The Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course, scheduled for February 11–12, 2026, has been added to ResearchAndMarkets.com’s expanding portfolio of professional training offerings. This intensive two-day workshop is designed to support professionals involved in the development, regulation, and commercialization of drug delivery devices by equipping them with practical knowledge and regulatory insight into human factors (HF) and usability engineering (UE).
As regulatory expectations continue to tighten across global markets, manufacturers of drug delivery systems and combination products are under increasing pressure to demonstrate that their devices are safe, intuitive, and fit for use by the intended population. Human factors engineering has become a critical component of device development, particularly in meeting compliance requirements under the EU Medical Device Regulation (MDR), IEC 62366, and U.S. FDA Human Factors Guidance. This training course has been specifically developed to address those needs.
A Practical, Interactive Learning Experience
The workshop is structured as an interactive, instructor-led program, with a strong emphasis on real-world application. Participants will benefit from the presenter’s extensive hands-on experience as a human factors specialist with deep familiarity in regulatory expectations across multiple jurisdictions. Rather than relying solely on theory, the course encourages active participation through discussions, practical examples, and guided exercises focused on executing successful human factors studies.
Delegates will work through key stages of usability engineering, gaining insight into how human factors considerations should be integrated into product development from early design through post-market activities. The format allows attendees to ask questions, share challenges, and explore best practices that can be directly applied within their own organizations.
Addressing Regulatory and Compliance Challenges
A core focus of the training is helping product developers understand how to generate and present usability data that meets regulatory scrutiny. Participants will gain clarity on how to satisfy regulatory authorities by providing robust human factors evidence that supports product safety, effectiveness, and user acceptance.
The course provides detailed coverage of IEC 62366 usability engineering processes, FDA human factors guidance, and the application of ISO 14971 risk management principles to combination products. It also explores regulatory requirements across multiple regions, including the European Union, the United States, the United Kingdom, China, and guidance issued by the European Medicines Agency (EMA).
Special attention is given to Article 117 of the EU MDR, which has significant implications for drug-device combination products, as well as evolving expectations for generic devices, biosimilars, and ANDA submissions.
Key Benefits for Attendees
By attending this training, participants will develop a comprehensive understanding of how human factors engineering fits within modern product development and regulatory frameworks. Key benefits include:
- Gaining a clear understanding of IEC 62366 and FDA human factors guidance
- Learning how to provide regulators with specific, defensible usability data
- Understanding the role of human factors in the design and development lifecycle
- Exploring how to validate drug-device combination products
- Identifying and managing use-related risks
- Understanding human factors requirements for generic products, ANDAs, and biosimilars
- Learning what human factors data the FDA expects for biosimilar submissions
Certification and Professional Development
Participants who complete the course will receive a Certificate of Completion and can record 12 CPD (Continuing Professional Development) hours, supporting ongoing professional and regulatory competency requirements.
Who Should Attend
The training is designed for professionals involved in any aspect of drug delivery device development, regulation, or commercialization. It is particularly relevant for individuals working in:
- Engineering and medical device development
- Packaging design and development
- Regulatory affairs and compliance
- Quality systems and quality assurance
- Risk management
- Marketing and product management
- Usability engineering and human factors disciplines
Comprehensive Topic Coverage
The course agenda covers the full scope of human factors engineering, starting with foundational concepts and progressing through advanced regulatory and practical considerations.
Participants will be introduced to the principles of human factors, usability, and ergonomics, along with an overview of current trends in drug delivery device technology. The training examines the scale and implications of use errors, how user interfaces are defined, and how usability research differs from clinical and market research.
The legal and regulatory section addresses U.S. design control laws, EU MDR usability requirements, UK medical device regulations, and international standards and guidance, including IEC 62366 and FDA expectations.
Further modules explore human factors methods and best practices, including perception, cognition, and action models, heuristic analysis, and the integration of usability engineering within design control processes. Attendees will learn how to define user needs, develop user interface specifications, and maintain traceability through design matrices.
The course also provides in-depth coverage of formative and validation testing, including regulatory expectations, testing methodologies, and documentation requirements. Use-related risk management is addressed through ISO 14971, with practical guidance on risk analysis, risk control, and residual risk evaluation.
Additional sessions focus on the relationship between human factors and clinical trials, technical documentation requirements, post-market surveillance, and the challenges associated with platform devices. The training concludes with detailed guidance on generic devices, biosimilars, ANDAs, and maintaining compliance with data protection and ethics regulations such as GDPR, HIPAA, and IRB requirements.
A Valuable Resource for the Drug Delivery Industry
As drug delivery devices become more complex and user populations more diverse, human factors engineering is no longer optional—it is a regulatory and commercial necessity. This training course provides a structured, practical pathway for organizations seeking to strengthen their usability engineering capabilities while meeting global regulatory expectations.
By combining regulatory insight, practical methodologies, and real-world experience, the Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course offers a valuable learning opportunity for professionals aiming to improve product safety, usability, and regulatory success in an increasingly demanding global market.
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