BM4201 Medical Device Design Syllabus:
BM4201 Medical Device Design Syllabus – Anna University PG Syllabus Regulation 2021
COURSE OBJECTIVES:
To understand about basic design processes of medical device
To introduce with basics of design, construction and development devices
To follow a deterministic engineering design process to create new products.
To apply engineering theory to practice.
To perform design transfer and countermeasure development.
UNIT I INTRODUCTION
Needs finding, problem identification, prior art searches, strategy and concept generation, estimation, sketching, sketch modelling, machine elements, ergonomics and prototyping.
UNIT II DESIGN OF MEDICAL DEVICES & SYSTEM
Medical device classification, bioethics, and privacy, biocompatibility and sterilization techniques, design of clinical , trials, design control and regulatory requirements, introduction to specific, medical technologies: biopotentials measurement (EMG, EOG, ECG, EEG), medical diagnostics (In-vitro diagnostics), medical diagnostics (Imaging), minimally invasive devices, surgical tools and implants.
UNIT III DEVELOPMENT STRATEGY AND PLANNING
Intellectual property strategy – research and development strategy – clinical strategy – regulatory strategy – quality and process management – reimbursement strategy – marketing and stakeholder strategy – sales and distribution strategy – competitive advantage and business strategy.
UNIT IV HARDWARE AND SOFTWARE DESIGN
Hardware design, Hardware risk analysis, Design and project merits, Design for six sigma, software design, software coding, software risk analysis, software metrics, licensing and alternate pathways
UNIT V DESIGN TRANSFER AND IPR
Transfer to manufacturing, documents and deliverables. Standard-ISO, IES, Intellectual Property – Patents, Copy rights, Trademarks, Trade secrets.
TOTAL: 45 PERIODS
REFERENCES
1. Matthew Bret Weinger, Michael E. Wiklund, Daryle Jean Gardner-Bonneau’Handbook of Human Factors in Medical Device Design’,CRC press,2010
2. Peter J. Ogrodnik, “Medical Device Design: Innovation from Concept to Market”, Academic Press Inc; 1st Edition, 2012
3. Paul H. King, Richard C. Fries, Arthur T. Johnson, “Design of Biomedical Devices and Systems”, Third Edition, 2014
4. StefanosZenios , Josh Makower , Paul Yock , Todd J. Brinton , Uday N. Kumar , Lyn Denend, Thomas M. Krummel, “Biodesign: The Process of Innovating MedicalTechnologies”, Cambridge University Press; 1 edition, 2009.