Biomedical Business Resources LLC is a network of experts in the Medical Device Industry. With over 35 years of industry experience, their services include:
Mr. Crosby's product experience includes implantable devices (cochlear implants, cardiac pacemakers, implantable defibrillators, artificial heart, neurostiumulation), in vitro diagnostics, imaging (ultrasound and X-ray), software, AEDs, and patient monitoring. His clinical domain experience includes ophthalmology, otolaryngology, cardiac surgery, cardiology, orthopedics, pain management, anesthesia and intensive care.View Peter Crosby's Expert Witness Profile.
Dr. Yadin B. David has over 35 years experience in Managing Medical Technologies from Pre-Purchasing Evaluation phase, to Installation, Training, Servicing and Incidents Investigation. His expertise includes wide variety of medical devices and accessories including infusion pump, laser, electrosurgery unit, monitors, X-ray, defibrillators, implants, monitors, warmers, surgical instruments and catheters. Dr. David is also an expert in Electromagnetic interferences (EMI) medical devices and in Telemedicine and TeleHealth systems. His experience includes review and analysis of patent infringements allegation and validity. Dr. David serves a Consultant for industry and institutions including the Food and Drug Administration (FDA), General Hospital and Personal Use Devices Panels, World health Organization (WHO)and medical devices manufacturers. His services include testing, adverse events investigation, engineering reports, equipment management program review and risk assessment. Dr. David has given many national and international presentations about medical technology management, telemedicine and medical devices regulations.He authored manuscripts, chapters and books.
One Way Consulting, LLC, is a Medical Device Consulting firm whose mission is to help get your device to the market sooner, to assure your quality systems meet FDA requirements, and solve any FDA issues in a timely and successful manner.
Principal, John Lawrence Stevens, RAC, has over 20 years of FDA Regulatory Compliance experience encompassing virtually all FDA field positions. He also has 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the Medical Device Industry, including several large and small cardiovascular companies.
Mr. Stevens has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular devices. He regularly perform webinars regarding FDA and issues regarding Clinical Studies and Medical Devices.
Parnell Engineering & Consulting (PEC) is a high-tech Mechanical Engineering Consultancy located in the heart of Silicon Valley. PEC focuses on providing technical support for early stage medical device and technology companies nationally and internationally. T. Kim Parnell, PhD, PE, Principal and Founder of PEC, is a Mechanical Engineering consultant with strong experience in a number of technology areas. Dr. Parnell holds PhD and MSME degrees from Stanford University in Mechanical Engineering and a BES from Georgia Tech. He specializes in the mechanical engineering design and behavior of Biomedical Devices, Superelastic and Shape Memory Metals (Nitinol), Bioabsorbable Polymers, Composites, Fiber-Reinforced Materials, Electronics, and Consumer Products.. Dr. Parnell consults actively in these areas using finite element analysis and other advanced technologies to improve designs, to perform failure analysis, and to improve reliability. Dr. Parnell served on the Mechanical Engineering faculty at Santa Clara University from 2010-2012 and was previously a Visiting Associate Professor at Stanford University. He lectured in the Stanford Composites Design Program, and is a coach and mentor for the innovative Stanford Biodesign Program. He has worked for companies including MSC Software, Rubicor Medical, Exponent Failure Analysis Associates, SST Systems, ATT Bell Laboratories, Stanford University, and General Motors. Areas of Expertise:
Selected Professional Memberships:
Georgia J. Persky RN, MBA, PhD, CLNC, is a seasoned nurse with over 40 years of broad Clinical Nursing experience and 25 years of Senior Leadership in Healthcare Organizations. She has expertise in the micro issues in direct patient care and the broad Management, Quality, State, Federal, and Joint Commission regulatory issues in hospitals and long term care facilities. Dr. Persky provides private consulting for hospitals that want to improve patient care quality and satisfaction. A national speaker and author, her services are in demand for engagements on healthcare issues.
Litigation Consulting Support - As a Certified Legal Nurse Consultant and Quality Reviewer, Dr. Persky has investigated hundreds of Malpractice and Injury cases as a quality reviewer and can assist in legal case review with chronologies, timelines, and evidence based reports. Dr. Persky's services are available to attorneys for plaintiff and defense seeking an expert in nursing and patient care with a strong understanding of how hospitals and nursing homes work.
Facility Consulting Services:
Background Experience - Dr. Persky has served as Vice-President of Nursing and Patient Care Services for 25 years and most recently, New York Presbyterian Hospital at Columbia University Medical Center. For nine years, she was responsible for Risk and Quality Management and Patient Satisfaction for a 750 bed academic hospital. She directed a $200 million budget with 33 patient services units and Care Management, Respiratory Therapy, Social Work and Admitting Departments with 9 direct reports and 2,000 patient care employees.