The Objective

Execution is where the "Guide" philosophy of Kapstone becomes tangible. Our industrial design and UI/UX team ensures that the physical and digital interfaces are intuitive, safe, and professional. We believe that a well-designed device reduces user anxiety and improves clinical outcomes.

Key Considerations

  • Physical Ergonomics: We design for the human hand. From surgical instrument balance and grip texture to the weight distribution of a handheld diagnostic, our engineering team prioritizes long-term comfort and precision.
  • Digital Interface & Software (SaMD/SiMD): We create digital displays that prioritize "information hierarchy." By emphasizing critical data and minimizing clutter, we reduce the cognitive load on the user and prevent software-related use-errors.
  • Labeling and IFU Design: The Instructions for Use (IFU) are a critical part of the user interface. We design labeling and quick-start guides that are easy to read and follow under pressure, serving as a primary risk control for the device.

Design for Manufacturability (DFM)

  • A beautiful UI/UX is useless if it cannot be manufactured at scale. Because Kapstone operates as a single-source partner, our Industrial Design team integrates directly with Kapstone Manufacturing to ensure your device enclosures, touchpoints, and ergonomics are fully optimized for processes like injection molding, CNC machining, and final assembly from Day 1.

FAQ

What are the FDA requirements for medical device labeling and UI?

FDA requirements for labeling and UI (21 CFR Part 801) mandate that information be "prominent and conspicuous." From a Human Factors perspective, this means the interface must be designed to minimize use-errors through intuitive controls, clear warnings, and legible displays that do not require excessive training for safe operation.

 

What is Industrial Design and why is it important?

As an integrated part of Kapstone's medical device development team, Industrial Design helps to shape products so they are intuitive, ergonomic and safe for clinicians and patients to use. ID works closely with engineering teams to translate user needs and human factors insights into functional, manufacturable devices. 

 

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If Kapstone sounds like the right fit for your business or you have further questions, please reach out to our team.

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