Design and Development of Biomedical Innovations

Catalog description

(same as BIOL_EN 8100 , ENGINR 8100 ). The overarching goal of this course is to help participants understand the design and development (drug or device) process in biomedical innovation. This course will help participants to understand the process of choosing unmet clinical needs, articulate a need statement without integrating solution, design and develop a solution. Participants will learn to assess the commercial potential of clinical needs by performing market analysis and valuing customer needs. A conceptual understanding about development of a prototype for a device and also drug development by different brainstorming process will be provided. Details of regulatory, reimbursement, patenting process required for product development will be explained with examples. An overview about how to evaluate preliminary designs, define product specifications, comply with manufacturing principles and methods, costs, cGMP requirements will be explained. Quality control and Quality assurance necessities for drug/device will be elucidated with case studies. Participants will gain knowledge about different business models for drug and devices, estimate market penetration and how to make profitable, patient-driven products. Graded on A-F basis only, Credit Hour s : 3