Ph.D.-trained respiratory and medical device expert witness with more than 30 years of experience in the medical device industry, this expert specializes in emergency and rescue breathing apparatus, mechanical ventilators, nebulizers, humidifiers, breathing circuits, tracheal tubes, membrane oxygenators, and pulmonary diagnostic instruments. Their background includes the development, manufacturing, regulatory review, and commercialization of cardiopulmonary medical devices and pulmonary function testing technologies, as well as the design of clinical protocols for inhalation drugs used to treat asthma, chronic obstructive pulmonary disease (COPD), and emphysema. The expert also has 25 years of experience providing expert witness consultations, depositions, and arbitrations involving respiratory care equipment, oxygen delivery systems, pulmonary medicine, and medical device technologies.

The expert’s experience includes executive leadership, operational oversight, and product development activities within respiratory and medical device organizations. Their work involved FDA 510(k) submissions, manufacturing operations, intellectual property licensing, commercialization efforts, and the implementation of regulatory strategies for respiratory and ventilation technologies. Additional experience includes the development of artificial ventilation modalities, cardiopulmonary function and exercise testing instruments, oxygen delivery therapies for hemorrhagic shock treatment, and portable emergency oxygen generation systems. As co-inventor of the R15 emergency oxygen delivery system, the expert holds multiple patents involving portable chemical oxygen generators and respiratory device technologies.

The expert has also designed clinical research protocols, conducted laboratory and clinical research, and served as principal investigator on Phase 3 studies evaluating therapies for asthma, COPD, and emphysema. Their research and publication history includes pulmonary physiology, hyperbaric oxygen therapy, respiratory therapy applications, humidification and nebulizer standards, pulmonary monitoring technologies, and chemical oxygen generation systems. Standards and professional involvement include participation with ASTM F29 Committee on Anesthesia & Respiratory Devices, ANSI Z79 standards activities concerning humidifiers and nebulizers for medical use, NIH SBIR grant review activities, the American Thoracic Society, the American Physiological Society, and the National Emphysema Foundation. Educational credentials include Bachelor of Science, Master of Science, and Ph.D. degrees in Biology, along with Registered Respiratory Therapist credentials.