“The number one rule of medical device development is do no harm to the patient,” says Dugan Karnazes, founder of Velocity Research.
As Hippocrates outlined in his eponymous oath, providing medical treatment where and when it is needed is a close runner-up. It’s also one of the most valuable impacts that product developers can enable during a global crisis.
Before pandemic prompted travel restrictions and stay-at-home orders in the U.S. it exposed a significant lack of critical medical supplies needed to save the lives of those who have contracted coronavirus disease (COVID-19). Within two months of the first case reported in the U.S., there were more than 20,000 further confirmed cases, and mounting evidence that this was a far bigger problem than health care systems could handle on their own.
A call went out to medical device experts, engineers, and innovators across the world. In the US, longstanding FDA standards were adjusted to motivate development of inexpensive and easily reproducible ventilators, which otherwise cost anywhere from $25,000 to $50,000 each.
While COVID-19 cases began to rise in the US, an Open Source Ventilator initiative began in Ireland, founded by three close friends from Ireland, Conall Laverty, Colin Keogh, and David Pollard. The OSV community grew from 5 members to 3000 in its first month, with makers from around the world contributing to more than a dozen different ventilator designs.
Karnazes was looking for a way to help. His mother was starting chemotherapy and he was worried for her health, as well as the implications of a worldwide pandemic. He knew others wanted to help, too. Rather than duplicating the efforts of thousands of others, Karnazes made his company’s resources available to COVID-19 response and corralled development firms in West Michigan interested in contributing to the project.
He kicked off the regional initiative with one of the OSV designs and the help of PCB design tool licenses donated by Altium.
Involved in the project:
The West Michigan OSV project was decoupled from the campaign in Ireland to encourage agility. The mechanical design of the OSV was completed first, followed by printed circuit board (PCB) prototypes and firmware. The final product comprises five separate PCBs connected to sensors and motor controls that operate a 3D printed gear, which is easily swapped with commercially manufactured replacements.
Spectrum Health is providing feedback on the OSV design. Nadim Conti from the European Organization for Nuclear Research is guiding the project through a series of environmental and safety tests, and individuals from Ford and GM are collaborating on a strategy to meet FDA approval.
In less than a month, the group developed and delivered a prototype that only costs about $500 to reproduce before the necessary software components are built in. This cost was met in part by a design that accommodates inexpensive and widely available commodities like Ambu bag valve masks, in part by the FDA EUA for ventilator devices that temporarily removed the risk of an otherwise time-consuming and costly review process, and in part by the fact that all the time and resources that went into completing this design were donated.
“The whole goal from the beginning was to keep it low cost,” Karnazes says. “This project was meant to create an emergency option for the short term, just for COVID. This is so no one is faced with having a ventilator or nothing.”
The bags wear out after about two weeks. They are not designed for long-term use, and neither is the OSV. This design has fewer features than top-of-the-line ventilators but it’s enough to give COVID-19 patients a much better chance of survival when they need it most
Karnazes and the team have so far been working with Wow Capital in Mexico and the University of Guadalajara to begin the process of clinical testing and ensure it provides critical value to healthcare centers around the world. Neither Velocity Research nor any other name on the list intends to sell these ventilators as a product. They met the challenge when they created an open source design, inherently free-use to organizations, hospital networks and other governments.
“Anyone can go out and get everything they need to create these or build them wherever they are in the world,” Karnazes says.
Even if global pandemic can’t be predicted in time to plan accordingly, open source resources like this ventilator go a long way to improving the chances that those who need medical treatment get it before it’s too late.
This video from Altium gives more insight into the project.