Academic researchers concentrate on the scientific and technological feasibility of novel treatments. Investors and commercial partners, however, understand that success depends even more on strategies for regulatory approval, reimbursement, marketing, intellectual property protection and risk management. These considerations are critical for technologically complex and highly invasive treatments that entail substantial costs and risks in small and heterogeneous patient populations. Most implanted neural prosthetic devices for novel applications will be in FDA Device Class III, for which guidance documents have been issued recently. Less invasive devices may be eligible for the recently simplified "de novo" submission routes. We discuss typical timelines and strategies for integrating the regulatory path with approval for reimbursement, securing intellectual property and funding the enterprise, particularly as they might apply to implantable brain-computer interfaces for sensorimotor disabilities that do not yet have a track record of approved products.
Keywords: intellectual property; premarket approval; regulation; reimbursement; return on investment; risk management.
Copyright © 2021 Loeb and Richmond.