Driving Innovation in Mental Health Technology Through Small Business Programs

When you think about trailblazers in mental health research, small businesses may not spring to mind. The reality is that small businesses are often at the forefront of innovative science, developing new technologies that push mental health research into the future. As we celebrate the 75th Anniversary of the founding of the National Institute of Mental Health (NIMH), we’re taking a moment to highlight how NIMH supports innovation by small businesses.

NIMH supports research led by small businesses through two main programs: the Small Business Innovation Research (SBIR) Program and the Small Business Technology Transfer (STTR) Program. SBIR was established in 1982 to support the development and commercialization of innovative technologies by small businesses. A decade later, STTR was established to increase the licensing and further development of academic inventions toward commercialization. These programs recognize the critical role of federal funding, supporting projects that may not appeal to traditional investment firms but have great potential for societal benefit.

Supporting advances in research and treatment

The SBIR/STTR programs have a long track record of supporting the development of technology in the service of mental health, from basic research tools to treatment-focused devices. Here are some recent successes that showcase the breadth of technologies NIMH supports through these programs.

Technology for understanding brain and behavior

Development of technologies for basic science rarely happens through venture investment. As such, NIMH’s SBIR/STTR programs play a critical role in supporting basic neuroscience tools that can advance our understanding of brain structure and function, from the level of a single cell all the way up to entire brain circuits. For example, Pinnacle Technology, a small business established in 1995, has become a global provider of neuroscience research tools  due partly to early NIMH support. Scientists are using these tools to collect and analyze data to understand how the brain works and how it may function differently in people with mental illnesses.

NIMH also supported the development of E-Prime® , a user-friendly program developed by Psychology Software Tools that enables researchers to design psychological and cognitive experiments without the need for programming skills. The program is now a common fixture in behavioral research labs, with over 100,000 users in institutions across 75 countries.

Medical device development

Mental health medications help many people manage their symptoms and go about their daily lives. But, for some, following a medication treatment plan can be challenging. Data suggest that people with schizophrenia are particularly affected, with medication adherence;challenges contributing to an estimated 40% of all symptom relapses. To address the need for new approaches, NIMH supported work by Delpor Inc. to develop a novel drug-delivery device  for people with schizophrenia. This device is designed to deliver the antipsychotic risperidone at consistent, therapeutic levels for up to 1 year – significantly longer than existing long-acting injectable medications. Unlike injectables, this innovative device can be withdrawn to manage side effects at any time. The device is currently in late-stage clinical trials.

Digital health technologies

The market for digital health technologies has exploded in recent years, and this interest is reflected in NIMH’s SBIR/STTR portfolio. NIMH is supporting a range of projects in this space, including research to develop devices and software applications that can help increase mental health care access, quality, and personalization.

For example, SBIR support allowed the start-up Health Rhythms to develop and test a smartphone platform  for patients with mood disorders. Using smartphone sensors, the application confidentially identifies daily behavior patterns that may signal the onset of a mood episode and informs the patient’s health care provider of those changes. The platform also deploys personalized, automated intervention advice to help patients regulate their mood. And it’s already having an impact. Two large integrated health systems serving over 5 million people are now using this platform to monitor changes in patients’ mental health symptoms and triage primary care patients to mental health services. And that’s just the beginning. The platform is also being tested in a multisite study, set to follow 600 individuals with bipolar disorder over 5 years.

Drug development

In the high-stakes world of drug development, costs can quickly soar, while the risk of failure looms large. NIMH’s SBIR/STTR programs have provided early-stage support to help drug development programs build prototypes and test feasibility so they can attract the investment required to navigate the regulatory approval process. As an example, Tetra Discovery Partners received SBIR funding  from NIMH to develop the compound BPN14770, which selectively inhibits an enzyme that controls signaling in brain cells and has been linked to memory improvement and other benefits. In 2020, Tetra Therapeutics was acquired  by an international pharmaceutical company, Shionogi & Co. Ltd., to support clinical trials of BPN14770 for a variety of central nervous system disorders.

Looking ahead

Over the years, NIMH has supported projects led by 750 small businesses, covering a broad range of applications from basic neuroscience technologies used in research labs to drug development, digital health technologies, and medical devices for research and clinical use. Our institute has supported SBIR/STTR awards in 44 U.S. states, the District of Columbia, and Puerto Rico (funding data are available since 1991 ).

Early on, NIMH’s SBIR/STTR programs supported small businesses such as Acadia Pharmaceuticals, Alkermes, Arena Pharmaceuticals, Cephalon, Invitrogen, Neurocrine Biosciences, Promega, and Sigma-Aldrich—companies that eventually became global businesses or were acquired by global businesses. Many small businesses that have received NIMH funding have gone on to receive the prestigious Tibbetts Award  from the U.S. Small Business Administration, recognizing companies that exemplify the spirit and intent of the SBIR/STTR programs through economic, technical, and societal benefit. Recent examples include Backyard Brains, Behavior Imaging Solutions, MicroBrightfield, Ripple LLC, and 3C Institute.

As we look to the future of technology development, there are many opportunities for the SBIR/STTR programs to aid in advancing the NIMH mission. One emerging area of interest is artificial intelligence (AI). For example, at Lyssn, pioneering researchers are harnessing the power of AI and machine learning to improve crisis counseling services. They’re investigating how AI can help automate quality assurance, assist in monitoring 988 crisis center calls , and provide support to each counselor. Researchers are also exploring how AI can aid in developing validated biomarkers for clinical research and clinical use. As the field develops, we’re paying close attention to ethical concerns and seeking effective approaches to address bias and other potential harms.

Since 1982, these vital investments have sparked a cascade of scientific progress, illuminating the path toward a brighter future for mental health research and clinical practice. We are excited to support the continued evolution of technologies through NIMH’s SBIR/STTR programs over the next 75 years and beyond.