Bench to Community Seminar - Series 1, Session 2: Medical Device Development Processes

Session 2 in this seminar series provides an overview of engineering design and development for medical devices. Viewers will gain insight into the key steps from need definition to product realization and validation. Session topics include product function and performance definition for the product, ideation/creation of solution concepts, engineering prototype development, preclinical verification, regulatory human factors considerations, user feedback, and FDA design control requirements during the product development process. Several tools and techniques will be presented to facilitate expediting multidisciplinary communications with engineering and other development personnel.

Topics

• Composing a clearly defined need statement
• Defining all stakeholders in chain-of-use
• FDA Design Input Criteria: establishing metrics for Functions, Performance, Constraints
• Ideation, concept development and evaluation
• Prototyping - initial methods: “frankenstein” prototypes, “alpha” prototypes
• Engineering Design Specification (EDS) 
• FDA design verification; bench evaluation
• Getting feedback from multiple users
• Preparing for multiple “beta” prototypes for clinical evaluation
• FDA Design Control documentation requirements

For more information on this session, please visit https://iem.vcu.edu/events/bench-to-community/december-4-2020/

For more information on the series or to sign up for an upcoming seminar, please visit https://iem.vcu.edu/events/bench-to-community/