Software Interface Design for Medical Devices

Integrated Computer Solutions Inc. www.ics.com
Software Interface Design
for Medical Devices
Presented by Rex Palmer
Principal User Experience Designer, ICS
1

About ICS and Boston UX
2
Delivering Smart Devices for a Connected World
ICS:
● Founded in 1987
● Provides integrated custom software development services across
many high-performance industries from medical to manufacturing
● Embedded, touchscreen, mobile and desktop applications
● Largest source of independent Qt expertise in North America
● HQ in Waltham, MA with offices in California, Canada, Europe
Boston UX:
● Part of the ICS family, focusing on UX design
● Designs compelling touchscreen interfaces for high-impact embedded and
connected medical, industrial and consumer devices

Agenda
3
• The role of poor design in medical errors
• The benefits of UX design for medical device software
• Software design as a cause of device recalls
• Relevant international standards and FDA regulations
• The emergence of software as a medical device (SaMD)

Poll Question
4

Software Design for Today’s Devices
5
• In many industries, hardware companies are increasingly becoming software
companies
• Building great software has always been challenging
• Smart, connected devices increase the challenge significantly
• Great software starts with serious attention to user experience

Case Study: Patient Controlled Analgesia Pump
6
4:30pm Feb 27, 2000
• Danielle McCray admitted to Tallahassee
Memorial hospital to deliver a baby
6:45pm Feb 27, 2000
• Connected to a patient-controlled analgesia
machine (programmable infusion pump)
Vicente (2006 ) p.142
2:30am Feb 28, 2000
• She had died of morphine overdose
Cause: “human error” Representative PCA only

Case Study - continued
7
• The PCA that Danielle McCray used required up to 27 programming steps
• “Human error” caused 68% of fatalities and serious injuries associated
with this device
• During a 12-year period, improper programming of this device caused at
least 65 deaths (Estimates range as high as 667)
Vicente (2006 ) p.143

Case Study - Denial
8
1996 - Warning: potential interface issues
1997 - Warning: Device “susceptible to misprogramming”
Company response: problem was not with the design, but lack of user training
Kim Vicente: The Human Factor, Routledge, 2006

Medical Error:
Third Leading Cause of Death in the U.S.
9
Martin A Makary, Michael Daniel. BMJ 2016; 353: i2139 (03 May 2016)

Bad Apples or Bad Design?
10
• The “bad apple” argument blames the user
• Use errors are not necessarily user errors
• Use error: “User action or lack of action that was
different from that expected by the manufacturer and
caused a result that:
FDA 1757: “Applying Human Factors and Usability Engineering to Medical Devices” (2016)
1. was different from the result expected by the user and...
2. was not caused solely by device failure and...
3. did or could result in harm”

How Many Use Errors Result
from Poor Design?
11
Kim Vicente: The Human Factor, Routledge, 2006

Use Errors and User Interface Design
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• More than one third of medical device incident reports involve use error
• More than one half of the recalls due to design problems can be traced to the
design of the user interface

Patterson, Patricia A. 2010

“
Design modifications to [a] device and its user
interface are generally the most effective means
for eliminating or reducing use-related hazards.
13
FDA 1757.” (2016)

Case Study - Redesign
Modifications included:
● A dialog structure with fewer steps
● A dialog overview showing the user's location in the programming sequence
● Better command feedback
● Easier error recovery
● Clearer labels and messages
14
Vicente. 2006. p.143
Lin, Laura. 1998

Case Study – PCA Programming
15
Lin, Laura, et al. 2001
Old Interface New Interface

Case Study - Results
Programming steps
User errors
Task time
16
Vicente:, 2006. p.143
Lin, Laura.. 1998
The specific programming error that had been linked to patient
deaths was eliminated
55%
56%
18%

What is User Experience Design?
17

UX Design for Medical Device Software:
Like UX Design for Anything, Except…
18
• Stakes
• Safety and risk management
• Regulation
• Documentation
• Best practices are crucial
• Guidance available
• Need for extra rigorous testing

UX Design for Medical Device Software
19
● UX design for device software is not blind adherence to a set of
guidelines; it is the sum of several processes
● The general discipline of User Experience Design practiced with an
awareness of medical standards and safety requirements
AAMI HE 75. 2006 R 2016

Focus on Safety: What is risk?
20
R = H x P

Focus on Safety:
Use-related risk management process
21
Includes:
• Use error analysis – iterated throughout the design process
• Hazard analysis
• Failure Mode Effects Analysis (FMEA)
• Usability testing- focused on detecting potential use errors
• CAPA plans - preventative measures related to use-error mitigation

Focus on Safety: More Than Risk Management
22
In addition to risk, the design process must consider the
severity of potential harms.

Focus on Safety: Sample sizes for user testing
23
Faulkner, 2003; HE75 p40
Percentage
of total
known
usability
problems
found
Number of users per group

Benefits UX-based Design
24
• Increases safety
• Reduces use error
• Decreases training time
• Increases ease of use
• Enhances user satisfaction
• Improves patient outcomes
• Improves task performance and optimal
device use
• Facilitates recovery from use error
• Reduces product liability risks
• Facilitates the regulatory approval process
• Increases the chance of commercial success
AAMI HE75 2006 R 2016

International and National Standards
25
International
United States

Some Important Standards
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• ANSI/AAMI HE75 Human factors engineering –Design of medical devices
• ISO 13485 Quality management systems for medical devices
• ANSI/AAMI/IEC 62304 Medical device software—Software life cycle processes
• ANSI/AAMI/IEC 62366 Application of usability engineering to medical devices

ANSI/AAMI HE75
27
Human factors engineering –Design of medical devices

ISO 13485
Quality management systems for medical devices
28

ANSI/AAMI/IEC 62304
Medical device software—Software life cycle processes
29

ANSI/AAMI/IEC 62366
Risk management for medical devices
30

Poll Question
31

National Regulatory Bodies
32

Regulation in the USA: Food and Drug Administration
33
FDA 1757. 2016
● Center for Devices and Radiological Health (CDRH)
● Focus is on safety and effectiveness

FDA Device Classification
● Class I - low risk
● Class II - moderate risk
● Class III - high risk
34

FDA Design Controls: 21 CFR 820.30
● Federal regulation of medical device design process
● CDRH enforces
● Device makers must comply
35

FDA Design Controls
36
Wilbon, Tonya A. (2018)

Compliance vs Quality
● Compliance and quality are not the same thing
● Quality is more important
37

FDA 1757
38

FDA Recall Data
39
Top 10 FDA medical device recalls classified by violated regulation, FY 2010 – FY 2012
FDA, CRDH. “Medical Device Recall Report FY2003 to FY2012” 2013.

FDA Recall Data
40
Reasons for FDA medical device recalls FY 2010 – FY 2012

FDA Recall Data
41
Most Common Cause of Recall – Software Design Failures
Number of Software Cause Recall Events by Fiscal Year 2008 - 2012

Integrated Computer Solutions Inc. www.ics.com 42
Recall Cause Categories, FY 2010 - 2012
FDA Recall Data

New Category of Regulation:
Software as a Medical Device (SaMD)
43
• Definition: Software intended to be used for one or more medical
purposes that perform these purposes without being part of a
hardware medical device.

Software as a Medical Device (SaMD) Examples
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• Software as active therapeutic medical device
• Computer Aided Detection systems
Qualification and Classification of Stand Alone Software -MEDDEV 2.1/6 July 2016 EUROPEAN COMMISSION
DG Internal Market, Industry, Entrepreneurship and SMEs Directorate Consumer, Environmental and Health Technologies Unit Health technology and Cosmetics

Software as a Medical Device (SaMD)
45
• International Medical Device
Regulators Forum (IMDRF) has
developed a framework for
regulating SaMD
• FDA and European Commission have adopted that
framework as guidance
• More regulation is expected to follow

Review
46

Conclusion
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Our relationship to technology is undergoing a revolution marked by an
understanding that technology must be fitted to human abilities…
…not the other way around
Software controls for medical devices are a critical part of this revolution

Thanks for Attending!
48
Rex Palmer — rpalmer@ics.com

Sources
49
Association for the Advancement of Medical Instrumentation. ANSI/AAMI HE75:2009/ (R)2013 Human factors engineering
–Design of medical devices. 2013.
International Electrotechnical Commission. ANSI/AAMI/IEC 62304 2006 & A1:2016: Medical device software--Software life cycle
processes. 2016.
Faulkner, Laura. “Beyond the five-user assumption: Benefits of increased sample sizes in usability testing.” Behavior Research
Methods, Instruments, & Computers. 2003
IMDRF SaMD Working Group. Software as a Medical Device (SaMD): Key Definitions. International Medical Device Regulators
Forum. 9 December 2013
Lin, Laura, et al. “Patient Safety, Potential Adverse Drug Events, and Medical Device Design: A Human Factors Engineering
Approach.” Journal of Biomedical Informatics. 2001.
Lin, Laura. “Human Error in Patient-Controlled Analgesia: Incident Reports and Experimental Evaluation.” Proceedings of the
Human Factors and Ergonomics Society Annual Meeting. 1998.
Makary, Martin A, and Daniel, Michael. “Medical error--the third leading cause of death in the US” British Medical Journal (BMJ),
2016
Patterson, Patricia A. and North, Robert A. “A Sneak Preview of FDA's Human Factors Standard.” Qmed. Medical Device and
Diagnostic Industry. 2010.

Sources
50
Speer, John. “The Ultimate Guide to Design Controls for Medical Device Companies.” GreenLight Guru: (eBook)
Stewart, Patrick J., et al. Software as a Medical Device (SAMD): Clinical Evaluation – Guidance for Industry and Food and Drug
Administration Staff. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and
Radiological Health, 2017.
Story, Mary Folette, PhD. “The FDA Perspective on Human Factors in Medical Device Software Development.” IQPC Software
Design for Medical Devices Europe. 2012.
U.S. Food, Drug Administration, Center for Devices, Radiological Health, Office of Compliance Division of Analysis, and Program
Operations. “Medical Device Recall Report FY2003 to FY2012.” 2013.
U.S. Food, Drug Administration, Code of Federal Regulations. Title 21, Volume 8. Revised as of April 1, 2018.
Van Schooenderwoert, Nancy and Shoemaker, Brian. Agile Methods for Safety-Critical Systems: A Primer Using Medical Device
Examples. Lean-Agile Partners and ShoeBar Associates, 2018
Vicente, Kim. The Human Factor: Revolutionizing the Way People Live with Technology. Routledge, 2006.
Wilbon, Tonya A. “An Introduction to the Quality System Regulation and Design Controls.” (webinar) 2018.

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