The TearLab success story began in 2007 when Minifab was approached to help turn the early stage eye health concept into a commercial product.
The relationship between TearLab and Minifab came at a pivotal moment. Prior to this partnership TearLab had invested considerable time and money with another developer / manufacturer only to be told that the concept was unworkable. Many other microfluidics experts had also voiced the opinion that the product was a technical impossibility.
Minifab however with its unique mix of expertise and manufacturing experience, soon found a technical and commercially viable pathway for the product with TearLab having now sold over 20 million units worldwide.
The development program implemented by Minifab lasted just 18 months resulting in a successful submission to the FDA. Today, the CLIA waivered product is registered in over 40 countries and has over 4,800 active users.
What is TearLab?
The TearLab Osmolarity System is a microfluidic point-of-care diagnostic device which detects the osmolarity of human tears for the diagnosis of dry eye disease. Prior to the invention of TearLab, diagnosis of dry eye disease often relied on a combination of visual examinations and other qualitative diagnostic procedures which were invasive, uncomfortable and prone to human error.
The TearLab system replaces these old testing methods with a highly accurate and consistent quantitative result (CV <1.5%) using an electrical impedance measurement to provide assessment of osmolarity.
Manufacturing to Extreme Tolerances
Central to the system is the TearLab Osmolarity Test Card, designed and manufactured by Minifab. When combined with the TearLab Osmolarity System, it can determine tear osmolarity using just 50 nanolitres (nL) of tear fluid collected directly from the eyelid margin. Success of the overall system relies on the performance of this microfluidic consumable.
Taking the TearLab card from early stage concept all the way to a high-volume commercial product required several key challenges to be overcome. The most significant of these challenges was achieving consistent test results with a coefficient of variation (CV) of < 1.5% using patient samples of just nanolitres of patient sample. To put this in perspective a typical cholesterol test uses a sample size of many millilitres and has an accepted tolerance anywhere between 5% and 10%.
Obtaining such high levels of test accuracy requires a level of manufacturing consistency, well beyond that typically required for a point-or-care diagnostic device. This was achieved through high precision moulding, bonding and Q/A infrastructure operated by experts specialised in manufacturing for microfluidics. When put together this mix of manufacturing knowledge, expertise and technology is achieving CV of <1.5%.
Continual COGS Reduction Drives Market Success
From the outset of the program, and throughout the products growth, Minifab has worked with TearLab to continuously reduce COGS whilst also managing CAPEX requirements.
When initially engaged by TearLab, Minifab were able to immediately make design change recommendations that radically changed the COGS of the product and its commercial viability. This pivotal early DFM work was made possible through Minifab’s combined focus on both design and manufacture under the one roof.
As manufacturing volumes increased Minifab reduced COGS even further through a combination of LEAN initiatives and the staged introduction of purpose-built automation into production lines. This staged automation ramp-up allowed TearLab to effectively balance COGS reduction and CAPEX requirements along-side increasing market demand.
Market Success Drives Second Generation Product
The commercial success of the first-generation product and the strong partnership between TearLab and Minifab are the foundation upon which a second-generation product is now being developed. This enhanced eye disease diagnostic will assist clinicians in making even more accurate diagnosis by combining osmolarity and multiplexed immunoassay in a single test.