MEDICAL DEVICE DESIGN, MANUFACTURE AND TESTING SYSTEMS

摘要

Described are methods and systems for testing regions of medical devices, for example lumens of cannulated delivery components or assemblies thereof, that may be used to deliver cells to a patient or otherwise contact cells or cell preparations during use. Test cells are contacted with walls of the lumens or other device regions and/or liquids that contact walls of the lumens or other device regions, potentially over an incubation period. The test cells are then assessed for an effect of the wall contact, or the liquid contact, on at least one and preferably multiple characteristics of the test cells such as innate immune response, metabolic activity, viability, cytotoxic response, colony formation and/or motility. Methods and systems as described can be used in the development and/or manufacture of cannulated delivery devices or other medical device, for example providing specifications for design or process inputs or outputs, design or process validations, and/or device lot approvals. Also described are devices or products produced in accordance with such methods and systems.