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Connected devices
1.
Shannon Clark, Founder
& CEO UserWise, Inc. January 2019 How to Enhance the User Experience of Connected Devices for Digital Platforms
2.
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. 2 Company Mission
3.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. 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 3
4.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. • 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 2 3 4 4 Overview 1
5.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. 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? 5
6.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. 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: 6 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)
7.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. 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 7
8.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. 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 8
9.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. Is This a Connected Device? 9 Glucose Monitor Mobile EKG Monitor
10.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. Types of Connected Medical Devices Diagnostic Monitoring Portable Therapeutic Surgical Combination Example device Example device Example device Example device 10
11.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. 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 11
12.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. 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 12
13.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. • 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 2 3 4 1 Overview 13
14.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. 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. 14 Purposes: • Provide design considerations • Provide recommendations for information to include in pre-market submissions and device labeling
15.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. 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 15 Efficiency/innovation/new HC models
16.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. 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? 16
17.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. 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? 17
18.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. 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 18
19.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. • 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 2 3 4 1 Overview 19
20.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. 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: 20 Simple Modern Engaging Persona l Accessible Contextual
21.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. Kaiser Web App Features 21 Access physicians through appointment system Access doctors through messaging system Access current medications and medical records
22.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. 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 22
23.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. 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 23
24.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. 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. 24
25.
www.UserWiseConsulting.com Copyright © 2018,
UserWise, Inc. • 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 1 2 3 4 25
26.
Shannon Clark, Founder
& CEO UserWise, Inc. January 2019 Thank you!