We decided on obtaining FDA approval of a simple handheld device and while that was in the approval process, we developed the more complex device that could run two treatments at once and had a full interactive GUI.  But, the methods of driving the device and the safety characteristics all remained the same and were unaffected by the software GUI, which made approval of the final LipiFlow Console much faster. The regulatory strategy on the LipiFlow paid off.

Our first step in moving beyond the handheld console was determining who in the practice was intended to use the device, where it would reside, and the workflows associated with an Ophthalmology practice. We went through several design iterations, presenting sketch concepts and appearance models to Key Opinion Leaders (KOLs) to receive their feedback and buy-in for adoption of the new product.

Through testing and human factors engineering, we developed an intuitive GUI and patient workflow, then executed the design in class B software written to IEC 62304.  The software contains items such as:

• Duration of treatment and time remaining
• Treatment profile with progress
• Temperature monitoring
• Settable pressure
• Error handling and reporting
• EMR connectivity
• Printable reports for paper records
• Activator installation instructions
• Entering and retention of patient data
• HIPAA compliant
• Cybersecurity

We developed the manufacturing systems to build and test the LipiFlow Console, then executed in-house at TearScience.  This process evolved with several stages of controlled manufacturing.  From V&V units through pilot builds into full-scale manufacturing, we evolved the process and quality at each stage.  Our R&D engineers led the charge, owning the process until it had truly achieved steady-state. This increased our speed to market and we were able to quickly work through pesky start-up troubles, developing solid solutions without delay. Problems we all know occur and need to be realistic about.  Things like:

• Proper, secure cabling routing
• Part tolerances
• Supply chain issues
• Out of spec parts
• Cosmetic defects
• Bringing together the quality paperwork (DHR) for the first time.

It takes an experienced team to quickly work through these issues, learning how to create efficiencies in the process and reduce potential quality defects. This is our method at Blur. We creatively handle issues and learn as much as we can about the process and costs while we build. And with Blur contract manufacturing, our learnings directly translate to improved ramp-up speed, better costs for our customers, and a quick reduction of manufacturing defects.

The Blur founders all originated from the successful ophthalmology start-up TearScience, which was acquired by Johnson & Johnson Vision in 2017. We were key members of the engineering team responsible for its commercially successful product line and TearScience remains our client today. We developed the science, engineering and manufacturing systems behind their diagnostic capital equipment imaging products and high-volume disposable treatment product. Many of Blur’s current employees, clients, and vendors were a result of the relationships we developed and fostered during our time there.