Page 97 - R2017 Final_BE Biomedical Curriculum and Syllabus - REC

Department of BME, REC

• Describe the need of medical standards.
• Develop Health informatics Module.
• Identify recent trends and different ICT applications in medical Informatics.

TEXT BOOKS:
1. Mohan Bansal, “Medical informatics”, Tata McGraw Hill Publishing Ltd, 2003
2. R.D.Lele, “Computers in medicine progress in medical informatics”, Tata Mcgraw Hill, 2005

REFERENCES:
1. Alain Venot, Anita Burgun, Catherine Quantin, “Medical Informatics, e-Health: Fundamentals
and Applications”, Springer Science & Business Media, 2013
2. Edward H. Shortliffe, James J. Cimino, “Biomedical Informatics: Computer Applications in
Health Care and Biomedicine”, Springer Science & Business Media, 2013
3. Orpita Bosu and Simminder Kaur Thukral, “Bioinformatics Databases, Tools and Algorithms”,
Oxford University press, 2007.
4. Shui Qing Ye, “Bioinformatics: A Practical Approach” , CRC Press, 2007

BM17E23 HEALTHCARE PRODUCT DEVELOPMENT L T P C
3 0 0 3
OBJECTIVES
• To understand the global trends and development methodologies of various types of
healthcare products and services
• To Understand requirement engineering and know how to collect, analyze and arrive at
new product development with regulatory norms
• To understand market strategy in converting a design into a product

UNIT I PRODUCT LIFE CYCLE FOR MEDICAL DEVICES 9
Introduction-FDA total product life cycle- European commission product life cycle-Product life cycle
management, current good manufacturing practices, end user purchasing stakeholders,
operational asset management- Medical device integration into existing workflow- Managing risk in
healthcare technology, existing point-of-care protocols. Engineering assessment of medical device
failure.

UNIT II REGULATORY PROCESS IN CLINICAL RESEARCH 9
History and role of regulations in clinical research, Indian Regulatory laws, Schedule Y, registration
of new drugs, requirements for registration, regulatory environment and practices, US regulatory
system, EU regulatory affairs, non-disclosure agreement, GMP regulations, patent and patent
laws.

UNIT III DRUG DISCOVERY 9
Drug design-Ligand based, Structure based, Active site identification, rational drug discovery High
throughput screening, Structure Activity Relationship(SAR), Quantitative Structure Activity
Relationship (QSAR), Computer assisted drug designing (CADD).
Terminology in clinical research, Preclinical phases, first in human trials, Single ascending dose
and multiple ascending dose studies, Exploratory clinical trials, Confirmatory clinical trials, post
marketing surveillance.

Curriculum and Syllabus | B.E Biomedical Engineering | R 2017 Page 97