Medical Device UI Design: Where Usability is Patient Safety.
Gravitonic engineers intuitive, error-resistant medical HMIs that meet IEC 62366 standards and accelerate your FDA 510(k) and CE mark approval.
For a medical device, the user interface is not a "feature", it is a critical safety component. A poorly designed UI can lead to use-errors that have catastrophic consequences for patients, clinicians, and your company. Your device's UI is too important to be an afterthought. It's a core component of your product's safety, efficacy, and commercial success.
In Medicine, a Confusing UI is a Critical Risk.
The FDA and other regulatory bodies know this. A device with a poor UI will be rejected, costing you millions in development delays.
Critical Patient Safety Risks
A confusing workflow, an ambiguous icon, or a poorly-designed alarm system can lead to a clinician making a life-threatening error under pressure. Patient safety is the #1 priority, and the UI is the first line of defense.
Regulatory & Compliance Failure
The FDA’s HFE guidance and the IEC 62366-1 standard are not suggestions. If you cannot prove your device is safe and usable through a formal Human Factors Engineering (HFE) process, your device will not be cleared or approved.
Poor Clinical Adoption
Even if approved, a clunky, inefficient HMI will be rejected by its users. Nurses and doctors will develop "workarounds" or abandon your device entirely, destroying your product's market viability and reputation.
Our End-to-End Medical Device UI/UX Services
Gravitonic is your specialized engineering partner for developing certifiable medical UIs. We integrate HFE and regulatory requirements into every stage of the design and development lifecycle.
1. Human Factors Engineering (HFE) & UX Research
This is our foundation. We follow the rigorous process outlined in IEC 62366-1, starting with user research, defining user profiles (e.g., surgeon, nurse, home patient), and analyzing use environments (e.g., OR, ICU, home). We conduct detailed risk analysis (uFMEA) to identify and mitigate all potential use-related hazards.
2. Formative & Summative Usability Testing
We conduct iterative formative testing with real clinicians to refine the design and eliminate usability issues early. We then plan and execute the formal, validation-ready Summative Usability Testing required for your regulatory submission.
3. UI Design for Medical Devices
We translate HFE requirements into a clear, error-resistant, and intuitive UI. We design for specific contexts, such as:
Patient Monitors: High-contrast, at-a-glance data visualization.
Infusion Pumps: Failsafe workflows for data entry.
Surgical Robotics: Minimizing cognitive load and providing clear feedback.
Home-Use Devices: Simplicity and guidance for untrained users.
4. Safety-Critical Software Development
Our expert embedded engineers turn the validated design into robust, production-ready software. We are masters of building reliable HMI applications on Embedded Linux and RTOS platforms, following the IEC 62304 software lifecycle standard.
...Beyond his technical expertise, George demonstrated a strong entrepreneurial mindset, proactively identifying opportunities and proposing innovative solutions. He also possesses impressive strategic skills, contributing to our product roadmap and helping us define a clear AI product to market strategy...
Sergio Z.
Co-Founder & CTO @ NutriCoach
We Build UIs Designed for Regulatory Approval
Why trust Gravitonic with your most critical asset? Because we are embedded engineers who speak the language of medical device compliance.
Compliance-Driven Design
We don't just "make it look nice." Our entire design process is built around the IEC 62366-1 standard and the FDA’s HFE guidance. We design for safety, usability, and certifiability from day one, ensuring no costly surprises at the end.
Full Traceability & Documentation
We provide the complete Usability Engineering File (UEF) you need for your FDA 510(k), PMA, or CE mark submission. We deliver comprehensive documentation that traces every design decision back to a user need or risk mitigation, making your regulatory review seamless.
Expertise in Clinical Environments
We understand the real world of healthcare. We design for the chaos of an OR, the alarm fatigue of an ICU, and the unique challenges of sterile fields, gloved-hand operation, and mobile cart-based systems.
Engineering That Meets IEC 62304
As a full-stack engineering partner, our software development process aligns with the IEC 62304 standard for medical device software. We deliver code that is reliable, maintainable, and verifiable—exactly what you need for a safety-critical system.
The Technology to Build Certifiable Medical Devices
Gravitonic has deep expertise in the high-reliability platforms and frameworks essential for the medical industry.
Standards: IEC 62366-1 (Usability), IEC 62304 (Software), ISO 14971 (Risk Mgmt)
HMI Frameworks: Qt / QML, LVGL, Crank Storyboard
Operating Systems: Embedded Linux (Yocto), RTOS (QNX, FreeRTOS, Zephyr)
Hardware Platforms: NXP, STMicroelectronics (STM32), Renesas, Toradex
Frequently Asked Questions (FAQ)
What is HFE (Human Factors Engineering)?
HFE is the formal, regulated process of designing a device to be safe and effective for its intended users. For medical devices, this is a non-negotiable requirement by the FDA and other bodies. It involves researching users, identifying use-related risks, and then designing and testing the UI to eliminate those risks.
What is the difference between Formative and Summative testing?
Formative testing is iterative, "find-and-fix" testing done during the design process to improve the UI. Summative testing is the final validation test, done on the finished device with real users, to prove to regulators that the device is safe and usable. Gravitonic manages both.
Do you provide the documentation for our FDA submission?
Yes. We deliver the complete Usability Engineering File (UEF) as a key part of our service. This file includes all HFE analyses, test protocols, and reports required by the FDA.
Can you build the UI software to meet IEC 62304 standards?
Yes. Our software development lifecycle is designed to align with the requirements of IEC 62304. We provide robust, well-documented, and testable code suitable for a Class B or Class C medical device.
Don't Let Poor Usability Risk Your Device Approval.
Partner with Gravitonic, the engineering experts who build safe, usable, and certifiable medical device interfaces.
Don't Let Poor Usability Risk Your Device Approval.
Partner with Gravitonic, the engineering experts who build safe, usable, and certifiable medical device interfaces.