Introducing Suabix™ by Successful Human Factors™ – First AI Solution to Optimize and Standardize Human Factors in Medical Device Design

New York-based Successful Human Factors™ introduces Suabix™, an innovative AI-powered platform that integrates human factors into medical device design, addressing industry challenges and fostering excellence. Suabix™ offers automated usability testing, intelligent reporting, expert guidance, and seamless integration, benefiting all stakeholders and accelerating time-to-market. Early access opportunities are available for select participants seeking to enhance their product experiences.

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Redefining Human Factors Validations: Strategies to Increase Maturity for Successful Human Factors in Medical Devices and Combination Products

The integration of human factors (HF) engineering (or human-centered design) in the development of medical devices and combination products has become increasingly crucial for ensuring their safety, usability, and overall effectiveness. However, the implementation of HF practices has been accompanied by various challenges, hindering successful validation projects and regulatory compliance. It is clear that traditional approaches […]

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Leveraging the SHF 2.0 Framework to Overcome Common Challenges in Human Factors Validation Projects: A Strategy & Implementation Approach

We have previously discovered through research the challenges that Human Factors (HF) Validation projects in the medical device and combination products industry often face – study participant-related, changes to IFU and packaging design, engaging sponsors, and more (Rojas et al., 2020). To effectively address these challenges, organizations can leverage the Successful Human Factors (SHF) 2.0 […]

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So – Has Anything Changed? A Silent Crisis: Addressing the High Failure Rate of Human Factors Submissions in the Medical Device Industry

In the fast-paced world where innovation and patient safety converge, Human Factors (HF) engineering plays a critical role that cannot be underestimated. However, beneath the surface of this dynamic landscape lies a pressing issue that demands the immediate attention of key stakeholders: HF service providers, the Food and Drug Administration (FDA), and manufacturers of medical […]

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