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

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

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

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)

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

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

Regulatory Basis for Human Factors in Medical Devices 21 CFR 820.30 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

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.”

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

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

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.

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

HF considerations in Digital Health Relevant Guidance Documents: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf https://www.fda.gov/MedicalDevices/DigitalHealth/ucm562577.htm

Requests for Feedback and Meetings for Medical Device Submissions Q-submission Program https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program Pre-Submission - Informational Meeting Study Risk Determination Agreement Meeting Determination Meeting Submission Issue Meeting Day 100 Meeting

CDRH Human Factors Mailbox HFPMET@fda.hhs.gov

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