Steven S. Brooks, MD MBA FACC

Steven Brooks, is a multi-faceted health care consultant, publisher, cardiologist and clinical trialist. Steve’s interests include regulatory strategy, scientific and medical due diligence. Most recently, Steve was the Chief Innovation officer at Sage Growth Partners (SGP), a healthcare consulting firm with expertise in healthcare management, health information technology, and marketing communication and go to market services. Sage has a venture business and a technology incubator called Canton Health Ventures. Steve serves as the incubator manager and assists in early stage company and product development.

Previously Steve served as a medical officer for the Food and Drug Administration in the Peripheral Interventional Devices Branch and Interventional Cardiology Devices Branches. In this role he performed medical device review of cardiac and vascular-related products throughout the full product lifecycle. From the pre-submission stage, he worked collaboratively with engineers, chemists, veterinarians, statisticians to assist in design testing and risk mitigation, as well as planning pre-clinical and clinical testing programs. A large role involved clinical trial design, review of clinical trial data, and assessment of the total data submission for the purposes of product clearance and approval. Steve worked collaboratively with the Office of Compliance for consideration of Health Risk Assessments and product recalls.

At FDA Steve’s main focus has been peripheral vascular disease, in particular lower extremity intervention. He also has an interest in device treatment modalities for hypertension and novel non-invasive modalities for the diagnosis of coronary ischemia. He participated in several multidisciplinary groups with the goal of standardizing clinical trial definitions across clinical trials.  The groups include CDISC, PARC and the Cardiovascular Imaging Workgroup, and consist of members from academia, industry and international regulators. Steve has been a medical consultant on the “Assessment of plaque composition, dynamic biomechanics, and therapeutic outcomes in subjects implanted with endovascular devices (ASPECT)” project. This is a multidisciplinary collaboration between academia, industry and government with the goal of describing the mechanical forces in the superficial femoral artery, modeling them mathematically, and applying these discoveries to stent design and testing. He served as a member of the Entrepreneur-in-Residence Program at FDA investigating FDA clearance/approval and reimbursement approval. The goal was to streamline FDA processes to optimize the reimbursement process. In conjunction with this effort Steve was named to a subcommittee of the Center Science Council and served a leadership role in the CDRH Medical Devices Reimbursement Task Force.

Prior to joining the FDA in 2007, Steve was an Interventional Cardiologist, triple boarded in Internal Medicine, General Cardiology and Interventional Cardiology. His first job was as an Assistant Professor in the Department of Medicine at the University of Maryland Medical Center from 2003-2005 as academic faculty in Interventional Cardiology. Following this he joined a large private practice in Baltimore, Mid-Atlantic Cardiology, from 2005-2007. Steve graduated from medical school from the University of Pittsburgh Medical Center in 1996 and completed a residency in Internal Medicine and fellowships in General and Interventional Cardiology at the University of Pittsburgh Medical Center.

Steve completed an MBA at the Johns Hopkins Carey School of Business in the Business of Medicine Program, and has continued to interact with the program as an adjunct faculty member lecturing on drug and device regulation and business strategy and consulting with students on their projects in the “Discovery to Market” course and the graduate and undergraduate programs as an advisor to the Johns Hopkins Centre for Bioengineering Innovation & Design (CBID). He is also a grant reviewer for the

Maryland State TEDCO program and active member of the Maryland Business Incubation Association (MBIA).