The 21st Century Cures Act Funds 3D Printing Innovations

Charles Goulding and Rafaella July look into 3D printing as part of the 21st Century Cares Act.

Three years ago, US Congress signed the 21st Century Cures Act into law – an act designed to accelerate medical product development and fund innovative research programs. The Cures Act authorized $6.3 billion in funding for a variety of medical and clinical research as well as innovative products. Many of the projects that received funding were 3D printing related, such as 3D printed medical devices or regenerative medicine.

Since the implementation of the Cures Act, research institutions and companies across the nation have greatly contributed to both medical knowledge and product innovation.

Regenerative Medicine

Regenerative medicine is influencing a shift in therapeutic treatments; going from palliative medicine to medicine that replaces, rejuvenates, or regenerates existing damaged tissue. With so many patients waiting for organ transplants, researchers are diligently working towards finding a solution in which the body can easily regenerate its own healthy tissue on a large scale.

The Cures Act authorized $30 million in funds for research and innovation in the field of regenerative medicine. These funds will be allocated to projects involving 3D bioprinting, such as implantable organ scaffolds. In the past 25 years, only approximately 10 regenerative medicine therapies have been approved by the FDA. With the funding from the Cures Act, many regenerative medicine therapies that are pending for approval by the FDA, or are in need of revision, will be expedited through the process.

UCLA

In early 2018, a UCLA bioengineer developed a technique to build complex, therapeutic biomaterials from multiple materials using a specially adapted 3D printer. The customized 3D printer is composed of two parts: a microfluidic chip and a digital micromirror. The microfluidic chip is a small, flat platform with multiple slots that each prints a different material. The digital micromirror is an array of more than one million microscopic mirrors that each move independently. The microfluidic chip releases the different materials, or bioink, while the micromirror directs the bioink into the desired shape and solidifies it. This is the first bioprinting process to use multiple materials at once.  

Massachusetts Institute of Technology

At MIT, engineers developed a new kind of bioink made from genetically programmed living cells. The cells can be programmed to form a response when exposed to certain stimuli such as chemicals or pollutants. Additionally, the team 3D printed a “living tattoo” made out of the bioink. The cells were 3D printed onto a transparent adhesive.  The bioink was printed in a tree branch pattern with each section corresponding to a certain sensitivity. When a stimulus was presented, one of the branches would light up in response to it. Although still in the research phase, the bioink could potentially be used to create wearable sensors and interactive displays with living material.

On top of the funding provided by the Cures Act, institutions and companies can take advantage of the Research and Development Tax Credit to help offset the costs involved in fine-tuning products or processes.

The Research & Development Tax Credit

Enacted in 1981, the now permanent Federal Research and Development (R&D) Tax Credit allows a credit that typically ranges from 4%-7% of eligible spending for new and improved products and processes. Qualified research must meet the following four criteria:

• Must be technological in nature

• Must be a component of the taxpayer’s business

• Must represent R&D in the experimental sense and generally includes all such costs related to the development or improvement of a product or process

• Must eliminate uncertainty through a process of experimentation that considers one or more alternatives

Eligible costs include US employee wages, cost of supplies consumed in the R&D process, cost of pre-production testing, US contract research expenses, and certain costs associated with developing a patent.

On December 18, 2015, President Obama signed the PATH Act, making the R&D Tax Credit permanent. Beginning in 2016, the R&D credit can be used to offset Alternative Minimum tax for companies with revenue below $50MM and for the first time, startup businesses can obtain up to $250,000 per year in payroll taxes and cash rebates.

Conclusion

The 21st Century Cures Act has provided funding for numerous research and innovative initiatives that will overall improve healthcare in the United States. Funding is specifically being allocated to medical 3D printing research initiatives such as regenerative medicine. Healthcare and medicine will benefit from these regenerative medicine advancements and become more modernized.