Page 19 - M.E. Medical Electronics Curriculum and Syllabus - R2019

Department of BME, REC

UNIT III ENGINEERING SOLUTION TO CLINICAL NEEDS 9
Document sketching, Modeling – software and physical, Model for all strategies, Testing
and clinical correlation, Material selection – sensors, actuators, Instrumentation circuit
design, Interface selection, Output visualisation and calibration
Case study: To identify a real time problem and to propose suitable engineering solution

UNIT IV REGULATORY AND ETHICAL ISSUES 9
Regulations and standards involved in the design – CE mark and FDA, Regulatory bodies in
India, Biocompatibility of the test probes, ISO 14155 standards for clinical investigations,
Steps for getting FDA approval, Function and role of ethical committee, Medical ethics
proposed by ICMR.

UNIT V MARKETING STRATEGY 9
Post market Surveillance and its role in design, Various tools – Process control chart,
bathtub curve, Weibull plot, Measles chart, Pareto analysis, Exploring various contacts –
early adopters, focus groups, conference, Vigilance, Promotion through media, Comparison
with existing products – merits and demerits.

TOTAL: 45 PERIODS
OUTCOMES
On completion of the course the students will be able to
• Analyse various strategies in product development
• Identify clinical need
• Provide engineering solution for medical applications
• Abide regulatory and ethical norms
• Develop product that suits market requirements

REFERENCES::
1. Peter J. Ogrodnik, Medical Device Design Innovation from Concept to Market,
Elsevier, 2013
2. Des O’brien, Medical Device Regulations Roadmap: A Beginners Guide, 2017
3. Richard C. Fies, Handbook of Medical Device Design, CRC Press, 2000.

MX19221 TECHNICAL SEMINAR ON RESEARCH TOPICS L T P C

0 0 2 1

OBJECTIVES:
• To develop the ability to understand a research topic and formulate suitable
approach
• To analyse the results and compare with existing methods

Every student, individually, shall undertake the Project work - under a qualified faculty
(faculty members with Ph.D. or P.G. with a minimum of 3 years of teaching experience).
Prior to phase1 of the work, student must work on the related papers and understand the
existing work. Once a work is allotted to the student, he/shall do the ground work, like
literature survey, understanding various technologies, data collection procedure and
analysis of result. Students are supposed to identify required software, modelling
technique or hardware required for the project and get ready to implement from third
semester.

R 2019 - Curriculum and Syllabus/ M.E Medical Electronics Page 19