3D printing has become a revolutionizing industry in hundreds of areas like commercial products and engineering, but the development has been especially notable in the biomedical field. It is being used to make prosthetic limbs; replacements for bones, tendons, and other functional organ pieces; as well as living human tissue for the testing and development of new drugs. Meticulous Research expects the medical 3D printing market to reach $983.2 million by the year 2020. The market is being driven by a wider application of biomedical printing, more investors, and increased government incentives for research and development. With the expansive possibilities that biomedical 3D printing can provide and the available federal R&D tax credit, the exponential growth of the industry is expected and welcomed.
The Research & Development Tax Credit
Enacted in 1981, the federal Research and Development (R&D) Tax Credit allows 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. This is particularly relevant to 3D bioprinting due to the long research and development time period the projects can take.
Founded in 2007 by Keith Murphy and Professor Gabor Forgacs at the University of Missouri, Organovo designs and prints functional human tissue for disease modeling and toxicology, drug research and testing in partnership with pharmaceutical companies, and for implants into the human body. They also provide 3D printed tissue to academic facilities for studying as opposed to model organs, allowing future medics to get better training. Their ExVive Human Liver is used to study predictive liver tissue-specific toxicity and their ExVive Human Kidney has been used to study nephrotoxicity due to drug responses. They are currently working on 3D printed tissue to be used as a source of therapy for patients with damage and disease to natural tissue. Organovo has been a leading company in biomedical 3D printing contributing to the expansion of technology in medicine and biology.
Product design studio MHOX introduced the idea of natural eyes being replaced by bioprinted ones in the future. EYE, standing for Enhance Your Eye, would, after surgical removal of the natural eyes, be docked into the skull and automatically connected to the Deck, a technology that would connect the eye to the brain via the optic nerve. The EYE comes in varying models including Heal, which is the most basic model providing a cure to sight diseases and traumas; Enhance, which builds on Heal by enhancing normal eyesight further to 15/10 vision and allowing for Instagram-like filters in vision; and Advance, the top model that includes all features of previous ones and Wi-Fi connection. Controversy has risen with the introduction of the concept as people wonder if they would actually be willing to surgically replace their natural eyes. The product is still in the research process but MHOX is expecting EYE to be 3D printed by 2027.
Cyfuse developed their own 3D bioprinter through a method they call Kenzan. With this method, the Regenova printer assembles cellular spheroids into a 3D shape by securing them to skewers. The cells are fused together after a few days and once the skewers are removed the tissue continues to mature and fuse together. Through this process, Cyfuse was able to create viable tissues including blood vessels, cartilage and bone, and even pumping heart muscle. Cyfuse develops and sells their Regenova bioprinter and plans on continuing prototyping tissues for future clinical use.
3D Printed Pancreas for Type 1 Diabetes Patients
Students at Binghamton University in New York have attempted to create a pancreas that could be transplanted into type 1 diabetes patients. Led by senior biomedical engineering student Thomas Hays, a group of students have been researching the possibility of the bioprinted pancreas. Type 1 diabetes, suffered by as many as 3 million Americans, is caused by the pancreas’ inability to produce insulin. The 3D printed pancreas, created from cells taken from the patient, would be created with the ability to produce insulin. Though it hasn’t been done yet, the idea is still under research and development with the goal of being developed by 2022.
One of the leading researchers in medical bioprinting, Wake Forest Baptist Medical Center in North Carolina has successfully proven the feasibility of printing replacement tissue. Through the combination of biodegradable, plastic-like material and a water-based gel containing cells, they were able to make and maintain a healthy environment for the cells long enough to implant and acquire a vascular system within the body. The testing was done by implanting a bioprinted human-sized external ear onto mice. After two months, the ear maintained its shape and was able to form cartilage tissue and blood vessels. Wake Forest is continuing development and anticipates the technology to be used for surgical implantation.
3D printing has proven to be one of the fastest-growing industries. From making better, and less expensive, prosthetics to creating synthetic eyeballs with seemingly superhero qualities, R&D tax credits support the development of 3D bioprinting, giving the companies of this industry more incentive to continue their growth.
Charles R. Goulding and Rafaella July of R&D Tax Savers discuss 3D bioprinting technology as it relates to tax credits.