BIOMEDICAL ENGINEERING DIVISION
From an emergency device to an intelligent mechanical ventilation system:
The innovation challenge that gave rise to the birth of the ION HEAT Biomedical Line
In March 2020, when the COVID-19 pandemic alarms went off, the ION HEAT Engineering Team took on the challenge of manufacturing an emergency mechanical ventilator in order to contribute to the stock-out of these devices in the preliminary phases of the health crisis.
It was estimated that more than 180,000 people would reach a critical condition that would require the use of assisted breathing devices in the first peak of the pandemic. And as a company we had the installed capacity for the development of highly engineered devices. So we set out to create our first biomedical team.
+ Clear and start over
Designing the first prototype
Read to know the step by step process of creating the IHT:
We relied on the guides available in open source for the automation of a resuscitation bag, applying improvements to instrumentation and functions.
GOAL / RESULT
+ We managed to manufacture a low-cost prototype / respirator in record time. But, during the first fatigue tests, we observed that the resuscitation bags presented a high risk of rupture after 200 thousand cycles.
+ The team made the decision to change the design and start over with a hybrid piston & turbine system, for high accuracy and greater flexibility.
We corrected the technical limitations of the emergency prototypes, popular in the world during the initial phases of the pandemic, and developed of effective ventilatory system.
GOAL / RESULT
We developed a device, with a long-range useful life:
+ Trigger assisted mode
+ Pressure and volume controlled mode
+ Higher response speed, with a very safe control system
+ Greater synchrony with the patient to allow a safe 'weaning' at the end of treatment
SEPTIEMBER 19 /2020
| Optimization 1
After several focus groups with renowned specialists in respiratory therapy, we improved usability for medical personnel and greater support during the patient's recovery phase.
GOAL / RESULT
We wanted more! That is why we continued to work with two objectives: precision and automation.
We develop new features: automatic FIO2, spontaneous mode and introduced an interface navigation knob.
Prototype 1 | Optimization 2
This prototype summarizes the interesting development curve of the IHT200 mechanical ventilator and represents the image of the ‘future’ that we had before starting the project.
GOAL / RESULT
The course of the pandemic showed that the development of the devices must go hand in hand with the possibility of remote monitoring. This device marks the beginning of the era of Tele-ICU ventilators.
+ Thinking + doing + improving + producing
Explore a new path
The ION HEAT team, with an undeniable know-how in plasma nitriding furnaces and high temperature solutions for the metalworking sector, had never faced the challenge of creating life support devices.
In March 2020, with the market closed worldwide, but with the clear challenge of putting engineering at the service of life, the different areas of the Company joined forces to adapt our production chain and open the way in a sector little explored until then in Colombia: the biomedical industry.
Three months later, with the first functional prototype about to begin the regulatory validation process, our engineers described the first learning curve like this:
+ Validations with a global approach
Timeline of the regulatory process
‘Doing it right the first time’ was the premise of inspiration for the creation of the first device in the ION HEAT Biomedical Line. For this reason, the engineering designs and the technologies used were conceived from the beginning as an exercise in innovation with a global focus.
Therefore, all the protocols for the manufacturing of IHT-200 mechanical ventilator from the beginning were outlined focused on obtaining certifications and regulatory approvals in the international arena.
With the advice of renowned specialists in critical medicine and intensive care, as well as the permanent accompaniment of Clinlogix, we moved on to the testing and validation phase. Here is the timeline of this process:
Saturday call to challenge the engineering team to make a mechanical ventilator
PROTOTYPE 0 (resuscitation bag mechanization) is ready. Full pressure cycling tests begin.
The mechanical system meets expectations, but the resuscitation bag fails at 200K cycles.
We have succesfully finished first-in-human trials and are preparing the report for the regulatory
PROTOTYPE 1 sees the light and is named IHT-200. The system meets inhouse fatigue tests and is ready to begin the regulatory process.
Prototype IHT-200 passes in vitro tests. Validated by Mebi, Biomedical Metrology
Prototype IHT-200 passes electromagnetic compatibility tests. Validated by the Faculty of Electrical Engineering of the UPB.
Prototype IHT-200 passes in vivo tests. Validated by the Veterinary Ethics Committee of the CES University
Prototype IHT-200 passes acoustic tests, validated by Phonon, and the alarm operation and battery autonomy tests. Applied by ION HEAT
With the support of Clinlogix, the IHT-200 mechanical ventilator enters the approval phase of the protocols for first in human studies at INVIMA.
Review Commission - In Vitro Diagnostic Reagents and Medical Devices Specialized Room of INVIMA approves the start of Phase I of the IHT-200 clinical Protocol to carry out tests on humans, within the framework of a clinical study
First test in humans, successful.
We developed OPTIMIZATION 1 of PROTOTYPE 1, with new features: automatic FIO2, spontaneous mode and interface navigation knob.
Optimization 1 of the IHT-200 passes the electromagnetic compatibility tests for medical equipment, according to Standard 60601.
We have succesfully finished first-in-human trials and are preparing the report for the regulatory agency
The second round of the optimization process of our IHT-200 has began and the first prototy of our go-to-market product is on its way...
We sent the Invima the results report of the 'First in human Study'
The Specialized Unit for Medical Devices and Un Vitro Diagnostic Reagents of INVIMA approves the results of Phase I of the 'Safety and performance evaluation of IHT-200 Prototype in humans'.