Bridging clinical relevance with regulatory rigor.

Dr. Frank has conducted more than 100 clinical trials over 40 years in the pharmaceutical and device industries and gained approvals and clearances to market drugs and devices by direct engagement of FDA review committees as well as National Coverage Decisions and Coverage with Evidence Development by direct engagement of CMS. He has served as the non-voting industry representative on FDA Advisory Committees and is experienced in giving expert testimony to MEDCAC, USPSTF, IAEA, Congressional Committees of Jurisdiction, World Bank, and the World Health Assembly. Dr. Frank is an Expert-in-Residence of a Venture Capital Fund. He chaired the AI Working Group of the AMA's Digital Medicine Payment Advisory Group, which authored the AI Taxonomy accepted as Appendix S of the CPT Code Set, and now serves as a voting member of the CPT Editorial Panel.

Dr. Toledano has more than 30 years of experience designing and analyzing clinical studies — 13 in academia and 19 as an independent consultant. She has successfully led several companies through multi-year projects from initial planning discussions with FDA, through study designs and statistical analyses, to PMA approvals and 510(k) clearances. Dr. Toledano has also served on FDA Medical Device Advisory Committees since 1998. She holds a Doctorate in Biostatistics from the Harvard School of Public Health.

Dr. Campbell brings more than 20 years of experience guiding medical-device and diagnostic products from innovation to market adoption, integrating clinical, regulatory, and commercial strategy. She currently serves as a Principal Consultant with Frank Healthcare Advisors, supporting companies developing AI-enabled diagnostics and software products. Previously, Dr. Campbell was Vice President of Medical & Clinical Affairs at Optina Diagnostics, where she led regulatory and clinical strategy for AI-based retinal diagnostics, established a 20+ site global clinical network, implemented a compliant QMS, and secured 510(k) clearance. Her earlier roles include senior leadership positions at Klox Technologies and Covidien RMS, where she built ISO-aligned R&D frameworks, established clinical departments, expanded innovation pipelines, and led evidence-generation programs that enabled successful product launches and strengthened reimbursement positioning. Dr. Campbell earned her PhD in Physiology from the University of Melbourne and is fluent in English and French.

Dr. Bogoni has over 25 years of experience transforming healthcare delivery through innovative technologies. He has held leadership roles at Carestream and Siemens Healthineers, overseeing multidisciplinary teams and managing portfolios that included groundbreaking AI solutions like Dynamic Digital Radiography and AI diagnostic systems for lung and colon (lungCAD and colonCAD). His expertise spans the full product lifecycle and has secured regulatory approvals (e.g., 510(k), CE), designing clinical trials, and fostering global partnerships with key opinion leaders and institutions. An inventor with 38 patents and 76 publications, Luca has driven initiatives that improved outcomes for conditions like COPD, pulmonary embolism, and lung fibrosis.