Course Outline

Course Title Biomedical Design I

Course Code BMED-4261
Cr.Hr/ECTS 2/4
Module BMED-M4261 (Biomedical Design)
Contact Hours Lecture Tutorial Laboratory or practical
1 0 3
Pre-requisite BMED-M3231(Biomedical Engineering)
Course Outline

1. Course Objectives and Description

1.1. Course Objectives

Up on successful completion of this course the students will be able to

 Understand the technical and business aspects of the product development process
 Get the skill of gathering data from customers and establish technical specification.
 Understand product functional decomposition.
 Participate in engineering problem solving.
 Define the components and their functions of product design and development processes and their
relationships from concept to customer over whole product lifecycle.
 Understand the principles behind product modularization, understand intellectual property issues
in product development.
 Understand ethical issues in product development, and Identify safety hazards based on
international standards and directives, associated with medical equipment.
1.2. Course Description:
The goals of this course is to acquire knowledge and skill of fundamental engineering design
work, enhancing communication skills, and practicing teamwork. It covers the following topics:
Introduction, essential transferable skills, market analysis, customer requirement, functional
requirement, specification, developing concept, concept evaluation, embodiment design and
detail design. Students with the guidance of course instructor choose a mini design project topic
and prepare the design proposal. Students are guided through the open-ended, real-world,
design process starting with the project definition, specification development, management,
team interactions and communication, failure and safety criteria, progress reporting, marketing
concepts, time and cost planning, oral and written reports, as well as construction,
troubleshooting and demonstration of a working prototype.
 2. Schedule of Lecture Topics
Weeks Lecture Topics References Assessment
1 1. Product Planning: [1]
1.1. Product planning processes, Pp53-Pp73
Progress report-1
1.2. Identifying Product development opportunities,
[2]
1.3. Evaluate and prioritize projects, Pp49-Pp105
1.4. allocate resources and plan timing,
1.5. Completing pre-project planning.

1 2. Identifying Customer Needs: [1]

2.1. Gather raw data from customers, Pp73-Pp90

2.2. Interpreting the raw data into customer needs, Progress report-2
2.3. Organize the need into hierarchy,
2.4. Establish relative importance of the needs, and
2.5. Reflect on the result and the process.

1 3. Product specifications:
[1]
3.1. Establishing target specification (prepare list of
Progress report-3
Metrics, Pp91-Pp113
3.2. select ideal and marginally acceptable target
values),
3.3. setting final specification (develop technical
model of the product,
3.4. develop cost model of the product, refine the
specifications, flow down the specifications

3 4. Concept Generation: [1]

Pp117-Pp140
4.1. The activities of concept generation,
Progress report -4
4.2. Problem clarification,
4.3. External and internal search,
4.4. Systematic exploration.
4 5. Concept Selection: [1]
Pp143-Pp160 Progress report-5
5.1. Concept screening and concept scoring (selection
matrix,
5.2. Concept rating, concept ranking, combining and
improving concepts, select one or more
concepts).

5 6. Prototyping and product testing: [1]

Pp165-Pp180
6.1. Principles of prototyping, prototyping techniques,
planning for prototyping, FDA applications and
 approval processes, importance of ethics in
device testing, management and assessment of
medical technology, risk factors, safety, quality
and management of medical equipment.

16 Final Exam

1. Assessment Methods

Assessment Type Assessment Weight (%)

Progress reports 5 Progress reports (25 %)
Lab Lab Assignment and Exam (25%)
50%
Written Exam 25%
Final Design Report and Presentation 25%
Total Mark 100

References

1. K. T Ulrich, S.D Eppinger 2012, Product Design and Development, 5th Edition.
2. Paul G. Yock, S. Zenios, J. Markower 2015, Biodesign : The Process of Innovating Medical
Technologies, 2nd Edition.
3. Peter J. Ogrodnik 2013, Medical Device Design: Innovation from Concept to Market
4. R.R. Kortum 2010, Biomedical Engineering for Global Health.
5. D.A. Vallero 2007, Biomedical Ethics for Engineers: Ethics and Decision Making in Biomedical
and Bio-system Engineering