초록 ▼

The invention comprises systems, methods and a computerized data management device for creating and using data relating to a medical or non-medical product or device to enhance the safety of the product or device. A vast amount of data regarding adverse events associated with a particular product or

The invention comprises systems, methods and a computerized data management device for creating and using data relating to a medical or non-medical product or device to enhance the safety of the product or device. A vast amount of data regarding adverse events associated with a particular product or device is analyzed to identify new essential adverse events associated with the product or device. At least one database of new essential adverse event information is created and utilized, and new characteristics of or uses for the product or device related to the new essential adverse event information are determined. Adverse event information is gathered for a large number of population sub-groups. The system may also be programmed to incorporate the information into intellectual property and contract documents. Manufacturers and/or distributors can include the proprietary information in consumer safety information, which accompanies the product or device, or which is provided to patients, users, consumers and the like, or in the case of certain medical products or devices, to prescribers of those products or devices. The system and methods also provide for commercializing the essential adverse event information.

대표청구항 ▼

1. A method of commercializing at least one previously unreported proprietary method of using a product of manufacture or device, wherein the proprietary method of using the product or device is established according to the steps comprising: accessing one or more data sources, wherein at least one d

1. A method of commercializing at least one previously unreported proprietary method of using a product of manufacture or device, wherein the proprietary method of using the product or device is established according to the steps comprising: accessing one or more data sources, wherein at least one data source stores adverse event data associated with the product or device;analyzing and comparing the stored adverse event data, with at least one previously-known adverse event associated with the product or device;identifying at least one previously unreported essential adverse event associated with the product or device from the adverse event data, wherein an essential adverse event is one regulated by a regulatory agency requiring disclosure of the event in a package insert or data sheet accompanying the product or device, and wherein an essential adverse event is unreported if it has not been reported in any known accessible database, andthen responsive to identifying of the previously unreported essential adverse event, identifying at least one previously unreported method of use for the product or device associated with said identified essential adverse event;documenting inventorship of the at least one previously unreported method of use for the product or device; andcreating a database of proprietary essential adverse event information, wherein the database comprises at least one of: a patent, patent application, patent publication, or data contained in at least one patent, patent application or patent publication, said at least one patent, patent application, patent publication, or data contained in at least one patent, patent application or patent publication, which discloses and relates to at least one of the at least one previously unreported method of use and the at least one essential adverse event, andwherein the at least one previously unreported proprietary method of using a product or device consists of a use selected from the group consisting of a restricted use of said product or device, providing warning(s) about the essential adverse event, providing instruction(s) for avoiding an essential adverse event, and any combination thereof; andcommercializing the at least one previously unreported proprietary method of using a product or device, the commercializing comprising exclusively disclosing the at least one previously unreported proprietary method of use and the associated at least one previously unreported essential adverse event information, which information, once identified, must then accompany the product or device. 2. The method of claim 1, wherein said computer system generates proprietary information that is incorporated into intellectual property, sale and/or licensing documents. 3. The method of claim 1, wherein said computer system generates printed product warning information derived from the essential adverse information database(s). 4. The method of claim 3, wherein said computer system generates the printed warning information in connection with packaging such as, for example, as product labeling or as product packaging inserts to advise the consumer (or product prescriber in the case of products or devices requiring a prescription) of contraindications or other adverse events. 5. The method of claim 1, further comprises determining value of commercializing the at least one use determined from the at least one identified essential adverse event, wherein the value depends on a potential value of making a generic product or device into a proprietary product or device, or preventing a proprietary product or device from becoming a generic product or device. 6. The method of claim 5, wherein the product is commercially available at the time of the analyzing step. 7. The method of claim 5, wherein the step of commercializing further comprises formatting the data relating to at least one adverse event associated with exposure to, or use of the product or device, or documenting same, such that a manufacturer or distributor of the product or device must inform consumers, users or individuals responsible for the user, physicians or prescribers about at least one adverse event associated with exposure to or use of the product or device. 8. The method of claim 1, wherein the product or device is commercially available at the time of the analyzing step, and wherein the at least one data source comprises information relating to patents and patent applications. 9. The method of claim 1, wherein the product or device is commercially available at the time of the analyzing step, and wherein the at least one data source comprises information relating to raw commercial or sales data, wherein said raw data is commercial or sales data before being processed and analyzed. 10. The method of claim 5, wherein the at least one adverse event comprises a drug interaction. 11. The method of claim 10, wherein the at least one data source comprises information relating to raw commercial or sales data, wherein said raw data is commercial or sales data before being processed and analyzed. 12. A proprietary kit containing a product or device, and labeling notifying a user of at least one previously unreported essential adverse event for the product or device, wherein the kit is used in accordance with the method of claim 1.