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CASE STUDY
Osmolarity Test Device for Dry Eyes
We improved the design of a dry eye detection device, while supporting I-MED in the manufacture of its new product.
Company
Industry
Healthcare
Sector
Ophthalmology
Product Type
Medical Device with Digital Interface
Expertise
- Electronic Engineering, Embedded Software Development, Industrial Design, Mechanical Engineering, Quality Assurance
A Fast, Accurate Diagnostic Tool for Dry Eyes
I-MED Pharma is a leader in the field of dry eye. To enable optometrists to diagnose and measure dry eye, and to provide indications of the disease’s severity, the company has developed the I-Pen system. Used with single-use sensors, it can detect and measure the increase in tear osmolarity in patients suffering from dry eye syndrome in seconds.
CLEIO was contracted by I-MED Pharma to identify new suppliers to relaunch the manufacture of its product. We seized the opportunity to redesign the product and enhance its ergonomics.
The modifications we made improved upon the first version while minimizing the impact on the regulatory file. This led us to requalify new manufacturers and a local assembler for this new version of the I-Pen.
How CLEIO Improved the Device's Design and Ergonomics
During the design process, our design teams collaborated closely with I-MED Pharma and optometric experts to ensure that every detail of the product met the highest standards of quality and functionality.
Refining the Concept through Market Research
Initially, we analyzed the first version of the I-Pen and its competitors’ devices. Interviews with experts provided insights into their user experience. We then sought inspiration from existing medical devices with similar functionality, particularly glucometers.
At the conclusion of our research, the adjectives “intuitive”, “ergonomic”, “reliable” and “minimalist” guided our initial sketches of the future product.
Seamless Handling: Elevating Usability in Every Step
We developed over thirty inspirational concepts before narrowing it down to four different versions to present to the I-MED team. The selected concept was transformed into a dozen 3D-printed models with the goal of enhancing small scale handling.
To achieve this, we conducted ergonomic tests by asking users to interact with the product prototype.
A sleek new look that captures the essence of I-Med’s brand identity
We modernized the product’s appearance compared to its first version by revising the product’s lines, colors and finish.
The chosen colors reflect the I-MED’s brand identity, incorporating navy blue for a more distinctive look than traditional black, complemented by white, and using bright blue as an accent for the button.
Previous Generation 
CLEIO's Design 
Subtle changes from the outside,
big impact in usability and daily use.
Enhancements to the Ejection Mechanism
By reconsidering the usage scenario, we’ve made major improvements to strip ejection and button visibility. It is no longer necessary to apply significant force to eject the consumable.
A More Practical Carrying Case
We proposed a new and more robust carrying case to house the strips, making it easier to transport the product from one clinic to another.
Modifying the Initial Device Without Compromising Its Certification
Throughout the project, we focused intently on change management. The first version had already been certified, and our goal was to facilitate the launch of the second version by minimizing the need for recertification.
To achieve this, our quality assurance team revisited the product’s technical file to make the necessary updates and add new documents. Meanwhile, our technical teams were tasked with implementing changes that minimally impacted the product’s operation. To demonstrate this, they conducted extensive tests to compare the old and new versions. They succeed in showing that the updated device achieves the same results as the previous one, not only in terms of measurement accuracy but also regarding usage and risks.
Additionally, our electronics team ensured that the device complies with the latest versions and amendments of the IEC 60601-1 standard for medical electrical equipment.
From Design to Production: A Collaborative Journey to Quality Assurance in Medical Device Manufacturing
Once the design phase was completed, the product was ready for manufacturing. It was at this point that we began searching for a supplier of parts and assemblies that comply with the ISO 13485 standard for medical devices. All our teams were involved in this step to ensure a quality product.
Industrial Design
Our industrial designers inspected the first units to ensure product quality. Several prototypes were produced early on to refine the elements that interact with users, including assembly and colors.
Mechanical Engineering
Our mechanical engineers were tasked with creating the manufacturing file, analyzing tolerances, and conducting leak tests.
Embedded Software Development
Our software developers streamlined and updated the customer’s code to integrate new components, including the display and microcontroller, ensuring accurate device results.
Electronic Engineering
Our electronic engineering team expertly refined the circuits to support efficient production while maintaining the full functionality of the previous version.
Quality Assurance
Besides documenting and updating the original technical file, our quality assurance team meticulously inspected the supplier’s parts. They also ensured compliance with inspection and assembly procedures.
Getting Ready for Production
To ensure the I-Pen was ready for production, I-MED had the pilot product tested by professionals in the field. This initial feedback allowed us to conduct several verifications, particularly regarding battery life.
Finally, we provided the customer with all the necessary drawings to pass on to the assembler, along with assembly, manufacturing and testing procedures. This way, I-MED had everything they needed to independently launch the production of their device.
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