3D printing is no longer the technology of the future – it’s now here to stay
The emergence of 3D printing as a viable technology which can be used in the medical industry is nothing new, but it has moved forward in leaps and bounds over the past 12 months.
Last year in India, a 32-year-old woman with tuberculosis of the spine who had suffered severe damage to her first, second and third cervical vertebrae and who was facing potential paralysis had her damaged vertebrae replaced with a 3D-printed implant by a team of specialist surgeons. Surgery of this type had never been performed in India before but the growing confidence of medical professionals in 3D printing technology and their keenness to use it as well as the obvious surgical skill allowed that woman to walk again.
This is one of a number of examples of how 3D printing is fast becoming a viable option in wider medical practice – and with the United States’ Food and Drug Administration (FDA) choosing to release the first “comprehensive technical framework” to advise manufacturers creating medical products on 3D printers, it seems that the technology is now here to stay.
In producing the guidelines, the FDA reviewed more than 100 devices currently on the market which were manufactured on 3D printers, including a number of patient-matched devices, tailored to fit a patient’s anatomy, such as knee replacements and implants designed to fit like a missing puzzle piece into a patient’s skull for facial reconstruction.
“In order to help ensure the safety and effectiveness of these products, we’re working to establish a regulatory framework for how we plan to apply existing laws and regulations that govern device manufacturing to non-traditional manufacturers like medical facilities and academic institutions that create 3D-printed personalised devices for specific patients they are treating,” said FDA Commissioner Scott Gottleib, upon the release of the guidelines.
“Overall, it will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology.”
“Promising new technology” may even be an understatement. It’s estimated that 100,000 knee replacement surgeries are now completed each year using 3D-printed, patient-matched surgical guides – just one specific application within the entirety of the industry.
Lauralyn McDaniel is Industry Manager of Medical Device Manufacturing for not-for-profit SME and she is as enthusiastic as anyone about the role 3D printing has to play in medicine moving forward.
“I would not be surprised if more than a quarter of hospital patients globally will be directly impacted by the technology in 10 years,” she says.
“Medical applications have always been a leader in using the technology for end-use. With the ability to build from medical imaging data to create truly personalised tools and devices, AM3DP (Advanced Materials & 3D Printing) is an enabler for precision medicine.
“From anatomic models to support patient education to developing patient-matched devices to treat rare diseases like Tuberculous Meningitis, I think the entire healthcare industry is beginning to understand the impact it can have.”
No doubt, the ability to match the construction of devices to an individual patient is one of the leading benefits. For some devices, additive manufacturing and 3D printing offers a method to more effectively create complex structures, more closely matching a person’s anatomy – “such as the porous structures need for osseointegration of orthopedic implants,” suggests McDaniel.
The ability to cost-effectively manufacture on a smaller, more precise scale has potential for development of devices for rare conditions. One of the greatest benefits of the technology for any industry is the complexity it enables, which is such that traditional design and engineering approaches often have to be put to the side. With 3D printing in particular, surfaces and structures can be optimised for strength, weight and material use.
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With this in mind, the FDA has characterised the guidelines not just as a “comprehensive framework” but also as what they are calling “leap-frog guidance” offering the Agency’s “initial thoughts” on medical devices created by additive manufacturing.
For McDaniel, this is an important distinction.
“Essentially, this a manufacturing method,” she says. “It’s not often that a regulatory body would provide guidance on a manufacturing method.
“That the FDA has done this indicates an understanding of the possibilities and a willingness to help the industry understand that it can use AM3DP for medical devices with some considerations. They have also dedicated resources to help better understand the technology, conducting research on material properties and other key factors in additive manufacturing.
“The key takeaways from the report are that the FDA is anticipating that even more applications will be developed due to the unique capabilities of AM3DP, and that they want to support the efforts through a regulatory process that supports the next generation of devices.
“With the publication of the final guidance, the FDA has indicated the technologies can be used safely and they’ve provided the framework to do that as AM3DP processes get faster and even more precise including to the micro and nano-scale. This can only help.”
One of the key goals here for the FDA is to establish a standard process for production of these devices which ensures they are safe.
“More capital needs to be invested developing integrated systems within the 3D printer that monitor the source code that designs the device, and the reliability of the output of the printer,” Dr. Robroy MacIver, a congenital heart surgeon who has pioneered the use of 3D printed models for surgery preparation, told Medical Design and Outsourcing. “Safety, therefore, will depend on adherence to a rigid process, rather than simply the end result.”
The requirement to establish a cover-all-bases approach which is safe does not, however, mean that all research into how the technology can be used, adapted and developed will now grind to a halt.
In fact, according to a recent report published by Market Research Future, the general global 3D bioprinting market is booming, and is expected to gain prominence by demonstrating spectacular growth over the next decade.
Many industry experts actually expect to see major innovation in the space over the coming years.
"The access to patient-matched devices will be enhanced greatly by the FDA's acceptance of this new technology,” Dean Carson, vice president of U.S. operations for medical-device manufacturer Anatomics, told Modern Healthcare.
“They're trying to create a pathway that people can walk along in order to create high quality implants that meet all the standards.
"You've got two ends of the spectrum: the companies trying to create the products that are going to advance healthcare and then FDA trying to ensure those products are as safe as possible. A guidance document like this is bridging the gap."
NHS care homes are better than private, report finds
A new survey has found that 60% of people with parents in NHS care homes believe the quality of care has improved, compared to just 49% of respondents with parents in private care facilities.
The survey was conducted by Kepler Vision Technologies, an AI-driven company formed at the University of Amsterdam. It was carried out among UK adults with parents over the age of 75.
Respondents cited more capable care staff and better monitoring systems as being the main reasons for improvement.
However those who do not have parents in assisted living facilities had a different viewpoint - in this case only 35% of respondents believe that NHS facilities are improving, compared to 32% who believe it is only improving in the private sector.
Only 18% of people whose parents live with them or independently believe care home staff are able to look after residents to a good standard.
Kepler Vision say this difference in opinion is due to perceived budget cuts and financial pressures, with 67% of people commenting that a lack of funding has had a negative effect on care in both NHS and private care facilities.
Other key findings of the survey include:
* Out of those who say quality has declined in care homes, 69% say the NHS is dealing with budget cuts and increased financial pressure, while 65% also said that the private system is dealing with these pressures too
* 55% said that they or their parent have money saved specifically to pay for their future care
* 35% said the idea of their parent in a care home makes them feel frightened, although 32% say it makes them feel secure
* 52% are worried about their parent catching COVID
* 47% are worried about their parent being lonely
* 46% are concerned they could fall over alone
The announcement of this research follows the UK government's decision to delay presenting its social care budget till the autumn.
Commenting on the research, Dr Harro Stokman, CEO of Kepler Vision Technologies said: “While it is good to see that people recognise the importance of staff and face-to-face interaction in elderly care, the huge gap in opinion between those with parents in care and those without shows that there are unfair negative perceptions around the residential care space.
"More can and should be done by care homes to give people the confidence that their relatives will receive the very best care - by highlighting the excellent work of staff and how well they are able to monitor resident’s needs with easy-to-use technology.”