When COVID-19 first reached its most deadly potential in the U.S. by mid-March, a critical shortage of life-saving ventilators forced a nationwide emergency response by major carmakers and dozens of engineering firms to produce many thousands more of the devices.
Along with the herculean effort to find the needed parts and assemble them, laboratory testing of each of many thousands of machines would be required to ensure they were effective and safe for patient use according to FDA guidelines.This is the story of how one small medical device engineering design and manufacturing firm in Houston, Velentium, rose to the task by testing Ventec Life Systems VOCSN ventilator systems to ensure mass production of many thousands of them at the idled General Motors Kokomo, Indiana, manufacturing plant.
Velentium was able to double its internal team with 60 more contractors in project engineering and other roles, many of them recruited from companies hurt by the pandemic as well as the oil and gas sector based in Houston. By the numbers, Velentium worked around the clock to provide in four weeks the first 90 test systems out of a total of 141 to ensure the ventilators met FDA-approved standards.
A test system is a complex machine in itself, with many parts that are used by technicians using computers to check the tubing, air pressure, electronic circuits and other components inside a ventilator. That meant sourcing all the right testing parts and assembling them. Velentium was able to ship its first test system within four days of GM’s first purchase request. As more test devices were made ready, Velentium shipped them in bulk by chartered planes from Houston to Indiana.
After first learning Ventec wanted to increase production of its ventilators, Velentium CEO Dan Purvis reached out to Ventec to help. Purvis, co-founder of Velentium in 2012, has an electrical engineering background with years spent in medical device design and manufacturing. He also knew Ventec’s ventilator from previous work on the system, so he flew to Ventec Life Systems in Seattle on March 19. On the next day, he met a GM team assembled with Ventec there.
“We realized the resources and the smarts of GM and their ability to work at speed and scale was the real deal,” Purvis said in an interview with FierceElectronics. “Within an hour of their arriving, they had 80 buyers sourcing parts for the ventilators. They meant business, and the only way we could keep up was to jump on.”
Back in Houston, Velentium’s expanded team created 16 different tests for various components, testing items such as metering valves, internal flow of air and various functions—like what happens when a patient coughs into a tube connected to a ventilator. “The testing levels are miniscule,” Purvis said. One test takes a tiny increment of water to see if 1/1000th of a pound per square inch of pressure inside the ventilator is exceeded. One of the tests took an hour to complete at first, while others could be done in 90 seconds.
Many Covid victims who are placed on ventilators die, and it is crucial not to exceed accepted levels of air pressure into the lungs. “You might think you could tolerate some high pressure, but your lungs would disagree,” Purvis said.
Keeping to standards was one thing, but meeting urgent demand was another. “With medical devices, you have to comply with FDA standards, but we also had to save the world,” Purvis recalled.
The way Velentium personnel responded could serve as a case study in crisis management. Here’s how Purvis described it:
“With 47 workers at first at Velentium, we had to buy 1,500 individual SKUs of parts in five days and rapidly upgrade purchasing and receiving, then have staff validate each part down to the serial number.
“We started adding engineering staff and technical staff, reaching 110 on staff for four to five weeks. They worked 16 to 18 hours a day, seven days a week. It was a hyper crisis. We were on ramp to produce 10,000 ventilators a month at the Kokomo plant.”
Purvis recalled sitting down with three other top managers in March:
“I said I needed 18 hours a day until this is done and I need you to expect the same from all your team.
“When oil and gas tanked in Houston, I didn’t want new hires showing up just for the money. If they raised the question of money in the interview, it was over. We ended up adding really stellar people and most of the contractors have returned to jobs they were furloughed from.
“The pace was staggering. Every morning in four locations in Houston we would meet, and then in the afternoon. We would start with a human moment. ‘Give me something that proves you are human,’ was the message. There was so much frenetic activity all day and we needed that. People were tired and on-edge so we had to remember to treat each other with civility…It was neat to see the men and women that did the work. They had full family support. The suppliers too.
“The hardest part, the biggest challenge, was the weight of what we were building to assure these ventilators were right. Not having ventilators is hard enough but having one that kills somebody is worse. We checked every single component and every Ventec at GM for 28 days from March 20 to late April.
“The idea that Covid could strike the plant in Houston was terrifying, the same for the plant in Kokomo where everybody took it really seriously. The only sickness we had was a woman whose son had flu symptoms. She was sent home and came back after it was determined he didn’t have Covid.
“On the mental side, we found that after working for nine days straight, a person is going to go wonky. When we saw it, we’d say, ‘Go home and sleep and then we’ll get back to it.’ We didn’t mandate it, but everybody’s stamina is different. I heard numerous times that workers would say, ‘We didn’t do all this for Ventec or GM, we did this for my mother and your mother.’
“When you work that hard you end up with uncommon energy, and you get a false aggrandizement of yourself, maybe like having a manic episode. We’re not a Christian company per se, but we are absolutely aligned with passion and values and our passion is to save lives. Quite honestly, everybody here has pre-selected themselves to be honorable with a humble charisma. No prima donnas work here. These people have a desire to serve when faced with a grand challenge. This was one of those moments.”