Human Factors and Usability Engineering Training Added to ResearchAndMarkets.com
ResearchAndMarkets.com has added the “Human Factors and Usability Engineering in the Development of Drug Delivery Products” training course to its portfolio. Scheduled for February 11–12, 2026, this two-day interactive workshop is designed for professionals involved in the development, regulation, and commercialization of drug delivery and combination products.
The program is tailored for product developers seeking to integrate human factors (HF) testing into their development processes, as well as for teams required to submit robust usability data to regulators in order to comply with the Medical Device Regulation (MDR) and other global standards.
Interactive, Expert-Led Training
The workshop will be led by an experienced human factors specialist with in-depth knowledge of MDR, IEC 62366, and FDA Human Factors Guidance. The format is highly interactive, combining expert-led discussions, real-world case examples, and practical exercises. Participants will work through critical elements of planning and executing successful human factors studies, while addressing common regulatory challenges.
Key Benefits of Attending
Participants will gain practical and regulatory insights to help them:
- Understand the requirements of IEC 62366 and FDA human factors guidance
- Provide regulators with appropriate and defensible usability data
- Integrate human factors into the product design and development lifecycle
- Validate drug-device combination products effectively
- Apply human factors principles to risk management
- Navigate HF requirements for generic devices, ANDAs, and biosimilars
Certification
- 12 CPD hours (for professional records)
- Certificate of Completion
Who Should Attend
This training is particularly valuable for professionals working in:
- Engineering and device development
- Packaging development
- Regulatory affairs
- Quality systems and quality assurance
- Risk management
- Marketing
- Usability and human factors engineering
Key Topics Covered
Foundations of Human Factors
- Definitions of human factors, usability, and ergonomics
- Trends in drug delivery device technology
- Use errors: scale, scope, and implications
- User interface definition and research methodologies
Regulatory and Legal Framework
- US design control and human factors requirements
- MDR usability expectations and Article 117 implications
- IEC 62366, FDA guidance, ISO 14971, EMA guidance
- UK and Chinese human factors regulations
Human Factors Methods and Best Practices
- Human factors engineering principles
- Heuristic analysis and perception–cognition–action models
- Design control integration and usability engineering outputs
User Needs and Interface Specifications
- Regulatory expectations for user needs
- Traceability and design matrices
- User interface specification development
Formative and Validation Testing
- Formative usability testing methods
- Human factors validation studies
- Managing use-related risks
Risk Management and Clinical Considerations
- ISO 14971 applied to combination products
- Risk analysis, control, and residual risk
- Differences between HF studies and clinical trials
- HF data collection during clinical trials
Technical Documentation
- HF documentation in design history files
- EU technical file requirements
- Post-market surveillance and platform devices
Generics, Biosimilars, and ANDAs
- Literature and database searches for known use problems
- HF requirements for ANDA and 505(b)(2) submissions
- FDA expectations for biosimilars
Compliance and Practical Guidance
- GDPR, HIPAA, IRB, and ethics approvals
- Common compliance challenges during HF testing
- Practical tips to remain compliant
Wrap-Up Session
The training concludes with a summary of common pitfalls, best practices, and expert tips to help participants apply human factors engineering effectively and compliantly across product lifecycles.
About ResearchAndMarkets.com
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