Description:

Obstructive sleep apnea (OSA) is a debilitating condition that causes sufferers to periodically stop breathing as they sleep. This can worsen existing cardiovascular disease and diabetes. Sufferers also usually perform poorly at work and are susceptible to accidents.

To treat the condition, continuous positive airway pressure (CPAP) therapy delivers air through a CPAP mask to the patient, enabling them to breathe and sleep without interruption.

However, cushions on conventional full-face CPAP masks, which seal around the mouth and over the nose, can put excessive pressure on the nose bridge. The large stability bar holding the cushion in place also sits between the eyes and impedes vision, preventing wearers from reading or watching TV before bed.

In short, CPAP therapy should provide people with a better quality of life. But traditionally oversized and uncomfortable masks can leave some feeling claustrophobic and anxious.

While the industry sought to address this issue and make the contact point on the bridge of the nose more comfortable, we started reimagining the whole mask’s design.

We asked: could we completely remove contact with the nasal-bridge area, plus eliminate the stability bar, without any compromises? Thus, the concept for F&P Evora Full was conceived.

Innovating an under-the-nose cushion was particularly difficult. Given the complex facial geometry variations of that region, we needed to develop an anthropometric database. This involved scanning the faces of a wide range of individuals and ethnicities and creating 3D plastic facial models.

The database resulted in the development of three cushion sizes that could serve 95% of the population. We also adjusted the silicone thickness so the mask was soft in sensitive areas, while still able to inflate and adapt to suit the individual wearer’s face shape.

The stability bar was removed and integrated into a horizontal frame design – called Stability Wings. These extended to the side of the cushion, so as not to inhibit the wearer’s field of vision, and lowered the mask’s profile. Constant fine-tuning of prototypes ensured the Stability Wings remained minimal while still holding the cushion in place during sleep.

Exceeding Sales Expectations
Evora Full has been Fisher & Paykel Healthcare’s most commercially successful OSA mask launch to date. Looking at the first 24 months of US sales results (our largest market), we surpassed all our financial goals:
− Exceeded sales target by 89%.
− Exceeded the launch performance of F&P Vitera (our incumbent mask in the category) by 54%
− Successfully grew Evora Full without cannibalising Vitera. Evora Full’s launch has likely created spill-over brand equity, with Vitera growing at 34%.

Clinical Validation
Our clinical validation trial shows that Evora Full was successful in delivering stable seal performance, in a compact design, for a comfortable experience.
The following percentage of trial participants confirmed our design goals were delivered:
− Seal performance: 91%
− Stability: 91%
− Compact: 98%
− Lack of claustrophobia: 98%
− Comfort: 93%

Market Reaction
Evora Full has the second highest Net Promoter Score (-14) in its category. This suggests strong market trial and adoption despite its recent introduction.

Care by Design is Fisher & Paykel Healthcare’s brand promise. We are proud of Evora Full’s deep patient research and the innovative thinking by our team of industrial designers and engineers. Together, we have enabled patients to sleep more comfortably and freely with life-changing therapy technology.