How ResMed designed its new AirFit F40 CPAP mask

ResMed Chief Product Officer Justin Leong and Global Sleep Product Manager Lai Ying Ho discuss the AirFit F40 mask’s design and development.

If you search FDA records for ResMed’s new AirFit F40 continuous positive airway pressure (CPAP) mask, you won’t find that name.

Instead, ResMed sought and won FDA 510(k) clearance for the AirFit F40 mask using the codename Oran Park after a raceway in Australia, where ResMed was founded.

ResMed is now headquartered in San Diego, but the engineering team still applies the names of Australian racetracks to the systems they develop.

“High performance is what we’re looking for,” ResMed Chief Product Officer Justin Leong said in an interview with Medical Design & Outsourcing. “And that’s this mask.”

The ResMed AirFit F40 mask

ResMed developed the AirFit F40 to offer the comfort of smaller masks without sacrificing performance. This could, in turn, help with sleep apnea therapy compliance for users of high-pressure CPAP machines.

The mask is designed to provide pressure support in a more comfortable, low-profile way. ResMed wanted to make the mask better for those who sleep on their side — an estimated 50% of the population, Leong said — and patients who are claustrophobic or want the stability and seal of a universal-fit mask in a minimalist design.

ResMed’s key, Leong says, is the AdaptiSeal cushion. The soft silicone material helps to maintain a facial seal, even when the patient is moving around during sleep.

Leong said it’s the first cushion of its kind made out of fully soft silicone material, eliminating the hard plastic chassis commonly used in full-face sleep apnea masks. That rigid component helps maintain the shape of the cushion, but can cause discomfort if the mask is too tight. The AirFit F40’s new cushion allows the mask to “float” on the user’s face, Leong said.

“The biggest thing we’ve done is make a small face mask that still performs well,” he said. “The way we’ve done that is a very innovative cushion that sits over your face. … It adapts to your face. That’s a really magical thing.”

In addition to the smaller, more comfortable features, the redesigned frame of the F40 sits “a bit differently” across the top of the face for clearer vision. Patients can even keep their glasses on while using the mask.

Another feature is a quick-release tube that allows users to easily disconnect the mask from the tube. The mask also has what Leong calls “simple headgear with four points to adjust, making it easier to remove than previous versions.

“Often, if you’re waking up in the middle of the night, you need to adjust your mask or take off your mask, so you want something really simple around your head,” Leong said. “We’ve redesigned that as well.”

ResMed AirFit F40 mask development challenges

Size was a key factor for ResMed to tackle when developing the new AirFit F40 mask. Face masks tend to be large, covering the mouth and nose. Along with the cushion, the frame was important, Leong said.

Lai Ying Ho, ResMed’s global product manager for sleep, said the challenge was to “design a mask with a cushion that is soft and seals well, [that] doesn’t collapse, and can be reliable and easy to manufacture.”

It was mainly a challenge of architecture, she said. With a different frame and an additional short tube compared to just an elbow in the previous version, the mask is flexible and sits differently than old frames, Leong said.

“The technical challenge is that these masks need to work under quite high pressure — that’s why usually they’re made with quite rigid material — and to make it keep in shape enough to seal but still be that comfortable, soft cushion,” Leong said.

“We all have very different-shaped faces,” he continued. “To design something that fits most faces is very difficult. That’s where the clever engineering had to come in with the facial scanning.”

For the first time, ResMed used facial scans to kick off the design of a new mask, Ho said, collecting thousands of scans to find the right design that would fit as many faces as possible.

“During the development process, we do go back to patients to fit them in order to make sure that this is really fitting a wide variety of faces as we intended,” she said.

Taming the supply chain

Finally, given the long-running recall issues that knocked Philips Respironics out of the CPAP business, ResMed has expanded its share of the market. That increased demand came as the COVID-19 pandemic continued to disrupt supply chains.

“We’ve always had big manufacturing capacity around the world,” Leong said. “But sourcing materials has been challenging over the last few years.”

ResMed ramped up production while incorporating new materials in its updated mask. The company is one of the world’s largest buyers of the silicone used for the mask’s soft cushion, Leong said.

“We’ve had to spend time sourcing new suppliers and working with them over the years so that we have multiple suppliers,” he said. “…We’re in a much better situation today and we have good supply — touch wood.”

Read more from our interview: ResMed is trying to solve the CPAP mask magnet problem

This post was published on May 30, 2024, and updated on June 25 to add more information about the AirFit 40 mask cushion design and correct the number of headgear adjustment points and tubes.