Our Story
Dr. Katia Rojas, a pioneer in driving human factors excellence for medical devices, noticed the high failure rate of regulatory submissions in this field. Motivated to improve outcomes, she developed the Successful Human Factors (SHF) framework, identifying key success factors and best practices through mixed methods research. Her process involved reviewing applicable standards and expert panels.
Now, Dr. Rojas is partnering with leading AI experts to create Suabix – an innovative platform integrating the SHF framework with advanced AI. Suabix enables optimized human factors in the design of medical devices and combination products, while facilitating smoother regulatory reviews and ensuring patient safety. We are currently working on further enhancing Suabix’s AI capabilities and platform features.
Our Mission
At Suabix, our mission is to elevate the standard of human factors engineering in the development of medical devices and technologies. By synthesizing research-based human factors practices and standards with data-driven AI insights, we empower stakeholders across the medical device lifecycle to optimize usability, user safety, and product experiences. Our goal is to revolutionize traditional development workflows to get safe, effective, and intuitive medical innovations to market faster, facilitating collaboration and regulatory reviews.
Our Team
Combines decades of expertise across human factors engineering, medical devices, project management/operational excellence, AI/ML, data security, and more. Led by Dr. Rojas, we are passionate about using technology to advance healthcare innovation. Our team is dedicated to collaborating with customers and stakeholders to enable the next generation of user-centered medical device design development with Suabix as your ally!
Our Customers
Suabix benefits any organization involved in medical device development – manufacturers, biotech startups, design consultants, regulatory, quality, risk management, and more. By standardizing processes, we help companies deliver human factors excellence with speed and confidence. Suabix will enable faster time-to-market and improvement in usability metrics.
Our Technology
Our patent-pending intelligent system takes the guesswork out of developing human factors project deliverables. Our technology seamlessly integrates the Successful Human Factors™ (SHF 2.0) framework with cutting-edge AI to deliver unparalleled value. Suabix automates best practices and standards, while providing personalized insights tailored to your medical device and intended users. Advanced AI interface help you optimize every step. Suabix continually expands its capabilities through machine learning, ensuring you stay ahead as standards and best practices evolve.
Focus on delivering human-centered medical devices, while we handle the human factors complexity. Suabix makes excellence easy.
Contact Us
To learn more about how Suabix can transform your human factors engineering workflow, contact us and schedule a demo today. We’re excited to partner with you on integrating Suabix to help you design medical devices more successfully.
