In general, to be entitled to the research tax credit, a taxpayer must be engaged in “qualified research.” Qualified research, in technical terms, is research that is undertaken to discover information which is technological in nature and the application of which is intended to be useful in the development of a new or improved business component; and substantially all of the activities constitute elements of a process of experimentation for a functional purpose. In practical terms, the medical industry involves established companies and start-up companies embarking on many endeavors that are considered “qualifying research” such as: inventing and designing new products, improving on products, improving equipment to satisfy new regulatory requirements, conducting testing and creating prototypes.
For example, research and development (R&D) related to wireless monitoring devices that are integrated with the web allowing patients and medical professionals to interact through video may qualify. Additionally, research related to developing wearables that collect data, provide medical accuracy and allow patients to link their data to their standard medical records may also qualify.
Another big development that continues to grow with additional research and experimentation is the 3-D printing of medical devices. 3-D printing of medical devices is becoming more commonplace because the devices last longer than those created through traditional methods, and generally take less time to create. Another benefit of 3-D printing of medical devices is that the device can be customized to the patient. The process to get 3-D printing to its current stage, and the process it will continually take to innovate, modify, and improve 3-D printing creates research and development tax credit opportunities.
The examples of medical equipment innovation are numerous and include a broad range of activities because of the unique nature and requirements of the healthcare industry. In addition to those mentioned, qualifying R&D also includes developing engineering drawings and specifications, performing CAD modeling, tooling and equipment fixture design and development, implementing factory automation and other automated efficiency improvements including robotic automation, developing microprocessor software code for the operation of a medical device, designing electrical equipment and implementing processes or robotics.
Clinical tests conducted prior to commercialization, conducting tests to satisfy foreign regulatory requirements, and generating prototypes for testing and validation also qualify as R&D.