Case Study

Enabling At-Home Monitoring for Heart Failure Patients 

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FIRE1 has developed the NORM™ System, an integrated management solution for heart failure patients designed for home use. This system detects early signs of deterioration, empowering the patients, and enables timely intervention before hospitalization becomes necessary. Studies have found that the average patient with heart failure spends approximately 32 days per year in a hospital, skilled nursing facility (SNF), or acute rehabilitation center, rather than at home.
  

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NORM system

 

The NORM™ System comprises a minimally invasive implant, a belt the patient wears for about 1 minute a day to capture data from the implanted sensor, and secure digital applications for both patients and clinicians. The implant is placed in the patient's inferior vena cava, the vein just below the heart, and continuously supports physiological heart failure management. Once per day, patients wear the measurement belt, which collects a range of key physiological parameters and securely transmits the data to the platform.

The patient receives daily information on the results, giving them feedback on how their disease is progressing. If any measurements fall outside predetermined thresholds, the system can automatically recommend clinician-defined, individual dosage adjustments. Conversely, if the readings return to normal, the system adjusts accordingly. While patients still have periodic visits with clinicians, this solution enables continuous daily monitoring and facilitates early intervention to prevent hospitalization. 

The project

The solution
Our role
Progression
The solution
The solution operates under a single product umbrella, the NORM™ System, which includes:
 
  • The implanted sensor
  • The wearable belt
  • A mobile app for patients
  • A web application for clinicians 
With FIRE1 focusing primarily on hardware and clinical innovation, they engaged S3 Connected Health as their software development partner, recognizing our expertise in medical device software and regulated environments. Since 2018, we have acted as FIRE1’s primary software development partner, supporting the evolution of the NORM™ System from early-stage clinical trials through to a large-scale US pivotal study.
Our role
Our role extended across the full digital ecosystem, including:
 
  • Mobile applications for patient self-measurement
  • Web applications for clinicians
  • Secure cloud architecture and data management
  • Integrating with the embedded software of the wearable measurement belt
  • Regulatory-ready documentation for clinical and FDA submissions
Progression
To date, the product has progressed through four generations. The initial version was a simple, clinician-operated system comprising a laptop-based application running in kiosk mode, with wired connectivity between the laptop and the measurement belt. 
 
Subsequent generations evolved into a fully wireless solution, incorporating a mobile application for patient measurements and a clinical web portal for data review. Later iterations introduced a cloud-based backend architecture to support secure data storage, sharing, and scalability, as well as embedded software running directly on the belt hardware. Each generation incorporated feedback from clinicians and patients, supporting increasingly complex clinical and regulatory requirements.

"S3 Connected Health has been an invaluable partner throughout our journey, from first-in-human (FIH) to our pivotal trial. They occupy a unique space in the industry, combining deep medical device software expertise with the agility to adapt as we iterated and scaled.


Their ability to be flexible alongside our evolving needs has been a cornerstone of our growth over the past several years. Their contribution was instrumental in helping us secure regulatory approval quickly, delivering an exceptional and compliant product."

 

Michael Kelly, Director Software Engineering FIRE1

Michael Kelly FIRE1

 

 

Results

S3 Connected Health has been working with FIRE1 on the NORM™ System since 2018. Since then, the following has been achieved:

  • Multiple clinical trial releases delivered on time

  • Completed a first-in-human trial with approximately 50 patients in 13 locations across Europe

  • Followed by a US trial involving approximately 40 patients across 8 locations

  • Secured FDA IDE approval for a pivotal study involving 800 patients

  • Verification completed with a single release candidate, accelerating regulatory timelines

  • Successful delivery under an accelerated schedule, avoiding delays

Throughout, S3 Connected Health has consistently been recognized as a reliable and agile partner, delivering high-quality software on realistic timelines while adapting quickly to evolving clinical, regulatory, and business requirements.

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