The National Heart, Lung, and Blood Institute Small Business Program: A Comprehensive Ecosystem for Biomedical...

Small companies working to develop products in the cardiovascular space face numerous challenges, from regulatory, intellectual property, and reimbursement barriers to securing funds to keep the lights on and reach the next development milestone. Most small companies that spin out from universities have the scientific knowledge, but product development expertise and business acumen are also needed to be successful. Other challenges include reduced interest in early stage technologies (Pharma & Biotech 2015 in Review, EP Vantage) and limited deal flow for cardiovascular products (Gormley B., Wall Street Journal, September 15, 2014). The NHLBI small business program is a comprehensive ecosystem designed to address these critical challenges and to provide resources and expertise to assist early stage companies developing cardiovascular and other products within the institute's mission. This article describes steps that NHLBI has taken to enhance our small business program to more effectively translate basic discoveries into commercial products to benefit patients and public health, including enhancing internal expertise and developing non-financial resources to assist small businesses as they develop their products and seek private sector investment and partnership.