The R&D Tax Aspects of 3D Printing Anatomical Models

Hospitals are beginning to integrate 3D printing technologies into their operations to better prepare surgeons for high-risk procedures. Practice makes perfect, but when it comes to healthcare, no two surgeries are exactly alike. Advanced software, medical imaging, and 3D printing technologies can now be used in conjunction to produce an anatomically correct model of a patient’s body. This means a surgeon can practice a procedure on a exact replica of a patient’s heart which allows them to know exactly the location of every part of the heart and prevent any surprises that might be encountered during the actual surgery.

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:

• New or improved products, processes, or software
• Technological in nature
• Elimination of uncertainty
• Process of experimentation

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.

Conventional Surgical Planning

Surgical planning is the process of pre-visualizing a surgical procedure and meticulously defining the steps required to perform the procedure. Conventionally, the process relies on looking at Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI) scans. CT scans are comprised of numerous X-rays taken at various angles, where computer software is then used to combine the X-rays to produce highly detailed cross-sectional images that display the locations of bones, blood vessels, and soft tissues. MRI machines produce highly accurate images by emitting strong magnetic and radio waves; software is then used to process how the waves interact with the body to produce images. Both of these technologies can be used to produce 2D and 3D images that are extremely helpful in the planning of surgeries, but ultimately the preplanning process is only as good as the doctor imagining the procedure.

Benefits of 3D Printing Surgical Models

The ability to print patient specific 3D models makes it possible for surgeons to physically feel how the body part that is to be operated on will physically react. The physician can cut away at the model as if it was real human tissue and discover exactly where different elements will be and how large they will be in relation to the medical tools they will be using. In addition, they will have an understanding of how finite elements within complex systems will be affected by stimuli. For example, patients may have different tissue thicknesses around their heart, which will affect how much force the surgeon will need to use to perform the required procedure. The surgeon will also gain muscle memory of the procedure that would otherwise not be possible.

Medical models are not printed using conventional manufacturing and prototyping 3D printers. In these two sectors, 3D printers are predominantly used to optimize geometries and develop products with geometries that are not possible to make using typical manufacturing practices. When it comes to printing anatomical models, the accuracy of geometries is extremely important but the development of a quality model requires unique surface textures, material responsiveness, and structure to ensure that the model provides an accurate experience. These requirements make it necessary to use high-end 3D printers such as the Objet and Objet350 Connex3 by Stratasys. Printers like these are able to print in multiple colors and materials, which is necessary for healthcare professionals to differentiate the different elements of the anatomical model and to feel a difference when cutting into the different components of the model. For example, it should feel different when cutting into fat, skin, muscles, tendons, and bone.

Room for Improvement

Developing the right texture for a model is challenging. When it comes to bone, the texture of the model has to be perfect. The medical tools that surgeons use during surgery generate heat through fiction. This does not create issues with normal bone, but the plastics used to print surgical models will deform from the heat, which will result in an unrealistic experience that will not sufficiently prepare a surgeon for the live surgery. Designers need to make the texture of bone thin enough so that the material does not melt under friction but thick enough that the model does not crack under the applied load of the surgical tool. One solution to this problem is to use honeycomb structures within the models to maximize the strength of the model in relation to material usage.

Adoption

The major trend in the healthcare industry is to improve the quality of care through personalized medicine and minimally invasive procedures. There are numerous structural heart treatments now that can now be performed through endovascular procedures, which use the body’s blood vessels as the access points for medical devices. The uses of endovascular procedures are less risky than open-heart surgery but the procedure requires extreme precision and accuracy.

Kaleida Health’s Gates Vascular Institute (GVI) in Buffalo, New York is just one of many healthcare facilities using 3D printers to develop realistic models of the human body, which surgeons then use to practice upcoming procedures. Specifically, GVI is using 3D printers to print vascular flow models, which enable surgeons to familiarize themselves with how blood vessels, tissue, and other fine elements within the body will behave during procedures.

A perfect example of the benefits of performing a procedure on a 3D printed model before an actual surgery is when GVI performed a pulmonic valve-in-valve replacement. At first, the surgeon planned on entering the right femoral vein through the right atrium. During the test run, the medical device buckled in the right atrium. The surgical team determined using a stiffer wire would prevent the buckle and therefore reduce the risk of complications during the actual surgery. If the failure occurred during the surgery, complications could have arisen that could have put the patient’s life at risk.

Hospitals are already realizing the major benefits of using 3D printers to help prepare doctors to perform medical procedures  and they are already looking for ways to optimize the process. Healthcare facilities that currently are using 3D printed models rely on third parties to process their images and print the models. Relying on a third party is costly and has a lead-time of a couple of weeks. This lead-time makes it impossible to develop medical models for surgeries that have to be performed right away. Many hospitals are looking to integrate 3D printing departments into their facilities to reduce cost and so that they can develop models for a wider range of procedures. Hospitals that have recently acquired 3D printers are already looking for ways to reduce the time to print models. The Holly Private Hospital in London experienced these same issues, which then prompted them to purchase an Ultimaker 2+ 3D printer and use open source software. The printer allows the hospital to print accurate fracture replicas in hours, which is closer to the timeframe needed for an injury of this nature.

Conclusion

3D printed patient specific anatomical models are increasing the quality of care in the healthcare industry. There is a major demand to make the models more life-like and to increase the speed in which the models can be printed. This presents a major opportunity for firms that are developing 3D printers, biomedical engineers specializing in the optimizing, and firms developing software to optimize the process of converting medical imaging data into accurate models and obtain R&D tax credits for doing so.

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