The document provides an overview of biomedical engineering design and related topics presented at Mbarara University of Science and Technology. It discusses what engineering design entails, the engineering design process, considerations for good design such as requirements and regulations. It also covers topics like prototyping, testing, human factors, intellectual property, and engineering ethics.

1. Biomedical Engineering
Design
3rd April 2019 at Mbarara University of Science and Technology
By Brian Matovu

2. if a “picture is worth a thousand words”, then in
medtech, “a prototype is worth a thousand pictures.”

3. Introductions…
• Is NOT research or craftsmanship!
• Involves devices, processes, re-engineering, systems, optimization,
regulations, finances, innovation, invention, entrepreneurship, etc.

4. Design is a Process with Passion

8. Biomedical
Engineering Design

9. Engineer
An engineer is a professional practitioner of engineering,
who has mathematical and scientific training and can
apply such knowledge, together with ingenuity, to
design and build complicated products, machines,
structures or systems and thus develops solutions for
technical problems.

10. Engineering Design
• An engineering design pulls together (i.e. synthesizes)
something new or arranges existing things in a new
way to satisfy a recognized need of society. Engineering
designs considers the limitations imposed by
practicality, regulation, safety, and cost.

11. Discovery versus Design
• Discovery is getting the first knowledge of something
• Design is the creation of new things

12. Design…
• Science versus Engineering
• Science is knowledge based on observed facts and tested truths
arranged in an orderly system that can be validated and
communicated to other people.
• Engineering is the creative application of scientific principles used to
plan, build, direct, guide, manage, or work on systems to maintain
and improve our daily lives

13. Design…
• Scientists versus Engineers
• Scientists see things as they are and ask, WHY?
• Engineers see things as they could be and ask, WHY NOT?

14. For What Uses Might Products be Designed?

15. Challenges of Engineering Design
• Creativity: creation of something that has not existed before
•
• Complexity: requires decisions on many variables and parameters
• Choice: requires making choices between many solutions at all levels, from
basic concepts to the smallest detail
• Compromise: requires balancing multiple and sometimes conflicting
requirements 15

16. Importance of Engineering Design
1. Design costs very little in terms of
the overall product cost but its
decisions has major event on the
overall cost
2. Defects introduced in the design
phase cannot be compensated in
the manufacturing phase
3. Design process should be
conducted to develop quality, cost-
competitive products in the
shortest time possible
16
[Source: Dieter & Schmidt 2013]

17. Engineering Design Process
Involves analysis and synthesis
Analysis
• Decompose problem into manageable
parts
• Calculate as much about the part’s
behavior as possible, using
appropriate disciplines in science,
engineering and computational tools,
before the part exists in physical form
Synthesis
• Identification of the design elements
that comprise the product, how it is
decomposed into parts and the
combination of the part solutions
into a total workable system
17
Requires Systems Thinking!

18. Iterative Engineering Design Process
• Complex systems can be decomposed into a sequence of design processes
• Iteration  repeated trials
• Gives opportunity to improve design on basis of preceding outcome
• More knowledgeable team may arrive at acceptable solutions faster
• Requires high tolerance of failure
• Requires determination to persevere and work out the problem
• Often involve tradeoffs and arrive at near-optimal solutions
18[Source: Asimov 1962]

19. Problem-solving Methodology for
Engineering Design
1. Defining the problem
o Needs analysis, a difficult task
o True problem not always what it seems at first
o Requires iterative reworking as the problem is better understood
o Problem statement must be as specific as possible
19

20. Problem-solving Methodology for
Engineering Design…
2. Gathering the information
o Understand state of the art
o Many sources of information, unstructured, unordered
o Ask questions
 What do I need to find out?
 Where can I find it?
 How can I get it?
 How credible and accurate is the information?
 How do I interpret the information for my specific need?
 When do I have enough information?
 What decisions result from this information?

21. Problem-solving Methodology for
Engineering Design …
3. Generation for alternative solutions / design concepts
o Use of creativity, simulation
o Apply scientific principles, use qualitative reasoning
o Need to generate high-quality alternative solutions
21

22. Problem-solving Methodology for
Engineering Design …
4. Evaluation of alternatives and decision making
o Selecting the best among several concepts
o Often under incomplete information
o May consider simulations
o Very important  checking, including mathematical check, engineering-sense checks (intuition)
o Consider all conditions / situations (e.g. humdity, vibration, temperature…) in selecting “optimal”
solution
5. Communication of the results
o Oral / written communication,
o Engineering drawings, 3D computer models, software, etc.

23. Problem-solving Methodology for
Engineering Design …
• Iterative nature
• Back and forth among the 5
steps
• Understanding grows 
evolve from preliminary to
detailed design
23
Define Problem
Gather Information
Generate Alternative Solutions
Evaluate Alternatives and Make Decision
Communicate Results

24. Problem-solving Methodology for
Engineering Design …
• Paradox
• Design knowledge grows as
design freedom diminishes
24
[Source: Dieter & Schmidt 2013]

25. Considerations of Good Design
• Performance Requirements
• Functional Requirements – for components, sub-assemblies, assemblies
• Aesthetic Requirements – shapes, size, touch and feel
• Environmental Requirements – operations conditions, e.g. temperature, humidity,
dirt, vibration, noise, corrosive conditions, energy conservation, chemical emissions,
(hazardous) waste production, recycling requirements
• Human Factors
• Cost, e.g. price-performance considerations
25

26. Considerations of Good Design
• Regulatory and Social Issues
• Code of ethics require engineers to protect public health and safety
• Regulating agencies include: Occupation, Safety and Health Council,
Consumer Council, Environmental Protection Department, etc.

27. Considerations of Good Design …
• Design Review
• Vital aspect of the design process
• Retrospective study of a design up to that point in time
• Systematic method to identify problems with the design
determining subsequent courses of action, initiate action
to correct problem areas
27

28. Computer-Aided Engineering
• Engineering drawing, facilitating visualization, supported by computer graphics
and modeling, e.g. AutoCAD, SolidWorks, etc.
• Spreadsheets and mathematical tools, e.g. MatLab, Mathematica, etc.
• Enabled concurrent engineering design to minimize time – all aspects of the
design and development are represented in a closely communicating team,
28

29. Engineering Project Management
• Mastery of engineering specialty no longer enough
• Project success requires collaboration across technical disciplines,
organizational elements, stakeholder interest
• Must think of a project as a cohesive whole and not separate parts!
29

30. 30

31. Engineering Project Management …
• Initial planning crucial
• NASA Rule # 15: a review of most failed project problems indicates that the disasters were well-
planned to happen from the start. The seeds of the problem were laid down early. Initial planning is
most vital [Madden, 100 Rules of NASA Project Managers]
• Project economics, e.g. NASA’s study of software development projects show that the cost of fixing
a defect increases:
• fixing at design phase
•  fixing at coding phase (10x)
•  fixing at testing phase (100x)
• Lesson
• Invest sufficient planning time and effort early because the cost savings are huge 31

32. 6 Dangerous Planning Mistakes
1. Tolerating vague objectives
2. Ignoring environmental context
3. Using limiting tools and process
4. Neglecting stakeholder interests
5. Mismanaging people dynamics
6. One shot planning
32

33. 4 Fundamental Questions
1. What are we trying to accomplish and why? (Objectives)
2. How will we measure success? (Measures and Verification)
3. What conditions must exist? (Assumptions)
4. How do we get there? (Inputs) 33

34. Q. Measuring Success
• Measures and Verification
• Quantity
• Quality
• Time
• Customers /Users
• Cost
34

35. Q. Inputs
• Actions and activities to produce
Outcomes
• Associated with resources
• Time
• People
• Money
• Etc. 35

36. Integration
36
[Source: Schmidt 2009]

37. Project Scheduling
• Gantt Chart
• Introduced by Henry Gantt, 1910
• Visualizes the project schedule
37

38. Budget and Resource Planning
• Time value of money (TVM)
• Capital budgets are essential for supporting project activities over the project
duration; but the value of money changes with time (because of
interest/discount rates) with the concepts of present value (PV), future value
(FV), and discounted cash flow.
• The starting time and finishing time of a scheduled project activity can have
a significant impact on budget planning
38

39. Example: Saving the World
God’s memo:
Noah, I have decided to make it rain for 40 days
and 40 nights. I want you to build a big ark to
hold a pair of all animals on earth, and people, so
you can survive the flood. After the flood, you can
restore life on earth and ensure the long-term
survival of human and animal life. Get everything
ready before the big rain starts in six months. 39
[Source: Schmidt 2009]

40. Noah’s Ark Project Management
[Source: Schmidt 2009]
40

41. Noah’s Ark Project Inputs
41
[Source: Schmidt 2009]

42. Noah’s Ark Project Resource Budget Details
42
[Source: Schmidt 2009]

43. Team Responsibility and Communication
• The Confused Project Team
• Four people named Everybody, Somebody, Anybody and Nobody worked together.
• An important Outcome needed managing, and Everybody was sure that Somebody would do it.
• Anybody could have done it, but Nobody actually did it.
• Somebody got angry because it was really Everybody’s job.
• Everybody thought that Anybody could do it, but Nobody realized that Somebody
wouldn’t.
• As it turned out, Everybody blamed Somebody when Nobody did what Anybody could have done!
43
[Source: Schmidt 2009]

44. Noah’s Ark Responsibility Chart
R: Responsible (may delegate), P: Participants, C: may be Consulted, A: Approves, I: must be informed
44
[Source: Schmidt 2009]

45. Project Reporting
• Clearly tell others
• Your Objectives
• What you have done
• Why decisions are taken
• Lessons learned
• Results
• Future opportunities
• Use proper quotations, citations and references
45

46. • Order of the Engineer: association for graduate and professional engineers in
North America emphasizing the pride and responsibility in the engineering
profession
• Code of ethics called The Obligations of an Engineer
• The Engineer’s Ring
46
[Source: Wikipedia]
Engineering Ethics

47. Code of ethics: The Obligations of an Engineer
I am an engineer, in my profession I take deep pride. To it I owe solemn obligations.
Since the stone age, human progress has been spurred by the engineering genius.
Engineers have made usable nature's vast resources of material and energy for humanity's benefit.
Engineers have vitalized and turned to practical use the principles of science and the means of
technology.
Were it not for this heritage of accumulated experience, my efforts would be feeble.
As an engineer, I pledge to practice integrity and fair dealing, tolerance, and respect, and to uphold
devotion to the standards and the dignity of my profession, conscious always that my skill carries
with it the obligation to serve humanity by making the best use of Earth's precious wealth.
As an engineer, I shall participate in none but honest enterprises.
When needed, my skill and knowledge shall be given without reservation for the public good.
In the performance of duty and in fidelity to my profession, I shall give the utmost.
47

48. Testing of Prototypes

49. Testing Definition:
•Establishing confidence that a
device does what it is
supposed to do

50. Testing Definition:
•The process of operating a
device with the intent of
finding errors

51. Testing Definition:
•Detecting specification errors
and deviations from the
specification

52. Testing Definition:
•Verifying that a system
satisfies its specified
requirements or identifying
differences between expected
and actual results

53. Testing Definition:
•The process of operating a device
or component under specified
conditions, observing or recording
the results, and making an
evaluation of some aspect of the
system or component

54. Testing…
•Subjecting a device to conditions that
indicate its weaknesses, behavior
characteristics, and modes of failure.
•Ultimate goal: satisfied customer

55. Testing of Prototypes
Problem
Design Constraints
Test Specification
Design
Simulation
Test Verification
Prototyping
Test Verification
Hardware
Implementation
Test Verification

56. Reasons for Testing
•Basic Information (Includes vendor evaluation, vendor
comparison, and component limitability)
•Verification (Process of evaluating the products of a given phase
to correctness and consistency with respect to the products and standards
provided as input to that phase)
•Validation (Process of evaluating a product to ensure compliance
with specified and implied requirements)

57. Types of tests
• Verification
• Validation
• Black Box
• White Box
• Hardware Testing
• Software Testing
• Functional Testing
• Robustness Testing
• Stress Testing
• Safety Testing
• Regression Testing

58. Stress Testing
•Designed to ascertain how the product reacts
to a condition in which the amount or rate of
data exceeds the amount or rate expected.
•Help determine margin of safety that exists
•Include Duration and Worst Case Scenario

59. Black Box Testing
• Verifies that the end-user requirements are met from the
end-user’s point of view
• Performed without any knowledge of internal structure
• Tester is only interested in finding circumstances in which
the device or program does not behave according to its
specification.

60. Usability activities are NOT clinical Trials
Generally the process will be less stringent:
• More loosely defined, faster
• Will likely involve a relatively small number of people per activity
• Initial studies stress simulation, with no medicinal agents or clinical
impact.
• Dovetail with interaction design, visual design, and marketing activities

61. Human Factor Considerations

62. Modern Human Factors Understands That …
PEOPLE USE TECHNOLOGY …
TO ACCOMPLISH THEIR GOALS …
IN THEIR ENVIRONMENT.

63. Understand human factors and its
relationship to patient safety

64. The application of knowledge about human
behavior, abilities, and other characteristics
of medical device users to the design of
medical devices to demonstrate safe and
effective use.

65. Human factors ‘engineers’
- discover and apply information about human
behavior, abilities, limitations, and other
characteristics to the design of tools, machines,
systems, tasks, jobs, and environments for
productive, safe, comfortable and effective human
use.

66. Human Factors And
Product Design
3 KEY FOCAL POINTS.
USEFUL
• Meets recognized needs
• Supports goals & objectives
• Improves the outcome
• Enhances performance or
efficiency
• etc...
USABLE
• Fit, reach, strength
• Visible, audible, etc.
• Understandable
• Informative
• Learnable
• etc...
DESIRABLE
• Pleasure in use
• Satisfaction with outcome
• Fit, feel, & finish
• Cultural, social, lifestyle
impact
• Sense of empowerment
• etc...
Successful
Products
SUCCESSFUL PRODUCTS
connect on all levels – they are
USEFUL, USABLE, &
DESIRABLE

67. Avoidable confusion is everywhere…
US Department of Veteran affairs

68. Human factors design principles
Senses
- Vision
- Hearing
Psychomotor
- Hands
Input Devices
- Buttons
Output
- Display
- Sound
I
N
T
E
R
F
A
C
E

69. Are the lines crooked or straight?
Optillusions.com

70. Why conduct Human Factor Studies;
• Lower the number of potential use or user errors.
• Reduces the risks associated with the use of the device.
• Lowers the training costs for the end users.
• Reduces the costly device service and support.

71. Intellectual Property (IP)

73. Intellectual Property (IP)
Intellectual property broadly connotes property rights in
creations of the mind including inventions, industrial
designs, literary and artistic works, symbols and images
(Atwine, 2003). The legal protection of intellectual property
thus identifies exclusive rights of a person to exploit or
license particular creations of human ingenuity (Atwine,
2003).

74. IP…
• intellectual property rights management geared
towards the development of research findings into
innovations, transfer thereof to users and private
sector aimed at their commercialization and
exploitation.

75. Categories of IP
• Copy Rights
• Patents
• Utility models
• Industrial designs
• Trade secretes
• Geographical
indications
• Trade marks

76. Copyrights- Eligibility
• The kind of works protected by copyright include, but not limited
to;
1. literary and artistic works such as; novels, poems, plays,
newspapers, adverts, films, musical compositions,
choreography, paintings, drawings, photographs,
2. sculptures and architecture, maps, technical drawings and
3. Computer software, programs and databases.

77. Copy Right…
• For such works to become eligible for copyright,
sufficient effort must have been expended to make the
work original in character and the work must have been
written down, recorded or otherwise reduced to material
form with or without consent or be a work which is
intended to be used by the author as a model or pattern
to be multiplied by any industrial process

78. • A creative work is automatically protected by copyright
after creation. The work must be original and fixed into
tangible form. Works are protected irrespective of their
merit but must not infringe another person’s work.

79. How long does copyright protection last?
• For Natural persons, Copyright is protected for the lifetime of the author
and 50 years after his death.
• For Corporations/ Companies, Copyrights is protected for 50 years after
the date of the 1st publication.
• Anonymous work or works of unknown authors, 50 years after.
• Computer programs; 50 years after the program becomes available to the
public.

80. UTILITY MODELS AND PATENTS

81. Patents
• The law (Patents Act, Cap 216) defines [Patents Act, S.8 (1)] an
invention as a solution to a specified technological problem,
which may be or may relate to a product or process. However the
following are not inventions: [Patents Act, S.8 (2) (a)]
(a) Discoveries and scientific and mathematical theories;
(b) Plant/animal varieties or biological processes for the production of: plants, animals
(c) Schemes, rules or methods for doing business performing purely mental acts or playing
games;
(d) Methods of treatment of the human animal body;
(e) Mere presentation of information.

82. Utility model
• A Utility Model is an exclusive right granted by the government for an
innovation/invention, which is either a product or process that offers a
new technical solution to a problem.
• A product or process that is new and is useful can be protected using
this system. Their term of protection is 10 years. Registration for a utility
model is simple and fast, and gives the holder the right to exclude
others from exploiting the protected innovation/invention.

83. • Utility Models provide protection for incremental
improvements to products and processes and it is
very relevant for SMEs.
• For Example: Printing- roller cleaning system, fruit
sorting machine, simple bottle cleaning machine etc.

84. A patent, like a utility model, is an exclusive
right granted by the government for an invention.
Protected inventions can range from simple things like a
safety pin to sophisticated items like juice processing
machine.
An invention that is Novel, Inventive and is industrially
applicable may be granted using a Patent.
The term of protection for patents is 20 years.
For the patent to remain in force the patent holder is
required to pay annual maintenance fees.

85. Industrial Design
The ornamental or aesthetic aspect of a useful article (product).
The design may consist of three-dimensional features, such as
the shape or surface of an article, or two-dimensional features,
such as patterns, lines or color.
The appearance of a product, it’s what makes a product attractive
and appealing to a consumer’s eye

86. • Industrial designs are applied to a wide variety of products
of industry and handicraft items: from packages and
containers to furnishing and household goods, from lighting
equipment to jewelry, and from electronic devices to
textiles. Industrial designs may also apply to graphic symbols
and graphical user interfaces (GUI)
• Industrial design rights are granted for FIVE (5) years
renewable for two more consecutive five year term.
• Industrial design protection does not protect the technical
features of the product.

87. Industrial design to be protected…
• New-there is no identical design already available to the
public before the date of filing, or application for
registration.
• Original-must be independently created by designer,
and not a copy or imitation of existing designs.

88. Trademark
• A trademark is a distinctive sign that identifies certain goods or services
produced or provided by an individual or a company from those of other
enterprises. A Trademark may consist of any word, symbol, design, slogan,
logo, sound, smell, colour, label, name, signature, letter, numeral or any
combination of them and should be capable of being represented
graphically. The Trademark has to be distinctive, non-descriptive and not
likely to cause confusion. The Trademark owner has the exclusive rights
to prevent others from using the same or confusingly similar mark.

89. Technology and Innovation Support Centers
(TISCs)
• The WIPO Technology and Innovation Support Center
(TISC) program provides innovators in developing
countries with access to locally based, high quality
technology information and related services, helping
them to exploit their innovative potential and to create,
protect, and manage their intellectual property (IP) rights.

90. Services offered by TISCs may include:
• Access online patent and non-patent resources and IP-related
publications;
• Assistance in searching and retrieving technology information;
• Training in database search;
• On-demand searches (novelty, state-of-the-art and infringement);
• Monitoring technology and competitors;
• Basic information on industrial property laws, management and
strategy, and technology commercialization and marketing.

91. 25TISC in Uganda
• Uganda Registration Services Bureau
• Mbarara University of Science and
Technology
• Kyambogo University
• Infectious Diseases Institute
• Busitema University
• Uganda National Council for Science and Technology
• Uganda Pharmaceutical Society
• Uganda Industrial Research Institute
• 9. NACCRI (NARO)
10. NAFORRI(NARO)
11. NABUIN(NARO)
• 12. MUZARDI(NARO)
13. NALIRRI(NARO)
14. RWEBITABA (NARO)
15. NARL(NARO)
16. NASARRI(NARO)
• 17. NACORI(NARO)
18. KAZARDI(NARO)
19. ABI ZARDI(NARO)
20. MBAZARDI(NARO)
21. BUGIZARDI(NARO)
22. NGETTA ZARDI(NARO)
23. BULINDI (NARO)
24. NAFIRRI(NARO)
25. Makerere University , Main Library

92. References
• M. Asimov, “Introduction to Design,” Prentice-Hall, Englewood Cliffs, NJ. 1962.
• C.S. Park, Contemporary Engineering Economics, Prentice Hall, 2002
• C. L. Dym, P. Little, E. J. Orwin, and R. Erik Spjut, “Engineering Design: A Project-Based Introduction”,
Third Edition, Wiley, 2009.
• T. Schmidt, “Strategic Project Management Made Simple,” Wiley 2009.
• E. A. Stephan, D. R. Bowman, W. J. Park, B. L. Sill, and M. W. Ohland, “Thinking Like an Engineer: An
Active Learning Approach”, Pearson, 2012.
• G. Dieter and L. Schmidt, “Engineering Design,” 5/e, McGraw Hill, 2013.
• IET publication: “A Guide to Technical Report Writing”, online www.theiet.org
• Personal communication, Dr. Dorbin Ng, CUHK SEEM
92