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LIVE WEBINAR

End-to-End Human Factors for Medical Devices and Reprocessing Usability Testing

January 21, 2026

1:00 pm ET

Chrystel Lloyd and Jessica Schafersman

Human factors engineering is essential to designing medical devices and healthcare products that are safe, intuitive, and effective in real-world use. Join us for a practical, high-level webinar that explores how human factors methods help manufacturers reduce use-related risk, improve usability, and meet regulatory expectations across a wide range of medical technologies. This session will walk through the human factors process from early user analysis through iterative evaluation, showing how these activities support better design and clearer instructions throughout the product lifecycle. Attendees will gain insight into how human factors apply across diverse use environments, including central sterile processing departments, operating rooms, and home-use settings. Examples will span reusable medical devices, capital equipment, and related products such as personal protective equipment (PPE), highlighting how real-world user behavior and workflows influence safety and performance.

The webinar will also explain why human factors are increasingly recommended for products that are reused, reprocessed, or supported by complex instructions. Participants will learn how and where human factors studies are conducted, what meaningful results look like, and how those results can be used to strengthen design decisions, improve instructions for use, and support regulatory submissions. Backed by the combined expertise of Regulatory Compliance Associates (RCA) and Nelson Labs, this webinar will equip attendees with practical insights they can apply to improve product safety, usability, and compliance.

By the end of this webinar, participants will be able to:

• Outline the key steps of the human factors engineering process

• Explain the role of the human factors engineering process in reducing use-related risks

• Describe why human factors studies are recommended for reprocessing of medical devices and how they are conducted.

• Apply human factors practices to improve design, labeling, and regulatory support

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Chrystel Lloyd

Senior Laboratory Operations and Strategic Planning Manager for Healthcare Reprocessing

Chrystel Lloyd is the Senior Laboratory Operations and Strategic Planning Manager for the Healthcare Reprocessing section at Nelson Labs. She helps bring new reprocessing offers to Nelson Labs through careful consideration of customer needs and regulatory expectations. She also helps to educate medical device manufacturers on the requirements of validating their reprocessing instructions for use. Chrystel graduated from Arizona State University with a master’s degree in clinical research management with an emphasis on regulatory. She supports the company's growth and development of healthcare reprocessing globally.

Jessica Schafersman

Subject Matter Expert, Design Controls

Jessica Schafersman is a Biomedical Engineer, Project Management Professional, and Certified Usability Analyst, with more than 20 years of experience in medical product development, combination products, sterile implants, sterile disposables, capital equipment and instrumentation spanning Class I, II, and III device classifications. As a Subject Matter Expert at Regulatory Compliance Associates® (RCA) she is responsible for helping clients create and improve design files for their products, and sometimes their entire Quality Management System. She also participates in company advocacy efforts with federal agencies, congressional personnel, and public health groups. Jessica started her career in a medical device startup, working directly with physicians and end users to develop a bleeding edge surgery system. Since then, her work experience has spanned combination products, sterile implants, sterile disposables, capital equipment, software, and instrumentation at all phases of development. She has worked within companies both big and small so she can appreciate the challenges and opportunities that each affords. She joined RCA as a full-time consultant in 2014. Jessica got her Bachelor of Science in Biomedical Engineering as well as her Certificate of Business Administration at Saint Louis University in Saint Louis, MO.