Intern, Regulatory Affairs (Digital Health)
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About The Position
MCRA, an IQVIA business, is a leading medical device advisory firm and clinical research organization (CRO). MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. MCRA's integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1500 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices. Interns will work closely with MCRA experts and mentors to gain critical hands-on knowledge in Regulatory Affairs, Digital Health. Usability study design usually starts with a task analysis which breaks down the workflow of using a device into individual tasks and assess the potential use errors pertaining to each task along with the resulted harms from said use errors. The process of task analysis should not be streamlined for devices with a dynamic or flexible workflow, such as software devices with various modalities and functions. A streamlined task analysis and use scenarios do not appreciate the possibility of a dynamic workflow where user is able to go back and forth in interfaces and prioritize certain modality over others in actual use scenarios. The use-related risks from the flexibility of the interface would be easily left out in the risk analysis. In this project, we will experiment various ways of task analysis and use-related risk analysis to find the best presentation of use scenarios for medical devices with a flexible workflow. The project will base on a case analysis of an SaMD (software as medical device), followed by an analysis of the applicability of the results to other types of devices. The intern can expect to learn to do task analysis and use related risk analysis according to IEC 62366 and FDA 2016 guidance on usability engineering, and get hand on experience in developing use scenarios for a usability study. The deliverable of the project will be templates for presenting the task analysis, use-related risk analysis, and use scenario for devices with complicated workflows.
