The product is a digital behavior change intervention (DBCI) software product intended for patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD). It is intended to support sustained adoption of clinically recommended symptom self-management behaviors leading to a reduction in breathlessness.
1. Background to the assignment
This will be the first medical software product developed by the company as the legal manufacturer and therefore needs experts in the field of medical device development. One key function within the team will be a Usability/Human Factors Engineer. As it does not have suitable resources and expertise for this internally, the contractor holds a unique position and provides significantly different services than the internal staff.
2. Concrete, detailed description of services
The project team works in agile, blending scrum and kanban, in sprints of 2 weeks, with the following ceremonies in addition to ad-hoc meetings:
1. Daily standup, 15 mins from Tuesday to Thursday, at 10:30am (CET)
During the daily standup, all team members provide an update on the tasks they have worked on the previous day. After that, the contractor supports independently on the defined tasks
2. Biweekly Sprint Review, Friday afternoon, 60 mins, with all stakeholders. During the sprint review, the team presents to the stakeholders an overview of the work done during the sprint, and answers their questions. After that, the contractor supports independently on the defined tasks.
3. Sprint Retrospective, Thursday afternoon, 1 hour, All team members discuss how the previous sprint went, what challenges occurred and actions for the next sprint are defined. The contractor will also provide input in the discussion and consult on next steps. After that, the contractor supports independently on the defined tasks.
4. Biweekly Sprint Planning, Monday morning 1 hour. The Project Manager and the Development Team define what will be the tasks for the next sprint, based on the availability, priorities and users feedback. After that, the contractor supports independently on the defined tasks.
The contractor has the following service description:
- Independently oversee and revise the usability engineering plan and usability engineering file, incl. use specifications, critical task analysis,
- Consult on activities related to Formative and Summative evaluations
• study planning based on research question, defined requirements and therapeutic area (details will be accessible for the freelancer)
o Independently defines target participants for studies
o Writes characteristics and demographics for recruitment of patients
o Independently define critical task to be tested in Human Factors Engineering studies (HFE)
o Individually prepares prototype for testing
• Independently analyze the synthesized study data to be compared to success metrics
o Synthesis to be documented and presented to the client
• Consulting on the work for review to create final draft for handover
- Independently translates findings and necessary changes according to the Risk Evaluation to Product Requirements
- Writes Instructions for Use / User guidance based on experience and external requirements to be approved by the client
- Consults the UX design and frontend development team regarding usability
- Write HFE/UE Summary Report
o Independently create a draft of the summary report based on the collected data
o Present and handover the draft for review to the client
o Create a final draft, based on feedback, and hand it over to the client