Presentation
Designing the Right Device the Right Way: HFE Incorporation Throughout Product Development
SessionPoster Session 1
DescriptionHuman Factors Engineering (HFE) has often been thought to apply for validation activities, as summative studies are frequently required for medical devices and combination products to submit to regulatory bodies. However, it is still an ongoing effort to encourage industry recognition that HFE can be utilized for additional assessments throughout the product development process beyond validation studies. There are opportunities well in advance of design validation to incorporate user touchpoints to get productive feedback to improve a product that manufacturers can take advantage of. As such, this presentation aims to outline the key areas where HFE can play additional roles during development to the advantage of overall product success, as well as provide techniques to communicate this importance to key stakeholders and effectively integrate HFE into discussions throughout the process.
This presentation will step through a few case studies for the audience to highlight theoretical scenarios that may be applicable, and various HF techniques and strategies to utilize in their own practice such as:
• Force injection usability study results informing user requirements (e.g., injection time, force to inject, force acceptability thresholds)
• Iterative IFU Testing providing users the opportunity to review, use, and recommend changes for IFUs to work collaboratively with end users towards clear and understandable labeling
• Inclusion of ease of use assessments with representative end users into early clinical trail questionnaires (e.g., End of study questionnaire for the participant to evaluate the ease of using the product, in conjunction with their actual use experience).
• Sketches, 3D printed mockups, and virtual concept assessments to orient development engineering and end user expectations on a product (e.g., product dimensions, form factor acceptability, audible/visual/tactile alerts)
• And more!
o Human Capability Requirements
o Field Research & Contextual Inquiry
o Comparative Evaluation
o Heuristic Analysis
o Expert Review
o Early & Later Stage Formative Studies
o Rankings & Ratings
o Secondary Packaging Layout & Accessibility Reviews
o User Feedback During Clinical Trials
Throughout the phases of product development, additional opportunities to incorporate HFE activities provide supplemental assurance that the products and devices have been both designed correctly to meet their design input specifications, and for the correct intended uses. They also allow HFE practitioners to take full advantage of their time and resources during already allotted HFE activities. For example, while participants are scheduled to participate in a validation study, additional time could be allocated to their session to perform the user needs validation. Or formative study task success criteria can be drafted in such a manner to fulfill user requirement verification in addition to providing user feedback on the product or device design.
As outlined in AAMI TIR59:2017, HFE is most impactful if incorporated throughout the entirety of the product development lifecycle and not viewed as a “checkbox activity” at the end of validation to be able to submit to regulatory bodies. This presentation highlights some overlooked areas of opportunity for HFE practitioners to integrate HFE assessments and techniques to not only design safe and effective products but maximize user satisfaction as well.
This presentation will step through a few case studies for the audience to highlight theoretical scenarios that may be applicable, and various HF techniques and strategies to utilize in their own practice such as:
• Force injection usability study results informing user requirements (e.g., injection time, force to inject, force acceptability thresholds)
• Iterative IFU Testing providing users the opportunity to review, use, and recommend changes for IFUs to work collaboratively with end users towards clear and understandable labeling
• Inclusion of ease of use assessments with representative end users into early clinical trail questionnaires (e.g., End of study questionnaire for the participant to evaluate the ease of using the product, in conjunction with their actual use experience).
• Sketches, 3D printed mockups, and virtual concept assessments to orient development engineering and end user expectations on a product (e.g., product dimensions, form factor acceptability, audible/visual/tactile alerts)
• And more!
o Human Capability Requirements
o Field Research & Contextual Inquiry
o Comparative Evaluation
o Heuristic Analysis
o Expert Review
o Early & Later Stage Formative Studies
o Rankings & Ratings
o Secondary Packaging Layout & Accessibility Reviews
o User Feedback During Clinical Trials
Throughout the phases of product development, additional opportunities to incorporate HFE activities provide supplemental assurance that the products and devices have been both designed correctly to meet their design input specifications, and for the correct intended uses. They also allow HFE practitioners to take full advantage of their time and resources during already allotted HFE activities. For example, while participants are scheduled to participate in a validation study, additional time could be allocated to their session to perform the user needs validation. Or formative study task success criteria can be drafted in such a manner to fulfill user requirement verification in addition to providing user feedback on the product or device design.
As outlined in AAMI TIR59:2017, HFE is most impactful if incorporated throughout the entirety of the product development lifecycle and not viewed as a “checkbox activity” at the end of validation to be able to submit to regulatory bodies. This presentation highlights some overlooked areas of opportunity for HFE practitioners to integrate HFE assessments and techniques to not only design safe and effective products but maximize user satisfaction as well.
Authors
Event Type
Poster Presentation
TimeMonday, March 234:45pm - 6:15pm EDT
LocationRhinelander Gallery
Medical and Drug Delivery Devices