Mitigating Medical Device Risk through Human Factors. Christina Mendat, PhD Director, Research & Human Factors

Size: px

Start display at page:

Download "Mitigating Medical Device Risk through Human Factors. Christina Mendat, PhD Director, Research & Human Factors"

Betty Arnold
6 years ago
Views:

1 Mitigating Medical Device Risk through Human Factors Christina Mendat, PhD Director, Research & Human Factors

2 A profound statistic one-third of medical device incidents involve user error and more than half of device recalls for design problems involve the user interface FDA spokesperson 2005 Who wants to have a product on the market that is used correctly 60% of the time?

Perception Statistics Experimental Design Anthropometrics & Biomechanics Industrial Design Human

3 So, what is Human Factors? A multidisciplinary field including: Learning & Behavior Cognitive Psychology Sensation & Perception Statistics Experimental Design Anthropometrics & Biomechanics Industrial Design Human Computer Interaction Ultimate Goal of Human Factors is to understand user interactions with product and systems to optimize the user experience and overall system performance.

4 How is Human Factors Unique? Beyond perceptions and attitudes. Multiple scientific-driven methodologies Analysis at multiple stages in the design process. Providing concrete and actionable design inputs.

5 Where else is Human Factors leveraged? Government and consumer sectors of industry have been incorporating human factors for many years: Aviation Transportation Telecommunication Continues to be the trend, in other industries to take a retroactive approach to Human Factors. Validation Testing after Tooling Focus groups after Tooling Risk Mitigation is best accomplished when involved Human Factors early and iteratively.

Movement of HF in Medical Devices Human Factors has received more attention from the medical community with the release of AAMI s standard: HE75 Good resource for Pharma

6 Movement of HF in Medical Devices Human Factors has received more attention from the medical community with the release of AAMI s standard: HE75 Good resource for Pharma Equipment developers. Key point is the importance of risk mitigation and the involvement of human factors early in the design process. Many industries can benefit from this standard.

Standards for HF are not completely new Code of Federal Regulations (Section 820.

7 Standards for HF are not completely new Code of Federal Regulations (Section ) (c) Design input Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the users and patient. (d)design output Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. (g)design validation Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions.

8 But the product works Technical functionality does not guarantee user functionality. Technical functionality does not prevent use errors. Users will do things with your product you never expected. Predicate devices don t guarantee risk mitigation. Instructions for use don t guarantee risk mitigation.

9 Mitigating Risk One Step at a Time

10 User-Centered Risk Mitigation The The user-centered old way of mitigating way of mitigating risk. risk.

11 Design Controls (no HF integration) Design Review (FRM0023) Design Review (FRM0023) Design Review (FRM0023) Design Input Design Output Design Verification Design Validation Design Transfer Product Initiation Summary (FRM0004) Customer Requirements Assessments (FRM0002) Product Performance Requirements Design Documents Mfg. Documents Testing Documents QA Documents B.O.M.s Label Prototypes Packaging Layouts Sterilization Spec (Initial) Design Verification Plan (FRM0024) Report (FRM0069) Design Validation Plan (FRM0026 Service Validation Plan (FRM0027) Report (FRM0028) Regulatory Assessment Plan (FRM0008 FRM0009) Mfg. Assessment Plan (FRM0014) System Level Requirements and Traceability Matrix (FRM0018) PROCESS VALIDATION Process Validation Protocol (FRM0072) Master Validation Plan Equipment IQ/QQ/PQ Sterilization Validation Packaging Validation Supplier Approved Sterilization Assessment Plan (FRM0017) Service Assessment Plan (FRM0021) System Level Requirements and Traceability Matrix (FRM0018) Regulatory Submissions DMR Initial Clinical Studies (if needed) Regulatory Approval DMR Final Device Master Record Release (P0008) Trademark/Patent Assessment (FRM0011) Labeling Assessment Plan (FRM0013) Initial Design and Development Plan (FRM0005) Packaging Assessment Plan (FRM0016) Supplier Assessment (FRM0015) RISK MANAGEMENT Risk Management Plan (FRM0006) Hazard/Safety Analysis (FRM0010) Design FMEA (FRM0036) Application FMEA (FRM0036) Process FMEA (FRM0019) Risk Assess and Control Workbook (P0002, FRM0036) Risk/Benefit Analysis Form (P003, FRM0037) Risk Management Report (FRM0022) Legal Release Authorization Risk Management File Project Schedule Clinical Assessment Plan (FRM0012) Materials Assessment Plan (FRM0007) Design History File Review (FRM0032) Risk Managment Design History File Design and Development Plan Design Changes

12 Design Controls (HF integration) Design Review (FRM0023) Design Review (FRM0023) Design Review (FRM0023) Design Input Design Output Design Verification Design Validation Design Transfer Product Initiation Summary (FRM0004) Customer Requirements Assessments (FRM0002) Product Performance Requirements Design Documents Mfg. Documents Testing Documents QA Documents B.O.M.s Label Prototypes Packaging Layouts Sterilization Spec (Initial) Design Verification Plan (FRM0024) Report (FRM0069) Design Validation Plan (FRM0026 Service Validation Plan (FRM0027) Report (FRM0028) 1 Exploratory Research Identifying opportunity areas via research methods 2 3 HF/E RESEARCH ACTIVITIES Competitve Bechmarking (if applicable) Field Observations Structured Interviews Video Analyses HF/E GUIDELINES Physical Ergo Standards Cognitive Ergo Standards GUI Standards (if applicable) 5 Regulatory Assessment Plan (FRM0008 FRM0009) HF Regulatory Assessment Sterilization Assessment Plan (FRM0017) Trademark/Patent Assessment (FRM0011) 8 Mfg. Assessment Plan (FRM0014) HF Sterilization Assessment Service Assessment Plan (FRM0021) Labeling Assessment Plan (FRM0013) System Level Requirements and Traceability Matrix (FRM0018) Heuristic Evaluation Label Prototypes 11 Supplier Approved Regulatory Submissions HF File FORMATIVE TESTING #1 Use-case based Tasks Ratings, Questionnaires DMR Initial System Level Requirements and Traceability Matrix (FRM0018) FORMATIVE TESTING #2 Use-case based Tasks Ratings, Questionnaires HF/E Requirements Tracing of human factors and ergonomics to product design PROCESS VALIDATION Process Validation Protocol (FRM0072) Master Validation Plan Equipment IQ/QQ/PQ Sterilization Validation Packaging Validation Clinical Studies (if needed) Regulatory Approval DMR Final Device Master Record Release (P0008) Initial Design and Development Plan (FRM0005) 4 Project Schedule Human Factors Integration Plan 6 7 HF Labeling Assessment HF Packaging Asessment Clinical Assessment Plan (FRM0012) Packaging Assessment Plan (FRM0016) Supplier Assessment (FRM0015) Materials Assessment Plan (FRM0007) 9 RISK MANAGEMENT Risk Management Plan (FRM0006) Hazard/Safety Analysis (FRM0010) Design FMEA (FRM0036) Application FMEA (FRM0036) Process FMEA (FRM0019) Risk Assess and Control Workbook (P0002, FRM0036) Risk/Benefit Analysis Form (P003, FRM0037) Risk Management Report (FRM0022) Human Error Safety & Risk Assessment 15 Human Error Safety & Risk Assessment Legal Release Authorization Risk Management File Design History File Review (FRM0032) Validation/Verification Testing HF File Risk Managment Design History File Design and Development Plan Design Changes Human Factors Integration Plan

13 Putting this into Action

Develop a plan Human Factors Integration Plan: Defining a path for various human factors activities and evaluations with the ultimate goal of mitigating risk one step at a time.

14 Develop a plan Human Factors Integration Plan: Defining a path for various human factors activities and evaluations with the ultimate goal of mitigating risk one step at a time. Human Factors File: Design History File should include a human factors file. Human Factors file includes all the human factors activities, design inputs, formative and summative reports. What submissions need HF? 510K PMA NDA is your drug in a device? Will it be a part of a system?

Age Abilities Limitations (modality-specific) Will users be

15 Who are your users? This is KEY! What is the primary condition? What are associated comorbidities? Who are the users? Age Abilities Limitations (modality-specific) Will users be trained on your device? Training documentation? Health care professionals? Environment?

Identify risks early and continue to evaluate Human Error Safety Risk Assessment/uFMEA: The primary goal of a HESRA/uFMEA is to proactively identify elements of a product, system or process

16 Identify risks early and continue to evaluate Human Error Safety Risk Assessment/uFMEA: The primary goal of a HESRA/uFMEA is to proactively identify elements of a product, system or process that present high risk of human errors that might lead to serious consequences which can be a product of perception, behavior, potential interactions, etc. Knowing your user makes this possible

Heuristic Evaluate Analysis early and often

Experts in human factors and usability can provide

-Human factors design principles -Compliance with

17 Heuristic Evaluate Analysis early and often (expert-based) Expert-based Heuristic Analysis: Experts in human factors and usability can provide early feedback on medical device designs using: -Human factors design principles -Compliance with standards and guidelines -Setup, use, breakdown -Labeling and instructions

18 Formative Conduct Formative Testing Research Per AAMI s standard, HE75: 3.39 Formative usability testing is usability testing that is performed early with simulation and the earliest working prototypes and that explores whether usability objectives are attainable, but without strict acceptance criteria Know your user Know where your product will be used Know the user-associated risks Know your open questions and/or concerns (i.e. size, force, intuitiveness)

19 Generative Conduct Formative research Research (continued) Formative research should be iterative Iteration allows a company to focus on different topics: Instructions for use User limitations and abilities Labeling Overall ease of use Early validation of claims 5 8 participants per Unique user group 19 19

Formative Conduct Summative Testing Testing Per AAMI s standard, HE75: 9.3.1.

20 Formative Conduct Summative Testing Testing Per AAMI s standard, HE75: Summative usability testing is performed late in design as part of a formal verification and validation and should have formal acceptance criteria (e.g., usability objectives for human performance). Instructions for use should be final Medical device should be production-like or ready Training materials should be established Critical and non-critical use-errors should be identified participants per Unique user group

21 Conduct Summative Testing (continued) Explain the Errors What kind of use-errors? Critical failure Non-critical failure Close call Unanticipated error or action Example: 2 Patients and 1 Caregivers recorded a non-critical partial dose failure: Reasons for Partial Dose: Wet Dose resulting from holding the button Didn t wait 15 seconds after injection

22 Risk Mitigation through Human Factors Human Factors is best when leveraged proactively and iteratively Identify your risk and opportunities early on. Make informed decisions throughout and be accountable for them. Validate your product/systems and decisions. Mitigate risk one step at a time!

23 Thank you

The Complete Guide to FDA Design Controls

The Complete Guide to FDA Design Controls Jon D. Speer Founder & VP QA/RA of greenlight.guru ABOUT THE PRESENTER Jon D. Speer is the founder and VP of QA/RA of greenlight.guru 20+ years in medical device