Les Bogdanowicz, PhD, MBA

Developing a novel modality for hemodialysis utilizing a chemisorbent dialysate recycling technology. Looking to decentralize hemodialysis and bring portable/wearable hemodialysis to patients.

Building eQMS providing regulatory strategy and Regulatory Filings for extracorporeal shock wave therapy (ESWT) devices with Curative Sound. Curative Sound is an emerging therapeutic ultrasound company. The products produce high-energy acoustical “shock waves” called ESWT that non-invasively repair and regenerate skin, musculoskeletal and vascular structures. ESWT is an emerging modality in “regenerative medicine.” The pressure waveform is similar to that used in Lithotripsy (to break up kidney stones), but at a much lower intensity. The Curative Sounds products are state-of-the-art, portable handheld devices that produces high-pressure, focused, acoustic shock waves. It was designed to provide health care professionals an effective and easy-to-use device for administering the latest and most advanced “focused” ESWT; an evidence-based therapy used across multiple orthopedic and wound healing indications. Focused acoustic shock waves trigger a biological healing response in tissue by the shear and pressure forces they produce.

Regulatory strategy, IP strategy and development strategy for Aeris Surgical, a device to improve end tidal CO2 measurements during sedation. Advanced technology development in medical devices/consumer electronics. Requirements management in Jama. Engineering Leadership role with Endotronix July 2016 - Dec 2017 Contract work With Garret Technologies May 2012 - Oct 2015 Optical System design for NanoCytomics Cancer screening system. • AOTF design and integration with high output Xenon lighting system for epi-flourescence. System Engineering for next generation Hospira Infusion pump. • Ground up requirements authoring • User Interface design Advanced Sensor design for Hospira Infusion Pump • Optical sensor design for fluid monitoring Designed Electronics and Software for Evenflo's Advanced Dual Breast Pump • Circuit design, Embedded System design, design for manufacturing • Full Systems Engineering - from Use Case authoring, Requirements authoring to Verification and Validation • Support for 510K filing Design of ECG front end pick up for Abiomed Symphony Heart Assist Pump • Circuit Design, Data Analysis, Animal Trials Lead designer of Intel Elkhorn Mountain Medical Device Reference Design • Implementing Intel/Apple Thunderbolt port technology • PCIe, SATA, USB 3.0, LVDS, projective capacitive touch interface, MiPi Camera interface, Audio 7.1, Com Express, Near Fear Communication (NFC), Accelerometer, GPS, GYRO • Multi-core virtualized machine

Crossing the fence between academia and industry. Instructor and lecturer for the bioentrepreneur and medical device industry 'skill sets' classes on medical device design, product development, ISO & FDA requirements, emerging medical technologies, and medical device commercialization.

Conduct forensic investigations related to injury causation and medical device failures.

Medical device startup developing technologies and products for the stratification of cancer with a simplified modality. Providing structured engineering development, clinical project management and team leadership/management.

Electrical and Software design services for consumer, industrial and medical industries.

Building an engineering team to manage requirements, compliance, risk management, regulatory, verification and validation for a complex medical device and patient management service. Roll out of Jama requirements management tool (RMT)

BOLD diagnostics is a startup providing a novel solution to managing hypertension. We are a NSF SBIR backed company for which I serve as the Primary Investigator. Primary Investigator (PI) - NSF SBIR Grant Award ID 1621937

Optimal Design is a first class engineering and design firm providing the latest technology offerings in virtual reality (VR), internet of things (IoT), and various mechatronics solutions. Brought aboard to grow the medical device/life sciences expertise offering. Designed connected wearable mouthguard fro SMART mouth. Designed electronics for Sage next generation AirTap device.

Dissertation: 3D Reconstruction of Ocular Structures with Quadroscopic Imaging Platform Completed degree Part Time

Bio-Venture Startup Management

Thesis: “Method for Heart Sound Diagnosis”