Reliability Testing and Analysis of the Medical Dialysis System

Client:

Confidential
(a medical device company based in Chicago, IL, with additional operations in Minneapolis, MN)

1. HALT Reliability Testing
2. MTBF Prediction & Calculation
3. FMECA Analysis
4. Reliability Growth Testing (RDT)

operations-in-minneapolis-mn

Objective:

Relteck set out to test and predict the long-term reliability of the medical dialysis system under extreme conditions of heat, vibration, and humidity. The work included HALT testing inside Qualmark environmental chambers, MTBF prediction and calculation, system modeling with Windchill Risk & Reliability software, and RDT growth testing backed by detailed data analysis.

The Challenge:

The client was preparing to introduce a new dialysis system to hospitals worldwide, including regions where equipment would be exposed to high temperatures and constant vibration. The problem was that they had no validated stress models to measure long-term durability or reliability, nor a clear view of potential failure modes, their causes, or their effects on system performance

Relteck’s Solution:

  • Created HALT stress profiles based on real-world customer use cases and ran environmental testing to push the system to its limits.
  • Modeled how thermal cycling, vibration, and humidity would affect long-term system performance.
  • Predicted MTBF, product lifetime, and failure zones using Telcordia SR-332 Issue 4 standards and NPRD/NSWC component failure data, supported by RBD simulation analysis.
  • Used FMECA, following MIL-STD-1629 principles, to map out potential failure modes, their causes, and system-level effects.
  • Conducted RBD modeling to simulate uptime, availability, and mean time to repair (MTTR).
  • Ran RDT reliability growth testing to measure and track MTBF improvements under simulated customer environments.

Recommended targeted design reinforcements, component changes, and improvements to strengthen overall system reliability.

Results:

  • Flagged three major failure risks before production began.
  • Increased the expected product lifespan by 2.5 times.
  • Gave the client confidence to move forward with large-scale field deployment.
  • Reduced the likelihood of expensive fixes after launch.
  • Recommended design and compliance improvements before production, strengthening regulatory readiness.
  • Set clear MTBF performance targets for field operations.

Successfully replicated customer environments in testing, proving reliability before deployment.

Keep your tech infrastructure ahead of the curve!

Relteck’s offers MTBF prediction, PCB Sherlock simulation,
reliability consulting, and testing services. For more information,
contact sales or visit their Los Angeles or Fremont offices.