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Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Biomedical Engineering; Medical Devices
IP Projects Catheter stabilizing device Dental Instrument Implant Seeds Intrauterine pressure catheter Vascular Catheters (3) Over 30 years experience in medical product design and development experiences in Anesthesiology, Assistive Technology, Cardiovascular, Catheters, Critical Care, Endoscopy, Implants, Instruments, IV Systems, Home…
Medical Consulting, Medical Writing, Effective Ad Strategies Targeting Physicians
Expert is a physician and medical writer with 16 years of experience. He has written research protocols and completed the studies while at NYU Medical Center. While in clinical practice, he published 8 articles in medical journals and published 5…
Medical Device Design and Manufacturing, Measurement Systems, Embedded Systems, etc.
Expert has extensive experience with biomedical imaging and medical diagnostic imaging as listed below: • Cell Counting – Used segmentation, clustering and classification techniques to count cells in fluorescent and scatter images. • DR Bone Densitometry – Developed automatic and…
Biomedical Engineering, Manufacturing Engineering, R&D
Expert has over 20 years of experience in the research and development of medical devices for: electrodes for transcutaneous sensing and stimulation (EKG, EEG, EMG, TENS, defibrillation, pacing); respiratory therapy, specifically spirometric measurements, exercizers, and nebulizers; thermometry for clinical applications;…