3D Printing: A Novel Approach to Optimization

Innovations with 3D-printed products are visible among a wide range of industries. But perhaps the most exciting advances in 3D printing can be found in the world of medicine.

Three-dimensional printing has revolutionized manufacturing in the healthcare industry. Its advantages over traditional manufacturing methods include: 

  • Customization. Patient-specific products have reduced surgery and recovery times, and improved surgery success rates. Application areas include orthopedics, dentistry, and maxillofacial surgery.
  • Value. 3D printing is cost-effective for small production runs, especially for small implants or prosthetics used for spinal, dental, or craniofacial applications. 
  • Productivity. 3D printing is much faster. Prosthetics and implants can be produced in several hours. Shorter lead times for new products can improve patient procedures and care.
  • Patient outcomes. Use of models or guides to plan complex surgeries can reduce the overall time that patients spend under the direct billable care of a specialist.
  • Democratization of design and manufacturing. 3D printing data files can be shared in open-source databases and used to create an exact replica of a medical model or device.
  • Variability. The technology allows for variations in printed parts, such as advanced texturing to enhance the osseointegration properties of a hip implant. 

Technologies and Raw Materials Used 

Common technologies that are used in 3D printing for medical applications include: 

  • Fused deposition modeling, a plastic filament extrusion-based technology '
  • Stereolithography, in which a laser solidifies liquid resin material. Ultraviolet (UV) light hardens liquid resin, bonding successive layers.
  • Digital light processing, which is similar to stereolithography but employs a projector as  a light source
  • Multijet modeling/polyjet technology, which jets a layer of liquid photopolymer onto a build tray and cures it instantly using UV light.
  • Selective laser sintering (SLS), in which a laser melts and solidifies layers of powdered material
  • Electron beam melting, which is similar to SLS but employs an electron beam as its power source
  • Binder jet or power bed technique, which also is similar to SLS but instead of a laser uses a binding agent

Commonly used raw materials include ceramics (a cost-effective choice in orthopedics and dentistry), polymers (widely used to make medical devices), bio-ink (for bioprinting) and metals (such as stainless steel and titanium for biomedical implants and tooling).

3D Printing Applications in Healthcare

3D printing is widely used to make pre-surgery models to guide complex orthopedic, maxillofacial, cardiac, neurological, oncological, gastrointestinal, and plastic surgery procedures. Other application areas include hearing aid shells, custom dentistry (e.g., bridges, crowns, and guides), titanium implants, prosthetics, and drugs. Spritam, a 3D-printed drug recently approved by the US Food and Drug Administration (FDA), is used for epilepsy treatment.

Promising applications include bio-printing and organ transplants, which hold significant potential but will take time to evolve. This category will be typically associated with the 3D printing of body parts, such as kidneys for dialysis patients, pancreases for diabetics, heart valves, bones, or perhaps even entire functioning hearts. Other areas in which 3D printing technology is being tested include making tissue with blood vessels; customized heart sensors that can transmit detailed information about a patient’s cardiac health, such as oxygenation, heart strain, and temperature; ear cartilage; bone scaffold with bone growth factors; and synthetic skin.

Challenges in Adoption of 3D Printing Technology

Though the technology is garnering interest among healthcare professionals and is widely used in dentistry, hearing aid shell manufacturing, and pre-surgery models, its adoption for treatment faces barriers including the high cost of 3D printers, which run from several hundred thousand to a few million dollars; hefty mark-ups for certain raw materials, such as those used for making implants, which can cost more than the materials used for traditional manufacturing; unease over the quality and reliability of 3D-printed products in the absence of standards and experience with the technology; and  partial or no reimbursement for 3D-printed implants and other devices. 

The lack of a regulatory framework is also expected to delay widespread acceptance of 3D printing technologies. The FDA now treats 3D-printed devices the same as conventionally manufactured medical devices. In May 2016, the FDA issued a draft guidance focused design and manufacturing and device testing. This draft (leapfrog) guidance is meant to share the FDA’s initial thoughts regarding technologies that are likely to be of public health importance early in product development. 

Other areas of concern are cybersecurity and intellectual property rights. Cybersecurity risks in the manufacturing process could affect the reliability of the end product. For example, a hacker could manipulate a 3D printer while it is connected to the Internet to introduce internal defects as a device is being printed; alteration of the printer head orientation could affect device strength by as much as 25%. Confidential and sensitive patient information within CT and MRI imaging could be compromised or stolen in the digital transmission process. Copyright issues stemming from using or copying a CAD file to generate a digital blueprint for 3D printing, and patent issues such as identifying who is printing and/or using unauthorized 3D-printed devices and finding the source of infringement, can be difficult to track and expensive to enforce. 

Conclusion

Medical technologies often are expensive when they enter the market, though costs tend to decline over time. The widespread use of this 3D printing technology will lead to better treatment modalities and approaches, better materials, and eventually better lives for patients and surgeons. As more surgeons and hospitals use the technology, innovations will continue. 3D printing has the potential to be one of the biggest game changers of the cen

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