Manufacturing and development of molecular/immunology devices
Molecular diagnostics devices and companion diagnostics devices.
Manufacturing, development, and assessment of cytology/pathology devices
Semiautomated cytology screening devices; cytology collection devices use in human papillomavirus tests; immunohistochemistry tests development in clinical trials.
Manufacturing of microbiology devices
Antimicrobial susceptibility devices.
Manufacturing of chemistry devices
Clinical Laboratory Improvement Amendments (CLIA) waived devices, blood collection tubes, fecal occult blood devices.
Manufacturing and development of hematology devices
Hematology analyzers (specific interest in new technology).
Manufacturing and development of coagulation devices
Coagulation assays and controls, platelet aggregatometers devices, prothrombin time/international normalized ratio meters and assays, D-Dimer analyzers and assays.
Observation of clinical testing in a CLIA high complexity laboratory
Observation of testing in a clinical testing environment.
Performance validation and reliability testing of intensive care unit ventilator and anesthesia gas machines
Ventilators, continuous positive airway pressure devices, anesthesia gas machines, and closed-loop ventilators.
Implantation techniques for spinal devices
Implantation training and assessment using cadavers and direct observation of surgical procedures for spinal implants including, but not limited to, lateral intervertebral body fusion devices, minimally invasive pedicle screw systems, and spinous process plates.
Manufacturing of ultra-high molecular weight polyethylene device components
All joint replacement devices.
Clinical use of orthopedic bone void filler devices
Observation of surgical procedures (posterolateral spine fusion, foot, ankle) utilizing bone void fillers.
Reprocessing methods and techniques in the clinical environment
Cleaning and sterilization methods and techniques for endoscopes (including colonoscopes, duodenoscopes, cystoscopes, etc.) and accessories; automatic endoscope reprocessors.
Observation of bariatric surgical techniques, with and without bariatric devices.
Manufacturing and assessment of hemodialyzers and filters
Hemodialyzers, hemofilters, hemoconcentrators, ultrafilters, and plasma filters.
Sourcing and manufacturing of animal-derived collagen
Surgical meshes, wound dressings.
Traumatic wound care, management, and treatment
Observation of clinical uses of wound management/treatment devices and hemostatic products for use on traumatic injuries.
Clinical use of plastic and reconstructive devices
Observation of surgical procedures utilizing surgical meshes, dermal fillers, hemostatic agents, and bone waxes.
Treatment of acute ischemic stroke
Clot retrieval procedures, clot retrieval devices and ancillary products (medications, angiograms), stroke centers, and acute stroke care programs.
Clinical use of neurosurgical monitoring devices
Neuro-evoked response devices that are used for real-time monitoring of patients undergoing a back procedure.
Clinical use of rehabilitation devices
Clinical use of physical medicine devices (prostheses, pressure-relieving seat cushions, tilt-in-space wheelchairs, and devices for pain relief) in a rehabilitation center setting for treatment of various conditions (e.g., spinal cord injuries, traumatic brain injuries, and amputations).
Clinical use of cardiovascular devices
Endovascular stent grafts and associated delivery systems; Stents and associated delivery systems.
Manufacturing of cardiovascular devices
Drug coated devices (e.g., stents and balloons), endovascular stent grafts and associated delivery systems, stents and associated delivery systems, percutaneous heart valves.
Animal testing for chronic care cardiovascular devices
Observation of surgical procedures and chronic care maintenance in animal models using chronic care cardiovascular devices, such as heart valves and ventricular assist devices.
Manufacturing of contact lenses and care products
All contact lenses and care products.
Treatment of severe hearing loss
Surgical implantation of cochlear implants, electro-acoustic stimulation using hybrid cochlear implants, preservation of residual hearing, postoperative evaluation of residual hearing and implant performance.
Auditory brainstem implants (ABIs)
Observation of ABI surgical procedures.
Management of clinical trials for medical devices
Understanding clinical trial infrastructure, roles/responsibilities of your organization, and relationships with other organizations involved in the management and conduct of clinical trials; institutional review boards; clinical research organizations.