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3D Printing Medical Devices and R&D Tax Credits

Charles Goulding

3D printers are now being used to develop the next generation of life-changing medical devices. Due to technological innovation in this field, it’s now possible to print medical devices that feature complex geometries, which allows devices to be customized to meet an individual’s needs. The unique capabilities of 3D printing also support the integration of new technologies, as printed devices are able to outperform medical devices fabricated using conventional methodologies. Over the next four years the global 3D printing healthcare market is expected to grow 26.2%, compounded annually, totaling $2.3 billion by 2020. Firms that are engaged in developing medical devices or refining 3D printing technologies for the biomedical industry are eligible for the Research and Development Tax Credit and should apply for the credit to offset their R&D costs.

The Research & Development Tax Credit

Companies in various industries, including firms that utilize 3D printing technologies have been taking advantage of the federal Research and Development (R&D) Tax Credit since 1981. Firms can receive a credit of up to 13 percent of eligible spending for new and improved products and processes. Qualified research must meet the following four criteria:

Eligible costs include employee wages, cost of supplies, cost of testing, contract research expenses, and costs associated with developing a patent. On December 18, 2015, President Obama signed the bill making the R&D Tax Credit permanent. Beginning in 2016, the R&D credit can be used to offset Alternative Minimum Tax and startup businesses can utilize the credit against $250,000 per year in payroll taxes.

Advantages of 3D Printing Medical Devices

Metal- and ceramic-based implants have been used for decades, but the manufacturing techniques necessary to make them have major limitations that hinder the overall efficacy of the medical device. Conventional fabrication techniques used to make medical devices include machining, casting, and forging. When using these techniques there are two options: make a custom-made piece for a patient, which is an extremely costly process due to there being no economies of scale, or make larger quantities of implants but in generic sizes, which won’t fit the patient perfectly.

The reason that 3D printing has become a game changer in the medical device industry is because it allows for the development of medical devices that are more personalized to the wearer while proving less expensive to create. Conventional biocompatible materials used in the construction of medical implants include composites, titanium, stainless steel, cobalt, chromium, and other metals. Advances in 3D printing, especially metal printing, have hinted that development of next-generation medical devices and implants will outperform anything that has come before them. By using extremely accurate renderings of digital 3D files, such as computer-aided design (CAD) drawings or a Magnetic Resonance Image (MRI), 3D printers can produce a device with more natural anatomical geometries that make it possible to customize the device for the individual. Similarly, 3D printing can also be used in the development of porous bone replacement scaffolds that can be integrated into an implant design. The integration of bone replacement scaffolds helps facilitate natural bone ingrowth, which increases the stability of the implant over time.

Design Factors

3D printing medical devices has proven to be a balancing act. Although designers have the ability to print implants in any geometry they want, it is necessary to ensure that the physical properties of the selected material can handle the structure of those unique geometries. For example, when integrating porous bone replacement scaffolds, it is critical for designers to not make the device too porous where its structural integrity can weaken and consequently fail from normal, shear, and bearing stresses. The development of geometrically complex and porous medical devices will also present cleaning challenges. It is imperative that medical devices are thoroughly cleaned to ensure that foreign bodies do not infect the patient during surgery. In the future, medical device designers will have to weigh the benefits of complex designs against the difficulty to effectively clean the device. Another factor that needs to be considered during the design process is the feasibility of utilizing multiple manufacturing techniques to develop the medical device. This might require keeping extra stock material on the device so that it can be machined at a later point in time.

3D printing will certainly improve the quality of medical devices, but there still exist challenges associated with using this technology. The biggest advantage of 3D printing medical devices is the ability to customize a device to meet a patient’s needs; however this is also one of the biggest hurdles in standardizing the manufacturing process. When a company fabricates a medical device, it is required that standards be put in place to confirm that the device is safe for patients.

When it comes to medical devices, biocompatibility is a primary concern that needs to be addressed. Firms that are developing medical devices will have to conduct more extensive experimental testing on other products if biocompatibility information is not available for a particular material. There are many initiatives underway, such as the Biocompatibility Consortium for Additive Manufacturing which seeks to identify the biocompatibility of materials.

3D Printed Pacemakers

Advances in biomedical engineering are propelling devices such as pacemakers to be 3D printed. Pacemakers help people with irregular heartbeats monitor and control their heart rate. An electrode is used to detect the electrical activity of the heart, which then sends data through wires to the computer in the generator. Once that data is processed, the generator will send electrical impulses to the heart, in turn correcting the user’s heartbeat. 3D printers are now being used to develop personalized pacemakers. Researchers at the University of Illinois and Washington University 3D printed a thin, flexible sheath of silicon that was customized and later tested on a replicated rabbit heart. Sensors and electrodes were then installed onto the silicon pouch, which were able to monitor the heart and ensure that it remained beating in a steady rhythm. Current pacemakers are a one-size-fits-all kind of device but in time 3D printing can be used to develop a personalized device designed to correct an individual’s unique heart problems. The major difference between each device would be the placement of sensors on the mesh, which would then prevent irregular heartbeats.

3D Printed Hearts

Scientists were recently successful in 3D printing a soft artificial heart made of silicone that beats almost like a human heart. Approximately 26 million people suffer from heart failure worldwide; the development of a fully functioning artificial heart would have significant ramifications in the healthcare industry. A Switzerland-based research group developed the heart to function in the same natural way that a conventional heart would, however the silicone materials from which the artificial heart was made can only perform for about half an hour before the materials begin to break down. The reason the team designed the heart to operate like a real human heart was because of the problems associated with conventional artificial hearts, which rely on mechanical pumps that carry the risk of failure or causing complications within the body. Still, the team has designed the heart as a proof of concept – further research is required to make the heart ready for permanent use. The team will have to experiment with printing different materials as well as altering the geometries of the artificial heart to ensure the least amount of stress on the material during contractions. It remains clear that 3D printing will play a major role in the future development of prototype hearts.

Metal Printing Implants

Historically, implants were fixed to bone using specialty cement, but now 3D printed implants make it possible for fixation without cement. This could be achieved by printing with highly textured surfaces, which create more friction while in use and ultimately promote bone ingrowth that stabilizes the implant. 3D printing also makes it possible for implants to be made in just one step where the design of the implant can be easily modified to optimize the structure and consequently control the ingrowth of bone.

Many universities are making strides in the development of 3D medical devices. There are two groups of undergraduate students at Duke University that are using a titanium metal 3D printer to develop surgical implants. The teams are developing a complex titanium spacer for spinal fusion surgeries and titanium scaffolds for large bone defects. Spinal fusions are preformed to alleviate back pain caused by two vertebrae rubbing together as a result of a disk of cartilage failing. The procedure entails installing a small hollow device between the two vertebrae, which promotes the growth of bone around the device, and eventually fuses the two vertebrae together, stopping further movement. Titanium scaffolds are used to provide strength, support surgically removed portions of bone, and to facilitate the growth of new bone.

Currently there are plastic- and metal-based devices for both procedures. Each material type has issues that prevent the procedure from being as effective as it could be. Current metal-based devices are too dense and do not allow imaging technologies to see how well the bone is forming around the implant, while plastic alternatives lack the strength to support the applied load and do not facilitate enough bone growth. The implants developed by the Duke University design teams feature intricate lattice systems that both encourage bone growth and accurately determine the progression of bone growth using medical imaging devices due the porosity of the lattice structure. Furthermore, the undergraduate teams were able to communicate with doctors to determine their needs and used a 3D printer to slowly refine the geometries of the implants.

Conclusion

The ability to 3D print medical devices is greatly improving the quality of care that patients are getting and can even make certain treatments more affordable. Innovation can be found in the development of new, 3D printable bio-inert materials, experimenting with unique geometries, standardizing the manufacturing process, and the application of 3D printing techniques to develop numerous artificial elements of the human body. Firms that are engaged in any of these activities should apply for the Federal Research and Development Tax Credit to offset the cost of their R&D related activities.

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Charles R. Goulding and Peter Saenz of R&D Tax Savers discuss 3D printing in medical devices. 

 

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