Updated on May 11 to reflect that inventor Mark Comunale received FDA approval for the Patient Isolation Transport Unit.
Covid-19 throws a spotlight on collaborations among inventors and the small- to midsize companies that bring their brainchildren to life. Among the most intriguing products to address coronavirus was jointly developed by a patent-holding physician, a venerable family business, and a startup less than a year old. Here is their story.
In 2014, Mark Comunale, the CEO of Inland Empire Anesthesia Medical Group, in Colton, California, was spending a lot of time at nearby Arrowhead Regional Medical Center, where he is also chairman of the department of anesthesia. That year the institution was preparing for another terrifying health crisis: Ebola.
At Arrowhead, Comunale observed a troubling situation. Most ICUs and operating rooms have positive air pressure to push airborne contaminants away from patients with diseases like cancer and diabetes, whose immune systems are compromised. With infectious disease, though, the equation changes. The goal becomes protecting medical personnel, other patients, and visitors by using negative air pressures, which contain contaminants until they are dispersed, in a controlled way, through an air filter.
"If we had a patient with Ebola, they would have to go into a negative-pressure room, and there were not enough of them," Comunale says.
So Comunale--a physician who holds a patent on a medical-transport cooler for blood and organs--created the Patient Isolation Transport Unit. The PITU is a vinyl enclosure a little more than six feet long and three feet high, which is mounted on a frame secured to a bed, or to a gurney, so infectious patients can be moved around the hospital without exposing others. Three motors suck out air and pass it through filters to create negative pressure. Two glove ports, with arm sleeves on each side, allow caregivers to stick their hands through. There are also pass-through chambers for things like thermometers.
"It is like building a little room around the patient," Comunale says. "When the patient is in there, hospital personnel don't have to use as much personal protective equipment. And there is enough room to carry out activities of daily living." Another advantage: someone in a PITU can receive visitors, which addresses the heartbreaking stories of coronavirus patients dying alone.
For the past couple of years, Arrowhead Regional Medical Center has been using a prototype made from non-medical-grade material. Recently, it ordered two more and has indicated it will buy the medical-grade versions once those are available. Comunale has fielded inquiries from several other area hospitals, as well as from ambulance companies "that are wondering whether we can adapt something for their tiny stretchers," he says.
A few weeks ago, Comunale, who had a preliminary patent and in January had started the process for FDA approval, filed with the regulator for emergency use authorization to help protect the frontlines fighting coronavirus. He received approval on May 8 and has now begun production, thanks to two small-company partners.
The Project Manager
In 1976, defense contractor TRW became the first client of A&R Tarpaulins, hiring the new business to make industrial curtains to discourage snooping in its El Segundo facility. A&R built a large aerospace clientele, developing protective products like acoustical and thermal insulation.
Today the business is owned by Bud Weisbart--the son of one of the founders--and his wife, Carmine Weisbart. The Fontana, California-based company, which now does business as AR Tech, reports $3.2 million in annual revenue. It recently created a contamination enclosure for NASA's James Webb Telescope.
A few years ago, Comunale approached the Weisbarts for help with product development, sales, marketing, and distribution for the PITU. Working from an early prototype, Weisbart identified a number of challenges, including how to create adjustable aluminum frames that would fit on any bed or gurney and how to secure them. He also needed medical-grade material for the enclosures that was fire-retardant, static-free, and resistant to bacterial growth.
Weisbart wanted help with the engineering and materials problems from a specialist in medical products. And since AR Tech was not set up to produce a potentially large volume of PITUs, he also needed a manufacturing partner.
In 2018, Weisbart had watched a webinar series on prototype development led by Chad Miller, who was then director of contract manufacturing for American National Manufacturing. Miller's family had launched American National 40 years earlier as a waterbed manufacturer. The company later segued into medical mattresses designed to prevent bedsores. In 2019, Miller spun off the contract manufacturing division, which served multiple industries, into a 10-employee startup called Industrus, based in Riverside, California.
Miller had industry expertise, as well as access to American National's FDA-registered manufacturing facility to develop a medical-grade version of the PITU. AR Tech and Industrus collaborated to re-engineer the frame to make it adjustable. To secure the frame, they came up with a mechanism that used the metal loops on the side of the gurney through which IV poles pass. Miller also redesigned the brackets that hold the pumps and filters.
Industrus can produce 25 PITUs a day with current resources, and ramp up to 1,000 a month, Miller says. He has ordered a new cutting machine and may invest in additional sewing and tooling equipment. The PITUs will likely sell for around $12,000, with replacement enclosures costing about $800. The three contributors will divide the revenue based on cost of manufacturing for Illustrus; and sales, marketing, and distribution for AR Tech; as well as an unspecified margin for Comunale.
As coronavirus bore down, all three members of Team PITU went into overdrive, collecting information for the FDA, finalizing the design, and tire-kicking the supply chain. Miller has informed his other clients that, for right now, PITU is his top priority. "It has kind of overwhelmed my life," says Miller, who has been working nights and weekends and requiring his vendors to do the same. "But it is reinvigorating me personally and creating brand new excitement for American manufacturing."