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Medical/Hospital Equipment: Markets, Unmet Needs, Concept, Design, IP, Automation, Manufacturing
Biomedical Devices range from simple items we use as consumers to complex instruments controlled by proficiently trained professionals. Expert's involvement and experience has been in the development of capital equipment that often included one or more disposables, were used in…
Due Diligence, Competitive Differentiation, Science Scouting, Innovation Assessment, Research Tools, Expert Witness, Cancer Biomarkers, Cancer Immunology, Assay Development, Research Devices
Developed multiple novel immunoassays and immunology products for start-up biotechnology company. Founding Director, Research and Development for privately held company in San Diego. Oversaw innovation and entrepreneurship at Mitchell Cancer Institute resulting in 5 spin-out biotechnology companies in the area…
Cardiac Surgery, Heart Transplant, Coronary Artery Bypass, Valves, atrial fibrillation, LVAD
Expert is a cardiothoracic surgeon. He has expertise in coronary artery bypass grafting (CABG), mitral valve repair/replacement, aortic valve replacement, aortic aneurysm repair, surgical treatment of heart failure with cardiac transplantation and left ventricular assist devices (LVADs) for Bridge To…
Quality System & Regulatory Compliance, Life Sciences, Re-Engineering, 21 CFR Part 11
Business system design, business process re-engineering, and business re-engineering are at the core of the expertise she offers her clients. She has designed, written, and implemented business-focused quality systems for start-up companies and well as provided re-engineering support for out…
Medical Device Design and Manufacture
Expert has over 25 years experience in the conception, design, and manufacture of medical devices. Experience ranges from high volume disposables to low volume implantables. Beginning as a manufacturing engineer responsible for all facets of device development and manufacture Expert…
FDA Regulations, GMP/GLP/GCP Compliance; IND, NDA, BLA, PMA and Product Regulation; Toxicology
Experienced in all aspects of validation and compliance including, GMP/GLP/GCP and part 11. Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and supporting approval process. In addition,…
Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals
Expert's legal practice focuses on intellectual property and patents. He is registered to practice both in California for general legal issues, and nationally for patent issues through the USPTO. In addition to filing and prosecuting patents, he also has experience…
Strategy Marketing Design, Pricing, Business Planning & Development
Entrepreneurship is "the process of looking at things in such a way that possible solutions to problems and perceived needs may evolve in venturing.” It is also the willingness to take the risks involved in starting and managing a business.…
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…
Emergency Room Nursing
Expert is experienced in assisting physicians in emergency department control of arterial bleeding. He also assists physicians in the emergency department with arterial line placement and maintenance. He is experienced in the care of patients with restrictive airway disease in…