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 medical device industries • Full service product validation, testing, certification, and consulting firm PROOF OF COMMERCIALIZATION PRODUCT CONCEPT
CAPABILITIES TESTING, VALIDATION, CERTIFICATION SMART TEXTILES, SENSORS MATERIALS CONSUMER MEDICAL SPORTS TISSUE PRODUCTS DEVICES EQUIPMENT MECHANICS
Background • OKT: Consulting Firm – Regulatory Consulting & Liason – Development plans, Preclinical test strategies – Data Analysis, Intrepretation, & Justification Reporting • OKT 2 : Consumer Product and Medical Device Test Facility – Consumer products – Medical Devices – Sporting Equipment – Textiles – Materials – Tissue – Combination products – Smart technologies
ABOUT US
Meet the Owners Lisa Ferrara, Ph.D. 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
Meet the Owners James Wickersham, P.E. 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
Our Team • Staff of highly qualified PhDs with 25+ years of research and testing experience. • A team of engineers that specialize in mechanical device testing and evaluation. • Regulatory specialists that strategize the proper pathway for successful FDA and CE submissions. • Material scientists with expertise in conventional and novel materials, failure analyses, particulate generation, and particulate characterization.
OKT Capabilities • Regulatory Guidance & Strategies • Preclinical Test Strategies • Design & Implementation of Test Plans • Protocol Development for all Test Strategies • Full Detailed Reports for FDA & CE • Due Diligence on New Technologies • Project Management
OKT 2 Capabilities • ISO 17025 Certified Test Facility, A2LA Accredited • Mechanical Testing per ASTM and ISO Standards • Failure Analysis, Creep Testing, Wear Testing • Life Cycle Testing • Tissue and Biologics Testing • Comprehensive Material & Particulate Characterization • Computerized Human Modeling & Predictive Outcomes • Biomechanical & Kinematic Assessment • Sensor Testing & Validation • Evaluation of Implantable, Programmable Pumps • Smart Technologies
Resources & Facility • Full service test facility – 12 biaxial & uniaxial servo-hydraulic machines, electromechanical test machines • MTS Wear Simulator – 6 station, 6 degree of freedom • Implantable pump test facility • Material Scientists – GLP compliant facility
Equipment • Calibrated servo-hydraulic materials testing machines, uni and biaxial, Electromechanical, high load • Climate controlled environment • Sensor & measurement capabilities (i.e. pressure sensors, LVDTs, accelerometers, etc.) • Vibration, pressure, strain, force, stress, velocity, acceleration, impact, and failure analyses • Material characterization • Wear & repetitive cycle testing • High resolution scales, measurement equipment • Accredited human tissue testing
SERVICES
PRODUCT TESTING LIFE CYCLE
Mechanical & Biomechanical Testing • Regulatory – ASTM / ISO • Consumer Product Testing • Sports Equipment Testing • Tissue Testing • Medical Device Testing • Biomechanical Evaluations
Fatigue Testing & Material Characterization • Material Characterization • Corrosion Testing • Failure Analyses • Particulate Morphology • Particle size • Size distribution • Particle shape • Particle composition • Number / Volume of particulate • Device related mass • Product Wear • Rationale & Justification for Certification
Examples of Services • Impact testing per ASTM or ISO standards • Product performance testing • Biomechanical performance testing & evaluation • Quality Control testing • Machine Validations • Wear testing and analyses • Fatigue testing • Failure and Surface analyses - (static and fatigue) • Material Characterizations • Mass, Dimensional, MOI, Coefficient of Restitution • Acceleration, Velocity, Pressure, Stress, Strain Analyses • Fretting, Corrosion, Wear analysis • Kinetics and Kinematics • Education, Training, Certification for all Test Equipment by trained engineers at ICON Technologies, LLC.
SPORTS EQUIPMENT TESTING
Sports Equipment • Compromise in performance of equipment = INJURY – Helmet failures = brain injuries – Bat and stick failures = skull fractures, lacerations, etc. • Compromise in performance suboptimal product • Bias can occur if testing not conducted at an independent facility • Comparison of products in the marketplace – 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
Sports Equipment • Validation & Verification of equipment in a standardized manner • State of the art quality system for consistent testing • High degree of repeatability, tight tolerances, low uncertainty for all testing conducted • No bias induced – independent 3rd party test facility • Reporting and assisting with certification • Quality Control monitoring • Competitive testing and comparisons for all types of product or equipment – Baseballs & Bats – Golf, Hockey, Football, Soccer – Gloves & protective gear – Textiles, New materials – Skis & Bindings – Helmets – And more…
The Future of Sports Equipment Provide continued feedback, auditing, & high quality evaluation and testing Determine performance of product, test plan, Protocol Certification and/or Manufacturer of potential failures or development, Validation of Product concerns upon Testing, Validation, product request, and if Verification compliant with Regulations Goal: EDUCATION AND TRAINING Improve upon current standards of testing to provide superior products with reduced Training & certification of Testing failures or risk of injury. Equipment & Standardized Tests
MATERIAL & PARTICULATE ANALYSIS
Wear Testing • MTS Bionix Simulator • 14 SEMs, ICP, EDX capabilities
Wear Testing & Material Analysis • Material Characterization • Corrosion Testing • Particulate Type – separate device related particulate • Particulate Morphology • Particle size • Particle shape • Particle composition • Number / Volume of particulate • Device related mass • Rationale & Justification
Analysis of Particulate in Tissue SEM of Tissue with Particulate
MEDICAL DEVICE TESTING
Industries Served • Orthopedic Devices • Cardiovascular Devices • Neurosurgical Devices • Oral / Maxillofacial Implants • General Surgical Implants • Biomaterials • Combination Products • Infusible Pumps • Smart Technologies
Biologics • Engineered tissue • Biomechanical analysis - implanted Biologics (in vivo studies) • Suture, burst, adhesion tests of tissue and engineered tissue
Biodegradables & Bioerodables • Degradable polymers – Sutures – Drug-delivery – Adhesion – Vascular grafts – Stents – Orthopedic fixation systems – Ideal Temporary Scaffolds – Temporary Barriers – PHB, PHV, polyanhydrides
Orthopedic / Neuro Fixation • Pediatric & Adult – Scoliosis – Limb lengtheners • Adult • Long bone • Extremity • Spine • Maxillofacial • Sternum
Tissue Testing • Shelf Life tests • Suture • Burst • Tensile • Young’s Modulus • Kinematics • Cadaveric • Surgical – Approaches – Tooling
Drug Pumps & Programmable Pumps • Test Strategies • Validation tests • Long-term tests • Isolated Environments
Oral / Maxillofacial • Implants & Abutements • Dental screws • Plates & fixation systems
Microsensors & Smart Technology
Management of In Vivo Studies • Biocompatibilty • Implant – Tissue interface • Biomechanical Performance • Safety Studies • Functional Performance • Collaborative Consultant – Dr. Thomas Schaer
Collaborative Partners CROs HISTOLOGY & ACADEMIA PATHOLOGISTS OKT & REGULATORY OKT 2 ATTYS / FILING VIVARIUMS AGENTS ASTM MATERIAL REVIEW EXPERTS & FACILITY BOARD
Team Approach for Regulartory Success Client FDA OKT OKT 2
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