Insight: Case Study
by Goken’s Medical Device Engineering Team

Creatinine Measuring Device Redesign: From Startup Prototype to Investor-Ready Medical Device

Published: October 17, 2026 Authored by Goken’s Medical Device Engineering Team

Creatinine measuring device redesign – investor-ready prototype with upgraded battery cover and display component

Key Takeaways 

  • Root cause of failures identified in all three prototype units

  • Battery cover redesigned 

  • Display component redesigned to clear the disc 

  • Three demonstration devices built with high-tolerance printed and painted parts 

  • Investor-ready prototype delivered with recommendations for high-volume production 

Quick Answer 

A healthcare startup had launched an early version of its portable creatinine measuring device, and customer feedback pointed to mechanical problems that were hurting confidence in the product. The startup needed a stronger prototype to raise more funds and a design that could move toward high-volume production. Goken reviewed the design documentation and the earlier failure analysis, found the root cause of failures in three prototype units, and upgraded the battery cover and the display component that collided with the disc. Goken also built three demonstration devices with high-tolerance printed parts and a painted finish. 

Context 

Creatinine is a marker that doctors use to check kidney function. The startup had built a portable device to measure it and had put an early version in the hands of customers. The device worked. It also showed weaknesses once people used it outside the lab. 

Challenge 

  • Three prototype units had three different problems: one unit failed outright, one had mechanical failures, and one had a single electrical connection that was never made 

  • The display component collided with the disc

  • The battery cover design needed an upgrade 

  • The device had been built to prove the concept, so the earlier failure analysis and assembly documentation had to be reviewed before any change could be trusted 

Approach 

  • Documentation and failure review: The team studied the mechanical design, the assembly steps, and the earlier root cause analysis before touching any hardware 

  • Root cause debugging with the electronics consultant: Each failing unit was debugged together with the electronics consultant of the client, so every failure was traced to the right cause 

  • Component redesign: The battery cover and the display component were redesigned, and the display component now clears the disc 

  • Prototype build for demonstration: Parts for three devices were 3D-printed to high mechanical tolerance and surface finish, then painted for an aesthetic look 

  • Robustness recommendations: The team suggested improvements for the mechanical longevity and robustness of the design, and supported the alpha prototype as new issues came up 

Results 

Area 

Outcome 

Failing prototype units 

Root cause identified for all three 

Battery cover 

Redesigned 

Display component 

Redesigned to clear the disc 

Demonstration devices 

3 built with printed, painted parts 

Prototype status 

Delivered as an investor-ready prototype 

The startup now has demonstration units and design recommendations for the move toward high-volume production. 

What This Reveals 

A prototype only needs to survive a demo. A shipped device has to survive daily handling by people who did not build it. Most of that stress lands on covers, connections, and the fit between parts, long before anyone questions the sensor or the software. Finding the true cause of each failure and fixing it at the point where it occurs is usually the fastest route to a product that an investor and a factory can both stand behind. 

Ready to Move Your Medical Device from Prototype to Investor-Ready? 

Discuss your creatinine measuring device redesign or medical device prototype challenges with Goken’s engineering team

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Frequently Asked Questions

Prototypes are built to prove a concept in a controlled setting. Real use brings repeated handling, wear, and tight packaging that a lab demo never tests. The weak points usually show up first at covers, connections, and moving parts.

Start with the design documentation and the earlier failure records. Then debug each failing unit on its own, with the electronics team involved, so that mechanical and electrical causes are separated before any redesign begins.

A prototype proves that the concept works in a few units. A production-ready device can be built repeatedly, at volume, with consistent quality and assembly. Getting there means fixing weak points, tightening tolerances, and simplifying how parts fit together.

Investors expect a device that works reliably, looks finished, and shows a credible path to volume production. Fixing known failure points and building demonstration units with a high-quality finish addresses the first two. Design recommendations for durability address the third.

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