Press release
Introducing Suabix™ by Successful Human Factors™ - First AI Solution to Optimize and Standardize Human Factors in Medical Device Design
Successful Human Factors™, a leader in the improvement of human factors practices in medical device design, proudly presents Suabix™. This cutting-edge AI-powered platform revolutionizes the integration of human factors into medical device development.Suabix™, currently patent-pending, represents a groundbreaking artificial intelligence system developed in collaboration with leading experts. It seamlessly incorporates human factors into medical device design, going beyond traditional guidelines to establish standardization through the Successful Human Factors (SHF) 2.0 framework.
The Suabix Story
"In the medical device industry, human factors engineering is often an afterthought, leading to usability issues and regulatory challenges," explained Dr. Katia Rojas, Founder and Principal Consultant at Successful Human Factors™. "Suabix changes the game by embedding human factors from the start, enabling companies to achieve excellence efficiently."
Suabix™ was born from Dr. Rojas' passion for elevating human factors in medical device projects. She observed and pointed out the prevalent challenges and alarmingly high failure rates in regulatory human factors submissions within the medical device industry. It was at this juncture that the idea for a solution took root - the creation of the SHF 2.0 framework, a meticulously built model encompassing research of industry best practices and pivotal success factors. Yet, despite its potential to propel the industry forward, ongoing research has revealed a seemingly sluggish (but expected) rate of adoption. "This hurdle can be ascribed to persistent industry challenges, including regulatory pressures, underdeveloped processes, a lack of awareness and collaboration among key stakeholders," Dr. Rojas pointed out.
Confronted with these roadblocks and the industry's hesitancy to directly embrace the SHF 2.0 framework, Successful Human Factors joined forces with AI experts to give birth to Suabix. This innovation seamlessly melds SHF 2.0 with AI, resulting in an optimized, fast-tracked maturity, and collaborative approach to human-centered medical device design.
Key Capabilities and Benefits
"By combining the SHF 2.0 framework with AI, Suabix™ enhances the human factors process to drive effective and efficient device usability, user safety, and overall product development," stated Dr. Rojas.
In a nutshell, Suabix delivers the following capabilities:
- Expert Guidance: Utilize SHF 2.0 principles with Suabix's intuitive chatbot assistant, optimizing project planning and execution.
- Automated Usability Testing: Streamline production of usability testing components, and product development efficiency based on industry-focused criteria.
- Intelligent Reporting: Gain comprehensive insights into human factors validation, empowering informed design decisions.
- Seamless Integration: Effortlessly integrate Suabix™ into existing workflows to promote collaboration.
Suabix™ benefits all stakeholders in medical device development, including manufacturers, startups, consultants, and regulatory experts. By standardizing processes, it enables faster time-to-market and improved human factors regulatory reviews, allowing you to focus on innovation.
Early Access
Suabix™ is now accepting early access requests from select medical device manufacturers and human factors service providers. Participants receive a risk-free 60-day trial and personalized onboarding.
Suabix™ is the ultimate AI-enhanced usability mate for achieving human factors excellence in medical device design. "With Suabix, we aim to make human-centered design effortless and accessible to all MedTech stakeholders, translating into better patient outcomes," concluded Dr. Rojas.
Learn more and request early access at www.suabix.com.
Suabix™ by Successful Human Factors™
PO Box 352
Middletown, NY 10940
suabix@successfulhf.com
(845) 237-2479
About Successful Human Factors: Successful Human Factors is a pioneering platform and framework in the field of human factors engineering for the medical device industry. Our primary offering, the SHF 2.0 framework, serves as an all-encompassing maturity model that facilitates standardization and excellence in human factors engineering practices for the medical device industry. Alongside the SHF 2.0 framework, we deliver specialized project management solutions tailored to the industry, conduct maturity assessments and HF project audits, training sessions and workshops, and assist in PMO or PM team establishment and management. Leveraging our expertise and unwavering commitment to best practices, Successful Human Factors empowers organizations to efficiently and effectively develop safe, user-friendly, and compliant medical devices.
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