School of Design Module – PD6002 – Human Factors in Health Systems Grading- 50% of the module Objectives • Develop an understanding and appreciate for human factors applied to medical device design • Apply ISO 62366 to the review of a device design • Apply elements of HE 75 to a medical device • Design solutions to formative evaluation issues • Develop skills in designing usability engineering studies • Conduct usability engineering studies and report on findings • Report on usability engineering studies as per ISO 62366 Requirements Choose a medical device for this project. The device could be used either in a home a healthcare setting. Get familiar with ISO 62366 – 1 (main standard) and ISO 62366- 2 (Technical Report – guidance). Design and perform a formative review of the device. At minimum, perform a task analysis with PCA and a heuristic evaluation. Use other methods as/if appropriate. Base your project 2-3 user groups. If you test with participants e.g. cognitive walkthrough and simulation, 2-3 participants will be sufficient. 4. Review the results from the formative assessment and apply elements of HE75 as could be used to address device deficiencies. 5. Design the summative evaluation study protocol. Detail each of the users and the testing protocol for each (max 2-3 user groups). Include every detail necessary to perform the study, including, devices/equipment, briefing instructions, environment, simulation equipment, and post interview questions. 6. At minimum perform simulated use testing on 3 surrogate users for one of your user groups. Given the COVID 19 restrictions test with circa 3 people from within your living bubble as if they were representative users. You may well have to make many assumptions given restrictions with access to people and equipment. In such case detail the assumptions. 7. Provide a Usability Engineering (UE) report addressing the requirements above arranged as per the FDA guidance for such reports. Submit your report in Word format. Grading 1. Adherence with FDA UE report structure 10% 2. Formative study protocol 10% 3. Formative study results 15% 4. Application of HE 75 to deficiencies identified from the formative testing 10% 5. Summative study protocol 15% 6. Summative study results 10% 7. Writing style and layout 10% 8. Overall comprehension 20%