NDI Medical has developed proprietary, innovative, neurostimulation-based platform technologies that can be modified for use in a variety of therapeutic applications. NDI’s staff of engineers has vast expertise in the field of active implantable medical devices (AIMDs). The design and development teams work closely with project directors and targeted clinician end-users to generate a comprehensive therapeutic system for a given clinical application. This system includes implantable pulse generators, leads, surgical deployment tools, external programmers, and patient controllers. The company conducts product development under design controls that are compliant with FDA and ISO 13485 quality system requirements.

Meeting strict regulatory guidelines is essential in the medical device industry. NDI Medical's regulatory professionals are well versed at steering neurostimulation devices through the sometimes choppy regulatory waters.

Principals of the NDI Medical regulatory team have worked together for more than a decade and have gained approval for IDE, PMA, HDE, 510k, and CE Mark applications for implantable, percutaneous, and intraoperative neurostimulation products and their enhancements.

NDI’s research team focuses on evaluating the use of electrical stimulation in new ways to treat important human health conditions. Principals of the Research team have worked together for over a decade, advancing the state of the art in neurostimulation therapies through the development of new technologies and clinical deployment methods. With input from our diverse network of scientists and clinicians, the Research team designs and executes laboratory, pre-clinical, and clinical feasibility studies to determine the viability of potential therapies. Clinical feasibility studies led by the Research team have been published in peer-reviewed journals and presented at clinical and scientific conferences.

Based on successful early studies, the Research team then refines, optimizes, and translates the findings into specifications that are ready for transfer to the full product development team. The Research Team works closely with the Engineering, Clinical Affairs, Regulatory Affairs, and Quality teams throughout the research and development process. This ensures an efficient and smooth progression of the neurostimulation therapy through all stages of product development and clinical trials.

Successful clinical studies are a critical step in the commercialization of a medical device. NDI Medical’s Clinical Affairs team has significant experience in the design and execution of medical device clinical studies to successfully achieve market clearance. The Clinical Affairs team works closely with the Regulatory Affairs team to ensure a successful clinical and regulatory strategy for commercialization.

Principals of the NDI Medical clinical team have worked together for more than a decade and have successfully managed all phases of clinical trials for implantable, percutaneous, and intraoperative neurostimulation products and their enhancements. The Clinical Affairs team is responsible for the management of the clinical studies, including protocol development, site management, data management, and clinical study reports in support of regulatory submissions.

Business Development is responsible for assessing new therapeutic and product opportunities, assisting NDI and its portfolio companies in identifying and building valuable ventures and in structuring and managing relationships with existing and new investors and business partners. Business Development also supports portfolio companies of NDI with their business and financial strategies.

Ultimately the commercial success of any medical technology is determined by its acceptance and use in the market place. We have expertise in identifying the right markets by analyzing market size and the current competitive environment. We research the established patient care pathways and use this knowledge to position and promote new medical technologies. Our team works with physicians and patients to understand the needs of the marketplace for a new medical product long before it is developed and launched, situating it for success.