Provide medical device and diagnostics consulting to clients with focus on new product development, requirements development, design control, systems engineering, electrical engineering, software engineering, risk management, clinical trial design, regulatory strategy, medical and scientific community outreach, market development, business modeling, competitive assessment, intellectual property, NIH/NSF grant writing and machine learning/artificial intelligence. Current projects include: • Medical device advisor for Global STL Innovation Initiative• Noninvasive detection of aortic stenosis using laser speckle contrast imaging of peripheral blood flow• Noninvasive assessment of fluid status for congestive heart failure patients

Vero Biotech‘s GENOSYL DS is the first tankless nitric oxide delivery system approved for treatment of pulmonary hypertension in critically ill newborns, COVID-19 patients and patients undergoing cardio-thoracic procedures such as heart valve replacement and lung transplant. The GENOSYL DS is an FDA approved combination product that produces nitric oxide gas at the bedside from liquid N2O4, eliminating bulky gas tanks. GENOSYL DS has captured 40% of the US market for inhaled nitric oxide since launch of the product in April, 2020.• Developed third generation GENOSYL DS nitric oxide delivery system requirements, control algorithms, validation with ventilation equipment and supported regulatory submission, resulting in FDA approval in December, 2022• Supported product launch of third generation GENOSYL DS in 2023 through close collaboration with respiratory specialist field team, solicitation of customer feedback and software updates• Go-to GENOSYL DS subject matter expert for the field team, R&D staff and C-suite• Expanded on-label compatible equipment list via comprehensive ventilator validation program• Delivered second generation GENOSYL DS lifecycle software improvements including additional customer requirements discovery, complaint assessment, solution generation, verification and validation• Led user needs discovery, industrial design concept generation and graphical user interface modernization project for a new generation of the GENOSYL DS optimized for inter-facility transport via road ambulance, helicopter and fixed wing modalities• Led Systems and Electrical Engineering group including resource allocation, hiring, performance appraisals and mentorship

Avisa Pharma is developing a noninvasive breath test for rapid, point of care detection of certain virulent forms of pneumonia to guide antibiotic therapy and monitoring of treatment efficacy in patients seen in the emergency department, hospital floor and intensive care unit.• Discovered customer needs, developed use scenarios and cultivated key opinion leaders• Led FDA interactions including pre-submission meetings and IDE applications• Led multi-site clinical trials development and conduct• Led development of Avisar breath test electronics and measurement software• Led development of calibration procedures and algorithms for Avisar spectrometer

Provide medical device and diagnostics consulting to clients with focus on product development, clinical trials, regulatory strategy, medical and scientific community outreach, market development, competitive assessment, intellectual property, NIH/NSF grant writing and machine learning/artificial intelligence. Projects included: • Automated detection of diabetic retinopathy from retinal images using machine learning• Automated assessment of retinal image quality• Noninvasive assessment of fluid status for congestive heart failure patients• Noninvasive, polarimetric measurement of glucose for patients with diabetes • Noninvasive measurement of skin intrinsic fluorescence to screening for undiagnosed pre-diabetes and type 2 diabetes• Next generation sequencing for diagnosis of urinary tract infections• Investment due diligence

Cofounder and core member of executive management team that developed and commercialized SCOUT DS, the world’s first noninvasive diabetes screening device based on skin intrinsic fluorescence spectroscopy (launched October, 2011).· Raised $32.5MM via equity financing to support company operations· Hired and led 25 person product development team that created and clinically validated the first and second generation SCOUT DS noninvasive diabetes screening devices· Drove product requirements, system/sub-system specifications, engineering design, industrial design, clinical research, and regulatory strategy for commercial versions of SCOUT DS· Led SCOUT DS medical advocacy efforts including establishing relationships with diabetes professional societies, key opinion leaders and health ministries· Provided medical and technical expertise in support of marketing and sales efforts in Canada, Europe, Mexico and the Middle East· Discovered new diabetes complications and coronary artery disease risk indications for SCOUT device via expanded collaborations with key opinion leaders and diabetes researchers· Managed and co-authored intellectual property portfolio resulting in eight issued and nine pending US patents plus a number of issued and pending foreign patents

Cofounder of InLight Solutions which developed novel optical measurement solutions for life science applications including noninvasive detection of pre-diabetes and diabetes, noninvasive measurement of glucose for patients with diabetes, and noninvasive measurement of blood alcohol levels for work place safety applications. Spun out four companies to capitalize on InLight developed technologies.

Developed system architecture, electronics interface hardware and software for massively parallel underwater acoustics simulator for real-time, hardware-in-the-loop testing of sonar guidance systems. This system was declared a National Asset by the Department of Defense because of the fidelity of the simulations and the huge cost savings relative to live fire test runs.