The Human Touch: Develop a Patient-Centric Injection Device Molly Story, PhD 27 September 2017 Photo credits:
Why should we care about being patient-centric? The FDA tells us: Our drugs must be safe and efficacious; Our drug delivery devices must be safe and effective; And we must present the evidence in our regulatory submissions. Is that the only reason we should care? The Human Touch - Develop a Patient-Centric Injection Device Molly Story - 27 September 2017 2
Why should we care about being patient-centric? The drug is great! The delivery device is great! The user? If users can t use the product well, none of that matters! The Human Touch - Develop a Patient-Centric Injection Device Molly Story - 27 September 2017 3
What happens if users can t use the product well? More customer complaints Bigger customer support burden More use errors Higher risk of harm and recalls More patient abandonment / lower compliance rates Less repeat business Fewer prescriptions Lower sales
What government regulation requires HF data? 21 CFR 820.30, Design Controls (a) General (b) Design & development planning (c) Design input (d) Design output (e) Design review (f) Design verification (g) Design validation. Design validation shall ensure that devices conform to defined user needs and intended uses. (g) (f) (c) The Human Touch - Develop a Patient-Centric Injection Device Molly Story - 27 September 2017 5 (d) (e) Source: FDA/CDRH Design Control Guidance (1997), Figure 1
What guidance has FDA published on human factors? Applying Human Factors and Usability Engineering to Medical Devices (CDRH, 2016) This guidance recommends that manufacturers follow human factors or usability engineering processes during the development of new medical devices, focusing specifically on the user interface. The goal is to ensure that the device user interface has been designed such that use errors that occur during use of the device that could cause harm or degrade medical treatment are either eliminated or reduced to the extent possible. The Human Touch - Develop a Patient-Centric Injection Device Molly Story - 27 September 2017 6
What guidance has FDA published on human factors? Define intended uses, use environments, user interface Identify use-related hazards Identify and categorize critical tasks Develop & implement risk mitigation/control measures Validate use safety and effectiveness NO Use-related risks acceptable? YES New use-related risks introduced? NO Document HFE/UE process YES Source: FDA/CDRH HF Guidance (2016), Figure 3 The Human Touch - Develop a Patient-Centric Injection Device Molly Story - 27 September 2017 7
What international standards define HF for devices? IEC 62366-1:2015 (+ IEC TR 6366-2:2016), Medical devices Application of usability engineering to medical devices This international standard describes a usability engineering process to provide acceptable risk related to usability of a medical device. This international standard strictly focuses on applying the usability engineering process to optimize medical device usability as it relates to safety. The companion technical report (IEC 62366-2) is comprehensive and has a broader focus. It focuses not only on usability as it relates to safety, but also on how usability relates to attributes such as task accuracy, completeness and efficiency, and user satisfaction. The Human Touch - Develop a Patient-Centric Injection Device Molly Story - 27 September 2017 8
What international standards define HF for devices? IEC 62366-1:2015 (+ IEC TR 6366-2:2016), Medical devices Application of usability engineering to medical devices Strong focus on safety Removal of terms and concepts: Application specification, Frequently Used Functions, acceptance criteria Retention of terms: Primary Operating Functions, abnormal use Addition of terms and concepts: Use Specification, Hazard-Related Use Scenario, UOUP Introduction of term and method of Formative Evaluation Addition of companion Technical Report (IEC TR 62366-2:2016) Provides much more guidance about how to meet the standard but also how best to utilize a variety of human factors methods The Human Touch - Develop a Patient-Centric Injection Device Molly Story - 27 September 2017 9
What international standards define HF for devices? 5 USABILITY ENGINEERING PROCESS 5.1 Prepare USE SPECIFICATION 5.2 Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS 5.3 Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS 5.4 Identify and describe HAZARD-RELATED USE SCENARIOS 5.5 Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION 5.6 Establish USER INTERFACE SPECIFICATION 5.7 Establish USER INTERFACE EVALUATION plan Source: IEC 62366-1:2015 5.8 Perform USER INTERFACE design, implementation and FORMATIVE EVALUATION 5.9 Perform SUMMATIVE EVALUATION of the USABILITY of the USER INTERFACE 5.10 USER INTERFACE OF UNKNOWN PROVENANCE The Human Touch - Develop a Patient-Centric Injection Device Molly Story - 27 September 2017 10
How much human factors testing is required? Generative Human Factors Evaluations Timing: While the product is still being defined Goal: Understand the users experiences and unmet needs Freedom: Any aspect of the product can be changed $ Formative Human Factors Evaluations Timing: While the medical device user interface is being refined Goal: Develop the right product Freedom: Some aspects of the device can be changed Summative Human Factors Evaluation, $$$$$ a.k.a. Human Factors Validation Testing Timing: After product development is believed to be completed Goal: Ensure that the product will be safe and effective in use Freedom: Usually only the labeling can be changed $$ The Human Touch - Develop a Patient-Centric Injection Device Molly Story - 27 September 2017 11
So who are the users? And who do we test? Health care providers Specialty Experience and training Patients Adults, elders, children Disease effects Experience level Test Participants Match the intended users Minimum of 15 per user group Use environments The Human Touch - Develop a Patient-Centric Injection Device Molly Story - 27 September 2017 12
So how do we assess use-related risks? Task analysis Based on use scenarios Use error analysis Conduct risk assessment: consequences, severity, risk control Simulated-use testing Drug = placebo or mimic Skin = injection pad Critical tasks of use The device can be used safely. Essential tasks of use The device can be used effectively. The Human Touch - Develop a Patient-Centric Injection Device Molly Story - 27 September 2017 13
How can we ensure FDA will accept our methods? It s very simple: Ask them!!! In advance! For example: Request a pre-meeting (e.g. Type C) Discuss regulatory pathway, ask specific questions Submit the protocol for the human factors validation study Ask for approval of methods and approach Submit the (draft) instructions for use Ask for feedback on wording, illustrations, layout The Human Touch - Develop a Patient-Centric Injection Device Molly Story - 27 September 2017 14
Is that sufficient? FDA approved products! Effectiveness Safety Safe and effective products! Safe products! The Human Touch - Develop a Patient-Centric Injection Device Molly Story - 27 September 2017 15
Why might we want to do more? Safe, effective and usable products that customers prefer and love to use! Emotion Preference Usability Safe, effective and usable products that customers prefer! Safe, effective and usable products! Effectiveness Safety The Human Touch - Develop a Patient-Centric Injection Device Molly Story - 27 September 2017 16
Why should we care about being patient-centric? The drug is great! The delivery device is great! The user? If users can use the product well, your product will be much more likely to be safe and effective for the patients and other users and to be commercially successful. The Human Touch - Develop a Patient-Centric Injection Device Molly Story - 27 September 2017 17
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