The Race To Build More Ventilators Highlights Supply Chain Risk
The coronavirus pandemic has put supply chains under intense scrutiny. While most reporting on this focuses on the delivery of essentials to grocery stores, it’s also found in the engineering of high-tech medical equipment.
A few years ago, one of a handful of Americans still living in an iron lung faced a problem. Martha Lillard spends about half the day inside a negative-pressure ventilator, better known as an iron lung. Infected with Polio in 1953, she’s spent the better part of seventy years inside a canary yellow cylinder. With so few people still living in an iron lung, replacement parts are scarce, and a broken ventilator is simply incompatible with life.
While a shortage of half a dozen iron lungs is a tragedy, it’s now been vastly overshadowed by the coronavirus pandemic. Tens of thousands of COVID-19 patients will potentially go without a ventilator. The situation is dire, and it all comes down to how ventilator manufacturers design their products and manage their supply chains.
The Problem of The Supply Chain
Although companies like Medtronic are publishing the designs for their ventilators and labor unions at GE are demanding laid-off workers produce ventilators, there are significant problems in ramping up production to meet demand.
Under normal circumstances, the parts needed to build a single ventilator are manufactured by several contractors. The injection molded parts might be manufactured in the US, but the circuit boards might be manufactured in China. The parts that go into a completed circuit board are manufactured around the world, and there might only be one manufacturer for the air pump on a ventilator.
Any missing item on the bill of materials of a ventilator must be replaced by a similar piece. For passive components on a circuit board, there can be hundreds of options, and all will work exactly the same. For more high-tech items, like injection-molded plastic, there might be only one supplier, because that’s the supplier that has the molds. For TFT displays, again, there might only be one supplier.
While the FDA is implementing a repurposing program for anesthesia machines to be used as ventilators, and modifying CPAP machines for use as ventilators, the coronavirus pandemic highlights the need for better designs and the ability to gain insights into the components engineers use. The availability of components and the ability to use alternate components is paramount, and there’s never been a clearer illustration of this fact.
The Need For Ventilators
Unfortunately, every strategy to combat the coronavirus pandemic will result in a health care system that is strained, at best. The Society of Critical Care Medicine projects that 1.9 million COVID-19 patients would require admission to an ICU, with nearly a million requiring mechanical ventilation. Only 62,000 mechanical ventilators are in operation in the US, with only another 100,000 older models available that could be pressed into service.
A device that allows for mechanical breathing is not new; the earliest — iron lungs — were built in the 1920s to assist the breathing of polio patients. These negative pressure respirators used a pump to create negative air pressure around the patients’ chest, forcing the lungs to expand. In the 1950s, respirators gave way to positive pressure ventilators, pumping air through the lungs through a face mask or a tube. Although new models of ventilators are computer-controlled and feature high-tech electronics, the basics of a ventilator haven’t changed in seventy years.
Today, there are a half dozen or so manufacturers of ventilators, including GE’s health care business, Medtronic, ResMed, and a handful of privately held companies. In recent weeks, these companies started to increase the production of ventilators in anticipation of expected demand.
The US Food and Drug Administration issued new rules allowing medical device manufacturers to skip the usual regulator review process normally required to make changes to existing products. In addition, related products like CPAP devices, are being drafted to serve as temporary stand-ins for ventilators.
The crisis of the coronavirus pandemic is simply one of ventilators; without enough ventilators the health care system will be overwhelmed and people will die.
Companies Step Up
While repurposing CPAP machines and extending ventilators to support half a dozen patients may help in the short term, companies are stepping up to provide ventilators to health care professionals.
Dyson, most famous for their vacuums, has designed a new ventilator in just ten days, and has received an order for 10,000 ventilators from the UK government. The Massachusetts-based Zoll Medical announced it will be increasing its manufacturing capacity to 10,000 ventilators per month. General Motors will be partnering with Ventec Life Systems to build more ventilators, and Ford is partnering with GE Heathcare and 3M to produce medical equipment and protective gear for healthcare workers, another item that is desperately needed in a pandemic.
Beyond manufacturing existing designs for ventilators, some institutions are exploring newer, low-cost designs that can be easily and quickly manufactured. MIT researchers are developing an an Emergency Ventilator that can be used to bridge the gap between deployed ventilators and devices that are in production.
The MIT E-Vent project is an outgrowth of a decade-old design for a mechanical ventilator, the origins of which were rooted in a tool for rural areas and developing nations. These areas have limited access to mechanical ventilators, but now it could serve as the cornerstone of a response to a pandemic.
The MIT E-Vent is a simple device, based on a manual resuscitator, or ‘Ambu-Bag’, that’s found next to nearly every hospital bed. With just a few electronics and a bit of mechanics, these Ambu-Bags can be repurposed as automated ventilators.
The MIT team is still exploring FDA approval and will require significant testing before making it into the field. However, given a potential shortage of hundreds of thousands of ventilators in the United States alone, all eyes are on these crude, prototype-level solutions.
Securing the supply chain
Medical companies are stepping up, most notably Medtronic, are stepping up and releasing all the design files for some of their products. The Medtronic PB560 ventilator has recently been released under a pseudo-Open Source license, with design documents and CAD files for all. Unfortunately, the release of these design files highlights the risk of supply chains, and how design decisions can put an entire project in jeopardy.
Although anyone can download the design files, schematics, and code for the PB560 ventilator, it’s extremely unlikely anyone could ever build one of these devices. Most notably, the microcontroller inside this ventilator, an ST Microelectronics part, is out of production and is unavailable at any distributor. It’s simply impossible to buy the parts to build this ventilator.
Building a product is a holistic process; it’s not about building one, it’s about building thousands over the course of years, or decades. The lifetime of a product isn’t determined by how long you’d like to build a product, it’s determined by how long your suppliers will support the components you use.
Tools like Supplyframe’s BOM Insight can be used to design a product for a long lifetime, derisk the components that go into a medical device, and deliver market intelligence relevant to the global supply. The coronavirus pandemic isn’t about building just one ventilator, it’s about building tens of thousands. Yes, we will all get through the coronavirus pandemic, but with the right engineering tools it could have been so much easier.
