Nanofluidics Osmolarity Test Card

MiniFAB's technical expertise, product delivery and manufacturing capabilities are demonstrated in the Award winning TearLabTM Osmolarity Test Card. The TearLabTM system is a product of TearLabTM Corporation. It consists of an instrument and a disposable nanofluidic sensor: the Osmolarity Test Card. In 2009 TearLabTM was awarded the prestigious Medical Design Excellence Award® for its design.

From the initial concept, to management of the development of the Osmolarity Test Card and through to full manufacturing, MiniFAB delivered a result in less than two years and is now the sole global manufacturer of the Osmolarity Test Card. MiniFAB are today manufacturing 75,000 Osmolarity Test Cards per month. As a start-up company, TearLabTM appreciated MiniFAB's careful management of the deliverables, milestones and timelines, all while keeping within a tight budget.

The design brief was to create a cheap, disposable device capable of collecting 50nl of tear fluid, preferably without the use of active components such as pumps and valves. Internal gold electrodes were to be integrated to perform an electrical measurement on the tear sample, providing an osmolarity reading with a CV < 1.5%. Previous experiences with other vendors of microfluidic solutions had been unsuccessful, however after an initial concept was agreed, MiniFAB delivered a working proof-of-principle within 3 months.

MiniFAB formed an internal multidisciplinary team that included engineers from the client's company. Following the successful proof-of-principle the Staged Development Plan delivered Concept Demonstration Prototypes to evaluate the design strategy: Alpha Production units for design evaluation, a Manufacturing strategy and implementation and Beta Production units for pre-clinical trials.

Today MiniFAB is the sole manufacturer of the TearLabTM Osmolarity Test Card and is now working with TearLabTM on future generations of the product. The complete development and manufacturing process was executed within MiniFAB's ISO 13485:2003 certified quality system.