Profiles Of Success

Artificial Hearts, Heart Assist and Heart Valves

○ Heart valves
○ Durability testing, Failure analysis
○ Flow simulation
• Pericardial heart valve animal testing
• Artificial heart clinical research and IDE submissions
○ Jarvik-7
○ Dayton Axial-flow pump
○ 3M/Pierce-Donachy, Milwaukee Heart

Read More

Biomaterials: Polymers, Surface Modifications and Combination Products

• Qualification and validation strategies for new and replacement biomaterials
○ Silicones
○ Polyurethanes
○ Surface coatings
○ PMMA
○ Polyester
• Combination drug/device
• ISO-10993 biocompatibility testing optimization for all types of devices
• Surgical mesh materials, physical, animal, clinical testing and premarket applications.
• Expert Witness concerning design control and review compliance for mesh implant trials
• Cranioplasty plates, 3D manufacturing.
Read More

Bone Graft Substitutes, Restorative Materials and Devices, Implants

• Orthopedic and dental biomaterial applications, clinical trial, IDE and premarket submissions
○ Coatings
○ Bone graft substitutes
• Hydroxyapatite
• Calcium sulfate and variations
○ Artificial ligaments
○ Cranial Plates
○ Artificial joints
○ Wedge osteotomy PEEK implant and instrumentation
○ Bone growth stimulation
○ Foot reconstruction systems
○ Hip implants and joint resurfacing
○ Intramedullary rod alternatives
○ Foot implant for Correction of Hallux Vagus deformity
• Spinal implant technologies in clinical trial, IDE applications and premarket submissions
○ Rods and screw
○ Total artificial disc
○ Spinal nucleus devices
Read More

Dental

• Bone and Defect Filler
• Dental Implants

Electrophysiology – Cardiovascular and Neurological

• Implantable defibrillators
• AED and multifunctional electrodes
• ECG Electrodes
• Pacemakers
• Leads and electrodes
• Wearable external pacemakers
• Electrophysiology stimulators
• Ablation catheters
• Guidewires and catheter navigation systems
• Pacing systems for congestive heart disease
• Bone and muscle electrical stimulation
• Hyperthermia System using Airflow
• Cerebral Spinal Fluid Filtration
• Automated ankle/brachial pressure index measuring device
• Intercranial neurological interface device
• Cranial replacement device
• Mechanical tapping device
• Plethysmographs
Read More

Minimally Invasive Technology

• Laparoscopic, arthroscopic, spinal and other minimally invasive technologies 510(k) notifications
• Qualification of unique materials and design features
• Protocol development and testing requirements
• Animal and clinical evaluations
• Specialty Surgical Instruments
• Reusability protocols for cleaning and sterilization validation
Read More

Ophthalmology and Otolaryngology

• Selection of biomaterials, device qualification, and clinical trials
• Comparative testing of lenses for optical quality related to clinical outcomes
• Cochlear implant devices investigational applications
Read More

Oral Appliances

• Qualifying biomaterials and device designs
• Premarket notification [510(k)] for Australian and US clients
• Bite guards, TMJ and bruxism
Read More

Powered Mobility, Prosthetics and Physical Medicine

• Powered stand-up wheelchair
• Physical medicine devices for the home
• Materials qualification for prosthetic interface
Read More

Reusability of Devices and Instrumentation

• Validated cleaning and/or sterilization studies
• Durability and reuse testing protocol development
Read More

Safety Syringe

• Clinical usability testing
• Premarket notification [510(k)]
• Nitrile gloves
Read More

Software, Electronics, Internet Medicine

• Implantable electronic device premarket notification [510(k)]
• Data storage systems
• Cybersecurity, software submission requirements
• Imaging diagnostic systems, such as gamma camera
• Radiology quality system device
• Software-based medical systems
• Hololens2 display/3D imaging
• Tablet-platform multiple diagnostic systems
• Internet-based home medical services
Read More

Sterility and Shelf-life Testing

• Shelf-life testing and expiration-date labeling protocols
• Qualifying materials and devices for use in alternative sterilization methods
Read More

Urological and Dialysis Catheters

• Clinical trial management, auditing and reporting
• Design qualification and review for numerous
• IDE applications and FDA interactions
• Premarket notification [510(k)] catheters
• FDA clearance of novel PU improved Foley catheter
• Biomaterials qualification
• Percutaneous implant port for bladder
• Anti-infective coatings and surface modifications
• Testing to voluntary standards
Read More

Usability Studies

• Protocol development and field testing for user manual validations
• Usability studies for “over-the-counter” products
• Usability studies for safety syringes
Read More

Vascular Grafts and Stents

• Peripheral vascular grafts
• Coronary artery bypass grafts
• Vascular stents technology
• Cell-seeding technology
• Tissue-derived vascular prostheses
Read More