Welcome to the first edition of Ask the Experts, where we find answers to the digital health community’s most pressing questions. This week, we’re joined by Jennifer Shieh and Patricia Weber, DrPH, from the National Institute of Health. So if you are interested in some FREE MONEY, read on.
Jennifer Shieh, NIH Fellow
Jennifer Shieh is a AAAS Science and Technology Policy Fellow at the National Institutes of Health (NIH) where she helps small businesses turn research on cancer technology into commercial products with the National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Development Center.
Patricia Weber, Program Director at NIH
Dr Weber works in the National Institute of Health in the National Cancer Institute’s Small Business Innovation Research (SBIR) Development Center in Oct of 2008. The SBIR Development Center is a division at the NCI that manages more than $100 million in technology projects within the small business community to accelerate the progress of cancer research. Her area of emphasis is in cancer prevention, digital health, statistical software, and biologics.
What stage and type (consumer, payer or doctor facing) of digital health company is a good fit for an SBIR grant?
Digital health companies of all stages and types are good fits for an SBIR grant. SBIR awardees span a wide range of stages; you could just have an idea, already have a developed prototype or have a developed product already in use.
If you’re an idea stage company, apply for a Phase I “Proof-of-Concept Grant” and use the money to develop a prototype.
Prototype stage companies should apply for Phase I grants and use the money to further develop the product, facilitate focus groups for user testing, gather information on features and design improvement. And protip: as with any type of application, providing evidence that your venture will succeed helps in the review process, so a developed prototype can help show that you are prepared to accomplish your milestones.
Developed product stage companies apply for fast track applications, which combine Phase I and II proposals and use the grant money for randomized, controlled studies to demonstrate that their product is effective and useful in (for example) causing a behavior change to improve health.
What are the best methods to search for grants that you are qualified to receive? Is there a way to set up alerts or notifications when relevant grants are announced?
To get notifications about National Cancer Institute (NCI) SBIR announcements and grant opportunities, sign up through our website. The NIH SBIR/STTR program also has a listserv for SBIR-related announcements and funding opportunities across different institutes, which can be found here.
The NIH Guide for Grants and Contracts is the official publication for NIH grant policies, guidelines, and funding opportunities. You can sign up for weekly notices of new opportunities through the NIH Guide listserv (though this will include opportunities that may not be relevant to you) here.
Always consider the NIH SBIR/STTR Omnibus solicitation. This is a funding opportunity for investigator-initiated applications that respond to the particular research missions and topic areas for all the different institutes and centers within NIH. With 3 receipt dates each year (April 5, August 5, December 5), the majority of applications are funded through this program.
Other agencies, including the Department of Defense and National Science Foundation (NSF), may also have relevant grants. To look for grants beyond NIH, check out the Grants.gov and SBIR.gov websites. Both allow you to search for funding opportunities based on specified criteria. Grants.gov also allows you to set up email notifications based upon specific searches. You may also want to check for SBIR information at specific agency websites (e.g., NSF’s SBIR program).
Are there any verticals within digital health that the NIH is targeting in particular? If so, can you point to some specific grants within those verticals?
NIH welcomes SBIR applications from small businesses in any biomedical or behavioral research area that falls within the NIH mission, which is to improve human health. NIH is made up of 27 institutes and centers, each with its own research agenda, often focusing on particular diseases or body systems (e.g. National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA)). The best places to look for topic areas of interest to a particular NIH institute are on the websites of the specific institutes, and in the program description document that accompanies the Omnibus solicitation.
Most institutes publish targeted grant solicitations that indicate research priorities for that particular institute. NCI SBIR expects to publish a program announcement on “Innovative Partnerships for Commercializing Consumer Health Information Technology” to accelerate the development and commercialization of consumer HIT products to prevent cancer and other chronic diseases by explicitly encouraging partnerships between the applicant small business and large businesses or health care organizations.
What does the application process entail and how long does it take? Are there any specific deliverables if you get the SBIR grant?
The guide for the NIH grant application process is the SF424 (R&R) SBIR/STTR Application Guide for NIH and Other PHS Agencies. This document lists all of the requirements to apply.
Start putting your application together at least 3 months before the deadline. Give yourself more time than you think you’ll need: you will need time to get supporting materials from others, such as protocols from a subcontractor or portions of the grant from a collaborator, and you will need time to write and re-write. Gathering high quality letters of support will also take time, and these letters are often an important addition to the application.
Have your research proposal read by someone (multiple people would be even better) who is not involved in the project and isn’t too close to your technology area to make sure can be understood by a broad audience, and that you are clear about the benefits of your work. Find someone who can still be critical about the work and give you useful suggestions.
For a first-time applicant, there are a number of registrations you’ll need to make sure are complete ahead of time, such as the EIN/TID (Employer Identification Number/Tax Identification Number), DUNS number, CCR (Central Contractor Registration), and eRA Commons registration so you can electronically submit your application. These registrations can take 4-6 weeks, so start this process early.
Though the actual grant application submission is electronic, you should try to submit at least 5 days before the deadline. Something is likely to go wrong if you wait to submit on the day of the deadline!
When you are awarded an SBIR grant, you will need to complete the specific aims you proposed in the application and submit a final report in order to be eligible for future funding. We all understand that projects evolve, though, so changes to those specific aims are okay as long as you discuss them with your program officer as they come up.
For digital health companies, an example Phase I deliverable would be results from usability testing or focus groups for product development and design. An example of a Phase II deliverable would be results from randomized, controlled studies with a product designed to impart behavior change in a particular population.
NCI provides resources for applying, like examples of grant applications and a presentation that includes tips for preparing and submitting an application. The National Institute of Allergy and Infectious Diseases (NIAID) also has a model SBIR Phase II application here.
Can you point out any success stories of health startups that have received NIH grants?
Here are three examples of digital health startups that have launched products using NIH SBIR funding:
eMedonline® integrates smartphones, RFID, and behavioral informatics to optimize medication compliance, track medication use, and extend patient care to the ambulatory setting.
Healia is a health search engine and online health community, providing access to high quality and personalized health information resources.
LanguageMate develops tools to improve patient-provider communication, workflow management, and outreach to vulnerable populations, especially individuals with limited English proficiency or low functional health literacy.
More examples of small businesses that have successfully used SBIR funding to create eHealth products can be found here.