Elevated Human Factors

The Moon on a Stick Ltd

Elevated Human Factors & the Usability of Medical Devices
“Kill the HF Buddha on the Road”

<h3>The most current, no-nonsense instruction for necessary techniques, advanced concepts, FDA review priorities, common costly misunderstandings, and future directions.</h3><p>Be prepared to contribute, question, discuss, and challenge.  </p><h3>Old McRonald has a Farm: Free-range organic, human factors theory and practice </h3><p>And on that farm, he has four barns: (don’t even try to sing this part) </p><ol><li>Bulls Eyes </li><li>Partly Applicable</li><li>Irrelevant, Distracting, Timewasters</li><li>Fantasies, Conspiracy-theories, and Snake Oil </li></ol><h3>Would you like to go on a guided tour?  Pet and feed the “animals” and, get to know them?  Inspect the pedigreed champion stock in the “Bulls Eyes” barn. You can take some of them home with you!  Everybody on the farm will learn how to KISS!  (you know… Keep It Simple).  </h3><p>Some very interesting topics, dare we discuss these?  Oh yes indeed we most definitely will! </p><ul><li>Internal HF advocacy: Speaking reason to power: Stop not making sense!</li><li>Imagining a dialogue between an industry advocacy group and the FDA about the need for and existence of the human factors pre-market review</li><li>The benefit FDA human factors review does.  How it could be a bit better. </li><li>“User needs” for medical device usability</li><li>The relationship between medical device usability and safe &amp; effective medical device use</li><li>Difference between usability as defined by HF/UE Validation Test Success and Usability-in-General</li><li>Similarities and differences between CDRH, OPEQ and CDER, DMEPA due to the kinds of devices they review and how they are used </li><li>Human factors Risk Management for Medical Devices Re-education Boot Camp Gulag </li><li>Formative Test Paralysis</li><li>Human Factors Engineering Paralysis</li><li>Achieving compliance with IEC-62366 and QSR  </li><li>HFE Inference Engine Only for real HFE’s</li><li>Achieving Harmony with Risk Management </li></ul><p>At Old McRonald’s Farm we have a bumper-crop of technical discussion topics.  Not only that, it’s an immersion study in speaking essential <em>Human Factoreese </em>and <em>Usabiliteese   </em>including this vocabulary and more: </p><ul><li>Actual Use</li><li>Baseline Error Rate</li><li>Bias</li><li>Candidate UI Design</li><li>Candidate UI Design Evaluation </li><li>Comprehensiveness</li><li>Controllable use-related risk </li><li>Data-driven Decision-making</li><li>Formative Testing Paralysis  </li><li>Formative Testing, Evaluation</li><li>Hawthorne Effect</li><li>Hazard</li><li>HFE Inference Engine </li><li>Interview </li><li>Interview Data</li><li>Murphy’s Law and Medical Device UI Design</li><li>No HF Validation Needed and Threshold Analysis </li><li>Overall Usability Questions</li><li>Performance Data, Assist</li><li>Performance Data, Close Call </li><li>Performance Data, Difficulty</li><li>Performance Data, Failure</li><li>Performance Notes/Performance Data</li><li>Reporting HF/UE Validation Data  </li><li>Representativeness</li><li>Residual Use-related Risk </li><li>Risk Priority Number (RPN) </li><li>Root Cause Analysis</li><li>Simulated Use</li><li>Simulated Use Test Environment</li><li>Simulated Use Test Process</li><li>Simulated Use Test Scenarios </li><li>Simulated Use Testing</li><li>Simulation Fidelity, Necessary </li><li>Test Artifact </li><li>Test Environment</li><li>Test Participant</li><li>Uncontrollable Use-related risk</li><li>Unknown Use-related Hazard</li><li>Usability Exploration Testing </li><li>Use Error</li><li>Use Error Frequency</li><li>Use Error Scenario </li><li>Use related risk Calculation</li><li>Use Scenario</li><li>Use-related Hazard (URHaz)</li><li>Use-related Hazard Elimination</li><li>Use-related Hazard Identification</li><li>Use-related Hazard Prediction</li><li>Use-related Risk (URR)</li><li>Use-related Risk Control</li><li>User Documentation</li><li>User Group</li><li>User Interface (UI)</li><li>User Interface design </li><li>User Interface design element </li><li>User Population</li><li>User Task</li><li>User Task Statement </li><li>User Task, Critical</li><li>User Task, Essential</li><li>User Task, Knowledge</li></ul><p><strong>Ron Kaye</strong> recently retired from the FDA’s Center for Devices and Radiological Health where he led the development of its Human Factors initiative during his 19 year tenure at the agency.  Ron was the lead author of the original FDA human factors guidance released in 2000, and the current HF guidance released in February 2016, which represents the perspective of the FDA on pre-market submission human factors requirements.  During his time at CDRH, Ron participated in over 1000 new device reviews involving human factors work submitted to almost all CDRH divisions, has trained FDA CDRH and CDER HF reviewers and (some) field inspectors, and has participated in Agency post-market responses and recalls associated with use error issues.  </p><p>Ron has been integrally involved in the education of the FDA and device manufacturers regarding the human factors process in device design and testing.  Ron’s participation as a faculty member of the AAMI HFE course has brought the FDA human factors message to over 1200 industry practitioners over the past seven years, resulting in a significant improvement in human factors work for new device submissions.  He has also been a co-author of the AAMI/ANSI (HE-75) Standard, Human Factors in the Design of Medical Devices and has participated in the international working group that produced IEC 62366, Application of Usability Engineering to Medical Devices.</p><p>Suggestion, prior to class : </p><ul><li>Think of your most difficult and challenging questions about HFE for medical devices, FDA regulation of medical device usability, or any related concept.</li><li>Send them ahead or make sure to ask during the class!</li><li>Review your copy of IEC 62366-1:2015 Application of usability engineering to medical devices (we’ll be talking about elevated compliance</li><li>Prepare for HFElevation</li><li>Wiki the term “paradigm” if you are rusty on that terminology (or never heard of it)</li><li>Follow up with terms “construct,” and “hypothetical construct” as compared to “real objects” </li><li>Think of three use-related hazards and a “hazardous situation” for each. </li><li>Read: https://bobsutton.typepad.com/files/saltpassage-2-1.pdf and explain what the satire is.  Extra “HFE Master” points to any who “get it.”</li><li>Describe a UI design problem from personal experience (for any kind of technology) that was fixed resulting in improved usability. </li><li>Read “The Design of Everyday Things” by Don Norman (or order it anyway if you don’t’ have a copy). Note: The original title was: The Psychology of Everyday Things but it was changed because that title didn’t sell well.  </li></ul>

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Elevated Human Factors

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