CASE STUDY

Adaptec Sensica Temperature Module


Client: Adaptec, Acquired by BD in 2019
Project: Sensica Temperature Module
Services: Industrial Design, Electrical and Mechanical Engineering, Firmware, Design Controls, Prototyping, Manufacturing


Adding Temperature

In the process of validating the Sensica system, we discovered another business opportunity for the Adaptec system: reading and displaying the temperature of Foley catheters that have built in temperature sensors.  We could take the measurement and display it with other Sensica outputs. Problem was, we already had the system designed and were in the final stages of preparing for manufacturing. We needed an accessory that worked with the existing system electronics and integrated into the design seamlessly.

01


Designing into the Sensica

The industrial design of the Sensica temperature module had to accomplish a few functional tasks, as well as fit in aesthetically.  We also had to move quickly to get the module ready for production so it could be released with the Sensica unit, and all software changes needed to be incorporated for testing to be completed.  Some of our design challenges were:

 

  • Cable routing
  • Integration as an accessory to the existing Sensica
  • Movement of the module if a patient needed to be moved or rotated quickly
  • A safety feature that would disconnect the sensor cable if tension was placed on the line
  • Integration into the Sensica aesthetics
  • Adding the module design controls and all of the testing into the Sensica design control system


Our final design easily strapped onto the Sensica pole and had a 360 rotating magnetic sensor attachment that would move with the patient’s movement and release under tension.

Biosensor temperature module with 360º rotating magnetic cable connection

02


Better Than the Competition

One of our engineering goals was that the temperature module had to read temperature sensors equally or more accurately than existing products on the market. We beat the 0.2 °F temperature accuracy specification.

03


Design Controls and Testing

As with any of our medical device products, we wrote the design controls and completed the V&V testing of the device, integrating it into the Sensica overall system.  We completed tests covering the following:

  • IEC 60601-1 safety and IEC 60601-1-2 EMC testing
  • ISTA 2A shipping testing
  • Cleaning validation
  • System compatibility testing with the Sensica
  • System communications
  • Software testing with the Sensica GUI
  • Temperature accuracy
  • Biocompatibility
  • Labeling verification

04


Manufacturing

The manufacturing of the temperature module had to be ramped up quickly and had an international supply chain. The device also had custom overmolded components to work through, something that Blur has vast experience with.  We went through controlled V&V builds, learning about the costs and the process of both the temperature module and the disposable cable assembly.  Then, we used that knowledge to build a better supply chain and improve our molding processes as we rolled into pilots and production builds.