Health Care with 3D Printing

The medical industry is currently facing a plethoric challenge in regard to high development costs for new and enhanced medical devices.

After evaluating several alternatives to address these cost concerns, one promising option is 3D printing technology. The benefits of 3D printing within the medical industry include improved economics and better clinical outcomes for patients and doctors. The technology offers opportunities to hasten medical device prototype development and improve patient care through customized medical solutions and precise anatomical models for surgical preparation and training.

The medical industry can use 3D printing to create a range of body parts and medical devices such as dental implants, hearing aids, prostheses, custom-made knee and hip implants, and surgical instruments. The industry is poised to bring about a number of landmark enhancements revolutionizing the health care industry. Given the advantages of 3D printing, it is incumbent on the medical community to consider how this technology can improve the process, products and services it provides.

This paper discusses and illustrates the wealth of possibilities that 3D printing offers to the health industry using Julia FDM machine. We not only discuss the several new opportunities that manufacturers can leverage, but also present ideas on overcoming potential challenges.

OVERVIEW

3D printing, also known as additive manufacturing, is the creation of 3D objects from a digital model. A 3D printer uses software that “slices” the model into thin layers and uses that information to deposit material, layer by layer, where it’s needed to create the object. Because it’s an additive process, material use is minimized and complex shapes that would be difficult or impossible to make with conventional manufacturing methods are easily achievable.

The FDM Process

The FDM process uses a wide variety of thermoplastic materials in addition with a number of composites, 3D printable solid filaments are heated to a semi-liquid state, forced through an extrusion tip, and deposited in fine layers as required by the design.

The print head moves in X-Y axis. Once a layer is complete, the base plate is lowered down the Z axis to allow for the next layer. In this manner, the model and its support material are built from the bottom up.

The support material holds up overhanging structures while the model is being built, allowing for complex designs including nested structures and moving-part assemblies. When the print job is complete, an operator removes the support material, by hand (breakaway support), and the model is ready for use or post-processing.

3D PRINTING APPLICATIONS IN THE MEDICAL COMMUNITY

Additive manufacturing applications within the medical community are diverse. The technology enables quick, cost-effective development of new medical devices as well as customized end-use products that improve the delivery and results of a patient’s care. These economic and outcome based benefits span the medical community from device manufacturers to the patients.

Rapid Prototyping and Product Development

The ability to quickly create new products and speed the development cycle is a hallmark of the 3D printing process. It achieves this by replacing, where appropriate, time-consuming and costly traditional manufacturing methods. It gives designers and engineers the tools to quickly create and iterate designs, communicate more effectively using realistic prototypes and ultimately reduce time to market. Functional prototypes using high-performance materials allow the designer to test the design in verification and validation protocols, earlier in the design process. Gaining feedback early helps designers identify areas for improvement, resulting in medical devices that can better contribute to positive outcomes.

Rapid prototyping also lets designers quickly gather physician feedback on part design. Over the course of hours, the designer can digitally iterate the design based on physician input and then print the revised part for evaluation. The fast feedback loop accelerates design development.

Anatomical Models for Surgical assistance

Planning, Training and Device Testing, clinical training, education and device testing have relied on the use of animal models, human cadavers, and mannequins for hands-on experience in a clinical simulation. These options have several deficiencies including limited supply, expense of handling and storage, the lack of pathology within the models, inconsistencies with human anatomy, and the inability to accurately represent tissue characteristics of living humans. When it comes to individual patient care, pre- surgical analysis and planning using computed tomography (CT) and magnetic resonance imaging (MRI) scans are still limited to two-dimensional screen images.

The advent of 3D printing — especially the capacity to print in multiple materials, colors and textures offers new possibilities in the training, device testing and execution of surgical procedures. 3D printed models made of different materials representing bone; organs and soft tissue are produced in a single print procedure.

These models can be designed based on actual patient anatomy to capture the complexity and realism of treating the human body.

The ability to model a patient’s anatomy and pathology for surgical analysis and practice prior to an operation also offers clinical benefits, like the anticipation of complications and reduction of surgery time. This increases the likelihood of favorable results and faster patient recovery. These models can be stored digitally to allow for production as needed, and can be used in an office without special environmental controls.

The realism in texture and form of 3D printed anatomical models also make them effective tools for testing new medical devices. Researchers used a 3D printed model to validate the performance of the Covidien Solitaire Flow Restoration stent retriever. Using the bio-model, researchers compared the performance of conventional catheters and the Covidien device, ultimately demonstrating a higher success rate of neurovascular recanalization with the new device. The model’s realism also let researchers note the specific anatomical location of blood clot loss during the tests.

Patient-Specific Surgical Guides

Scanning technology has made it possible for doctors to accurately visualize a patient’s anatomy, helping them plan for surgical procedures. But when it comes to the precision needed during joint replacement or to repair bone deformities, this technology has limitations. Doctors must still rely on scan images and experience, as well as generic surgical guides, to accurately place hardware for bone repair. The use of 3D printed surgical guides refines the traditional means of orthopedic care by allowing doctors to shape them to the patient’s unique anatomy, accurately locating drills or other instruments used during surgery. This makes the placement of restorative treatments more precise, resulting in better post-operative results.

End-Use Parts for Clinical Trials

Reducing the time it takes to bring a medical device concept to the clinical trial stage has positive ramifications throughout the medical supply chain. Producers reduce cost and get more products to market faster, and patients benefit from new devices sooner. One barrier to success is the time and cost it takes to manufacture the product and revise it sufficiently to arrive at the right design. Lead times to create the tooling, whether in-house or outsourced, can be lengthy and expensive.

Additive manufacturing can drastically shortening the development process. Concepts can be produced overnight in the 3D printer, validated or quickly revised as needed, and be ready for clinical use without the need to implement the full design and manufacturing process. Manufacturers can use these additively manufactured parts to support clinical trials or early commercialization while the final design is still in flux.

Personalized Prosthetics, Bionics and Orthotics
Additive manufacturing is well suited for individualized health care. It enables the creation of prosthetic and orthotic devices tailored to a patient’s specific anatomy and needs, making those solutions more effective. In addition to the technical capabilities, the economics of 3D printing are ideal for low-volume and custom production, meaning cost often drops even while effectiveness increases.

Laboratory and Manufacturing Tools

A more conventional but equally significant application of 3D printing involves the creation of tooling, fixtures and other equipment that lets labs and medical device manufacturers work faster and reduce costs. Tools specific to a lab or process can be created quickly and revised as needed for little cost, simply by changing the tool’s CAD file and reprinting it. They can also be stored in a digital file, eliminating the need for physical storage. Hospitals and clinics can benefit by making custom surgical trays tailored to specific needs.

Conclusion
Additive manufacturing offers new possibilities for the medical community with benefits for both medical device developers and health care providers. It does this by circumventing traditional manufacturing methods, replacing them with faster, less costly 3D printing technology, suitable for customization. It enables the creation of complex shapes, in multiple colors and textures, that can’t be practically molded or machined.

Medical applications of 3D printing range from the prototyping and development of new medical devices to the creation of bio-models for surgical planning. The individualized nature of health care is a perfect fit for the customization that 3D printing offers, and is already benefiting individuals through personalized orthotics and bionics.

Julia’s FDM technology gives medical device developers the tools to reduce product development costs and time to market. They give physicians the capability to model a patient’s anatomy using realistic materials for better planning that shortens surgical procedures.

This is not technology to come; it has already been adopted by producers and providers in the medical industry as an essential means of improving the economics and outcomes of health care

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