Tackling the world's healthcare challenges with 3D printing
The many challenges healthcare systems face were thrown into the spotlight in 2020 due to the pandemic, among them medical supply shortages, supply chain disruptions, and a lack of personal protection equipment (PPE) for healthcare staff.
Almost overnight there was an urgent need for swabs to help test for the virus. Few healthcare providers, if any, were prepared for this sudden demand. "Supply chains for hospitals to suddenly test 5,000 people just didn't exist," explains Gautam Gupta, Vice President and General Manager, Medical Devices at 3D Systems Corporation.
"It can take a month to establish a new factory, and what happens during that month? It's a healthcare nightmare, as well as a PR nightmare."
A sustainable supply chain
Gupta and his colleagues soon realised they had the technology to quickly print thousands of swabs each week, with a 3D printer that occupies less space than a refrigerator. "The hospitals can own this supply chain, without having to open a factory or clear a major area of their facilities. They could print 10,000 swabs tomorrow, and 20,000 the day after, giving them the power to service their patients as needed."
3D Systems has also contributed to the Covid-19 response by 3D printing face shields and parts for ventilators. So how exactly can you 'print' a medical device?
The most common technique is stereolithography, or SLA, which uses a laser to harden liquid resin in a basin that creates the required shape. It was developed by Chuck Hull in the early 80s, who then founded 3D Systems in 1986.
"The fundamentals of 3D printing have more or less stayed the same, where you have a computer file that provides the basic input for the printer to create an output of a certain shape and type," Gupta explains. "It has evolved into different segments, and there are different polymers you can print with, as well as metals."
When Hull created the first 3D printer he wasn't specifically thinking about how it could support healthcare, but it seems an ideal solution for many of its challenges, the pandemic being a clear example. "When Chuck started 3D printing, the idea was to make something quicker, faster, cheaper, and if a one-off was needed, to make it really quickly instead of relying on a traditional supply chain."
The technology is being adopted in various aspects of healthcare. 3D Systems is currently working with a variety of healthcare providers throughout the US and Europe on dental moulds, anatomical modelling, and surgical planning.
Creating three-dimensional anatomically correct models helps with surgical training, as well as planning an operation, and Gupta says this leads to reduced surgery time and increased accuracy. It is especially beneficial for complex surgeries like separating conjoined twins. "In a lot of cases these models end up in the operating room right next to the patient as a reference point, because they are sterilizable objects."
Techniques evolve depending on the industry they're trying to serve, Gupta says, so the technology has developed for the jewellery sector, engineering, and even aerospace.
Solutions for those who most need them
The latter is an area that Julielynn Wong specialises in, more specifically aerospace medicine. As the founder of the social enterprise 3D4MD, she combines creating medical devices for space with her other fields of expertise: public health, general preventive medicine, and occupational medicine.
While these may seem like disparate fields she explains that creating a digital catalog of 3D printable supplies for space missions can actually benefit millions of lives on Earth.
"The austere environment of space is useful for testing healthcare solutions for resource-constrained regions on Earth," she says. "Nearly half the world's population lives in rural areas, where they often lack affordable and timely access to medical supplies. Having a regulatory-compliant 3D printing system that can be solar-powered, in a remote setting, would allow locals to produce medical supplies on demand locally at a much lower cost, and without any delays."
"Part of the reason we invest in space exploration is because we can spin off benefits here on Earth," she adds. "And the bigger the benefits, the better."
To that effect, Wong devised a solar-powered 3D printing system to create medical supplies on-site. Since 2017, she has led crews of analogue astronauts at the Mars Desert Research Station to test designs and find out whether this 3D printing system can work in a harsh, dusty, austere environment.
The types of medical devices they are focusing on are used for non-urgent procedures. "3D printing takes time, so you wouldn't rely on it to make supplies during a medical emergency,” says Wong. “But if medical items are used up for an emergency procedure, you could 3D print replacement consumables afterwards."
"The ISS Crew Medical Officers are trained to perform basic dental procedures, because dental problems are common on earth so they're common in space too. Dental issues are important to fix because otherwise the astronaut will be miserable, and it'll affect their morale and crew cohesion.
"Normally you'd use three instruments made from metal, so we came up with a 3D printable, multifunctional dental tool made out of a filament that's quite a bit lighter, but still strong. This will save money because launching supplies to space is expensive."
Given the environments she's designing for, the main challenge for Wong is ensuring the devices won't require post-processing after they've been printed. "You wouldn't want to 3D print something and then have to sand down excess material, or go find a tool and screws to put it together," she says.
"We've become real experts at designing devices that print support-free, can be 100 per cent 3D printed, and are ready to use right off of the print bed. It's more challenging to meet these design requirements but it makes sense for austere environments."
3D4MD has also been printing 100 per cent reusable face shields for frontline workers. "The current paradigm of single-use personal protective equipment (PPE) is not sustainable," she explains. "The Canadian government estimates that 63,000 tons of PPE will end up in landfills over the next year. PPE can't be recycled because it is potentially contaminated with biohazards."
The 3D4MD 100% Reusable Face Shield, which consists of a clear visor, comfort band and frame, can be sanitised in home or commercial dishwashers, and the clear visor has been rated for over 1000 autoclaving cycles – the gold standard sterilisation process in healthcare. "We've developed the technical knowledge on how to 3D print sanitizable and sterilisable filament. It's better to make a reusable medical device because it reduces supply chain dependence for single-use items."
3D4MD have also printed prototypes for a low-cost, intrauterine device (IUD) insertion trainer. While designing this device, they discovered that the copper IUD is the most effective method of emergency contraception, and can be inserted up to seven days after unprotected sexual intercourse as opposed to the 72-hour window of the morning-after pill.
Wong sees this as especially beneficial for teenage girls and women who have been sexually assaulted, and hadn’t received medical care straight away. "We want to provide IUD insertion training for physicians, nurses, and midwives to improve access to high quality, long-term and emergency contraception in rural areas and low to middle income countries" she says.
As well as 3D4MD, Wong is also the founder of Medical Makers, a social enterprise that aims to provide people with the skills to create high-quality medical devices with 3D printing. There are chapters around the world, from northern Alberta in Canada to Uganda. Interestingly, 50 per cent of their members are women and girls. Wong believes this is because of Medical Makers' mission and values. "We approach innovation by focusing on designing products for social good," she says. "We use human centered-design to create life-changing solutions that serve vulnerable populations."
Both Gupta and Wong believe wider adoption of 3D printing is on the horizon. "3D printing is one of the few technologies that allow doctors the ability to personalise a solution for a patient. We're seeing more and more of this. To find the best solution for a patient, the answer is very simple – give them something that is customised for them. And within the next three to five years, I think 20 per cent of orthopaedic devices will be made using 3D printing technology."
In the distant future, Wong says bioprinting – printing using cells and biomaterials to create organs – will become more common. "People have been bioprinting in space as well, but I think that's much further on the horizon because of the complexity of organs. It's not just about printing the solid organ, you've got to have the blood vessels, the nerve supply and lymphatics. We've got a long way to go, but it's great that people are working on it."
A guide to labelling compliance for medical devices
Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.
Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.
But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it.
On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.
Putting a plan in place
MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.
Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance. They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.
When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.
Why labelling in the cloud offers a roadmap forward
Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.
The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.
When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.
A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.
The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.
While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.
Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.