1. Human Factors in Digital Health
Kimberly Kontson, Biomedical Engineer, CDRH, FDA
Yarmela Pavlovic, Partner, Hogan Lovells US LLP
Kimberly Snyder, Senior Partner, Validant
Moderated by Karen Corallo, Of Counsel, Skadden, Arps, Slate, Meagher & Flom LLP

2. Human Factors in Digital Health
Medical Devices: FDA Regulation in the Era of Technology and Innovation
San Francisco, CA
June 6, 2019
Kimberly Kontson, Ph.D.
Biomedical Engineer
Human-Device Interaction Laboratory
Division of Biomedical Physics
Office of Science and Engineering Laboratories
Center for Devices and Radiological Health

3. Increasing Complexity
Humans are exceptionally good at dealing with complexity,
HOWEVER,
sometimes the rational action in the moment can have unintended consequences

4. What is Human Factors (HF)?
Ergonomics (or human factors) is the scientific discipline concerned with the understanding of interactions among humans and other elements of a system, and the profession that applies theory, principles, data and methods to design in order to optimize human well-being and overall system performance.
International Ergonomics Association (IEA)

5. Goals of incorporating HF
Provide the best possible user experience
Combat the medical error problem1
Reduce risk of use errors resulting in harm or compromised medical care
Optimized
design
Original
design
Low
High
Risk Level
1www.ncbi.nlm.nih.gov/books/NBK225187

6. Goals of incorporating HF
Provide the best possible user experience
Combat the medical error problem1
Reduce risk of use errors resulting in harm or compromised medical care
Optimized
design
Original
design
Optimized
design
Original
design
Low
High
Risk Level
1www.ncbi.nlm.nih.gov/books/NBK225187

7. Regulatory Basis for Human Factors in Medical Devices
21 CFR
Design controls
Design input
Address intended use of the device, including needs of user/patient
Design verification
Confirm design output meets design input requirements
Design validation
Ensure device conforms to user needs…and includes testing of production units under actual or simulated use testing
Product development

8. Regulatory Basis for Human Factors in Medical Devices
Medical Devices; Current Good Manufacturing Practice (cGMP); Quality System Regulation Preamble to Final Rule 21 CFR Parts 808, 812, and 820 (61 FR 52502)
i.72. “…when designing a device, the manufacturer should conduct appropriate human factors studies, analyses, and tests from the early stages of the design process until that point in development at which the interfaces with the medical professional and the patient are fixed…”
i.159. “…FDA emphasizes that any death, even if the manufacturer attributes it to user error, will be considered relevant by FDA and will have a high risk potentially associated with it. User error is still considered to be a nonconformity because human factors and other similar tools should have been considered during the design phase of the device.”

9. 2016 FDA CDRH HF Device Guidance
Aims to clarify expectations around:
applying HFE to medical device development,
when to submit a HF report for a pre-market submission, and
the content of the HF report

10. Information Perception
User
Cognitive Processing
Information Perception
Control Action
Use error
Hazard
USER INTERFACE
Device
Output
Input
Processing & Reaction
Critical task: A user task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care.
Adapted from Redmill and Rajan, 1997

11. HF considerations in Digital Health
Mobile Medical Applications
Three levels: Regulatory oversight, enforcement discretion, and apps that are not medical devices.
HF will be required depending on the evaluated risk level.

12. HF considerations in Digital Health
Define intended users, use environments & UI
Identify use-related hazards; identify and categorize critical tasks
Develop and implement risk mitigation/control measures
Naïve users or negative transfer effects
Overreliance on technology output
Training expectations
Representative use scenarios to evaluate critical tasks
Validate use safety and effectiveness
Document HFE/UE process

13. HF considerations in Digital Health
Relevant Guidance Documents:

14. Requests for Feedback and Meetings for Medical Device Submissions
Q-submission Program
Pre-Submission -
Informational Meeting
Study Risk Determination
Agreement Meeting
Determination Meeting
Submission Issue Meeting
Day 100 Meeting

15. CDRH Human Factors Mailbox

17. Human Factors in Digital Health
Kimberly Kontson, Biomedical Engineer, CDRH, FDA
Yarmela Pavlovic, Partner, Hogan Lovells US LLP
Kimberly Snyder, Senior Partner, Validant
Moderated by Karen Corallo, Of Counsel, Skadden, Arps, Slate, Meagher & Flom LLP