How 3D printing can help your medical device manufacturing project

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3D printing has the potential to drive cutting-edge healthcare by providing cost-effective and accessible medical devices. In 3D printed electronics, a 3D inkjet printer is used to print the electrical circuit compared to the conventional method of etching copper traces onto a substrate. The ink used is a conductive material that can print circuits not only on flat 2D surfaces, but also on 3D products. While the traditional printed circuit board (PCB) follows a subtractive manufacturing method, 3D printing is part of the additive manufacturing process.

The subtractive manufacturing process involves engraving, drilling, or cutting a solid board to build the final product. It is ideal for applications using a wide variety of materials and in the Printed Circuit Board Manufacturing large 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 ability to include complex features makes this process versatile. It is used in a range of engineering and manufacturing applications, particularly in custom fabrication.

Benefits of 3D printing in medical device manufacturing

3D printing is economical and offers rapid PCB prototyping without the need for complex manufacturing steps. It optimizes the PCB design process by avoiding possible design flaws in the early stages of PCB design. 3D printing is easy on flexible PCBs and multi-layer PCB printing is possible using the latest design software. With 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 recently been used for the manufacture of final parts of several medical devices such as hearing aids, dental implants, etc. It is more beneficial for low volume productions.

With the growing demand for miniature medical devices, 3D printing has become the right choice for efficient manufacturing. Biomedical sensors, medical implants, and surgical assist devices are some of the important applications of 3D printed electronics in healthcare. In the future, 3D printing can contribute to new treatment strategies by providing personalized and low-cost health services in the medical 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 fusion deposition modeling (FDM). If the device is constructed using metal, the direct metal laser sintering (DMLS) or service laser melting (SLM) methods can be used. The SLA technique is suitable for prototypes with tight tolerance and smooth surfaces like dental and medical end-use parts, while SLS is the best choice for complex geometries like prostheses. In applications using metals, low cost prototyping can be achieved with FDM printing. DMLS or SLM printing is used in the construction of strong and durable parts like orthopedic implants.

Applications of 3D printing in medical devices

  • Build rapid prototypes: Prototyping of medical PCBs is a crucial process and involves multiple iterations. 3D printing provides the flexibility to develop prototypes of complex circuits used in medical devices. It can be quickly tested and validated for characteristics such as strength, functionality and heat resistance. 3D prototypes can be used as proof of concept in new designs and as templates for investor proposals. Building efficient and personalized medical devices is now possible thanks 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 replace human organ transplantation. These developments will transform health services in the years to come.
  • Production of personalized drugs: The introduction of 3D printing offers personalized preparation of drugs in the pharmaceutical sector. Doctors can provide more specific medications based on the patient’s age, weight, and medical history. This can save costs and resources significantly. Bioprinted organs are used for clinical drug trials. This has improved the drug productivity rate and also reduced adverse effects on animals which are often used for drug testing purposes.
  • Cost-effective prostheses and organ models: Synthetic organs are a great help in medical research and treatment plans. Organ models can be used to understand complex surgeries and educate patients about their health status. Dentures are expensive and not easily affordable for many patients. However, 3D printing has reduced the cost and increased the accessibility of these support facilities.
  • Improving the lifestyle of the elderly: Chronic diseases have always challenged health services. With the increase in the elderly population, there is a need for innovative treatments capable of reducing side effects. 3D printed orthopedic implants, synthetic heart valves and bones have improved the overall quality of life for many patients.
  • Advanced Health Services: 3D printing can provide biocompatible personalized medical dressings. The flexibility of these materials promotes rapid wound healing. Surgical instruments developed through 3D printing have improved the precision of the operation. Lab-on-a-Chip is one of the latest technologies that uses microfluidic chips based on 3D printing technology. These chips can detect abnormalities in the human body and have the potential to be used for real-time diagnosis.

3D printing regulations

Manufacturing a medical device has become quite easy thanks to 3D printing technology. The flexibility to produce highly customized products has enabled widespread use of 3D printing in the production of medical devices. It is important to balance the merits with the safety of medical equipment. Therefore, 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. Although the FDA does not regulate 3D printers, it does regulate medical devices made using 3D printing. Regulatory review increases with the category of the medical device.

  • Category 1 includes low-risk parts such as bandages or portable surgical instruments.
  • Category 2 is for moderate risk devices like syringes, blood transfusion sets, etc.
  • Products used as life support systems belong to category 3 of medical devices. These may be pacemakers, defibrillators, ventilators or implanted prostheses. To ensure the safety of Class 3 category medical devices, detailed clinical trial data is required.

Conclusion

Healthcare departments can deliver a high-quality patient experience using medical devices based on 3D printing technologies. The possibilities for development in the medical and pharmaceutical sectors are enormous and can be achieved by using the capabilities of emerging 3D printing technology.

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