Principals of the NDI Medical clinical team have worked together as a unit for more than a decade, and have experience conducting pre-clinical and clinical feasibility studies and multi-center pilot and pivotal clinical trials for implantable, percutaneous, and surface neurostimulation products and their enhancements.

Led by the Senior Director, Project Management and Clinical Affairs, the team's work has involved the design, management, conduct and monitoring of clinical trials using statistical methods and following Good Clinical Practices. Data from those trials were analyzed and clinical reports were generated for regulatory submissions and peer-review publications.

NDI Medical conducts studies designed to demonstrate a concept's feasibility in animals or humans, which may include acute surgical experiments, temporary testing through percutaneous access to targeted neural areas, and anatomical cadaver studies. We then conduct pilot and pivotal studies in humans to provide the safety and efficacy data needed to support FDA marking applications, as well as support for reimbursement.