ResMed management stayed off the gel mask bandwagon until they created a product that sleep apnea sufferers would actually use for the long term.
Back in 2004, ResMed developers had a gel technology under review, but it wasn’t quite good enough. Engineers eventually went back to the drawing board. For Don Darkin, Senior Vice President of the Patient Interface business at the San Diego, California-based sleep medicine powerhouse, the early false starts were all part of a learning process that would ultimately lead to masks that patients would embrace.
Why the delay? The last thing Darkin wanted was a “me-too” product thrown into the mix to capitalize on the growing gel trend. The market would still be there, so he wanted it done right the first time. With the recently introduced Mirage™ SoftGel, Darkin reveals that ResMed engineers operated under the principle that a single gel feels good, but with two gels we can make it more effective.
By focusing on long-term compliance instead of short-term tactility, he concluded that a product with varying softness was essential. Using a tooling technology imported from Europe, ResMed found what they needed. “Instead of having a mask with a single layer, we created a double layer; the base layer being more stable for support, the top layer with a very soft interface to the patient. With that concept, we brought forth this product, and a number of internal and external studies showed that the preference numbers were quite staggering.”
Looking at performance, visual appeal, noise level, and softness, ResMed tallied satisfaction numbers in the 70, 80, and 90 percentiles. “Once we had done that, we figured that we could make the bold claim that of all the products on the market, the SoftGel would actually be the most comfortable in that gel segment,” says Darkin. “It is a preference issue some people will get on really well with SoftGel, while others will say that our existing products are as comfortable.”
Encapsulating an essentially soft and structured material proved to be the difference in dealing with the free flowing’ gel substance which makes things difficult with long term use. Other technologies used polyurethanes, and that is inherently difficult to manage, particularly with odors. We needed to change the materials, but also needed to find outhow we could encapsulate gel in a way that would not leak, but also be robust over time and more reliable to meet the ResMed quality criteria.”Darkin says the added reliability means the mask will not break or leak, a fact that long-term gel users will appreciate.
As stated earlier, the proprietary SoftGel cushion’s outer layer provides the softness people typically associate with gel, while the blue gel layer maintains stability and support. Small, built-in vents diffuse air quietly, a feature appreciated by bed partners. The combination of the familiar Mirage dual-wall cushion with the SoftGel cushion also aids in fitting and adapting to facial contours.
“We have also removed the gel around the nasal bridge; we believe that is inherently one of the issues that cause soreness,” adds Darkin. “It could even be considered a hybrid, and it also has the opportunity to be multi-patient and multi-user, which I believe the others do not.”
The Race has not Begun
ResMed started shipping orders for the SoftGel in November, but in many ways the global fight against sleep apnea has not really started. According to Darkin, Peter C. Farrell, PhD, Executive Chairman and Founder of ResMed, once put it this way: “If you really think we are in a sprint, forget it. We are in a marathon, and we have not even tied our shoes laces yet.”
To put it in even more perspective, ResMed has had 59 consecutive quarters of growth. When Darkin joined the company in 1999, about 350 people roamed the halls—now there are approximately 3,000 employees worldwide.
Are the shoes laces tied yet? When Darkin analyzes the vast potential market, he basically agrees with Farrell’s analogy with one small twist. “We really haven’t even gotten our shoes on,” says Darkin. “There is a high proportion of the population who suffer with cardiac problems who also have sleep disordered breathing (SDB). You also have the growing awareness of the prevalence of SDB in the diabetes space. On top of that, you have an explosion in obesity globally. When you analyze the long term effect of the disease and run the numbers, you realize that we really have not started.”
The biggest problem is ignorance. Education for the medical community and the public to make them more aware of the effects of SDB and the co-morbidities is a key factor.
In 10 to 20 years, he estimates that SDB will be associated with overall wellness plans. Whether or not it gets impacted by reimbursement in the form of health care reform, he believes people will embrace the treatment, which blessedly has no side effects, unlike most pharmaceuticals. I honestly believe in the future that CPAP will become part of a wellness program. It can take up to a decade to turn around the medical community and the public from skepticism to the realization that this really can help prevent many diseases and allow a much better quality of life.
Don Darkin has been with ResMed for over 10 years. He has lived and worked in Europe, Asia and the USA. Don has run Product Development and Operations for many high growth companies over a thirty year period and more recently has moved into business related roles.