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HFE for Medical Devices
mHealth Israel
Yakir Yaniv
June 18, 2018
USER INTERFACE
› GUI definition
› Usability of products
and machinery
› Interface design
RESEARCH & TESTING
› Users research
› Usability testing
› Prototyping
ERGONOMICS
› Ergonomic analysis
› Ergonomic solutions
design
› Production flow
optimization
ED&U Studio
HF Engineering Solutions
s
ED&U Studio
HF Engineering
Human Factors Engineering (HFE) is the discipline of
applying what is known about human capabilities &
limitations to the design of products, processes, systems,
and work environments.
It is distinctive in being the only discipline that relates
humans to technology.
HFE objectives are to improve EOU, safety and productivity
Design
Engineering Human
Factors
Human
Factors
• Ease of use
• UX / UI
• Ergonomics
• Error prevention
• Mental models
• Operational concept
User
Function
Environment
Usability
Usability is the extent to which a product can be used by
specified users to achieve specified goals with effectiveness,
efficiency, and satisfaction in a specified context of use.
Usability is a qualitative attribute that assesses how easy user
interfaces are to use.
Usability Factors
• Learnability
• Efficiency of use
• Memorability
• Errors
• Subjective satisfaction
•‫ע‬‫ק‬‫ו‬‫מ‬‫ת‬‫ל‬‫מ‬‫י‬‫ד‬‫ה‬
•‫י‬‫ע‬‫י‬‫ל‬‫ו‬‫ת‬
•‫ז‬‫כ‬‫י‬‫ר‬‫ו‬‫ת‬
•‫ט‬‫ע‬‫ו‬‫י‬‫ו‬‫ת‬
•‫ש‬‫ב‬‫י‬‫ע‬‫ו‬‫ת‬‫ר‬‫צ‬‫ו‬‫ן‬
Usability engineering
process
HFE Process
User Research
Concept Design
Design Feedback
Interface definition
Design
Usability Testing
Population definition, interviews, user expectations
Task analysis, flow description, interaction
definition, ergonomic requirements
Detailed screens and controls
Graphic design, industrial design,
mechanical design
Hi & lo fidelity prototypes, simulations,
Alpha products
Usability Testing
Usability Testing
User story
Concept design
• Users (patients & therapists) need research
• Solution definition
• Medical cases research
• App definition, design and development
Sensor
Set up
(Password protected)
Each	line	can	be	expanded	by	
clicking	“+”	to	expose	more	data	
(detailed	in	next	slide)
1. Sensor	data	update.	
2. Data	shall	be	updated	by	a	
technician		
3. Requires	password	to	protect	
unintended	 changes
4. Relevant	data	is	always	presented
Sensor	name	– as	given	by	
technician
1. Sensor	real	time	status.	
2. Options:
- Connected	(green)	– sensor	
connected	and	moving
- Sandby (orange)	– sensor	
connected	and	not	moving
- Blank	– sensor	not	
connected
1. Real	time	battery	status	as	
reported	by	Gemsense application
2. Icon	color:
- >15%	- green
- <15%	- red
1. Sensor	location	presented	on	a	
crutches	schem
2. The	crutches	schem is	a	static	
figure
3. Labels	location	are	static.	One	at	
the	bottom	and	one	near	the	
handle
4. The	names	will	be	presented	
according	to	the	actual	location	of	
the	physical	sensors
RL
UX Design
Error
prevention
Mental
model
Error
prevention
Error
prevention
Error
prevention
The effect of HFE on a PRODUCT
• Ease of use
• Safe working environment
• Error prevention
• Shortening training time
• Reduction of service costs
• Satisfied users
“ If the user can’t use it, it doesn’t work”
Susan Dray
Dray & Associates, Inc
Good design is
all about people
WWW.EDU-STUDIO.NET
+972.54.644.5158 yakir@edu-studio.net
+31.61.3102207 noa@edu-studio.net

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mHealth Israel_Human Factors Engineering for Medical Devices_Yakir Yaniv

  • 1. HFE for Medical Devices mHealth Israel Yakir Yaniv June 18, 2018
  • 2. USER INTERFACE › GUI definition › Usability of products and machinery › Interface design RESEARCH & TESTING › Users research › Usability testing › Prototyping ERGONOMICS › Ergonomic analysis › Ergonomic solutions design › Production flow optimization ED&U Studio HF Engineering Solutions
  • 4. HF Engineering Human Factors Engineering (HFE) is the discipline of applying what is known about human capabilities & limitations to the design of products, processes, systems, and work environments. It is distinctive in being the only discipline that relates humans to technology. HFE objectives are to improve EOU, safety and productivity
  • 6. Human Factors • Ease of use • UX / UI • Ergonomics • Error prevention • Mental models • Operational concept
  • 8. Usability Usability is the extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency, and satisfaction in a specified context of use. Usability is a qualitative attribute that assesses how easy user interfaces are to use.
  • 9.
  • 10. Usability Factors • Learnability • Efficiency of use • Memorability • Errors • Subjective satisfaction •‫ע‬‫ק‬‫ו‬‫מ‬‫ת‬‫ל‬‫מ‬‫י‬‫ד‬‫ה‬ •‫י‬‫ע‬‫י‬‫ל‬‫ו‬‫ת‬ •‫ז‬‫כ‬‫י‬‫ר‬‫ו‬‫ת‬ •‫ט‬‫ע‬‫ו‬‫י‬‫ו‬‫ת‬ •‫ש‬‫ב‬‫י‬‫ע‬‫ו‬‫ת‬‫ר‬‫צ‬‫ו‬‫ן‬
  • 12.
  • 13.
  • 14. HFE Process User Research Concept Design Design Feedback Interface definition Design Usability Testing Population definition, interviews, user expectations Task analysis, flow description, interaction definition, ergonomic requirements Detailed screens and controls Graphic design, industrial design, mechanical design Hi & lo fidelity prototypes, simulations, Alpha products Usability Testing Usability Testing
  • 17. • Users (patients & therapists) need research • Solution definition • Medical cases research • App definition, design and development Sensor Set up (Password protected) Each line can be expanded by clicking “+” to expose more data (detailed in next slide) 1. Sensor data update. 2. Data shall be updated by a technician 3. Requires password to protect unintended changes 4. Relevant data is always presented Sensor name – as given by technician 1. Sensor real time status. 2. Options: - Connected (green) – sensor connected and moving - Sandby (orange) – sensor connected and not moving - Blank – sensor not connected 1. Real time battery status as reported by Gemsense application 2. Icon color: - >15% - green - <15% - red 1. Sensor location presented on a crutches schem 2. The crutches schem is a static figure 3. Labels location are static. One at the bottom and one near the handle 4. The names will be presented according to the actual location of the physical sensors RL UX Design
  • 22. The effect of HFE on a PRODUCT • Ease of use • Safe working environment • Error prevention • Shortening training time • Reduction of service costs • Satisfied users
  • 23. “ If the user can’t use it, it doesn’t work” Susan Dray Dray & Associates, Inc
  • 24. Good design is all about people WWW.EDU-STUDIO.NET +972.54.644.5158 yakir@edu-studio.net +31.61.3102207 noa@edu-studio.net