HE Consulting
Consultancy providing human factors and usability engineering services for medical device development. Services cover user-centered design and task analysis, predictive use-error analysis and integration with risk management, formative and summative usability evaluations (including a configurable on-site test laboratory), human factors evidence and report preparation for regulatory submissions, post-market use-error investigation and CAPA support, and training/embedded human factors personnel for product teams.
Industries
Nr. of Employees
small (1-50)
HE Consulting
Andover, Minnesota, United States, North America
Services
Consulting on user-centered design, user needs, task and function analysis, formative and summative evaluations, and integration of human factors into product development and design controls.
On-demand usability testing in a configurable lab that supports realistic environment simulation, observation and meeting rooms, and recorded media with event marking for analysis.
Lead predictive use-error analyses that produce failure mode assignments, error mechanism mapping, root-cause identification, and prioritized mitigations integrated with risk management.
Prepare HF/usability validation reports and advise on human factors deliverables for premarket submissions and agency interactions, including task selection rationale and residual risk discussions.
Seminars and training on use-error analysis, HF methods, integrating HF into design and manufacturing, and creating instructional materials for intended users.
Consulting on user-centered design, user needs, task and function analysis, formative and summative evaluations, and integration of human factors into product development and design controls.
On-demand usability testing in a configurable lab that supports realistic environment simulation, observation and meeting rooms, and recorded media with event marking for analysis.
Lead predictive use-error analyses that produce failure mode assignments, error mechanism mapping, root-cause identification, and prioritized mitigations integrated with risk management.
Prepare HF/usability validation reports and advise on human factors deliverables for premarket submissions and agency interactions, including task selection rationale and residual risk discussions.
Seminars and training on use-error analysis, HF methods, integrating HF into design and manufacturing, and creating instructional materials for intended users.
Expertise Areas
- Human factors engineering and user-centered design
- Formative and summative usability evaluation and validation
- Predictive use-error analysis and uFMEA
- Task and function analysis, contextual inquiry
Key Technologies
- Formative and summative usability testing
- Predictive use-error analysis / uFMEA
- Task analysis and function analysis
- Contextual inquiry, interviews, and focus groups
News & Updates
Summary report on challenges and priority actions for medical technology used outside clinical settings, relevant to home-use device design and regulation.
Article discussing regulatory pressures and approaches to meet FDA human factors validation requirements without redoing development work.
White paper presenting a formal Use Error Analysis method to integrate human error taxonomies with FMEA processes for predictive assessment during design.
Guidelines for deciding when and how to automate clinical tasks to improve safety and usability without introducing new risks.
Biographical article on the principal consultant's career path and human factors focus in medical device development.
Presentation and notes summarizing FDA draft guidance on human factors for premarket submissions, common review concerns, and HF/usability report content.
Summary report on challenges and priority actions for medical technology used outside clinical settings, relevant to home-use device design and regulation.
Article discussing regulatory pressures and approaches to meet FDA human factors validation requirements without redoing development work.
White paper presenting a formal Use Error Analysis method to integrate human error taxonomies with FMEA processes for predictive assessment during design.
Guidelines for deciding when and how to automate clinical tasks to improve safety and usability without introducing new risks.
Biographical article on the principal consultant's career path and human factors focus in medical device development.
Presentation and notes summarizing FDA draft guidance on human factors for premarket submissions, common review concerns, and HF/usability report content.