3D printing has the potential to drive advanced healthcare by providing cost-effective and accessible medical devices. In 3D-printed electronics, a 3D inkjet printer is used to print the electrical circuit as compared to the conventional method of etching copper tracks on a substrate. The ink used is a conductive material that can print circuits not only on flat 2D surfaces, but on 3D products too. While the traditional printed circuit board (PCB) follows a subtractive manufacturing method, 3D printing is a part of the additive manufacturing process.
The subtractive manufacturing process involves etching, drilling, or cutting from a solid board to build the final product. It is ideal for applications using a wide variety of materials and in the PCB fabrication of large-size products. In the additive manufacturing process, a product is developed by adding material one layer at a time and bonding the layers together until the final product is ready. The ability to control material density and the possibility of including intricate features makes this process versatile. It is used in a range of engineering and manufacturing applications, especially in custom manufacturing.
Benefits of 3D Printing in Medical Device Manufacturing
3D printing is economical and offers quick PCB prototyping without the need for complex manufacturing steps. It optimizes the PCB design process by avoiding possible design faults in the initial PCB design stages. 3D printing is easy on flex PCBs and multilayer PCB printing is possible using the latest design software. With the growing manufacturing trends and improving software, 3D printing will be more than a prototyping tool and can be a viable alternative for production parts. 3D printing has been recently used for the end-part manufacturing of several medical devices like hearing aids, dental implants, and more. It is more beneficial for low-volume productions.
With the rising demand for miniature medical devices, 3D printing has become the right choice for effective manufacturing. Biomedical sensors, medical implants, and surgical assisting apparatuses are some of the significant applications of 3D printed electronics in healthcare. Going forward, 3D printing can assist in new treatment strategies by providing low-cost and personalized health services in the medicine and pharmaceutical sectors.
3D Printing Technologies in Medical Device Manufacturing
The most commonly used 3D printing technologies for plastic parts are stereolithography (SLA), selective laser sintering (SLS), and fused deposition modeling (FDM). If the device is built using metal, then direct metal laser sintering (DMLS) or service laser melting (SLM) methods can be used. The SLA technique is suitable for prototypes with stringent tolerance and smooth surfaces like dental and medical end-use parts, while SLS is the best choice for complex geometries like prosthetics. In applications using metals, low-cost prototyping can be done with FDM printing. DMLS or SLM printing is used in building strong and durable parts like orthopedic implants.
Applications of 3D Printing in Medical Devices
- Building quick prototypes: Medical PCB prototyping is a crucial process and involves multiple iterations. 3D printing provides flexibility to develop prototypes of complex circuits used in medical devices. It can be quickly tested and validated for features like strength, functionality, and heat resistance. 3D prototypes can be used as proof of concept in new designs and as models for investor proposals. Building efficient and customized medical devices are now possible due to 3D printing technologies.
- Tissue engineering with biomaterials: Regenerative medicine uses biomaterials, cells, etc. to create synthetic organs, blood vessels, bones, valves, and even synthetic skin. 3D printing supports tissue engineering which has the potential to substitute human organ transplantation. These developments will transform healthcare services in the coming years.
- Production of customized drugs: The introduction of 3D printing offers personalized medicine preparation in the pharmaceutical sector. Physicians can provide more specific medicines based on the patient’s age, weight, and medical history. This can save costs and resources significantly. Bio-printed organs are used for clinical trials of medicine. This has improved the drug productivity rate and has also reduced the adverse effects on animals that are often used for drug testing purposes.
- Cost-effective prosthetics and organ models: Synthetic organs are of great help in medical research and treatment plans. The organ models can be used to understand complex surgeries and educate patients about their health conditions. Prosthetics are expensive and are not easily affordable for many patients. However, 3D printing has reduced the cost and has increased the accessibility of such support facilities.
- Improved lifestyle for the elderly population: Chronic disease has always challenged healthcare services. With the increase in the elderly population, there is a need for innovative treatments that can reduce side effects. 3D printed orthopedic implants, synthetic heart valves, and bones have improved the overall quality of life for many patients.
- Advanced healthcare services: 3D printing can provide personalized medical dressing materials that are biocompatible. The flexibility of these materials promotes quick wound healing. The surgical instruments developed using 3D printing have improved the accuracy of operation. Lab-on-a-chip is one of the latest technologies that uses microfluid chips based on 3D printed technology. These chips can detect anomalies in the human body and has the potential to be used for real-time diagnosis.
Regulations in 3D Printing
Manufacturing a medical device has become quite easy using 3D printed technology. The flexibility to produce highly customized products has enabled the wide usage of 3D printing in medical device production. Balancing the merits with the safety of the medical equipment is important. Hence, the regulatory approvals for 3D printed medical devices are mandatory.
The Food and Drug Administration (FDA) classifies medical devices into three categories based on the risk involved. Though the FDA doesn’t regulate 3D printers, it regulates the medical devices made using 3D printing. Regulatory scrutiny increases with the category of the medical device.
- Category 1 includes low-risk parts like bandages or handheld surgical instruments.
- Category 2 involves moderate-risk devices like syringes, blood transfusion kits, etc.
- Products used as life-supporting systems belong to category 3 of medical devices. It can be pacemakers, defibrillators, ventilators, or implanted prosthetics. To ensure the safety of medical devices in the class 3 category, detailed data on clinical trials are necessary.
Healthcare services can provide a high-quality experience for patients by using medical devices built on 3D printed technologies. The scope for development in the medical and pharmaceutical sectors is huge and can be accomplished using the features of emerging 3D printed technology.