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Medical Device Design, Simulation and Development
Expert has 25 years of industrial experience in medical devices, consumer products, automotive, robotics, cutting tools and machine tools. He has helped companies to launch 200+ products, published several papers, patents, and chapters in books. His expertise is in medical…
Medical Device Failure Analysis, Medical Device Product Liability, Patent Infringement Analysis, Patent Invalidity and Validity Analysis, Patent Claim Construction
Expert has over 20 years in the medical device and electronics industries, with contributions exemplified in the numerous products that were developed under his leadership. These products today are improving the quality of healthcare, in hospitals, sub-acute and alternate care…
soy products utilization, nutritional product formulation, probiotics and prebiotics, nutritional clinical study designs
An accomplished and global clinical and nutritional leader with over 25 years of progressive experience in the botanicals, nutritional vitamins, prebiotics/probiotics, multinational healthcare, and consumer products industry sectors. Demonstrated leadership in partnering with internal technical and cross-functional operating teams in…
Quality Assurance, Regulatory Affairs, and New Product Development Consultant
BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and…
Medical Device Product Management, Product Launch, Marketing, Sales, and Sales Operations
Expert has over 30 years commercial experience in medical and diagnostic device product management and development, marketing, sales, operations, distribution and finance as an individual Contributor, Director, Vice President and CEO. Expert provides strategic advice to start-up medical device companies,…
Product Design and Development; Plastic Part Design and Molding; Expert Witness, Patents
Expert has managed engineering and design consulting businesses since 1976. He has served clients in fields ranging from aerospace to sanitary services to medical monitoring and instrumentation. He has utilized his extensive experience in engineering, product development, manufacturing and aesthetics…
Plastic Surgery Products, Lymphedema, Wound care, Tech Transfer, Cosmetic products, Fat reduction
Expert serves as the Director of Wound Care Services at a long term acute care hospital. He has several years of wound healing experience and use. Practice Areas: • Wound Care Management • Involved in treating patients with lymphedema •…
Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…
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…
Medical Device Marketing, Market Research, Competitive Analysis, Business Analytics, Medical Writing
Expert has over 12 years of marketing experience in the Class III and Class II medical device industry, specializing in new product launches, new product development, market research and marketing communications. She is highly skilled in analytics, research, tactical execution…