VP of Software Product Development & Regulatory Affairs
Hong Chen holds a Ph.D degree in Biomedical Engineering with post-doctoral training in non-destructive ultrasound and corneal elastography which was granted about 1.7 million dollar funding by NIH. He has over 17 years of experience with signal processing and image processing. He holds over 10 patents granted and pending. With 7 plus years of industrial experience in the development of ambulatory ECG and blood pressure monitoring (BP) products and services, he successfully led the launches of over 7 ECG, ABP and multi-vital monitoring devices, managed the releases of 4 major generations and continual updates of ECG and ABP analysis and reporting software. He created a SaaS business model by implementing Cloud-based ECG analysis platforms, increasing software’s value by millions of dollars. He worked with leading medical devices companies over the world to create business relationships. Through training in regulatory affairs for non-invasive monitoring and therapeutic medical devices, he supervised the medical devices compliance to different regulatory authorities, including FDA by 510K application, CE marking, ANVISA registration and NMPA registration etc. He was also a great mentor by coaching student interns and lecturing undergraduates and graduates at Stony Brook University while being an adjunct professor.