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L T P C
B.E./B.Tech B23BME901 - MEDICAL DEVICE DESIGN
3 0 0 3
Course Objectives
1. Introduce the Medical device standards and requirements.
2. Illustrate the design procedure of medical devices.
3. Outline the quality assessment in design.
4. Describe about the design realization.
5. Understand the validation and verification of various medical devices
UNIT-I NEEDS FINDING AND CONCEPT GENERATION 9
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 9
FDA, Medical devices classification, Medical Devices Directive Process – Harmonized Standards,
ISO13485, ISO 14971, IEC60601-1, IEC 62304. NABL- Reliability, Concept of failure, Product Design
and Development Process.
UNIT-III DESIGN ENGINEERING 9
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 9
Basis and Types of Testing, Hardware Verification and Data Analysis, Software Verification and Data
Analysis.
UNIT-V DESIGN TRANSFER AND MANUFACTURING 9
Transfer to Manufacturing, Hardware Manufacturing, Software Manufacturing, Configuration
Management, Intellectual Property-Copy Rights-Trademarks-Trade Secrets. Case Study.
Course Outcomes : At the end of the 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.

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CO5 Interpret the various design transfer and manufacturing methods
Text book
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
Reference book
1 Richard C. Fries and Marcel Dekker AG, Handbook of Medical Device Design,2ndedition,2005.

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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.

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B23BME902 - EMERGENCY MEDICAL L T P C

B.E / B.Tech
DEVICES 3 0 0 3

Course Objectives
1. To learn about the fundamental concepts of Emergency medicine.
2. To study about the casualty equipment and its role in emergency medicine.
3. To emphasize the role of equipment’s in emergency ward.
4. To Gain knowledge on critical care.
5. To know the fundamentals of maintenance and trouble shooting.

UNIT - I INTRODUCTION TO EMERGENCY MEDICINE 9

Structure and organization of a hospital and its departments- Functioning of an ideal emergency
medicine department- Emergency medicine: Casualty, Emergency Ward, Critical Care Area and
operation theatre.
Ambulance services - Pre-hospital care. The emergency response team- Documentation - Multiple and
mass casualties- Medico-legal aspects.

UNIT - II CASUALTY EQUIPMENT AND INSTRUMENT 9

Emergency Patient shifting Trolley with Oxygen cylinder carrying facility, Wheelchair, Emergency Crash
Cart trolley. Electrical Suction-Thermometer - Tracheostomy tray- Catheterisation tray - Suturing tray-
Equipment for wound care - Pulse oximeter- NIBP- Sphygmomanometer- Weighing machine

UNIT - III EMERGENCY WARD EQUIPMENT AND INSTRUMENT 9

Emergency beds with propped up facility and railings- Central Oxygen and suction ports - Cardiac
monitors
Resuscitation cart- Defibrillator- ECG machine - Infusion pumps, Equipment for intubation-Adult,
Paediatric, Neonate. Portable suction machine, Ultrasonic Nebuliser, Glucometer. Infant radiant warmer

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with bassinet, Blood and fluid warmer, Electric warming blanket

UNIT - IV CRITICAL CARE AREA EQUIPMENT AND INSTRUMENT 9

Fowler beds - Central Oxygen and suction ports- Cardiac monitors - Resuscitation cart- Defibrillator
ECG machine

NIT - V EQUIPMENT MAINTENANCE AND TROUBLE SHOOTING 9

Mechanical Ventilators & Non‐invasive ventilators; Pumps: Infusion, syringe; Monitors: Stand‐alone &
multi‐parameter, Cardiac Output monitors; ECG machine; ABG machine; Defibrillator; Ultrasound
machine, Bronchoscope.

Total Instructional hours : 45

Course Outcomes: Students will be able to

CO1 Explain the fundamentals and purpose of emergency medicine.

CO2 Analyze functional aspects of casualty equipment’s.

CO3 Identify the emergency ward equipment.
CO4 Summarize the fluid and hemodynamic derangements.
CO5 Outline about the equipment maintenance and calibration.

Text Books
1. The ICU Book – Paul L Marino (Lippincott, Williams & Wilkins)
2. Geddes and Bakar, “Principles of Applied Biomedical Instrumentation”, John Wiley and Sons
Inc., New York, 1968.

Reference Books
1. "Medical Devices: A Practical Guide" by Prakash Srinivasan and Timiri Shanmugam

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2. R.S. Khandapur, “Hand Book of Biomedical Instrumentation,” Tata McGraw Hill Publishers,
New Delhi,1990.
"

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L T P C
B.E / B.Tech B23BME903 - MEDICAL EQUIPMENT TESTING
AND CALIBRATION 3 0 0 3

Course Objectives
1. To understand and learn about testing of electrical equipment.
2. To know testing of electronic components
3. To Gain knowledge about troubleshooting of instruments used for diagnosis and
4. To learn the calibration of various medical equipment.
5. To learn how to maintain the overall working of equipment

UNIT - I TESTING OF ELECTRICAL EQUIPMENTS 9

AC, DC power supply, Grounding, shielding, Guarding, insulation testing, insulation resistance
measurement, Types of Circuit Breakers, Rating - Testing of circuit breakers – Tranformer testing-
Earthing Earth wires - Earthing of appliances – contactor, relay testing–CT and PT, Panel wiring-
Megger-Testing equipment and instruments.

UNIT - II TESTING AND TROUBLESHOOTING OF ELECTRONIC 9

COMPONENTS
Testing of electronic components: Troubleshooting of PCB boards, Calibration of analog and digital
sensor probe, Display interface, DC Power supply design, testing, Safe electrical practice, Cables and
standard, Fuse.

UNIT - III TESTING OF MEDICAL EQUIPMENT 9

Testing of surgical Equipment: Functions and operating procedure-Testing and maintenance of Heart
lung machine, surgical lights, ventilator, patient monitor, anesthesia machine, dialyzer, surgical tools.

UNIT - IV CALIBRATION OF MEDICAL ELECTRONIC DEVICES 9

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ECG; Infusion Pump, cardiac pacemaker, defibrillators, incubator, baby warmer, X-ray machines and
annual maintenance, contract requirements, vendor services, and quality and safety standards.

UNIT - V MAINTENANCE MANAGEMENT 9

Life cycle management of medical equipment: Cost of the medical equipment, maintenance cost,
replacement analysis, managing equipment service, decision making.

Total Instructional hours : 45

Course Outcomes: Students will be able to

CO1 Identify major reasons for equipment failure.
CO2 Compare general testing and troubleshooting of equipment.
CO3 Analyze the OT instruments.
CO4 Solve the calibration issues of medical equipment.
CO5 Analyze the management issues pertaining to medical instruments and safety standards.

Text Books
1. Carr –Brown, “Introduction to Biomedical Equipment Technology”, 2011, 1st Edition, Pearson,
New York

2. Shakti Chatterjee,Aubert Miller, “Biomedical Equipment Repair”, Cengage Learning Technology&

Engineering, 2010
3. David Herres, “Troubleshooting and Repairing Commercial Electrical Equipment”,
McGrawHill ,Professional edition, 2013.

Reference Books
John G. Webster, “Medical Instrumentation Application and Design”, 2015, 4th Edition, John
1.
Wiley and sons, New Jersey
R S. Khandpur, “Handbook of Biomedical Instrumentation”, 2014, 3rd Edition, Tata Mc Graw Hill,
2.
New Delhi.
Medical Devices: Regulations, Standards and Practices; 1st Edition, Imprint: Woodhead
3.
Publishing; Hardcover ISBN: 9780081002896 (Authors: Seeram Ramakrishna, Lingling Tian,

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Charlene Wang, Susan Liao, Wee Eong Teo)

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L T P C
B.E / B.Tech B23BME904- MEDICAL INNOVATION AND
3 0 0 3
ENTREPRENEURSHIP

Course Objectives

1. To learn fundamentals of entrepreneurship

2. To apply the methods of entrepreneurship in medical field
3. To develop effective business models
4. To evaluate the financial oppurtunities
5. To evaluate the medical devices and market trends

UNIT - I CREATIVITY, INNOVATION AND IPR 9

The role of creativity – The innovation Process – Sources of New Ideas – Methods of Generating Ideas –
Creative Problem Solving – Entrepreneurial Process. Patents – Copyright - Trademark-Geographical
indications – Ethical and social responsibility and challenges.

UNIT - II SCOPE FOR BIOMEDICAL ENGINEERING ENTREPRENEURSHIP 9

Definition– Characteristics and Functions of an Entrepreneur – Common myths about entrepreneurs.
Fundamentals and models, Advancements in biomedical field, Supporting societies and professional
activities. Impact of innovation in medical devices. Case study.

UNIT - III NEW VENTURE 9

Developing an Effective Business Model: The Importance of a Business Model – Starting a small-scale
industry - Components of an Effective Business Model. Assessing the venture, establish venture
invention, market research, presenting the business plan. Forms of Business Organization: Sole
Proprietorship – Partnership – Limited liability partnership - Joint Stock Companies and Cooperatives.
case study., and start-ups

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UNIT - IV FINANCING THE NEW VENTURE AND GLOBALIZATION 9

Evaluating Various options and future investments – Medical Device entrepreneurship incentives and
subsidies – Determining Financial Needs – Sources of Financing: support for product development,
funding agencies, collaborative initiatives, and angel investors. Impact of Globalization: Medical product
manufacturing, marketing, leadership, quality management. Case studies.

UNIT - V MARKETING FUNCTION 9

Industry Analysis – Competitor Analysis – Marketing Research for the New Venture – Defining the
Purpose or Objectives – Gathering Data from Secondary Sources – Gathering Information from Primary
Sources – Analyzing and Interpreting the Results – The Marketing Process. Case study.

Total Instructional hours : 45

Course Outcomes: Students will be able to

CO1: Describe the role of biomedical engineers in entrepreneurship

CO2: Interpret the background for biomedical engineers in entrepreneurship
CO3: Acquire the skills and techniques required towards innovation
CO4 Categorize the resources and funding agencies and judge the right product based on market
CO5 Compile and quantify the opportunities and challenges

Text Books
1. 1. Jen-Shih Lee “Biomedical Engineering Entrepreneurship”, World Scientific Publishing, USA.
Vasant Desai, ―The Dynamics of Entrepreneurial Development and Management‖,
2.
Himalaya Publishing House, 2010.

Reference Books

1. Brant Cooper, Patrick Vlaskovits, “The Lean Entrepreneur”, Wiley, 2nd edition, New Jersy,2016.
2. Nathan Furr, Jeff Dyer, “The Innovator's Method: Bringing the Lean Start-up into Your
Organization”, Harvard Business Press, Boston, 2014

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3. Donald F.Kuratko and Richard M. Hodgetts, “Entrepreneurship”, South-Western.
4. Gupta S.L., Arun Mittal, “Entrepreneurship Development”, International Book House, 2012.

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L T P C
B.E / B.Tech B23BME905 - PATIENT SAFETY, STANDARDS AND
3 0 0 3
ETHICS

Course Objectives
1. To understand the importance of patient safety against electrical hazards
2. To explain the patient safety laws and regulations
3. To understand the standards and testing of patient
4. To know the patient safety specialties in clinical
5. To know about the health care organization ethics, legal aspects and regulatory affairs

UNIT - I EFFECTS OF ELECTRICITY 9

Physiological effects of electricity - important susceptibility parameters –medical analysis of electric
shocks and its effects, shocks due to flash/ Spark over’s, prevention of shocks, safety precautions
against contact shocks

UNIT - II PATIENT SAFETY: AN ORGANIZATIONAL FUNCTION 9

Anatomy of a patient safety Law: Compliance Tips, Federal patient safety Legislation Initiatives, Patient
safety Goals and standards- Safety cultures -Healthcare associated infections-Risk factors of adverse
drug events- rapid response systems

UNIT - III STANDARDS AND TESTING 9

Guidelines and safety practices to improve patient safety, Electrical safety codes and standards - IEC
60601-2005 standard, Basic Approaches to protection against shock, protection equipment design,
Electrical safety analyser - Testing the electric system, establishing quality assurance committee, clinical
audit -establishing criteria for diagnosis, Investigations and treatment.

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UNIT - IV PATIENT SAFETY AND RADIATION AREA SAFETY 9

Intensive care and Anesthesiology, safety surgery save lives, Emergency department clinical risk,
Obstetric safety patient, Patient safety in internal medicine, Patient safety in Radiology. OSHA ionizing
radiation standards, caution signs, radiation safety committee, Radioactive waste management, safety
recommendations for non-ionizing radiations in healthcare facilities.

UNIT - V MEDICAL ETHICS, LEGAL ASPECTS AND 9

REGULATORY AFFAIRS

Definition of Medical ethics, American medical Association code of ethics, CMA code of ethics-
Fundamental Responsibilities, The Doctor and the Patient, The Doctor and The Profession,
Medical/Professional acts, hospital responsibilities- Medical indemnity insurance against malpractice
suits. Medical regulatory affairs: Introduction to Regulatory Affairs, Regulatory Bodies and Agencies,
Medical Device Registration, Quality assurance and Management Systems, International Regulatory
Frameworks, International Medical Device Regulators Forum (IMDRF). Inspection of medical device
and IVD establishments, Import and export of medical devices and IVDs.

Total Instructional hours: 45

Course Outcomes: Students will be able to

CO1 Outline the importance of patient safety against electrical hazards
CO2 Implement the concept of the patient safety specialties in clinical
CO3 Explain the standards and testing of patient
CO4 Identify the patient safety laws and regulations
CO5 Explain about various health care organization acts, code of ethics and regulatory affairs on
medical devices

Text Books
1. John G. Webster, “Medical Instrumentation Application and design”, 4th edition, Wiley India Pvt
Ltd, New Delhi, 2015.
2. Liam Donaldson, Walter Ricciardi, “Textbook of patient safety and clinical Risk management”,

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Springer.
3. Fay A. Rozovsky, James R. Woods, Jr, “The Handbook of Patient Safety Compliance”, 2016

Reference Books
Sharon Myers "Patient Safety & Hospital Accreditation - A Model for Ensuring Success", Springer
1.
Publishers, 1st edition, 2012

2. Donaldson, Liam, Walter Ricciardi, Susan Sheridan, and Riccardo Tartaglia. "Textbook of patient
safety and clinical risk management", Springer Nature, 1st edition, 2021

3. Ramakrishna, Seeram, Lingling Tian, Charlene Wang, Susan Liao, and Wee Eong Teo. "Medical
devices: regulations, standards and practices", Woodhead Publishing, 1st edition, 2015

4. Vincent, Charles, "Patient safety", John Wiley & Sons, 1st edition, 2011

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L T P C
B.E / B.Tech B23BME906– IPR IN HEALTHCARE INDUSTRIES
3 0 0 3

Course Objectives

1. To develop understanding of the basics of intellectual property law.

To give overview of the domestic and international legal regime dealing with intellectual property
2.
law
3. To understand the current norms relating to bioethics and bio-safety in context of patenting.
4. To understand Trademarks, Trade Secretes and GI of goods.
5. To understand the concepts of Cyber laws in IPR..

UNIT - I INTRODUCTION 9

Introduction to Intellectual Property Rights, types of intellectual property, importance of intellectual

property rights in Healthcare industries, Evolution of IP acts and treaties, Agencies responsible for IPR
registrations, Role and value of IP in international commerce, Issues affecting IP internationally.

UNIT - II TRADE MARKS 9

Purpose and function of trademarks, Acquisition of trade mark rights, transfer of rights, Selecting and
evaluating trademark, registration of trademarks, claims. Trade Secrets: Trade secret law, determination
of trade secret status, liability for misappropriation of trade secrets, Medical trade secret litigation.
Geographical Indication of Goods: Basic aspects and need for the registration

UNIT - III PATENTS 9

Patents-Objective, Introduction, Requirement for patenting- Novelty, Inventive step (No obviousness)
and industrial application (utility), Non-patentable inventions, rights of patent owner, assignment of
patent rights, patent specification (provisional and complete), parts of complete specification, claims,
procedure for obtaining patents, compulsory license.

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UNIT - IV ENFORCEMENT AND PRACTICAL ASPECTS OF IPR 9

Introduction – civil remedies – injunction, damage, account of profit – criminal remedies – patent,
trademark. Practical aspects – Introduction, benefits of licensing, licensing of basic types of IPR,
licensing clauses of IPR. Case studies of patent infringement, compulsory licensing, simple patent
license agreements

UNIT - V INTERNATIONAL BACKGROUND OF INTELLECTUAL PROPERTY 9

International Background of Intellectual Property- Paris Convention, Berne convention, World Trade
Organization (WTO), World Intellectual Property Organization (WIPO), Trade Related Aspects of
Intellectual Property Rights (TRIPS) and Patent Co-operation Treaty (PCT).
Total Instructional hours : 45

Course Outcomes: Students will be able to

Students will the concept of IPR and different subject matter of IPR like trademark, copyright,
CO1
trade secret, Patent and geographical indication
Students will develop and apply a personal understanding of patent and biosafety, and there
CO2
impact on day to day life.

CO3 Understand the relation between IPR and bioethics and biosafety in relation to patent.

Provide the information about the different enforcements and practical aspects involved in
CO4
protection of IPR
Understand the interrelationships between different Intellectual Property Rights on International
CO5
Society

Text Books

1. N. Nagpal, M. Arora, M.R.D. Usman, S. Rahar, “Intellectual Property Rights” Edu creation
Publishing, New Delhi, 2017.
2. B.S. Rao, P.V. Appaji, “Intellectual Property Rights in Medical Industry: Theory and Practice”,
2015

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Reference Books

Basic Principles of patent law – Basics principles and acquisition of IPR. Ramakrishna T. CIPRA,
1.
NLSIU, Bangalore, 2005
S. Lakshmana Prabu, TNK. Suriya prakash, “Intellectual Property Rights”, 1st ed., In Tech open
2.
access, Croatia, 2017.
The Patents Act, 1970 (Bare Act with Short Notes) (New Delhi: Universal Law Publishing
3.
Company Pvt. Ltd. 2012.

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T T P C
B.E/ B.Tech B23BME907 - HAPTICS
3 0 0 3

Course Objectives

1. To understand the theories, and concepts of human haptic system

2. To study the various haptic devices and its application

3. To explain the concepts of computational haptics

4. To learn the technology behind the virtual reality

5. To develop the haptic technology for various applications.

UNIT - I HUMAN HAPTICS 9

Human senses- vision, audition and touch, Human haptic system, Multimedia haptics-audio visual
ultimedia system

UNIT - II HAPTICS DEVICES 9

Sensors and actuators, Computer aided design, touch haptic devices, PHANTOM device, Haptic
feedback force feedback, vibrotactile feedback, Electro tactile feedback, ultrasonic tactile feedback,
thermal feedback – its applications.

UNIT - III COMPUTATIONAL HAPTICS 9

Haptic Rendering; Rigid bodies, Deformable bodies, Stability Rendering effects, Human
performance and evaluation; collision detection effects.

UNIT - IV HAPTICS IN VIRTUAL REALITY 9

Virtual reality system, virtual environment representation and rendering, display technologies, input
device to virtual reality system, interaction with virtual environment,virtual fixtures

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UNIT -V HAPTICS FOR MEDICAL APPLICATIONS 9

Surgical Simulations, Stroke-Based Rehabilitation, Support to the Visually Impaired, Tele-

Robotics, Tele-Operation and Tele-Surgery.

Total Instructional hours : 45

Course Outcomes : Students will be able to

CO1 Understand the basic principles, theories, and concepts of haptics

CO2 Comprehend human touch perception

CO3 Build a haptic technology for medical applications

CO4 Learn how to develop immersive user interfaces with haptic feedback

CO5 Understand the causes of instability in virtual reality and teleoperation systems

Text Books
1. Mark Paterson, The Senses of Touch: Haptics, Affects and Technologies, Bloomsbury, 2007

2. Abdulmotaleb El Saddik, Mauricio Orozco, Mohamad Eid, Jongeun Cha, Haptics

Technologies-Bringing Touch to Multimedia -Springer-Verlag Berlin Hei , 2011

Reference Books

1. A.El Saddik, Haptics Rendering and Applications, Intech, 2011

2. Femke Elise van Bee, Making Sense of Haptics: Fundamentals of Perception and
Implications for Device Design, Springer International Publishing,2017

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