Human Factors Engineering is not only Design Validation. It can be integral in characterizing and identifying your user’s needs, critical in ensuring that the product meets and exceeds their expectations, as well as required to validate the design and achieve regulatory approval. The session will provide guidance from industry experts as to how HFE can benefit your products and your business. Access to the experts will be available in a panel session to address all of your HF questions.
The Key Takeaways:
- Understand the different phases and tools that are part of HFE and how to use them
- Learn how to truly know your users through early HF research
- Integrate HFE during product design to achieve the best product for you customer
- Appreciate the keys to success in designing and executing Usability studies
Using an Integrated HF approach to Design and Validation
With the release of various FDA guidance documents and most recently, the guidance for human factors and combination products, human factors is a now a requirement for drug development partners and manufacturers. However, understanding the regulatory expectations defined by these documents can be challenging. Some manufacturers have adopted a "checkbox" approach and conduct formative and validation studies with the sole objective of satisfying regulatory requirements. In this workshop, we will discuss the value in moving beyond the "checkbox" approach and more effectively integrating human factors into your product development and risk management activities.
Christina C. Mendat, Ph.D, Partner and Senior Technical Director, Human Factors MD
Role of preconcept and concept phase human factors
Marty Coyne, Matchstick • Sherri Biondi, Genentech
While the need for human factors studies to validate combination products is generally well-recognized, less emphasis is typically placed on early understanding of users and use environment. This understanding has become critical as industry considers products beyond the drug delivery device that focus on patient engagement and therapy adherence. To support effective technical development and clinical interventions, we sought to better understand the user's mindset, behavior and the resulting therapy management challenges. We will present a case study of how these human factors studies are being used to empower development of “smart” devices and an ecosystem of connected supporting tools that aim to improve the patient's ability to be successful with prescribed therapies.