 In many countries around the world, including the US and Japan, there are laws in place to protect patients with rare diseases from being denied access to drugs and medical devices. Surgeons have been using off-label or self-assembled medical devices for decades to help treat these patients, but without proper authorization they can be at risk of legal action if something goes wrong. This paper argues that we need both drugs and medical devices to provide adequate care for patients with rare conditions and provides for examples of how such devices could benefit patients. This article was authored by M. Dooms.