Connected devices

Shannon Clark, Founder & CEO
UserWise, Inc.
January 2019
How to Enhance the User Experience of Connected
Devices for Digital Platforms

www.UserWiseConsulting.com
Copyright © 2018, UserWise, Inc.
To inspire usability engineering best practices within medical device companies
and to facilitate the development of usable medical devices.
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Company Mission

Goals
• Gain familiarity with mobile app
and connected device FDA
regulations
• Walk through case studies
• Review applications for
connected medical devices
• Review common pitfalls related to
connected devices and digital
health
• Consider Human Factors strategy
and details of usability testing for
apps and connected devices
Overall: to gain insights and tools to evaluate and design
connected medical devices
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• Connected Devices and Digital Health – Current and Future Applications
• Overview of Applicable U.S. FDA Usability Engineering Requirements &
Regulatory Requirements for Connected Devices and Digital Health
• Review Unique Usability Engineering Considerations Related to
Connected Devices
• Conclusion and Q & A
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Overview
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Connected medical devices are medical devices that exchange and use
information with at least one other product, technology, or system.
What are Connected Medical Devices?
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What are not Connected Devices?
The FDA has not yet provided guidance as to what is not considered a
connected (“interoperable”) device, but their 2015 guidance “Mobile Medical
Applications,” Appendix A does provide some insight into this.
Examples of products that are not connected medical devices:
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Connected, but not a medical device A medical device, but not connected
Low risk general wellness products Traditional AED
Electronic health records Traditional autoinjector
Portal for training and reference materials Gigli saw (bone cutter for amputation)

BETACONNECT
Autoinjector and
myBETAapp
• Autoinjector and connected app
for patients with multiple
sclerosis (MS)
• Calendar for injections
• Tracks injection site rotation
• Records how you feel with
Wellness Tracker
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Medtronic MiniMed
670G
• Closed-loop system calculates
blood glucose adjustments and
administers insulin automatically
• Garg et al. (2017) reported that
patients using this product
experienced:
• Fewer high and low blood
glucose readings
• More time in ideal range
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Is This a Connected Device?
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Glucose Monitor Mobile EKG Monitor

Types of Connected Medical Devices
Diagnostic Monitoring Portable
Therapeutic Surgical Combination
Example device Example device Example device
Example device
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Potential Uses: Manufacturers
• Clinical and ethnographic research
• Gather data more accurately
and efficiently
• Reduce costs with improved
adherence
• Post-market surveillance for
adverse event reporting and future
improvement
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Potential Uses: HCPs and Caretakers
• Access to patient data and logging
information
• Access to patient medication needs
• Reduce data that is unused but
takes up memory or physical space
• Patient monitoring
• Medication/operation support
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Connected Devices
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Overview
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Introduction: FDA’s “Interoperable Medical Devices”
The FDA calls the ability to connect devices and systems “medical device
interoperability,” and supplied a guidance in 2017.
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Purposes:
• Provide design considerations
• Provide recommendations for
information to include in pre-market
submissions and device labeling

FDA’s Foci
Through the sharing of information,
interoperable medical devices
promote:
• Efficiency
• Innovation
• “New models of health care
delivery,” including across products
from different manufacturers
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Efficiency/innovation/new HC models

Risk Analysis Considerations
Safety and risk assessment remains central to the device design process.
In risk analysis and testing, consider:
• What are the risks with interoperability?
• Who are the anticipated users (more than only the intended users)?
• What are the reasonably foreseeable misuses?
Also consider:
• What are the reasonably foreseeable combinations of events that can
result in a hazardous situation?
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Risk Management
Considerations
Considerations:
• Does implementation and use of the interface
degrade the basic safety or risk controls of the
device?
• Does implementation and use of the interface(s)
degrade the essential performance of the device
as defined in IEC 60601-1?
• Are the appropriate security features included in
the design?
• Is the device able to handle data that is corrupted
or outside the appropriate parameters?
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Mitigate Failures and Malfunctions
Safety must be maintained during normal and fault
operations. Mitigate failures or malfunctions
caused by:
• Direct or indirect connection of intended devices
• Invalid commands
• Receiving and processing erroneous data or
commands
• Not adhering to the non-functional requirements
of the communication specification
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Connected Devices
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Overview
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Connected Product: Kaiser Permanente Web App
In response to poor user experience (UX) ratings and increasing competition
and online usage, Kaiser Permanente worked with Redshift Digital to
reimagine their website and patient web portal.
They developed the following UX goals for their web application:
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Simple Modern Engaging
Persona
l
Accessible Contextual

Kaiser Web App Features
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Access physicians through
appointment system
Access doctors through
messaging system
Access current medications
and medical records

Kaiser Web App Development Process
Delivery
Problem Definition and
User Research
● Audit of websites
● User research:
context of use,
competitive analysis,
industry benchmarks,
user needs (both
online and in physical
locations)
● Prioritize use cases,
features, and design
principles
● Ideate
Iterative Building
and Testing
● Prototype
● Formative user testing
● Build realistic product
● Usability validation
testing
● Prepare final assets for
delivery
● Perform QA
● Polish, package, and deliver
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Kaiser Web App Study Approach
Intended Users
Leaders, family
members,
partners, and
support team
members
Use Environment
Home
Training Decay
None
Medical Devices
None
Training
None – users will
not receive
training in reality
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Kaiser Web App UE Considerations
Usability engineering considerations during development of an app and
connected device:
• Focus on human factors early in development to determine user needs.
• Focus on developing an interface that intuitively meets user expectations.
• Leverage non-medical sources and interfaces to ensure that there is no
negative transfer. Users will be coming in with prior expectations drawn
from other digital devices and interfaces.
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• Connected devices exchange information. This exchange must be
considered in terms of usability, device reliability, safety, and security.
• Safety and risk management remain central to the device design
process for connected devices.
• The same usability engineering process should be used on connected
devices, including: risk management, formative and usability validation
testing.
• There are many resources currently available, including guidance
documents, devices on the market, and other sources.
Conclusion
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Shannon Clark, Founder & CEO
UserWise, Inc.
January 2019
Thank you!

Connected devices

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