Invasive/Non-Invasive Ventilator

Project: Invasive/Non-Invasive Ventilator

Client Need:

  • Provide the software and algorithms for different breathing patterns (different sicknesses need different therapy profiles)
  • Adapt to abnormal breathing events (mask leaks, coughing)
  • Add a cost-efficient internal handpiece (by making it autoclavable)

How RBC Added Value:
By adding new electronics, mechanisms and software to the predicate ventilator, RBC created a new and improved combination invasive/non-invasive ventilation product.

RBC designed and developed the mechanical, electrical, and software for this improved ventilation product.

 We created the embedded grey nozzle, a complex electro-mechanical, autoclavable module.

With the “sidecar” enhancement, the invasive/non-invasive ventilator now includes these benefits:

  • Patient adaptation: The invasive/non-invasive enhancement allows for quick patient adaptation to from invasive to non-invasive care.
  • Cost containment: The invasive/non-invasive ventilator electro-mechanical control module is autoclavable for repeated use and cost containment.
  • Single unit: Hospitals now have a single ventilator (since the functionality of two units were combined) to meet the changing therapeutic needs of adult and pediatric patients.
Before RBC
After RBC
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Design improvements
  • Addressed leaks: When the hospital switches a patient to a non-invasive ventilation approach by using a face mask, the invasive/non-invasive ventilator can quickly adapt to the dynamics of possible mask leaks and active exhalation (coughing or patients fighting the ventilator).
  • Added alarms: RBC also designed into the invasive/non-invasive ventilator an emergency ventilation mode (and alarms) to provide the same oxygen settings for a single limb until help can arrive.
  • Ensured easy training: RBC designed the invasive/non-invasive ventilator GUI (Graphical User Interface) with the same look and feel as the previous ventilator to minimize training for the staff.
Technical & Design Challenges

Creating a functional autoclavable module presented several challenges:

  • Finding materials that could be autoclaved without cracking or warping.
  • Designing the autoclavable electro-mechanical control module for easy user connection to the added control module and base unit.
  • Developing effective software algorithms for the patient’s breathing response to adapt to mask leaks by the patients, coughs due to their illness, or the patient fighting the ventilator.
  • Adhering to the appropriate FDA mandated alarms, RBC designed a ‘synchrony’ flow dynamics algorithm which adapts for the best respiratory care of critically ill patients.

By choosing RBC, the client’s engineering team was able to work on a different strategic initiative while we addressed this one.


Depending on your needs, RBC Medical Innovations can produce all or part of the design documentation required for a FDA 510(k) submission, pre-market approval, or a CE Mark technical file.