3D-printing, while not a brand-new technology, holds huge potential and promise within healthcare. In respiratory care specifically, 3D-printing may help us better understand the complex anatomy of the lungs, provide a means to assess drug effectiveness and even serve as artificial breathing systems for those patients needing rehabilitation. While there are naturally some potential barriers to overcome, the impact of 3D-printing on healthcare could be huge.
The role of 3D-printing in healthcare (also known as additive manufacturing),1 is rapidly expanding.2 The process involves the production of a three-dimensional object from a digital file. A 3D printer is used to print successive layers of images or files on top of each other until the final 3D object is created.1
The scope of medical 3D-printing is vast and ranges from tissue or organ fabrication and customized prosthetics, to anatomical models and implants.2 The benefits of 3D printing now, and in the future, could well be considerable; enhancing customization and personalization of medical products, and increasing cost-effectiveness and democratization of healthcare globally.2 With a seemingly vast scope of potential in healthcare, many disciplines have already started to explore the benefits that may be afforded with 3D-printing technologies and respiratory care is no exception.
Globally, pulmonary diseases are reported to be the third leading cause of death, making the treatment and diagnosis of these complex disorders more important than ever.3 Given the complex anatomical structure and physiological processes of the lungs, 3D-printing has become of considerable research interest as it may be suited to supporting the need for well-understood structural-physiological relationships within the lungs.3 Printed lung structures may serve to help us understand the pathophysiological mechanisms behind lung conditions and help us to better explore the complexity of lung infrastructure itself.3
It is not only for research that 3D-printing may prove to be helpful; it might also be used as a means of treatment too. In cases of severe respiratory disease, ventilators may be used to help compensate for patient lung function when they are unable to work effectively on their own.4 This, however, is a challenging task and high airway pressures and oxygen concentrations can often result in tissue and lung trauma, and actually exacerbate the existing condition.4 Because of this, interest in artificial lung technologies has seen growing interest as a means to allow a patient’s lungs to sufficiently heal while they are rehabilitated.4 Indeed, in more severe cases, artificial lungs could even serve as a bridging therapy before transplant, helping to preserve patient quality of life in the interim.4
In this way, artificial lungs are designed to replicate the function of natural lungs; i.e. they add oxygen to the blood and remove carbon dioxide.4 In practice however, existing artificial lung systems are not fully satisfactory.4 Systems are limited to use only within intensive care facilities and are not portable. They may also be associated with side effects of inflammation, device clotting and hemolysis and have only very short clinical lifetimes.4 This is where 3D-printing may be able to help. Dr Joseph Potkay, a biomedical engineer, has developed a new artificial lung design that reduces device size (enhancing portability), enhances gas transfer performance and biocompatibility and mimics pressures, sheer stresses and branching angles as present within a real lung.4 In doing so, the 3D lung system aims to simplify use, reduce incidence of side effects and improve patient outcomes.4
Another way that 3D-printed lungs may prove beneficial in respiratory care is to provide a reference standard for inhaled drugs.5 3D-printed lung systems could be used to determine whether inhaled drugs settle in the right areas of the lungs as intended and in the right concentrations; 5 providing invaluable information as part of a new drug discovery process.
As with all new technologies with the potential to change healthcare practices, there remain some challenges to address. Most importantly perhaps is the regulatory considerations that must be made for all 3D-printed medical products.6 Review of existing medical device regulatory protocols is required to ensure that new products of this nature are rigorously assessed for safety and effectiveness.6
Moreover, adequate evaluation of the risks associated with 3D-printed products is crucial; whether that be for personalized products for individual patients or those developed to be serialized.6 Materials and manufacturing processes must be evaluated and standardized, and their risk considerations established.6 Finally, there is a need to standardize the quality standards which these products must meet. In the US, the Additive Manufacturing Standards Collaborative (AMSC) was established to develop a standardization ‘roadmap’, which provides information on existing standards, related standards and gaps for further development.6 Alongside this, the Standards, Specifications and Guidelines database is an online tool updated weekly to establish a toolkit for standards and guidelines related to 3D-printing for medical devices.6
While regulatory authorities like the Food and Drug Administration (FDA) are taking steps to issue guidance on regulation of these products, it is likely that recommendations will continue to evolve alongside the technology itself.1 Similarly, limitations of the 3D printing technology itself may prove to delay the full realization of the potential of these devices in medicine.1 Product turnout time is a big hurdle; in clinical scenarios where time is of the essence, being able to produce 3D-printed devices quickly is of crucial importance.1
While there are still some hurdles to overcome, the future of 3D printing certainly seems bright. Discover more about healthcare innovation in our articles on remote patient monitoring, artificial intelligence and the digital transformation of healthcare. Sign up for our monthly updates too here.
December 2020 RESP-42264
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