Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_998_Библиотеки_им_академика_М_И_Перельмана

A crucial rst step in the path to commercializa­tion is to protect innovations via obtainment of intellectual property (IP). In an academic set­ting, this process begins with invention disclo­sure to the university technology transfer ofce (TTOs). Since the passing of the Bayh-Dole Act of 1980, the United States requires that all fed­erally funded academic researchers disclose their inventions to their university. The univer­sity will then own and be responsible for pro­tecting the product’s intellectual property. Following disclosure, TTOs will subsequently work to protect IP through patents and univer­sity licensing to allow for future commercializa­tion [5, 9].

Regulatory approval is a major milestone for a novel drug, device, or combination device towards commercialization and clinical impact. In the United States, the regulatory process is overseen by the Food and Drug Administration (FDA). Medical devices are classied as class I, II, or III, in order of increasing risk and there­fore requirements. Most Class I (low/minimal risk) devices obtain exempt status and only have registration and labeling requirements. Most Class II devices require 510(k) clearance, which requires identication of a predicate device and proof that the proposed device is safe, effective, and has substantial equivalence to the predicate device. Class III devices usu­ally require a Premarket Approval (PMA) path­way to FDA approval. PMA devices generally pose the greatest risk or do not have a predicate device, and therefore require the most data to prove safety and efcacy. A newer pathway, de novo 510(k), provides potentially less stringent requirements for novel devices with no predi­cate that are not deemed to be of signicant risk to the patient [10]. Consultation with an experi­enced regulatory consultant in the specialty the device is intended is recommended to develop appropriate regulatory strategy. For example, although pursuing the PMA pathway requires more time and money for the required submis­sion, approval via this route provides strong defensive strategy against competitor devices. Engaging the FDA through pre- submission meetings generally is useful to help a new com­pany nd out what type of studies would be required to prove safety and efcacy for the likely regulatory pathway for that device, and helps plan out time and funding requirements to meet this milestone.