TearLab™ Osmolarity System – In-vitro Diagnostic Tear Testing Platform

Client

TearLab, Inc
(San Diego, CA - USA)

Product

TearLab™ Osmolarity System

Awards

Winner 2009 Medical Design Excellence Awards, In Vitro Diagnostics.

Their scientific research had led them to a breakthrough in formulating a fast turnaround initial indicator for dry eye syndrome and they were on the verge of being able to turn an idea into a medical instrument reality.

Our Ingenuity

Invetech supported our client through the product development journey, including:

• Refinement of core technology ideas to enable the concurrent development of the consumable and the Instrument,
• Generating Instrument concepts that would meet the expectations of ophthalmologists, patients and investors alike,
• Consideration of human factors to ensure safe and comfortable tear sample collection, and
• Developing a design that could be manufactured within the constraints of timeframe and budget, while retaining the key elements of the concept.

Our team used systematic development processes to develop the product from concept to manufacture, including:

• Prototype build, test and verification of a reader instrument and smart collection device to interface directly with the disposable and the measurement base station
• A disposable encapsulation system for easy and reliable disposable interfacing
• An ergonomic user interface for tear collection and base station usage
• A simple to use interface which facilitates operation in a near autonomous operation, and finally
• Transfer to manufacture

The project was conducted following our FDA QSR compliant development processes.

Key challenges included:

Utilisation of an in-house developed communications protocol to ensure reliable message transmission between the Pen and Reader

• Understanding medical safety standards IEC 60601-1 and UL 60601
• Combining digital and sensitive analogue architectures in a limited space
• Handling and ensuring integrity of a patient sample of as little as 50nl of tear fluid
• Adapting a simplified measurement topology to accommodate an ever increasing measurement frequency range
• Reducing mechanical constraints for tightly coupled electronics and mechanical designs

Your Advantage

TearLab™ offers, for the first time, on-site tear testing made safe and simple, without the complexities of reflex tearing, evaporation or volume dependent testing, minimizing subsequent diagnostic variability.

The final product is a milestone in Ophthalmologic care and includes revolutionary features such as:

• An integrated disposable and instrument system to remove all superfluous sample handling
• Active tear collection feedback to users, letting operators know sample collection was complete (completely new in Ophthalmologic care!)
• An almost instantaneous measurement result