National Institutes of Health: Specific Aims & Research Strategy

National Institutes of Health: Specific Aims and Research Strategy

Success rates vary at NIH, but are generally in the 15-25% range, depending on the Institute.

Preparing and writing a high-quality National Institutes of Health SBIR/STTR proposal that meets the scientific merit demanded takes considerable time and effort. A NIH application needs to clearly present an early-stage product research and development project that is clinically significant, addresses a major gap in the field, and that is clear, concise, succinct and focused with clear milestones. In this session, you will learn the key aspects of writing a compelling application. Applications are reviewed by outside reviewers (peer reviewers) to evaluate the significance, the investigators, the innovation, the technical approach and the environment (resources, labs, equipment).

  • Dr. Anja Metzger, Founder and CEO, Innovative Minnesota Medical Solutions, provides consulting services for non-dilutive funding opportunities, focusing on NIH and DoD SBIR/STTR grant proposals for novel medical device technologies. Services include identification of specific grant opportunities, professional review and critique of proposals and applications, proposal editing, proposal writing and submission, pre-clinical and clinical study design/procurement assistance, proposal brainstorming and research strategy outline, and complete proposal preparation.

    Dr. Metzger has 30 years of medical device experience with the most recent 20 years focused on cardiovascular medical devices and obtaining over 20MM dollars in non-diluted small business grant funding from the NIH and DoD SBIR and CDMRP programs to explore innovative technologies and bring them to market.

    She has written and served as PI or a co-investigator in over 30 Phase 1, Phase 2, and Phase 2+ grant applications to support product development, pre-clinical and clinical trials with an 80% original submission success rate. In addition to her experience in cardiovascular medical devices, she has assisted several companies focused on devices for orthopedics, cancer, and other disease states.

    In 2012, during her tenure at Advanced Circulatory Systems, she received the SBA’s SBIR Tibbets award and was recognized as being in the top 25 NIH Grant Recipients in 2013.  She has extensive knowledge of pre-clinical, clinical, and product development strategies, the ability to bring theory into practice, and is recognized as a named inventor on over 30 U.S. patent applications. Work with multiple firms including Johnson & Johnson, Medtronic, and several start-up medical device companies has provided Anja an in-depth understanding of clinical, regulatory and quality aspects of the medical device business including risk assessment, the development of requirements and product specifications, design assurance, and pre-clinical and clinical design and execution.

    Anja has a Biomedical Engineering PhD from the University of Minnesota and a Bachelor of Arts in Chemistry from the College of St. Catherine. She is also an Adjunct Associate Professor in the University of Minnesota’s Emergency Medicine Department and is an author of over 40 publications.

To register, please select one of the upcoming dates below.

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