Medical Devices

Core Expertise:
Shaving Products, nutritional and cosmetic products, over the counter (OTC) medications, medical devices, FDA Approvals, clinical study evaluations, Product Portfolio Strategy Development, New Product Development (NPD), female athletic apparel products, Organizational Leadership and Product Management
Accomplishments:
Assisted non-profit facilities with conducting research on hair, skin, cosmetics and textiles, Member of global community of experts advising world class women-led, high-growth startups, 20 US patents
Previous Companies:
Schick, Texas Instruments, I-Health Inc
Core Expertise:
• Areas of expertise include full life cycle product development of medical devices from conception through development including: o Manufacturing o Bench testing o Verification o Validation o Packaging o Labeling o Clinical trials o Regulatory approval o Marketing o Sales training.
Previous Companies:
• ONUX Medical • ALARIS Medical Systems
Summary:

• Master of Science in Mechanical Engineering

• Medical device & automation experience since 1986

• Recognized as one of 100 notable people in the medical device industry by the Medical Device & Diagnostic Industry (MD&DI) publication in June 2008

Core Expertise:
• IP Valuation, IP Litigation Support (infringement analysis, invalidity analysis) • Product Development Support: technical design reviews, FDA and GMP compliance reviews, FDA, GMP Guidelines • Laparoscopic and endoscopic devices: surgical waste management, suction irrigation devices, surgical knives, linear cutters, linear staplers, circular staplers, dissectors, graspers, surgical staplers, skin staplers, anastomotic stapling devices • Respiratory devices: oxygen concentrators, liquid oxygen systems, compressed oxygen gas tanks, gas pressure regulators, oxygen conserving devices, portable ventilators, breathing circuits • Sleep Therapy Devices: CPAP, BPAP, portable ventilators, sleep masks • Respiratory Diagnosis: Spiromters, Flow Sensors, Polysomnograpgy
Previous Companies:
Nellcor Puritan Bennett • Ethicon Endo-Surgery • Digital Equipment Corporation • Tektronix
Summary:

Specialized in Endoscopic Surgical Devices, Respiratory Devices, Drug Delivery Devices,
Manufacturing Process Design, Design Verification and Validation, FDA and CE quality systems
regulations and Regulatory Approval Process, Product Liability, Failure and Root Cause Analysis,
Forensic Investigation, Patent Validation and Valuation, and Patent Infringement Analysis.
Experienced patent analyst: mining, infringement analysis
Experienced expert witness (incl. depositions & reports): infringement, invalidity, IPR, ITC

Core Expertise:
• Research and development of tissue engineering • Medical devices research and development • Orthopedic and Medical Devices materials market analysis • Investigational studies to develop preventive therapies to minimize the progression of post-traumatic osteoarthritis. • Implementation of preclinical animal studies on bone morphogenetic protein-2 dosing and calcium phosphate coatings for treatment of maxillofacial and long segmental bone defects.
Accomplishments:
• 5 Research grants
• 4 patents
• 68 publications (1876 citations)
• Award from Center for Regenerative Medicine
• Presented in over 70 international and national conferences and as invited speaker in 8 international
• Associate Editor, Progress in Biomaterials, Springer
• Professional membership 1) Tissue Engineering Society International 2) American Association for the Advancement of Science 3) American Chemical Society 4) Controlled Release Society
Previous Companies:
• Mayo Clinic
Summary:

Over 17 yrs of experience
Expert in biomaterial, medical devices and tissue engineering
Highly knowledgeable on FDA regulatory and standards

Core Expertise:
• Medical device manufacturing • Plastic injection molding • Thermoplastic extrusion • Polymer materials • Technical communications
Previous Companies:
• Breathe Technologies • Interface Catheter Solutions • Alsius
Summary:

• 25+ years of experience in the medical device, optics, packaging, military & consumer products industries
• Has held technical leadership positions in management, engineering, manufacturing & product development
• Decades of experience managing production transfers & cross functional teams