Lecture 2 Design Display

Design of Medical Devices
Prof. Võ Văn Tới

Vice-Provost for Life and Health Science, Engineering and Technology
Development
School of Biomedical Engineering, International University
Department of Biomedical Engineering, School of Medicine
Vietnam National Universities – HCMC
Outline
• Importance of Medical devices
• Design Engineering
• Project Management
– Critical Path Method (CPM)
– Gantt’s chart
• Standardization
– Renard Series
• Manufacturing and Mass Production
• Entrepreneurship in BME
What is the main difference
between a medical device and a
common device?
Life and death

FDA: Title 21 Code of Federal Regulations (21CFR) Parts 800 –
1299 for Medical Devices
• Class I, II and III: Less severe for Class I, very severe for Class III
devices.
• Some requirements:
– Premarket Notification 510(k): New devices are similar to those
already on the market. Required for Class II; not required for most
Class I devices.
– Premarket Approval (PMA): Severe requirements for new devices.
Required for almost all Class III.
8
Good manufacturing practices (GMP)
• GMP help a manufacturer better recognize, investigate and
take appropriate planned action to protect the consumer and
marketplace from exposure to any potentially harmful
ingredients or practices
• GMP consist a lot of rules and guidelines applied mainly in
pharmaceutical product industry
9
Role of a Device Physiological
Investigations
Initial Ideas Prototype &

or Phenomena Experiments
Clinical
Applications
10
Constituent components of a medical device
Applications
Medical device
Informatics
Electronics
Mechanics
Legal compliance & Scientific research

12
Design Engineering
(Synthesis)
13
Conceive and realize
an engineering solution (tool or method)
to solve a scientific issue
Example
Design a circuit:
• I = 0.9-1 µA
• R = 1Ω-10MΩ
Design is an iterative process
Solutions Prototype
Initial Deployment
idea of final
product
https://upload.wikimedia.org/wikipedia/commons/thumb/3/39/
Iterative_development_model.svg/512px-Iterative_development_model.svg.png
16
Design is a Trade-off process:
– Cost vs. quality ratio
– Standard vs. home-made components
– Decision matrix
Solution 1 Solution 2 Solution 3 Solution 4
Requirement 1 7 5 6 4
Requirement 2
4 5 2 8
X5
Requirement 3
7 3 6 9
X2
Requirement 4
3 6 4 2
X2
Requirement 5
9 3 2 8
X4
Total 83 48 44 98 17
Design is an Open-ended process
List of iPhone models (2007-2020)
1 iPhone (2007) 16 iPhone 8 (2017)
2 iPhone 3G (2008) 17 iPhone 8 Plus (2017)
3 iPhone 3GS (2009) 18 iPhone X (2017)
4 iPhone 4 (2010) 19 iPhone XR (2018)
5 iPhone 4S (2011) 20 iPhone XS (2018)
6 iPhone 5 (2012) 21 iPhone XS Max (2018)
7 iPhone 5c (2013) 22 iPhone 11 (2019)
8 iPhone 5s (2013) 23 iPhone 11 Pro (2019)
9 iPhone 6 (2014) 24 iPhone 11 Pro Max (2019)
10 iPhone 6 Plus (2014) 25 iPhone SE (2nd generation) (2020)
11 iPhone 6s (2015) 26 iPhone 12 mini (2020)
12 iPhone 6s Plus (2015) 27 iPhone 12 (2020)
13 iPhone SE (1st generation) (2016) 28 iPhone 12 Pro (2020)
14 iPhone 7 (2016) 29 iPhone 12 Pro Max (2020)
15 iPhone 7 Plus (2016)
20
Design is a multiple solution process
21
Ultrasound devices
22
BME Department - International University - VNU HCM -
23
Vietnam www.hcmiu.edu.vn/bme
In summary: Design is
• An iterative process: repeat the same step several times
• A Trade-off process: compromise between advantages and
disadvantages
• An Open-ended process: we can still improve the solution
• Multiple solution process: one problem may have different
viable solutions
24
Design steps
1. Initial Idea
2. Initial requirements
3. Competitor checking and reverse engineering
25
Reverse Engineering
(Analysis)
26
27
Design steps
1. Initial Idea
4. Final Requirements
5. Possible Solutions
6. Analysis of solutions
7. Selected solution
8. Design and fabrication
9. Testing
10. Final characteristics
11. Final prototype
12. Report 28
Keys for success in the design:
- Simplicity
- Accuracy and Precision
- Test for reliability

- Teamwork coordination
- Good documentation
Scientific/Engineering logbook
A logbook is a very important tool to accompany
throughout scientific/engineering career. The logbook
serves several purposes, including, but not limited to:
– Prove your due diligence and care
– Protect you from professional liability, claims
– Record new ideas, observations, inventions, remarks
– Record the processes, data obtained
– Must be timely, thorough, sustained, and fully
detailed (detailed disclosure)
– Should show a chronology of your train of thoughts
and investigations and the people involved.
Development of a device for
dry eye
31
Design steps
1. Initial Idea
9. Testing
11. Final prototype
32
Dry Eyes
• Keratoconjunctivitis sicca (KCS) or keratitis sicca
• Sjögren’s syndrome (dry eyes and dry mouth)
33
Physiological Investigations
34
35
36
37
38
Design steps
1. Initial Idea
9. Testing
11. Final prototype
39
Design steps
1. Initial Idea
9. Testing
11. Final prototype
40
41
42
Design steps
1. Initial Idea
9. Testing
11. Final prototype
43
Conceptual Device
44
Principle of the mechanism
45
46
Design steps
1. Initial Idea
9. Testing
11. Final prototype
47
Block Diagram: Functioning Principle
On/Off Power
Switch supply
Micro Rotating
Motor Reservoir Eyeglasses
Processor Valve
Manual
Sensors
Controller
48
Block Diagram: Control System
49
Flow chart Start
Read values of
Adjustment
speed, pace, position
Activate
motor
Valve in right No Continue

position? Motor
Yes
Stop Motor
Yes Manual
depressed?
No
No
Off?
Yes
End 50
Prototype
51
Design steps
1. Initial Idea
9. Testing
11. Final prototype
52
53
54
Voltaren
55
Design steps
1. Initial Idea
9. Testing
11. Final prototype
56
A.M.I.E
57
58
59
60
Technological Ophthalmic Instruments, Inc.
AMIE
Automatically Medicated Instrument for Eyedroplets
(Automatic Drug Delivery Device for Chronic Eye Diseases)
Physiological
Investigations
Initial idea or Device on

Prototype &
Phenomenon the market to
Experiments
end users
Clinical
Investigations
62
63
64
65
1.2
Relative Magnitude (AU)

1.0
0.8
Blink Rate
0.6
Dry Eyes
0.4
0.2
0.0
-0.2 Baseline Air Saline
66
Standardization
(building standards)
67
Standards are an important part of our society,
serving as rules to measure or judge capacity,
quantity, content, extent, value and quality.
Purpose: to get people “on the same page”
68
69
70
71
72
How to establish a standard?
Renard Series
1. All values are regrouped into decades: 1-10; 10-100;
100-1,000; ...
2. Each decade has the same numbers of values
3. Numbers of values are determined by an
agreement: R5 has 5 values, R10 has 10 values; …
4. Method to determine those values:
73
R5 in 1-10 decade
• Values: 1 , , , , and V = 10.
I



 = 10
=>
• Values: 1 – 1.585 – 2.512 – 3.981 – 6.309 – 10
=> 10 – 15.85 – 25.12 – 39.81 – 63.09 – 100
74
ISO standard values in 1-10
75
Resistor Power 1/4W
R(12)=1.211527659
1 1Ω 10 Ω
1.211527659 1.2 Ω 12 Ω 1
1.467799268 1.5 Ω 15 Ω 2
1.77827941 1.8 Ω 18 Ω 3
2.15443469 2.2 Ω 22 Ω 4
2.610157216 2.7 Ω 27 Ω 5
3.16227766 3.3 Ω 1 /12
𝑅= ( 10 )
33 Ω 6
3.83118685 3.9 Ω 39 Ω 7
4.641588834 4.7 Ω 47 Ω 8
5.623413252 5.6 Ω 56 Ω 9
6.812920691 6.8 Ω 68 Ω 10
8.254041853 8.2 Ω 82 Ω 11
10 Ω 100 Ω 12 76
Project Management
77
Questions
1. How long does it take to complete a project?
2. How soon can I start a task?
3. How late must I finish a task?
78
• Event: landmark of a task
• Activity: action during a certain time that links two events
79
80
𝑅 = ( 10 ) 1 / 5 =1 . 585
30 months 81
Critical path method (CPM)
2 6
1 3 5 8
82
8
2 6
1
2 4 3
2 2
1 3 5 8
2
1
1 4 7
83
8
2 6
2 10 1
2 4 3
2 2
1 3 5 8
2
1
0 2 6 11
1 4 7
8
4
1
84
8
2 6
2, 2 10, 10 1
2 4 3
2 2
1 3 5 8
2
1
0, 0 2, 5 6, 7 11, 11
1 4 7
8, 10
4
1, 3
85
8
2 6
2, 2, 0 10, 10, 0 1
2 4 3
2 2
1 3 5 8
2
1
0, 0, 0 2, 5, 3 6, 7, 1 11, 11, 0
1 4 7
8, 10, 2
4
1, 3, 2
Earliest event time Latest event time Event float time

86
Gantt chart
0 1 2 3 4 5 6 7 8 9 10 11
1-2
1-3
2 8
6 1-4
1
2
2, 2, 0
4 3
10, 10, 0
2-5
1
2
3 2
5
2
8 2-6
1
0, 0, 0
1
2, 5, 3
4
6, 7, 1
7
11, 11, 0
3-5
8, 10, 2 4-5
4
1, 3, 2
5-6
5-7
6-8
7-8
87
Gantt chart
0 1 2 3 4 5 6 7 8 9 10 11
1-2
1-3
1-4
2-5
2-6
3-5
4-5
5-6
5-7
6-8
7-8 88
Keys for success in the project
management
- Clear plan
- Clear organization
- Clear leadership
- Team work coordination
Important points on the Design of Medical Device
1. Design specifications: incl. data to achieve, literature

review, analysis of existing devices, market study, etc.
2. Decision process of determined solution: incl. analysis
of different solutions, decision matrix, etc.
3. Design and prototype fabrication details: incl. drawings,
methods, information on standard or home-made
components, etc.
4. Prototype tests: incl. the use of statistical and standard
methods from ISO, FDA, etc. to evaluate the accuracy/
reliability/ effectiveness of the device
5. Issues to be improved in comparison with data in (1)
6. Cost of prototype/ production
7. Results from physiological and clinical tests.
90
Grading and schedule of your project
1. You must form the group ASAP (max 3 students/group)
2. Grading policy and due dates for the project
a. Project initial: Electric circuit for the car (by Mar. 1st): 10% of the
class grade
b. Project Midterm presentation: 1st prototype (by May 3): 10% of the
class grade
c. Project Final presentation: Final product (To be announced by TA):
10% of the class grade
91
Grading and schedule of your project
1. You must form the group ASAP (max 3 students/group)
2. Grading policy and due dates for the project
a. Project initial: Electric circuit for the car (by the end of Oct.): 10% of
the class grade
b. Project Midterm presentation: 1st prototype (by the end of Dec.):
c. Project Final presentation: Final product (To be announced by TA):
3. Each group must have a logbook.
92
Manufacturing Processes
• Making prototype
• Mass production
93
Mass production
Manufacturing company
OEM (Original Equipment Manufacturer)
ODM (Original Design Manufacturer)
OBM (Original Brand Manufacturer)
96
Original Equipment Manufacturer (OEM)
OEM is a company that mass produces for and sells devices to
another company based on the design and specifications of the
latter who is responsible for distribution. Products are marketed
under the brand name of the latter.
Example: Apple is responsible for technology research and
product selling under its name. Foxconn is an OEM company
which makes actual products.
97
Original Design Manufacturer (ODM)
ODM is a company that does R&D, designs and builds products
for another company. The latter has identified the need and the
market of the product but doesn't know how to design it or
doesn't have the manufacturing capabilities to make it. When
the actual product comes out, the latter will market it.
Difference:
- OEM makes products for a company that did R&D and market
research;
- ODM does R&D and makes products for a company that did
only market research. 98
Original Brand Manufacturer (OBM)
OBM is a company that is not involved in the design or
production process but only develop the brand. This company
buy back products made entirely by other companies and just
put their brand on it to add value to the product.
99
Kinds of company
• Spin-off or Spin-out
• Start-up
• Venture capital
100
Entrepreneurship in BME
A method of bringing:
- Academic medical products to the market and
- Needs from the market to academia to make a
commercially viable product.
101
Entrepreneurship Mindset
102
People have done it. Why do we need to do?
They did it. How can we do better than them?
Do what people think it’s impossible
103
We did well! Why do more?
Always happy but never satisfy
Take calculated risks
Look to the future and perform well at the present 105

Entrepreneurship in BME
R&D, Invention,
Design,
Production
Engineering
Investment,
Transfer, Start-up,
Administration Regulations,
Laws, Contracts,
Medical Ethics
Policy,
Business
Rule
106
Entrepreneurship components
Market Human factors Finance Health Insurance
Ideas Prototype Re-design Production Distribution End users
Intellectual protection Policy Bio-ethics After-sale
107
Entrepreneurship Process
Focus group
Market study
Fabrication method
Official Laws/Rules
Commercialized
Prototype for Start-up/Spin-
New idea Prototype in lab viable product Production Business
market out company
Human factor
Business plan
Users¶club
Issues in Entrepreneurship Situation in Vietnam
• Engineering: Cheap labor but too expensive products => need to develop
logistics in manufacturing and production
• Policy and rules: The transfer of technology to enterprises is difficult and
the admin. mechanism is complicated => need professional legal personnel
• Business: Big competition => need people who are capable raising capital
and well manage business
=> There is a need for a seamless system so that when a commercially viable
product is created, it is mass-produced at a competitive price, meets
regulatory requirements, and is rapidly put to the market.
Summary: Entrepreneurial Journey
• Re-Design => Prototype
• Fabrication => Final Product
• Marketing => Product in user’s hands
5-M Factors for Success in Entrepreneurship/Leadership
1. Manpower
2. Money
3. Materials
4. Management
5. Mindset
ENTREPRENEURSHIP ORIENTATION IN BME
BME CURRICULUM ROADMAP
Semester 1 Semester 2 Semester 3 Semester 4 Semester 5 Semester 6 Semester 7 Sem. 8

(19 credits) (21 credits) (20 credits) (20 credits) (18 credits) (21 credits) (15 credits) (10 cr.)
Calculus I Calculus II Calculus III Differential Statistics for Free Elective I Free Elective II
4(4,0) 4(4,0) 4(4,0) Equation Health Sc. 3(3,0) 3(3,0)
4(3,1) 3(2,1)
Physics I Chemistry Chemistry Applied Mechanical Machine Design BME Capstone

2(2,0) for Eng.+Lab for BME Infomatics Manufacturing 3(3,0) Design Course
4(2,2) 4(3,1) 4(3,1) 4(2,2) 4(3,1)
Physics II Biology for Human Anat. Biomaterials Eng. Chal. AI for Healthcare Entrepreneur-
2(2,0) BME & Physiology 4(3,1) in Medicine I 3(3,0) ship in BME
4(3,1) 3(3,0) 3(3,0) 3(3,0)
Critical Principles of Introduction Technical Electives Bioethics

Thinking EE1+Lab to BME 10(9,1) 3(3,0)
3(3,0) 4(3,1) 4(3,1)
Academic Academic HCM thought Technical Electives

English I English II 2(2,0) 16(12,4)
4(4,0) 4(4,0)
Lab 1A Lab 1B Design 2A Design 2B Project 1 Project 2 Pre-Thesis Thesis

1(0,1) 1(0,1) 1(0,1) 1(0,1) 1(0,1) 1(0,1) 1(0,1) 10(0,10)
Triết học Chủ nghĩa Xã 2nd year summer semester 3rd year summer semester
Mác-Lênin hội khoa học Military Internship
3(3,0) 2(2,0) training 3(0,3)
Mathematics & Basic Design and
Physical Physical A B Take B after passing A
Science Research Cluster
Training I Training II
Humanity, Social Science, Foundation Cluster
1st year summer semester and Political Cluster Take B after taking A
A B
Academic English Concentration but passing A is not
Kinh tế chính trị Mác-Lênin
Cluster Cluster required
2(2,0)
Technical Elective 113
Lịch sử Đảng Cộng sản Việt Nam Free Elective Cluster
2(2,0)
Cluster
TECHNICAL ELECTIVES for ENTREPRENEURSHIP
ORIENTATION in BME from 2019
Môn Tech. Elective Hướng Thiết bị Y tế
Môn 1 Electronic Devices for Biomedical Design (BM089IU)

Môn 2 Medical Instrumentation (BM095IU)
Môn 3 Digital Systems (BM060IU) + Digital Systems Lab (BM061IU)
o Micro-electronic Devices (BM062IU)

o Medical Imaging (BM073IU)
Môn 4, 5,6
o Biomedical Photonics (BM075IU) + Biomedical Photonics Lab (BM076IU)
(chọn 3 môn trong danh
o Information Technology in the Health Care System (BM033IU) + Information Technology
sách bên cạnh)
in the Health Care System Lab (BM070IU)
o Principle of Clinical tests and Instrumentation (BM094IU)
Môn 7 Chọn 1 môn Technical Electives bất kỳ trong danh sách trên
Free Elective courses
From School of Business (BA)/Khoa Quản trị Kinh doanh
• BA154IU - Entrepreneurship and Small Business Management
• BA003IU - Principles of Marketing
• BA035IU - Marketing Research
From School of Industrial Engineering and Management (ISE)/
Khoa Kỹ thuật và Quản lý Công nghiệp
• IS019IU - Production Management
• IS020IU - Engineering Economy
Thesis requirements
• Literature review:
– Identify a biomedical device/product to be commercialized (priority:
the one previously designed in the BME School), its state of
development, its merits and drawbacks,
– Identify the needs of this kind of biomedical device/product,
– Analyze the market and existing products including competition,
cost/price, benefits
Thesis requirements (cont.)
• Investigate one of the following aspects:
– Engineering and technology aspect: improvement to make the device/product
commercially viable, cost effective, to identify manufacturers for mass production
– Legal aspect: identification of the device/product class and methods to obtain
permission for its commercialization, licensing, intellectual property
– Business aspect: market survey, financial/cost analysis for pilot and industrial
production scale, business plan, fund raising, start-up or transfer of technology,
customer segment and finance, marketing channels, management
• Report practical achievements: test, product cost, legal compliance, sale,
benefits/loss, success/failure
• Discussion
• Conclusion
Võ Văn Tới
School of Biomedical Engineering
International University of Vietnam National Universities
HCM City, Vietnam
Email: [email protected]
Website: www.hcmiu.edu.vn/bme
118

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Design of Medical Devices

Prof. Võ Văn Tới

Life and death

Initial Ideas Prototype &

Legal compliance & Scientific research

- Test for reliability

Valve in right No Continue

Initial idea or Device on

Relative Magnitude (AU)

-0.2 Baseline Air Saline

Earliest event time Latest event time Event float time

1. Design specifications: incl. data to achieve, literature

They did it. How can we do better than them?

Do what people think it’s impossible

Take calculated risks

Look to the future and perform well at the present 105

Market Human factors Finance Health Insurance

Ideas Prototype Re-design Production Distribution End users

Intellectual protection Policy Bio-ethics After-sale

Semester 1 Semester 2 Semester 3 Semester 4 Semester 5 Semester 6 Semester 7 Sem. 8

Physics I Chemistry Chemistry Applied Mechanical Machine Design BME Capstone

Critical Principles of Introduction Technical Electives Bioethics

Academic Academic HCM thought Technical Electives

Lab 1A Lab 1B Design 2A Design 2B Project 1 Project 2 Pre-Thesis Thesis

Môn 1 Electronic Devices for Biomedical Design (BM089IU)

Môn 3 Digital Systems (BM060IU) + Digital Systems Lab (BM061IU)

o Micro-electronic Devices (BM062IU)

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