Adam Saltman, PhD, MD

As a Board-Certified Cardiothoracic Surgeon, Dr. Saltman has more than 25 years’ experience in the management of complex patients with multiple comorbidities. He also worked for 12 years as a Medical Officer at the U.S. FDA Center for Devices and Radiological Health, where he gained a deep understanding of the requirements for successful medical device introductions, as well as quality systems, compliance and benefit-risk evaluations. Before joining NAMSA, Dr. Saltman earned industry experience as the first Chief Medical and Regulatory Officer for two medical device organizations, during which he successfully brought three AI-powered devices through R&D, clinical validation, regulatory approval and market introduction.

Dr. Saltman obtained his Bachelor of Arts (magna cum laude) from Harvard University and MD and PhD degrees (alpha omega alpha) from Columbia University. In addition:

• He conducted his general and cardiothoracic training at the Harvard/Deaconess surgical service.
• He holds a Certificate of Advanced Studies in Bioinformatics from the University of Illinois at Chicago, and has Board Certification in General Surgery, Thoracic Surgery and Clinical Informatics.
• He has served as an Associate Professor of Surgery at Stony Brook University, the University of Massachusetts and Ohio University.
• Dr. Saltman has conducted extensive research, lectured and published on such topics as Cardiac Arrhythmias and Wound Healing.
• He is a Fellow of the American College of Surgeons, the American Heart Association, the American College of Cardiology and the American College of Chest Physicians.

CORE COMPETENCIES

• Identifying and defining unmet clinical needs to drive product development

• Guiding company product strategy to achieve the best product/market fit, from product conception through obsolescence

• Developing regulatory strategies that optimize company efficiencies and speed-to-market
• Interfacing with clinicians, scientists, technologists and business executives to achieve broad stakeholder buy-in

RECENT PROJECTS

• Redefined ground-truthing methods and drove preclinical validation of an AI/ML device to identify critical anatomic structures using light spectroscopy
• Developed and executed the regulatory and evidentiary strategy for a de novo request to the U.S. FDA
• Designed, grew and oversaw the clinical operations and medical affairs departments of two start-up medical device companies
• Revamped, redirected and oversaw the regulatory affairs and quality assurance departments of two start-up medical device companies, achieving 21 CFR part 820 and ISO 13485 compliance

• Instituted a new product development prioritization process to achieve relentless focus and avoid distraction
• Built and executed both internal and external education programs
• Provided clinical input for company pre and post-market risk assessments and mitigations, as well as review of marketing materials and product labeling