Published in Manufacturing
Advanced Interactive Response Systems’ digital diagnostic system, above, would give patients and caretakers the ability to monitor and control oxygen levels. The device can transmit that data to a mobile application monitored by caretakers. Advanced Interactive Response Systems’ digital diagnostic system, above, would give patients and caretakers the ability to monitor and control oxygen levels. The device can transmit that data to a mobile application monitored by caretakers. Courtesy Photo

Newaygo firm leverages $600K to bring medical device to market

BY Sunday, May 28, 2017 03:53pm

NEWAYGO — One West Michigan entrepreneur hopes to use data science to make users of medical oxygen systems safer with a handful of new products. 

Valerie Obenchain founded Newaygo-based Advanced Interactive Response Systems LLC (AIRS) in 2013 to address what she perceived as flaws in current oxygen delivery products. 

Many systems lacked easily accessible monitoring, so patients did not know how much oxygen was left in the tank or if the proper amount of oxygen was flowing through the system, according to Obenchain.

“There was an oxygen patient who passed away because their tank ran out,” she said. “Seeing how great the need was and not having the right solutions out there, I think it was partly frustration that started this out, and why there wasn’t a good solution available is what got me started.”

Since then, Obenchain has developed a series of products that she believes will help elderly patients and their health care providers administer and track their oxygen usage. 

This December, AIRS plans to launch its digital flow monitor, which can be attached to any oxygen source to control and track flow, the concentration of oxygen and other useful data points. 

The information is then transmitted through a mobile app that health care providers can track to ensure patients are complying with their doctors’ instructions and that the systems are working properly. 

The company currently is raising $600,000 to help fund the commercialization process. According to a filing with federal securities regulators, the company had raised $480,000 from 17 investors as of earlier this month. 

AIRS also is working to develop prototypes and preparing to seek approval from the U.S. Food and Drug Administration (FDA) to put its product on the market. 

To do so, AIRS partnered with Keystone Solutions Group, a Kalamazoo-based contract manufacturer that specializes in medical devices. 

“I felt like they knew the medical space (and) they knew the FDA,” Obenchain said. “I could see that they were doing what would be needed through the FDA guidelines and the quality systems they had in place. Not only that, but you want to make sure it’s done right. We don’t want it done the cheapest. … One of the big reasons we chose Keystone is because we really felt like the quality was there. They’re really able to take the product from very early stages, from what we had as an existing prototype, into a fully finished product.”

For Keystone, working with companies such as AIRS marks a key component of its growth strategy as a contract manufacturer.

“It seems like there’s an entrepreneur walking in daily asking about our services,” said Jason Barr, a product development manager at Keystone. “They have this idea and they see us having the ability to design the product and manufacture it for them.” 

In addition to its flow-monitoring technology, AIRS also plans to develop an oxygen regulator and changeover system as part of a complete suite of digital products. 

The digital regulator would give health care providers and patients even more control over their oxygen levels and other data points. Meanwhile, the company’s changeover system would allow a patient to switch oxygen tanks electronically if their primary system runs out. 

Outside of digital products, the company also is developing sterile oxygen tubing. Existing products are easily disconnected and can become contaminated from bacteria in humidification systems. Obenchain notes that her company’s products will help keep systems sterile because they aren’t easily removed.

“There’s a lot of bacteria and stuff that can grow in the current water humidification systems that are being used,” Obenchain said. “We’re trying to eliminate those and have a nice portable solution for the oxygen users.”

Obenchain hopes to launch the tubing systems by fall of this year. 

AIRS plans primarily to target the nursing home and home health care markets with its products before moving into the hospital sector, Obenchain said. 

“In a nursing home, you’ve got maybe one nursing assistant and they have 12 patients that they’re monitoring,” Obenchain said. “That’s where I’m seeing a lot of the need and the issues with the patients running out of oxygen and having problems directly related to that.” 

Made in Michigan: Advanced Interactive Response Systems LLC hopes to leverage a capital raise of $600,000 to complete the commercialization and federal certification process for its first product, a digital monitoring system for oxygen delivery products. Founder and CEO Valerie Obenchain created the Newaygo-based company in 2013 to bring monitoring solutions to the oxygen market. She plans to target nursing homes and homecare facilities for her products, including a sterile tube to deliver oxygen to patients. The company hopes to bring its digital monitoring and sterile tubing system to market this year.

Read 4601 times Last modified on Sunday, 11 June 2017 21:59