Have you thought about Covid-19 Ventilator – Engineering Requirement Specification document? Although, the impact of such engineering innovation is invaluable, it is nothing different to any other systems that engineers design. Being medical device, undoubtedly – slows down the process of bringing such device into the market. It is mainly due to the requirements for additional certifications, However, technically and from the engineering perspective – it is based on same principles. Before designing and engineering, we need to establish our ‘Requirements’. What is it that we really want! Such design document is called ‘Requirement Specification’ document. Requirement Specification will include sections on how the device should look like. It should reflect in great deal what the device is expected to do.
Modularising the Requirement Specification:
It is essential to divide the specification in to modules. In this way, it is easier to assign jobs to more engineers and get work done faster. For engineering projects such as Designing a Covid-19 Ventilator, the modules could be 1- Functional Requirements, 2-Mechanical Design Requirements, 3-Electrical Design Requirements, 4- Software Design Requirements, 5-Safety Requirements, 6- Operational Requirements, 7-Commercial/Pricing Requirements. It is also inevitable to find that there are further sub-modules for identified modules. The list could easily extend to many more modules. It is essential to focus back on questions ‘ What is it that we really want?’.
Software Design Requirements:
Software Design could be further categorised into Settings, Indications, Diagnostics and Outputs. The video below indicates what these sub-modules are. How to tackle software development tasks to meet these requirements.
Covid-19 Ventilator has offered a technical challenge to engineers and innovators. Firstly, a ventilator that could have readily treated covid-19 could not have existed. The existing approach to ventilation by means of BVM offers further harm and patients could be at a risk of barotrauma state. Covid-19 treatment requires continuous ventilation to provide oxygen to bloodstream whilst allowing immune system to prepare the right type anti-bodies. But!!!
How difficult is it really to invent a ventilator when we have found out the requirements? After all, we have reached space. Two hundred years ago, cars came to notice and with automotive and avionics developments, we have accelerated our journey across the land, through the air!
The easiest way to innovate is to lay out the design requirements in terms of Settings, Indications, Diagnostics, Outputs. In this way, we can modularise the Engineering Requirements and have a realistic ambition and a plan to achieve the innovative solutions.
In this video, I explain the main requirements of Covid-19 ventilators. What is tidal volume and how does it relate to patients of all sizes? What is the PIP and Peek pressures? What is Inspiratory and Expiratory Ratio ? How to design user and practitioner interface to operate Covid-19 ventilators.
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