Program-level continuous design process with FEA support for medical devices - PROJECT SUMMARY / ABSTRACT Our NIH R25 Education proposal’s main goal is to develop a continuous team-based medical device design process incorporating clinical, business, and state-of-the-art features via the enhancement of Hofstra University’s Bioengineering (BE) Program educational activities, culminating in the improved Bioengineering Capstone / Senior Design Course experience. Through this approach, our BE undergraduates including diverse and underrepresented minorities will have increased knowledge, competency, practice, and modern skills that are vital to meet the workforce demands in biomedical and healthcare technology industries. This innovative proposal of three design phases: Device conceptualization, Performance evaluation using Finite Element Analysis (FEA), and Further development in the Senior Design course, effectively extends the traditional one-semester course into a productive three-year experience, allowing students to explore prototyping, translational, and business aspects of matured device concepts. The project’s Specific Aims are: 1) Offer real-world perspectives to design ideas, and 2) Strengthen the design process education with FEA support. These will be accomplished through a collaborative clinical immersion program for identification of critical patient needs and generation of device concepts early on, mentorship of key professionals involved in medical device design, integration of Senior Design work to multiple BE team-based design activities, extracurricular FEA workshops to further evaluate and iterate the device ideas through computer simulation, and a website for storing and sharing of these activities. We will evaluate the effectiveness of this innovative alternative approach based on three overlapping batches of BE undergraduates as they navigate through their development and maturation of medical device tasks over the project’s 5-year period.
