Nevada Patent of the Month – January 2025
Innovation in medical technology requires a balance between progress and patient safety. DeepWell DTx has introduced a groundbreaking approach to risk management, seamlessly integrating regulatory compliance with technological advancements. Their latest invention—a computer-implemented method for automated risk mitigation—redefines how medical software and devices evolve while maintaining stringent FDA standards.
At the heart of this innovation lies a sophisticated Risk Trace Matrix (RTM) engine. This system dynamically links risk mitigations to various product elements, ensuring that any proposed changes undergo rigorous scrutiny. When a modification is suggested, the system instantly retrieves associated risks and evaluates their impact. If the change introduces unacceptable risks, it is automatically rejected. Otherwise, it triggers an update to product specifications while maintaining compliance.
This real-time decision-making mechanism eliminates human error, reduces regulatory burdens, and accelerates product development. By embedding risk assessment into the development process, DeepWell DTx ensures that critical mitigations are never overlooked. Developers receive immediate feedback on proposed changes, allowing for proactive risk management rather than reactive corrections.
Furthermore, this technology fosters seamless documentation control by linking risk data across multiple design components, from software modules to hardware specifications. The automated association of new design elements with pre-existing risk profiles enables informed decision-making, even when institutional knowledge is limited.
DeepWell DTx’s approach revolutionizes quality management in the medical industry. By leveraging automation and AI-driven risk assessment, they are paving the way for safer, more efficient innovation in medical technology. This invention not only enhances compliance but also empowers developers to push boundaries while maintaining patient safety at the forefront.
Are you developing new technology for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.
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