3D Printed Medical Devices: Evolution and Future in the Medical World
The use of 3D printing in the medical industry is revolutionary and has a huge potential while unlocking unprecedented possibilities to customize devices as per the need of the patient. Additive manufacturing, otherwise known as 3D printing was first used in the medical industry as custom prosthetics and dental implants in the 1990s. Ultimately, scientists used 3D printed scaffold to provide support to the organs grown from the patient’s cells. With the evolution of the technology, healthcare providers focused on developing full functioning organ without the need for scaffold support. By this time, medical researchers started combining medicine and 3D printing while opening door to many new uses.
3D Printing Started Gaining Media Visibility
In 2000, the first 3D printed kidney was developed, however, it was transplanted into patient much later and today these 3D printed kidneys are perfectly working. With another medical application, 3D printing gained much attention in 2008 with the launch of the first 3D printed prosthetic limb, incorporating all the parts of biological limb. After this, many medical 3D printing advances took place and manufacturers started creating medical devices and patient-specific devices. Today, various medical devices are being produced using 3D printing technology such as surgical instruments, cranial and orthopedic implants, external prosthetics, and dental restorations.
3D Printed Medical Devices: Current Scenario
Recent progress and advancement in 3D printing application in healthcare has changed the modern medicine, for instance, 3D printed implantable devices can be customized to meet patient’s need, while providing cost-effective alternative to current implants and devices. One of the greatest advantages of 3D printed medical devices is increased accessibility compared to their traditional counterparts. Areas that often face challenges in getting access to basic medical devices are using 3D printing technology to create medical devices while improving accessibility.
3D printing has expanded rapidly in the healthcare industry last few years, with printing everything from medications to organs, perhaps prosthetics has been most commercially successful 3D printed device. 3D printing technology is being used on a large scale to produce patient specific components of prosthetics. Ability to produce complex structures such as highly customized facial prosthetic with using a range of materials is resulting in wide application of 3D printing technology. Currently, 3D printing technology is being used widely to produce low-cost prosthetics owing to the massive rise in amputees’ population unable to afford prosthetics.
3D Printing Technology for Neonatal Devices
Complications during preterm birth and childbirth have increased in recent years resulting in need for immediate medical attention with need for specialized medical devices. Despite the development of novel medical devices, the efforts to produce neonatal specific devices are limited. However, in recent years, 3D printing has emerged as the reliable, fast and cost-effective way to produce medical devices for neonates and infants. For instance, in 2015, researchers developed 3D printing technology to create medical devices such as catheters and surgical implants for newborns. Researchers are closely following cases of newborns to use 3D printing technology to develop medical devices that can successfully restore neonatal patients. Meanwhile, 3D printed airway splints have been used recently for treatment of infants suffering from severe tracheobronchomalacia.
Neonatal rural hospitals and emergency transport services are also using 3D printing technology in order to print medical devices spare parts, medical and surgical instruments which are most of the times not readily available in rural areas or the areas outside city limits. It is likely that 3D printing technology in coming years will find wide application in neonatal care, although studies and research are still needed to ensure safety, find possible application, and realize full potential of 3D printed medical devices for newborns.
Regulatory Framework on 3D Printed Medical Devices
The rapid expansion of 3D printing technology in medical devices and tissue engineering led to the formation of new regulations. Since mid-2000, more than 100 3D printed medical devices have been approved by the US Food and Drug Administration (FDA) across three categories including implants, external prostheses, and instrumentation. Meanwhile, FDA has been focusing on providing comprehensive regulatory pathway, while ensuring safety and effectiveness of 3D printed medical devices.
Owing to the growing number of approved 3D printed medical devices, guidance for 3D printing medical device manufacturers was issued by FDA in 2017 which was bifurcated in two categories of including design and manufacturing considerations, and design testing. FDA currently has two major classes of 3D printed medical devices. The first group includes medical devices or products that are manufactured using any processes, including 3D printing. While the second class includes medical devices that are of high risk and need to go through pre-market approval process as there is no similar device in the market.
Other regions are also increasingly focusing on the approval process and guidance on 3D printed medical devices. For instance, the European Union has also followed FDA’s example and relevant authorities have approved 3D printed medical devices and also offers advice for manufacturers and others who use 3D printing technique to develop medical devices. Meanwhile, in 2015, after approving its first 3D printed medical device which was a hip implant, China FDA issued guidance on regulatory requirement for 3D printed medical device in 2018.
Guidelines by national regulators on 3D printed medical devices have also been accompanied by organizations such as American Society for Testing and Materials (ASTM) and International Organization for Standardization (ISO), thus, creating consistent standards for 3D printed medical devices.
Metal 3D Printing Gaining Traction in the Healthcare Industry
Metal 3D printing continues to drive innovation in the medical device development. Several projects are ongoing with the goal of developing safe medical devices and speed the time-to-market. Some are focusing on the production of titanium pins in order to attach prosthetic limbs. Direct metal laser sintering and electron beam melting are two primary methods being used to produce 3D printed titanium implants for Osseointegrated. Moreover, various studies have also verified biocompatibility of titanium fabricated implants these methods.
Next-gen metal 3D printing technology using biomedical metals is making it possible for medical implant manufacturers to develop 3D printed patient-specific medical implants. Manufacturers are opting for 3D printing technology for building metal objects using variety of metals.
External-only contact is likely to result in the rapid adoption of metal 3D printed medical devices such as metal 3D printed braces. Metal 3D printing is also being adopted on a large scale in dental restorative products development such as moldings, bridges, and crowns. A few years ago, getting a crown was a multi-step and lengthy process. However, with 3D printed metal crown the process has become fast and frictionless. Orthodontal, dentures, and retainers devices are rapidly growing segments in metal 3D printing.
Owing to the small size and increasing need for customization, dental products are developed on a large scale using 3D printing technology. Compared to the traditional processes, 3D printed metal dental devices takes short production time, and are high-quality and low cost products.
3D Printing Boosting Customization in Medical Field
3D printing technology is leading towards the customization in wide variety of medical fields. Customized 3D printed medical devices are being produced on a large using drug-contact and bio-compatible materials. Increasing number of medical device giants are leveraging 3D printing technology to develop customized implants as per patient’s need.
Recent technological advances are resulting in the conversion of 2D medical images including CT scans, MRI into 3D computer aided design files and these files are sent to 3D printers to develop customized medical implants. Manufacturers are largely adopting, 3D printing technology facilitating just-in-time manufacturing, thereby, enhancing productivity and offering cost-efficiency.
Medical device manufacturers in order to stay at the forefront of 3D printing technology are focusing on the strategic collaboration and acquisition of the companies offering 3D printing technologies and systems. For instance, in 2017, Johnson & Johnson acquired advanced platform from Tissue Regeneration Systems Inc. The platform can help in creating customized bone-like implants along with the special coating that help in absorption and healing.
3D Printed Medical Devices: Challenges to Overcome
Owing to the distinctive capabilities of 3D printing, especially in the healthcare industry, there are several risks and challenges encountered by medical device manufacturers. The two biggest challenges being faced by manufacturers are the quality assurance and validation. Manufacturers are facing difficulties in implementing design control plan to comply with regulatory requirement in customization of 3D printed medical devices. Identifying design flaws and validation of device performance are some of the steps being taken by manufacturers.
Validation of 3D printed medical devices is also emerging as the biggest challenge for manufacturers due to the unique specification of each device as the device is customized for patient. With several evolving technologies in 3D printing, challenges are also on a rise. Creating complex devices can be time-sensitive and requires high-level of expertise, lack of skilled workforce is impacting the quality of the devices.
The regulatory landscape in the 3D printing will continue to develop with the introduction of new materials, printed implants, and bio-printed devices. Moreover, chances of errors in customized 3D printed implants including heart valves, orthopedic, and dental implants are high, owing to the high accuracy and surface finished required. Moreover, efficiency of the implants made using 3D printer also depends on operator’s skill, and software used for controlling 3D printer, failure of both is likely to increase the chances of errors.
The 3D printing technology is also influencing the Do-it-yourself culture, this can result in high risk and damage in the case of self-treatment. Although guidelines on printing implants and other medical devices are being provided, unawareness regarding proper protocols among patients are likely to result in damage and error.
Opportunities Ahead in 3D Printed Medical Devices
Technical advancements in 3D printing are expected to continue, especially in terms of the printers and materials being used to make 3D printed medical devices. There is an on-going demand for cost-effective 3D printed medical devices owing to the high cost of traditional medical devices used currently in the healthcare industry. Continues improvement in terms of cost and properties is being witnessed in the options including flexible and soft materials mimicking biological tissues.
Although plastic is one of the most used materials in 3D printed medical devices, the future will witness increasing use of bio-materials. Owing to the better contact with biological systems, biomaterials can help to replace or repair any tissue or organ of the body. 3D printing technology in medical field is expected to witness wide application of biomaterials such as ceramics, metals, composites, hard polymers.
Bio-printing, that refers to the 3D printing to develop scaffolds for the growth of tissue or printing of biomaterials or cells is also one of the areas offering growth opportunities in the near future. Advancing technology leading to the evolution of bio-printing technique into clinical use is likely to boost its use in the coming years.
Another technology likely to lead towards the advancement in 3D printing is machine learning. Machine learning has gained immense popularity in recent years. In terms of 3D printing, techniques based on machine learning will be of huge potential in order to reduce effort and time required to create advanced and complex medical devices using 3D printing.
3D printing technology used for developing medical devices is likely to enter a dynamic phase because of the wide application in creating various medical devices. Moreover, with governments across countries increasingly spending on healthcare is leading to the rapid adopting of new technologies with focus on specific needs of the patients than one-size-fits-all approach. Customized 3D printed medical devices and products will be adopted on a large scale as these products help to improve medical care along with reduced in the healthcare cost.
A number of adverse reactions including chronic inflammation, collateral tissue damage, allergies, infections, and possible loss of functionality in immune systems due to the implantation of 3D printed medical devices have emerged as the biggest concerns leading to general reticence in the 3D printed medical devices market. However, Advantages offered by 3D printed medical devices greatly outweigh the disadvantages of 3D printing. Currently, optimization and improvement in 3D printing technology is one of the key focus areas of manufacturers in order to provide best possible outcomes for patients.