& OrthoKinetic Testing Technologies, LLC Lisa A. Ferrara, Ph.D. - - PowerPoint PPT Presentation
OrthoKinetic Technologies, LLC & OrthoKinetic Testing Technologies, LLC Lisa A. Ferrara, Ph.D. lisa@orthokintech.com 910.253.9883 OKT and OKT 2 Mission To provide a turn key approach to the consumer product, sports equipment, and
Lisa A. Ferrara, Ph.D.
lisa@orthokintech.com 910.253.9883
PRODUCT COMMERCIALIZATION PROOF OF CONCEPT
TESTING, VALIDATION, CERTIFICATION
CONSUMER PRODUCTS TEXTILES, MATERIALS SPORTS EQUIPMENT MEDICAL DEVICES SMART SENSORS TISSUE MECHANICS
– Regulatory Consulting & Liason – Development plans, Preclinical test strategies – Data Analysis, Intrepretation, & Justification Reporting
– Consumer products – Medical Devices – Sporting Equipment – Textiles – Materials – Tissue – Combination products – Smart technologies
Bioengineer & Biomechanist for 25+ yrs. Published 40+ journal articles, 15+ book chapters, 50+ lectures, editor of 4 journals Served as forensic engineer assessing musculoskeletal, spinal, brain, sports injuries Experience with medical device, consumer product, and sports equipment testing and validation
Mechanical engineer, 30+ yrs. Served as forensic engineer assessing sports and recreational equipment Experience with medical device, consumer product, and sports equipment testing and validation
research and testing experience.
device testing and evaluation.
pathway for successful FDA and CE submissions.
machines, electromechanical test machines
uni and biaxial, Electromechanical, high load
sensors, LVDTs, accelerometers, etc.)
acceleration, impact, and failure analyses
– ASTM / ISO
Certification
Technologies, LLC.
– Helmet failures = brain injuries – Bat and stick failures = skull fractures, lacerations, etc.
– Cannot occur if test equipment across manufacturers is not ‘standardized’ or validated annually – Could result in false marketing claims – Could contribute to injuries if test results are not validated on test machines that are in strict accordance with the accreditation standards and quality system
conducted
– Baseballs & Bats – Golf, Hockey, Football, Soccer – Gloves & protective gear – Textiles, New materials – Skis & Bindings – Helmets – And more…
Manufacturer of Product Determine performance of product, test plan, potential failures or concerns upon request, and if compliant with Regulations Protocol development, Testing, Validation, Verification Certification and/or Validation of product
EDUCATION AND TRAINING
Training & certification of Testing Equipment & Standardized Tests
Provide continued feedback, auditing, & high quality evaluation and testing
Goal: Improve upon current standards of testing to provide superior products with reduced failures or risk of injury.
SEM of Tissue with Particulate
– Sutures – Drug-delivery – Adhesion – Vascular grafts – Stents – Orthopedic fixation systems – Ideal Temporary Scaffolds – Temporary Barriers – PHB, PHV, polyanhydrides
– Scoliosis – Limb lengtheners
– Approaches – Tooling
– Dr. Thomas Schaer
CROs
ACADEMIA REGULATORY ATTYS / FILING AGENTS MATERIAL EXPERTS & FACILITY
ASTM REVIEW BOARD
VIVARIUMS HISTOLOGY & PATHOLOGISTS