She is the Managing Partner of MediStrat360, the Chief Operating Officer (COO) of Otricath, and a medical device commercialization advisor at the Texas Medical Center. For more than 25 years, she has collaborated with medical technology companies, investors, and public‑sector organizations to accelerate the successful adoption of innovative medical technologies through integrated regulatory, clinical, reimbursement, and commercialization strategies.

This presentation explores the clinical evidence, reimbursement and market access requirements, stakeholder strategies, and commercialization preparations necessary for success in the U.S. market after obtaining FDA clearance. It will address integrated commercialization strategies that connect regulatory approval, reimbursement, and hospital adoption, as well as common gaps companies often overlook during U.S. market preparation.

David McDonough is a medical device commercialization expert with 35 years of experience in the U.S. healthcare market and a resident entrepreneur at the Texas Medical Center’s medical device innovation institute. He is the Co Founder and CEO of Convergent Medical and currently supports U.S. market entry for medical device companies in the Netherlands (Spatium Medical) and Australia (Roam Technologies). He is an active speaker on U.S. market entry and adoption strategies.

This presentation examines how medical devices are purchased, contracted, and scaled within the U.S. healthcare system. Focusing on IDNs and GPOs, it will detail purchasing structures, contracting pathways, and practical adoption strategies—from initial evaluation to post adoption utilization and broader market expansion.

• To be updated

This presentation examines how medical devices are evaluated and approved for purchase within U.S. hospitals, focusing on the role of the Value Analysis Committee (VAC). It will address clinical, operational, and economic value assessments, the roles of key stakeholders, and the requirements companies must prepare to meet in order to achieve hospital adoption.