths by the end of next year if the problem isn’t rectified.
Many healthcare organisations have now acquired the skills needed to deploy automation, therefore it will be easier for them to build more robots to respond to the backlog going forwards. Software robots that had been processing registrations at COVID test sites, for example, could now be taught how to schedule procedures, process patient details or even manage procurement and recruitment to help streamline the processes associated with the backlog. The possibilities are vast.
The technology, however, should not be considered a short-term, tactical and reactive solution that can be deployed in times of crisis. Automation has the power to solve systematic problems that healthcare providers face year-round. Hospital managers should consider the wider challenge of dealing with endless repetitive work that saps the energy of professionals and turns attention away from patient care and discuss how investing in a long-term automation project could help alleviate these issues.
How widely adopted is this technology in healthcare at the moment?
Automation was being used in healthcare around the world before the pandemic, but the COVID-19 outbreak has certainly accelerated the trend.
Automation’s reach is wide. From the NHS Shared Business Service in the UK to the Cleveland Clinic in the US and healthcare organisations in the likes of Norway, India and Canada, we see a huge range of healthcare providers deploying automation technology.
Many healthcare providers, however, are still in the early stages of their journeys or are just discovering automation’s potential because of the pandemic. I expect to see the deployment of software robots in healthcare grow over the coming years as its benefits continue to be realised globally.
How do you see this technology evolving in the future?
If one thing is certain, it’s that the technology will continue to evolve and grow over time – and I believe there will come a point in time when all processes that can be automated, will be automated. This is known as the fully automated enterprise.
By joining all automation projects into one enterprise-wide effort, the healthcare industry can tap into the full benefits of the technology. This will involve software robots becoming increasingly intelligent in order to reach and improve more processes. Integrating the capabilities of Artificial Intelligence and Machine Learning into automation, for example, will allow providers to reach non-rule-based processes too.
We are already seeing steps towards this being taken by NHS Shared Business Service, for example. The organisation, which provides non-clinical services to around two-thirds of all NHS provider trusts and every clinical commissioning organisation in the UK, is working to create an entire eco-system of robots. It believes that no automation should be looked at in isolation, but rather the technology should stretch across departments and functions. As such, inefficiencies in the care pathway can be significantly reduced, saving healthcare providers a substantial amount of time and money.