CBM353 Medical Device Design Syllabus:
CBM353 Medical Device Design Syllabus – Anna University Regulation 2021
COURSE OBJECTIVES:
The student should be made to:
Introduce the Medical device standards and requirements.
Illustrate the design procedure of medical devices.
Outline the quality assessment in design.
Describe about the design realization.
Understand the validation and verification of various medical devices
UNIT I NEEDS FINDING AND CONCEPT GENERATION
Strategic Focus – observation and problem identification – Need statement development. Ideation and Brainstorming – concept screening, concept selection: intellectual property basics – reimbursement basics – business models – prototyping – final concept selection. Safety and Risk Management – Tools, Documents and Deliverables.
UNIT II MEDICAL DEVICES STANDARDS AND REQUIREMENTS
FDA, Medical devices classification, Medical Devices Directive Process – Harmonized Standards, ISO13485, ISO 14971, IEC60601-1, IEC 62304. Reliability, Concept of failure, Product Design and Development Process.
UNIT III DESIGN ENGINEERING
Hardware Design, Hardware Risk Analysis, Design and Project Metrics, Design for Six Sigma, Software Design, Software Coding, Software Risk Analysis, Software Metrics.
UNIT IV TESTING AND VALIDATION
Basis and Types of Testing, Hardware Verification and Data Analysis, Software Verification and Data Analysis.
UNIT V DESIGN TRANSFER AND MANUFACTURING
Transfer to Manufacturing, Hardware Manufacturing, Software Manufacturing, Configuration Management, Intellectual Property-Copy Rights-Trademarks-Trade Secrets. Case Study.
COURSE OUTCOMES:
On successful completion of this course, the student will be able to
CO1: Define the medical devices standards and requirements.
CO2: Summarise the concept of medical device development.
CO3: Recall the engineering design and project metrics.
CO4: Demonstrate the testing and validation of medical equipment.
CO5: Interpret the various design transfer and manufacturing methods.
TOTAL :45 PERIODS
TEXT BOOKS
1. Zenios, Makower and Yock, ―Biodesign – The process of innovating medical technologies‖, Canbridge University Press, 2009
2. Theodore R. Kucklick , The Medical Device R&D Handbook, Second Edition, CRC Press, 2012
3. Peter Ogrodnik,Medical Device Design Innovation from Concept to Market, Elsevier, 2013
REFERENCES
1. Richard C. Fries and Marcel Dekker AG, Handbook of Medical Device Design, 2nd edition, 2005.
2. Gail Baura, Medical Device Technologies: A Systems Based Overview Using Engineering, Elsevier science, 2012.
3. Matthew Bret Weinger, Michael E. Wiklund, Daryle Jean Gardner-Bonneau‘Handbook of Human Factors in Medical Device Design‘,CRC press,2010.
4. Jagdish Chaturvedi, Inventing medical devices: A perspective from India, Create Space Independent Publishing Platform, 1st edition, 2015.