The Sterifre Aura disinfection system [Photo courtesy of Sterifre]

The Aura is a portable machine that circulates hydrogen peroxide and activated oxygen with the push of a single button to disinfect stethoscopes, sensors, pumps, tablets, phones, keys, badges and anything else you can fit in the chamber. The device emits no harmful chemicals, leaves no residue and can get into the nooks and crannies that are hard to reach with the disinfectant wipes and handheld sprays traditionally used in health care settings.

“About 85% of things that are cleaned and disinfected in the hospital go through disinfection, not sterilization,” Sterifre CEO Rick Shea said in an interview. “We thought if we could take this technology, miniaturize it and get it close to point of care, we would clearly have a unique opportunity for a long time because the sterilization companies have this big equipment sitting in the basement of hospitals and clinics.”

Sterifre CEO Rick Shea [Photo courtesy of Sterifre]

The device uses a 600 ml Aura-D hydrogen peroxide cartridge that lasts about 600 cycles, cleaning between 4,000 and 6,000 devices depending on their size.

That single cartridge replaces about 44 canisters of disposable disinfectant wipes, Sterifre Chief Commercial Officer Mike Goonewardene said, saving storage space, reducing waste and freeing up healthcare staff who are currently wiping or spraying by hand.

The company is selling the system as a monthly subscription that covers the cost of the device, repairs, maintenance, training and consumables such as the Aura-D cartridge and indicator strips that confirm disinfection each cycle.

Such a business model is “very unique for medical devices,” said Shea, who was an executive with Goonewardene at Stericycle before the company went public. “It’s not unique in the medical field, as we’ve been successful using this model in the past.”

Sterifre Chief Commercial Officer Mike Goonewardene [Photo courtesy of Sterifre]

That risk could prove disastrous for Sterifre if the machines need repair or replacement too frequently, so the company hired expert help for design, development and manufacturing.

The Sterifre Aura disinfection system with its doors open, revealing the Aura-D hydrogen peroxide cartridge. [Photo courtesy of Sterifre]

The company hired Cleveland-based Nottingham Spirk for development design and market research to consider whether to pursue sterilization or high-level disinfection — both are FDA regulated — and decided on intermediate-level disinfection, which is regulated by the EPA.

As Sterifre moved through the process leading up to its November 2021 EPA registration, it hired Vancouver, Washington-based Simplexity Product Development to get the product ready for scaled manufacturing. Their task: cut the 60 lb device’s weight in half, quiet the operating noise from around 60 decibels to under 30, and reduce the cost of manufacturing by about 40%, all without changing the system configuration as tested.

Simplexity CEO Dorota Shortell [Photo courtesy of Simplexity]

Simplexity also identified St. Paul, Minnesota-based Minnetronix Medical as the best contract manufacturer to build the products, aiming to deliver the first units to customers as soon as late spring or summer.

Pre-sale buyers have already signed up for the devices, Shea said, and three Sterifre salespeople in Boston, New Orleans and Kansas City, Kansas, are demonstrating the devices in the field.

“We’re in a pretty good spot,” he said. “We have a great patent portfolio. The company was started on two initial patents and we’ve expanded that both domestically and internationally. We’ve got regulatory behind us, so it’s really commercial execution now.”

For more design details, dive into this Aura case study on Simplexity’s website.

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS