Success in today's growing sleep disorder market requires a team effort, and manufacturers are donning their jerseys to contribute to the win by focusing energy and product development on a common goal: compliance.

Manufacturers, along with physicians and dealers, want to ensure that sleep disorder products are working for patients, and that these products are being used when, and as, instructed.

In particular, physicians referring a patient to a sleep lab are, according to some manufacturers, pressuring home medical equipment dealers to provide patients' compliance information. Responding to this demand, manufacturers are developing products that focus on tracking compliance information with the least demand on the dealer's time.

“It's driven at the sleep lab level,” says Tim Quinn, vice president of alternative care at Viasys Health Care. “Referring physicians want to know about compliance.”

But what physicians want to know about compliance is not clear to manufacturers, because the parameters of the compliance information that physicians request are vague. “Each physicians group is its own little kingdom,” Quinn says.

The general understanding among industry leaders is simple enough: physicians want to know whether or not patients use the sleep device. But how to gauge this use is the tricky part, according to Quinn, because right now, “[a] compliance plan is left up to each manufacturer.”

To answer the demand for compliance information — however vague that demand — leading manufacturers tend to focus product development on one of two things: gathering compliance information or communicating compliance information to the physician. To these ends, manufacturers develop products to reduce the burden of data collection on the dealer and the end user.

“Dealers are pushed to track compliance for 30 to 60 days,” says Rich Kocinski, vice president and general manager of Devilbiss. “If a patient is compliant at the 61st day, typically [he or she is] going to stay that way,” he says.

So manufacturers are developing compliance modules, such as Devilbiss's eCompliance, that can be attached to a standard continuous positive airway pressure device to monitor a patient for 30 to 60 days, and then be removed. Once removed, the module and its data then can be picked up or shipped to the provider for analysis.

“This allows the patients to have the same piece of equipment from the start,” Kocinski says. “Their CPAP never changes.”

This also allows for a paperless compliance-information gathering system, that saves the dealer time, he adds. “With 10 patients, it's no big deal. But with 1,000 patients, the dealer spends 80 hours a month looking through all the paperwork before [he or she] deciphers whether the patient is compliant or not,” Kocinski says. “There's no value in that. None.”

Another tool in the struggle to communicate compliance information to the physician are products with more intuitive software, according to Ron Richard, ResMed's vice president of marketing for the Americas.

“Clinicians are looking for more data and information on devices,” Richard says, adding that ResMed is developing products to “better and more quickly assess problems in real time.” These products are more interactive with the patient, to encourage end users “to take more interest in their own treatment,” Richard adds.

There also are manufacturers who focus product development on treating non-compliance, rather than on gathering data or communicating that data to the physician.

“At Fisher & Paykel, we have taken the view of treating non-compliance rather than measuring compliance to find ways for patients to become more compliant,” says Steve Moore, director of marketing for Fisher & Paykel Healthcare. Products geared toward treating non-compliance focus on comfort for the end user. “The more comfortable [masks] are, the more compliant the patients are,” Richard adds.

One reason for non-compliance, according to Moore, is dry nose and throat. Treating these discomforts is leading to the development of adding heated humidification to some devices. “We make humidifiers to take the edge off of the cold, dry gas passing through the nose,” says Mike West, senior product manager for Hudson RCI.

Another reason for non-compliance is an uncomfortable, leaking mask. New mask interfaces are being developed to address the concerns of everyone from claustrophobic patients to patients who want to read in bed before going to sleep. “Interfaces are the most important area of compliance,” says Kelly Rudolph, marketing manager for HANS Rudolph. “A blower is a blower. [Blowers] each have their features and benefits, but they all do the same thing. The biggest issue is the mask. If they won't use this, they won't use the CPAP.”

No matter which focus manufacturers choose for product development — gathering compliance information, communicating that information to physicians, or treating paitent non-compliance — industry leaders still need a clearer picture of what exactly “compliance” means, Quinn says.

“We need a clear definition of how and what data should be presented, and to whom,” he says. “The biggest challenge is trying to figure out what people mean by compliance,” Quinn says. “Is it just a phone call to get a ‘yay’ or ‘nay’ from the patient? Or is it tracking compliance hours or printing reports? It would be nice to know what people are looking for.”

Increased Awareness Makes for A Booming Market

THE MARKET FOR SLEEP disorder products is robust, according to leading manufacturers, and the future looks promising as the population base for sleepdisorder products expands.

“This is an under-diagnosed regime,” says Rich Kocinski, vice president and general manager of Devilbiss.

Steve Moore, director of marketing for Fisher & Paykel Healthcare, agrees. “There are a lot of undiagnosed patients out there,” he says. “The awareness each year is greater and greater.”

And the awareness is beginning to take root at the physician level, according to manufacturers.

“Physicians are recognizing sleep as an integral part of a patient's health,” says Ron Richard, vice president of marketing for the Americas for ResMed. And as experts continue to link sleep to multiple other diseases, such as hypertension, cardiovascular diseases and diabetes, that recognition will increase, he notes.

“This is not a new physiological problem,” says Kelly Rudolph, marketing manager for HANS Rudolph. “But there is greater awareness in the medical community that sleep apnea is a real problem.” As that awareness grows, and clinicians begin to realize the vast implications of sleep apnea, the market inevitably will expand, he says.

“As cardiac health comes into play, the market is going to go from huge to humungous,” says Tim Quinn, vice president of alternative care at Viasys Health Care.

The key to opening the market, according to Quinn, is education. “It's a matter of cardiologists looking at sleep disorders,” he says. “Respironics and ResMed have really done a good job of waking people up and bringing sleep disorders to the attention of physicians.”

According to Quinn, things in the sleep disorder market are moving in the right direction. “All you have to do is watch TV,” he says. “Sleep disorders are a high profile problem right now in the United States.”

A Call for Standards in Home Diagnosis of Sleep Disorders

LEADING MANUFACTURERS IN the sleep disorder market would like to see growth in the diagnosis of sleep disorders in the home, but they don't know how or where to begin, according to Tim Quinn, vice president of alternative care at Viasys Health Care.

“To diagnose the number of patients out there without putting [these patients] in a sleep lab, we need to know how. What are the requirements for home diagnosis of sleep disorders? What's the right device to put out there?” Quinn asks.

Professional sleep society guidelines changed in June of this year, but professional sleep physicians still need to make it clear how to diagnose a patient with a sleep disorder, Quinn continues. For example, when diagnosing OSA, “Exactly how many channels are necessary?” he asks. “Is it four channels? Six channels? Twelve channels?”

Currently, manufacturers are making devices that offer as few as two and as many as 12 channels.

“We need guidelines,” Quinn concludes. “Someone needs to set the standards.” And some manufacturers agree that with the establishment of standards, diagnosis — and the sleep-disorder market — will take off.

Experts Interviewed: Rich Kocinski, vice president and general manager of Longmont, Colo.-based Devilbiss; Steve Moore, director of marketing for Laguna Hills, Calif.-based Fisher & Paykel Healthcare; Tim Quinn, vice president of alternative care at Yorba Linda, Calif.-based SensorMedics/Viasys Health Care; Ron Richard, vice president of marketing for the Americas for Poway, Calif.-based ResMed; Kelly Rudolph, marketing manager for Kansas City, Miss.-based HANS Rudolph; and Mike West, senior product manager for Temecula, Calif.-based Hudson RCI.