Many technical minds are needed to assure such projects are updated both extremely accurately and with the speed necessary during a pandemic. Ryan Prosser, CEO of Very, an IoT design and development firm that has created HIPAA-compliant devices in the past, currently has team members participating in a crowdsourcing COVID-related ventilator project. To learn more, Digital Journal caught up with Prosser.
Digital Journal: What types of equipment are in short supply for healthcare workers during the COVID-19 pandemic?
Ryan Prosser: With coronavirus cases soaring, doctors, nurses and other front-line medical workers are all facing a dire shortage of masks, surgical gowns and eye gear to protect them from the virus, so much so that the average person is familiar with the abbreviation PPE (personal protective equipment). There’s also a short supply of surgical supplies, sedatives, anesthesia, and painkillers to treat patients, manufacturers are scrambling to produce and distribute ventilators and masks, while rumors about potential treatments are leading to drug shortages.
DJ: What contribution are IoT engineers making to help address this shortfall?
Prosser: The range of skills necessary to develop and deploy IoT devices are applicable to a wide range of pandemic response technologies. IoT engineers design end-to-end systems — from the electronics and enclosures that gather data to the applications that display that data and make it available anywhere in the world. Unsurprisingly, many of the same skills that apply in an IoT setting are directly translatable to designing medical equipment. There are many engineers that have worked on HIPAA-compliant systems, FDA-compliant devices, and the software to integrate huge swaths of data.
Fittingly, engineers across the globe have joined a litany of projects such as 3D printing face guards and other PPE, helping update company apps and devices to provide updates and critical information to users, and crowdsourcing solutions to address the shortfall in ventilators.
DJ: What are the main technical challenges?
Prosser:If you are not familiar with the extreme complexity of a ventilator, it is critical to understand that it typically takes two to three years to develop and launch it. Not only is it an extremely complex machine, but it is a lifesaving medical device that breathes for a patient and monitors several vital signs including oxygen content, flow rates, and pressure.
The biggest challenge for many IoT engineers will be familiarizing themselves with the tougher requirements placed on the system. In many typical IoT applications, the requirements are not quite as stringent. For example, materials used for medical devices must be specified for a handful of properties like temperature and humidity and requirements about contamination that can limit the spread of diseases and infection, so everyone must familiarize themselves with the stringent parameters required for such an undertaking.
There are also a higher set of requirements for the level of documentation. Any change that has been made to an FDA-approved product must be documented, including for each component.
DJ: How are Very IoT engineers helping out?
Prosser:At Very, we have several engineers that have joined one crowdsourcing ventilator program, called the GitLab Medtronic OpenVentilator.
The Medtronic OpenVentilator plans were originally completed in the mid-2000s, and since then, many of the components that were once cutting edge and common are now obsolete or in short supply. When the shortage of ventilators became known, engineers turned to open-source projects to update, translate and recalibrate plans so that ventilators could be more rapidly prototyped, tested and approved by the FDA — then installed in hospitals around the world.
More than 50 engineers are attacking the hundreds of various components and updating them based on current requirements around the power supply, inputs, and other necessary amendments.
It is an extremely complex undertaking, and we are honored and humbled by the work of our teammates who joined this initiative. Our engineers have provided critical project management and collaboration experience, facilitating collaboration within a rapidly expanding team and ensuring that work is not being duplicated. They are also identifying missing or obsolete components in a bill of materials consisting of six circuit boards and over 500 components, documenting changes, modernizing outdated design files and reconstituting the firmware that runs on the electronics. Their goal is to use as many parts as possible from the original schematics because each change has to be properly documented for the FDA’s re-approval process.
DJ: How is the imperative for speed counterbalanced with the need for accuracy when producing ventilators?
Prosser:Accuracy is non-negotiable. While everyone participating in this project is fueled by the desire to help people as soon as possible, the work is only impactful if it is irreproachable. The Very team is familiar with implementing processes for distributed technical teams while ensuring that every update is tracked against the necessary safety requirements and protocols.
Our engineers are able to use a percentage of their company hours to work on this project, in addition to their free time. Very’s experience in managing projects remotely and across asynchronous timelines is helping the project to be efficient.
When timelines start to feel overwhelming as COVID-19 cases continue to skyrocket, we have to remember that healthcare challenges and shortages are happening at different velocities worldwide.. In Latin America, for example, the curves of infection are only just beginning, so there will soon be a need for ventilators there. Additionally, the ventilators currently being distributed are going to be used heavily and will soon need to be replaced. Even if only 1,000 ventilators are produced from this program, it would be a success.
DJ: What progress has the Very team made so far?
Prosser:Our experience at Very has provided invaluable expertise in managing IoT projects with a completely distributed team. This knowledge was directly applicable to implementing processes to the Medtronic OpenVentilator project. Additionally, we have contributed updates to portions of several of the schematics, and we are currently working on standardizing all parts used within the designs. Lastly, we have taken the lead on the evaluation and reconstitution of the firmware.
From a hardware standpoint, the electronics are about 60% of the way done at this point. From the firmware side, we’re now less than 50% of the way to completion.
IoT design and development can be challenging, and doing this 100% remotely can provide another different suite of challenges. However, our experience of working completely virtually for almost two years has put us in the best position possible to help where we can in tackling the pandemic.
