The International Medical Device Regulators Form defines software as a medical device as any software that is intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. Because software as a medical device must operate accurately to make the difference between life and death for patients of chronic conditions, developing and perfecting this software takes considerably more time in order to prevent vital mistakes in terms of life and liability.
A remarkable example of software as a medical device is software that sends parameters to hardware concerning the flow of medication. Correct dosage is essential to the safety of the patients and the prevention of expensive medical malpractice suits. Patents of software as a medical device have been issued to support surgeons during complex operations. For example, US9833292B2 – Robotic system and method for spinal and other surgeries. This U.S. patent utilizes a mounted robot that helps a surgeon place screws in a spine.
As an experienced Intellectual Property Attorney, Derek Fahey is able to effectively obtain a patent for software as a medical device. If you developed software as a medical device, it is important to protect your invention by speaking with an intellectual property attorney. Contact patent attorney Derek Fahey, Esq. for a free consultation to discuss your software as a medical device application and how we can help protect your intellectual property.