Manufacturing technology
Additive manufacturing has traditionally been used for producing different metal implants, such as stents.
trial revolved around bioprinting an auricle based on autologous chondrocytes that was customised to the dimensions of the patient’s ear. The main outcomes of the study were based on safety and efficacy. Another trial conducted by ROKIT Healthcare involved bioprinting wound dressings for diabetic foot ulcers. Adipose tissue (derived from adipose stem cells) was used to print custom-fitting wound patches. In this completed trial, all subjects showed complete wound healing after 12 weeks, whereas the control group only had a 50% complete healing rate. Currently, there are more model-based clinical trials due to the extra safety, ethical and regulatory risks associated with implants. Even though there are some clinical trial examples that have both been completed and ongoing, the volume is still quite low. However, this shows that bioprinting is now starting to make the transition from the bench to clinical stages, with the hopes that they will soon be at the patient’s bedside. This could still be a while off yet according to Zang, who noted that “to date, there is no single bioprinted FDA-approved product for clinical use that is commercially available in the market”. However, even though bioprinted implants are making their way through clinical trials, there isn’t much transparency surrounding them, and many early-stage trials are potentially not being registered – so it could be that there are more out there than has been officially confirmed. More transparency and participation in registering clinical trials could eventually help clinicians compare bioprinting methods across trials and draw connections to clinical outcomes, which would eventually speed up the time to market for future bioprinted products – as the best approaches for different implants would be known to more people. But that is something that is for the future, and the challenges with regulations for bioprinting (and medical additive manufacturing in general) also need to be sorted before we see more clinical bioprinted implants.
FDA regulations are ambiguous The US Food and Drug Administration (FDA) has
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drafted a framework that outlines the potential manufacturing scenarios for 3D-printed devices in the medical field. Zang states that, “The FDA has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialities referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.” However, the framework is very ambiguous. It doesn’t provide enough information on how regulations will apply to additive manufacturing facilities – both traditional and bioprinting. This brings questions as to whether clinicians will have a legal liability if they choose to print their own medical devices. For devices that are bought by hospitals from third parties, it’s not clear if the FDA will have the ability to oversee the full supply chain, as many sites (such as hospitals) are not typically regulated by the likes of the FDA. On top of that, the printers themselves are not regulated, as it is the manufacturing process and output that is regulated, which could lead to significant variation for each print – something that is not ideal for medical implants. For bioprinting specifically, there has been no specific guidance issued by the FDA’s Center for Biologics Evaluation and Research (CBER) and it has not yet approved any bioprinted products. There needs to be more clear regulatory requirements for additive manufacturing in general for the medical industry before bioprinting regulatory guidelines get a look in. It may be that they all fall under the same regulatory umbrella, but they may not, and it will then take even longer to get regulations in place for bioprinted implants. There are, however, potential avenues that could be exploited for companies looking to bring bioprinted implants to market before firm regulations are in place. This is because there is an exemption for custom-made devices, which bioprinted implants would potentially fit into – as the exemption states that fewer than five should be manufactured and the device is being used to treat a condition that other medical devices cannot treat. In 2021, this pathway was exploited for a unique 3D-printed implant for treating a rare bone disease, but it remains to be seen if bioprinted clinical products will be able to take this route. Overall, there is a lot of potential for improving patient outcomes at the point of care using bioprinted implants. While they are moving towards a clinical readiness, many challenges remain that makes it difficult to predict what the market penetration might look like in a few years – especially when the FDA and other regulatory bodies have not kept up with the rapidly growing pace of the additive manufacturing and bioprinting fields. The technology and capabilities are there – the rest just needs to fall into place. ●
www.medicaldevice-developments.com
Carlos Ferraez/
Shutterstock.com
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