Adaptec came to Blur with the idea of using load cells to measure urine output with any commercially available drainage bag. Seems simple, but is not. The business model used a disposable load cell cartridge that, through initial market and customer research, we determined was too expensive to be viable.  Through our ability to quickly estimate manufacturing costs, we determined other ways to develop a product that would support a successful business structure: namely, the technology in the capital equipment and a disposable element for calibration and to prevent contamination between users.  These innovative ideas ultimately became the business that was successfully acquired.

After understanding the technology and business model of the Sensica, we built a robust design language around the challenging ICU and OR environments.  We looked at things like:

• Placement near, on, and under a hospital bed
• Minimalistic footprint as the device sits near the foot of the patient bed
• Accessibility to the GUI screen
• Cleaning and maintenance
• Assembly
• Weight and portability
• Ruggedness

We knew that having thorough IP coverage was critical to the Sensica being a success both in the marketplace and in acquisition.  The Sensica uses load cell technology to measure weight, which cannot in and of itself be patented. Despite being a very simple way to measure weight, we realized that in using the load cell there were several key methods of innovation that needed to occur to make the use of the load cell successful.  Namely, we identified methods on the use of strain relief and the algorithms indicating actual urine measurement.  Without those, urine cannot be accurately measured using a load cell given all the variables that occur during actual use.  We developed IP with Adaptec and our patent attorneys to ensure that we had those items completely covered and the true value of the company was created.

Our mechanical engineering effort on the Sensica covered a wide array of processes including:

• Plastic injection molding
• Sheet metal forming
• Tube bending
• Machining
• Mechanisms for disposable attachment
• Structural analysis to determine load bearing of the monitor housings
• Gripping of multiple size drainage tubes by the Sensica housings

We designed the electrical and firmware systems to drive and operate the Sensica.  This included:

• 4 individual PCB designs that pass IEC 60601-1 (Safety) and IEC 60601-1-2 (EMC)
• Implementation of Cypress PSOC microcontroller
• EEPROM communications to prevent disposable misuse
• Sensors to detect the presence of the drainage tube
• Implementation of a tablet and two battery sources
• Internet communication via WiFi or Ethernet
• Firmware to operate the system and integration with GUI application
• Firmware to regulate system batteries usage and charging
• Ability to integrate with hospital EMR systems

The most challenging aspect of the Adaptec product was being able to differentiate between urine events and non-urine events, such as a moving patient or other disruptions from the hospital environment.  We flexed our engineering muscle and designed experiments to characterize urine measurements and bag/tube responses across a wide range of bag types and outside influences.  In the end, we implemented a robust series of algorithms that we can confidently prove detect accurate urine measurement when it occurs and nothing else.

In collaboration with Adaptec’s medical personnel, we developed the GUI and wrote all of the software to IEC 62304 medical device standards. The software included EMR connectivity, HIPAA compliance measures and cybersecurity measures. We ran user validations and human factors testing on the GUI, validating that the GUI design reduced usability risk.

A product isn’t complete without finishing all of the details like labeling and packaging.  We commonly develop these solutions for our clients, and the Sensica was no different.  We developed and performed user testing of the different packages for the product as well as the labeling, user manuals, and quick start guides.

Our Blur quality system has been developed over time for the benefit of fast-moving start-ups. We’ve successfully implemented it here and at other companies, and Adaptec is no exception. Adaptec implemented our quality system and used it as their own.

It makes sense that the designers and engineers of a product should also manufacture the product. Who else has the training, the in-depth knowledge, and the experience to understand the critical aspects of the supply chain and manufacturing methods? For Sensica, we manufactured V&V and clinical systems at Blur, operating under the Adaptec quality system, which was an adaptation of our own.