Leading Device Qualification for Delivery System of Biologic for Phase II Clinical Study while Leveraging EdgeOne Medical QMS
Client is a large biologics company that is in the process of developing a biologic for subcutaneous administration. The biologic was already in a phase I clinical trial and the development team was preparing for phase II clinical trial. In light of the combination product regulations, client needed to implement and follow Design Controls and summarize the device development efforts as part of the IND submission for Phase II clinical trials. The client organization had minimal internal device expertise and at project initiation did not have any of the quality procedures in place to support device Design Controls as dictated by the FDA combination product regulations.
EdgeOne Medical initially engaged with Client to help advise and guide client on the device development process as client sought to understand how to comply with new FDA combination regulations. A few months into the project, the Client recognized that they did not have the internal bandwidth to adequately support to the development of necessary quality procedures and documentation for the device development program. At the Client’s request, EdgeOne Medical pivoted in its engagement with Client from advising to leading the device development effort for the phase II clinical trial. Specifically, the project is being developed under EdgeOne Medical’s ISO 13485 certified QMS including Design Control and Risk Management, and EdgeOne is providing project management and quality leadership. In addition, EdgeOne will validate certain test methods (TMV) and subsequently conduct device design verification and validation testing in their ISO 13485 certified engineering lab.
Conducting Design Verification and Validation Testing on Custom Device
Client is a company focused on development of respiratory drugs, and has developed a custom drug delivery device which uses various custom test fixtures for evaluating device performance. The device, being developed under device design controls, required full design verification testing. The client company does not have an internal engineering GDP/GLP lab to conduct necessary test method validations (TMV) and design verification and validation (DV&V) testing. As Client began to prepare and plan for design verification, they needed a partner that could define and conduct all test method validations, and then conduct all design verification testing. This company proactively identified gaps in their internal resources and entered into a partnership with EdgeOne Medical prior to the device design being “frozen”.
EdgeOne Medical has partnered with the Client to conduct TMV for all various custom test methods and fixtures developed by Client. Upon completion of the TMV’s the methods will be issued as standard operating procedures (SOP’s) in the EdgeOne Quality Management System, and EdgeOne will leverage these SOP’s when conducting the DV&V testing of the device per quality controlled test protocols.