Product Development from Start to Success

InterFlo/Baxter Benefits from Paragon Innovations’ Approach of Collaboration, Innovation and Efficiency to Develop Cardiac Output Monitor


For years, the accepted method of monitoring and measuring blood temperature in a patient with cardiac problems was to inject 10 to 20 cc’s of freezing saline solution into the patient and then track the liquid through the body. This procedure was less than ideal since the cardiac output reading was so critical to the patient’s care and lacked the highest levels of accuracy. In addition, the process of adding fluids complicated the patient’s condition.

InterFlo/Baxter Healthcare (now Edwards Lifesciences) was committed to finding a better way to monitor and measure a patient’s blood temperature.

Challenge

InterFlo/Baxter Healthcare sought to develop, design and manufacture a diagnostic device that combined the concepts of a thermo-dilution and revolutionary new catheter.

Paragon Innovations was retained to work collaboratively with a team of seven InterFlo/Baxter software and hardware development engineers. They realized that quality was of the utmost importance in designing, developing and manufacturing a medical device.

Solution

Paragon brought high standards of performance to the design and development process. And by contributing several innovative approaches – such as recommending and then implementing an extensive real-time diagnostic system – Paragon helped InterFlo/Baxter reduce costly development errors, accelerate its time- to-market, and eliminate the gap that often exists between designing a device and being able to manufacture it reliably and efficiently.

Result

  • Produced the first electronic medical device to secure FDA approval on its first submission.
  • Engaged in a collaborative approach to produce better problem resolutions, which helped deliver a high quality device while reducing design and development time.
  • Developed a diagnostic system that allowed animal studies and human studies of the prototype to occur six to nine months ahead of normal schedules.
  • Provided complete hardware and software documentation that became a standard procedure in other Baxter design and development projects.

Today, both the device and the process developed by Paragon are still hard at work, helping physicians obtain high-quality information for saving lives.

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