80 to 08: Respiratory's Most Influential Products

Respiratory Management celebrates the pioneers of technology with a spread that unites recent history and history in the making. RM talked to product managers, respiratory providers, therapists and industry experts to determine which products have made an undeniable impact on industry trends and patient outcomes — and collected the hottest products for the coming year.

These aren't your average product write-ups. We've delved into the heart of each product to find out what makes it tick — from its history, to its influence, to its clinical efficacy. What RM discovered is that where the industry has come from is not so far from where it's going. Yes, 2008 brings with it new technologies and improvements on existing technologies, but it also brings something tried and true — products that make a difference in the way patients live. These products include revelations in portability, usability and convenience.

Still, knowledgeable providers and therapists are essential to matching the right product to the right patient. To borrow the words of industry veteran Bob McCoy, "The tools that we use are just tools. They don't create solutions. … I can have a hammer and a saw, but I can't make a cabinet. But there are people that can take basic tools and make beautiful cabinets. So, it comes down to the skill in using the tools."

CLAIM TO FAME: Makes liquid portable
MANUFACTURER: Covidien Respiratory and Monitoring Solutions (www.covidien.com)
In 2000, building on the success of its Companion portable unit, Puritan Bennett released the Helios (High Efficiency Liquid Oxygen System). "Engineers were able to refine the oxygen conserving algorithm and improve the normal evaporation rate (NER)," says Diane Hunt, director of global marketing communications. "These and other enhancements resulted in a portable liquid oxygen unit that was amazingly small and lightweight — weighing only 3.6 pounds when filled. Yet the new Helios portable unit was also long-lasting, delivering oxygen for up to 10 hours at a demand flow setting of 2. This meant patients could stay out all day without needing to refill their portable unit."

The unit incorporates a built-in pneumatic oxygen conserving device. Helios delivers the bolus of oxygen at the start of inhalation and then a tail flow of oxygen for the remainder of inspiration.

Despite the obvious benefits for oxygen patients — a hands-free unit that keeps them active — the Helios faced challenges in the market at first. Physicians, used to standard modes of oxygen delivery, were unaware of the new technology. So, Puritan Bennett launched a consumer TV campaign targeted directly to oxygen users and increased its marketing efforts to physicians and HME providers. Today, the Helios has evolved into two units: the Helios Plus with the original settings and the Helios Marathon, which is slightly larger and lasts up to 20 hours at 2 lpm with continuous flow settings up to 6 lpm.

INFLUENTIAL PRODUCT: Portable Oxygen Concentrators
CLAIM TO FAME: Improved ambulation
MANUFACTURER: AirSep (www.airsep.com), Inogen (www.inogen.net), SeQual (www.sequal.com)
Portability has driven many influential respiratory trends, and oxygen therapy is no exception. Today's portable oxygen concentrators have greatly improved ambulation because they're easier to manage and they take away the stigma of using oxygen. "Our patients basically look like the average business traveler," says Kelly Riley, director of The MED Group's National Respiratory Network.

The revolution began with AirSep's LifeStyle, which earned FDA approval in March 2002. The "wearable" concentrator weighs less than 10 pounds.

Inogen's Inogen One debuted shortly behind in October 2003 as a single solution for oxygen patients, meaning it could be used as a stationary, portable and travel device. The product was the brainchild of Alison Perry, whose grandmother Mae complained about the difficulty of staying ambulatory. Perry and fellow students Byron Myers and Brenton Taylor entered the 2001 Center for Entrepreneurship and Engineering Management Business Plan Competition at the University of California Santa Barbara with a solution to Mae's frustrations. After earning first-place honors, the trio proceeded to build a business. "Our technology and concepts have been thoroughly tested on the bench and clinically validated through additional original science and work," says Taylor, director of technology and founder.

It wasn't long before Inogen and AirSep realized a potential for POCs. The companies began working with the FAA for approval to use the POCs in flight. Today, many airlines allow POCs onboard, making traveling even more convenient for oxygen users. "AirSep is pleased that we were directly in the forefront of working tirelessly with the FAA and others in the aerospace medical industry early on when developing a revolutionary, non-hazmat product like LifeStyle, which gave both airlines and passenger/patients safe alternatives to cylinder oxygen," says Kathy Sanchez, marketing and public relations specialist.

More recently, SeQual introduced a POC with continuous flow capabilities. "Much of what has gone into the design of the Eclipse came from the work that was done to develop a solution for the military," says Ron Richard, senior vice president of sales and marketing. The military needed a portable oxygen device that would be viable in a war zone. The Eclipse traversed easily to the consumer oxygen market. With continuous flow up to 3 lpm and the delivery of a high dose of oxygen in pulse mode, the device addresses fears of running out of oxygen. Richard says the Eclipse also will be beneficial with the 36-month oxygen cap's transfer of title because it will accommodate patients' changing needs as their disease progresses. The Eclipse continues to evolve, and Richard says a new version, the Eclipse II, will be out soon with new patient-focused features and accessories.

Today, the POC market is going strong. Many other manufacturers have entered the market with enhancements to address specific user needs.

CLAIM TO FAME: Treatment for central/complex sleep apnea
MANUFACTURER: ResMed (www.resmed.com)
The VPAP Adapt SV, which launched in 2006, is known for making waves in the treatment of complex sleep apnea, but it wasn't always so.

The device first launched in Europe as the AutoSet CS, a treatment option for heart failure patients with central sleep apnea, often associated with a periodic breathing pattern known as Cheynes-Stokes respiration, according to Drew Terry, ResMed's director of product management, Americas. "In the FDA trial for the device here in the States … 75 percent of the patients in our trial had a different kind of central sleep apnea, which has now been identified as complex sleep apnea," he says. "It has elements of both obstructive and central sleep apnea."

Three factors created ideal conditions for an increased interest and awareness of complex and central sleep apnea: the FDA study, the device and in the spring of 2006, the Centers for Medicare & Medicaid Services' (CMS) update of the reimbursement guidelines for central sleep apnea devices.

Terry says, "We typically go in and spend the night with a lab when they're titrating their first patient with the device. The reaction has been nothing short of phenomenal because often they choose a patient who's tried everything else. They've tried CPAP; they've tried bi-level; they've tried bi-level plus oxygen and nothing works. Because of the way this device responds to individual patient needs, it's worked very often where nothing else has."

Because the VPAP's use has expanded beyond the standard profile of the central sleep apnea patient, ResMed plans to enhance the device to include a higher pressure range. The new device, the VPAP Adapt SV Enhanced, launches in January.

CLAIM TO FAME: Alleviates mask pressure
MANUFACTURER: Contour Products (www.contourliving.com)
The CPAP Sleep Aid launched in 2007, but it had a marked impact on CPAP compliance well before that. The pillow actually evolved from Contour Products' existing pillow line because of a cult following by CPAP users. Scott Davis, president and founder, says CPAP users were buying these products to help them sleep better with their masks — though originally the pillows were not marketed for CPAPs.

"These customers' positive comments about how the pillows were making it easier to sleep inspired us to come up with a custom-designed pillow specifically made for CPAP patients," he says.

The result is a pillow constructed with two hollowed out spaces on each of the lower sides for a mask and hose. The design relieves mask pressure, helps prevent leaks and allows patients to sleep on their sides or stomachs. Davis says the pillow sells well off the shelf, which is helping providers boost retail sales. Soon, the company plans to launch a CPAP accessory kit, which will include a 1-inch foam piece that can be added to the bottom of the pillow for larger users.

CLAIM TO FAME: Rescues those who can't use CPAP
MANUFACTURER: Respironics (www.respironics.com)
When BiPAP, the first bi-level device to market, launched in the late 80s, its mission wasn't much different than it is today.

"BiPAP is the rescue therapy," says Brian Bunofsky, global product manager. "If a patient cannot comply with CPAP therapy, you put them on BiPAP and you will have a very good chance of rescuing that patient and keeping them compliant on therapy."

The BiPAP, which minimizes expiratory pressure, made a significant clinical impact, especially in sleep labs, which could switch patients to bi-level in the lab when they showed signs of difficulty with CPAP. "That was such an asset whenever working with sleep labs to be able to have an alternative, because up until that point, if somebody didn't like CPAP, the only thing that we could do is to put them on oxygen," says Joyce Black, CRT, RTSGT, clinical sales trainer, who worked with BiPAP creator Dr. Mark Sanders. "Their airway was closed off so the oxygen wasn't even helping them. You could get their SpO2 up a little bit, but it really wasn't effectively treating them."

Since its release, the BiPAP has undergone many evolutions to further improve the compliance of CPAP-intolerant patients.

For the 10 years following the launch, Respironics honed its Digital Auto-Trak technology, which triggers a reduction in pressure on expiration by matching flow to the patient's unique breathing pattern. In 2001, Respironics launched Bi-Flex technology to further improve comfort, and then in 2005, the company introduced an auto-titrating bi-level device.

CLAIM TO FAME: Improved compliance
The impact of Flex technology on compliance was an accidental discovery. A Brown University study on motivational enhancement therapy associated with CPAP compliance used Respironics' CPAPs. Mid-way through the study, the CPAP standard unit began incorporating C-Flex. When researcher Mark Aloia, Ph. D., statistically analyzed the data, he found the variable of CPAP vs. CPAP with C-Flex. Turns out, patients on C-Flex used the therapy an hour and 42 minutes longer per night on average.

The Flex family actually debuted in 2001 as Bi-Flex for BiPAP. Shortly thereafter, Resepironics launched C-Flex for CPAP and later A-Flex for autoCPAP. "When you think of bi-level as two different pressure levels to enable it to be more tolerable, the next evolutionary step is that transition from inspiration to expiration and expiration to inspiration," says Maura Weis, marketing manager for sleep therapy.

Perhaps the best kept secret to the product's success is Digital Auto-Trak intelligence that matches the flow to the patient's own breathing pattern. "The amount of pressure relief to make it comfortable is going to be determined by yourself by exactly what you're exhibiting every breath," Weis says. Flex technology rounds the corners off breathing cycles to make the transition from full-on pressure to minimal pressure feel as natural as possible.

INFLUENTIAL PRODUCT: Self-filling Oxygen Devices
CLAIM TO FAME: Eliminates oxygen delivery
MANUFACTURER: CHAD Therapeutics (www.chadtherapeutics.com), Invacare (www.invacare.com), DeVilbiss (www.devilbisshealthcare.com)
Transfilling, self-filling, in-home filling — whatever you call these devices, one thing remains constant: The products have opened up a world of opportunities for both patients and providers. The first two companies to enter this market were CHAD Therapeutics with its TOTAL O2 and Invacare with the HomeFill. The HomeFill was later relaunched at the HomeFill II. Shortly thereafter, DeVilbiss Healthcare (formerly Sunrise Medical) released its version, the iFill.

Mike Irvine, product manager for HomeFill at Invacare, says the concept of a device that could fill cylinders in the home first came about in the late 90s. The idea was that such a device would cut the costs of delivery and address patients' greatest fear: running out of oxygen. The initial challenges were building a small enough compressor and designing a product that would be easy for patients to use.

At first, the idea was slightly difficult to sell. "It's not just a product sale, it's a business model sale," Irvine says. "The issue really is we're asking them to change how they do business. We're asking them to reduce their fleet of delivery trucks, put out a HomeFill and totally change their business model."

DeVilbiss turned to its customers when developing the iFill. The company presented four different transfilling concepts and let key customers choose. "Honestly, we were a bit surprised when they selected the stand-alone transfilling system," says Kristin Mastin, director of marketing. "However, when we started listening to all the benefits they would reap from such a system, we knew we had something."

The iFill launched at Medtrade Spring 2006 with an integrated cylinder Pulse Dose conserving device. "PulseDose offers great responsiveness and delivery of oxygen in a lightweight, durable design," Mastin says. The unit also fills M6 cylinders in a little more than an hour with 93 percent oxygen.

Nowadays, however, the idea of a self-filling device isn't so difficult to imagine and these products are starting to come into their own. "It's been a perfect storm: rising costs — gasoline, driver pay, maintenance, all of those things — combined with potential or threatened cuts in oxygen reimbursement and competitive bidding," Irvine says. "I think it's forcing the industry as a whole to look at its costs and they're realizing that a non-delivery model is definitely the way to go."

Recently CMS gave its stamp of approval for the new technology by creating a separate reimbursement category for oxygen-generating portable equipment.

CLAIM TO FAME: Smaller particle size for more effective drug delivery
MANUFACTURER: Omron Healthcare (www.omronhealthcare.com)
In 2003, Omron released the MicroAir, a product that sought to improve the portability, efficiency and effectiveness of aerosol delivery. The nebulizer incorporates Vibrating Mesh Technology (VMT), which uses a mesh plate with more than 6,000 holes in it and a low vibration to create an aerosol. The result is a smaller particle size for more efficient aerosol delivery. "The vibrating mesh is similar to hitting a water pipe with a hammer at the rate of 1,800 times per second," says Lori Byrd, product manager for respiratory. Smaller particle size means more efficient delivery of aerosol medications. "Particle size is important because clinicians believe that particles that are too large end up in the large bronchi of the lungs, and particles that are too small are exhaled by the patient," Byrd says. "Like Goldilocks and the three bears, the particles need to be 'just right' so that they end up in the lung tissue where the drugs can be effective." The MicroAir uses two AA size batteries and weighs 6 ounces. It slides discreetly into a backpack, purse or large pocket.

CLAIM TO FAME: Reduces delivery costs
MANUFACTURER: Responsive Respiratory (www.respondo2.com)
What started off as a device to compete against transfilling systems has morphed into a phenomenon in and of itself. The Cyl-Fil, which launched in January 2007, fills oxygen cylinders in the home, but unlike many transfilling systems, it requires no electricity. The system fills portables using pressure within 15 minutes and can also be used to top off cylinders.

Tom Bannon, president, says the product hit the market at just the right time to make a difference with hardships created by the 36-month cap on oxygen and competitive bidding. "If (patients are) ambulatory 11 to 20 hours a week, which is typically 31 percent of (providers') patients, (providers) would see that patient every six or seven weeks and drop off or replace that large cylinder," he says. For patients who are less ambulatory, providers will make even fewer deliveries, according to Bannon. "Instead of going … every second, third or fourth week in a month, they're now going to go anywhere between two months and six months. So, it dramatically reduces their costs," he says.

CLAIM TO FAME: Reduces claustrophobia for mouth breathers
MANUFACTURER: Teleflex Medical (www.teleflexmedical.com)
Long the bane of mouth breathers, full-face masks have been reported to cause patient discomfort, leaks and a feeling of claustrophobia. The Hybrid, launched just over a year ago, sought to offer a compromise. The design limits the points of contact on the patient's face, prevents leaks around the eyes and doesn't block the bridge of the nose, so patients can wear glasses with the mask. "One thing is clear when looking at the marketplace for CPAP masks: Patients are desperate for comfortable, easy-to-use products," says Teleflex's Whitney Reynolds, marketing manager for respiratory. "That was the design goal behind Hybrid." The mask also sports a built-in chin flap to support the mouth during therapy and five points of adjustability. Medicare recently carved out a new category for oral/nasal masks to support this new technology.

CLAIM TO FAME: Patient-friendly sleep screening
Part of the problem with many past screening devices was that multiple leads made it difficult for patients to set up the devices on their own, says Angel Mason, diagnostics market manager. The ApneaLink, however, is truly user-friendly: The patient handles only a standard nasal cannula, the device and a standard finger probe for oximetry.

Originally a single-channel device that recorded patient flow, the device first launched in March 2004 under the name MicroMesam by Germany-based MAP. ResMed acquired MAP in April 2005, at which time the device was rebranded as ApneaLink and channels were added to monitor and record pulse and oxygen saturation. The device launched with oximetry in November 2006.

"When we initially released it, we didn't expect it to take off as quickly as it did," Mason says. "But one of the things I think really helped drive that was the ability to not only monitor flow but you can also use it separately and use it to qualify patients for oxygen. The addition of oximetry meant that physicians could get reimbursed for a sleep study if oximetry was included as well. The cardiology market was a very interesting co-morbidity or overlap segment for ResMed, and cardiologists are much more familiar with oximetry signals than flow."

Although private payors reimburse under CPT code 95806, interest in the product is being refueled by Medicare's proposed decision to reimburse for portable studies.

ApneaLink features are also clinician-friendly. Data downloads via a USB cable, and reports can be customized to the individual patient. The device automatically calculates BMI and gives a risk indicator for obstructive sleep apnea. "There's very low failure rate," Mason says. "It has a very high sensitivity and specificity. So, it is able to identify those patients that have obstructive sleep apnea as well as rule out those patients that do not have obstructive sleep apnea."

INFLUENTIAL PRODUCT: Inscrybe Healthcare
CLAIM TO FAME: Implements eCMNs
MANUFACTURER: AuthentiDate (www.inscrybe.com)
Think back before airline e-tickets and you'll have an idea of where Paul Skinner, vice president of sales and client service, sees the HME industry and where he hopes it will go. "There are certain things that an industry in maturity needs to get on board about where it needs to compete and where it needs to cooperate," he says.

Skinner envisions an efficient, paperless order processing system via InScrybe Healthcare, a secure electronic network with e-signing capabilities.

The program launched in September 2006. "The first implementations, which offered a pure eCMN all-electronic process, were well received but were limited by physician adoption of e-signing technologies," Skinner says. "The lesson learned by 2004-2005 was that a comprehensive standardized order processes for respiratory needed to be able to accommodate at least some paper (as digital images or e-faxes) without breaking the integrity of the electronic order process."

Since many physicians have a low volume of daily respiratory patients that require HME, getting them to ascribe to an online portal has been the biggest challenge. Skinner hopes that the future will bring the acceptance of a cohesive processing system that physicians will use to complete paperwork across the spectrum of health care.

For providers, Inscrybe speeds payment by tracking each hand that touches paperwork and incorporates logic to ensure CMNs are completed entirely and correctly the first time.

CLAIM TO FAME: Compliance tracking
While the SmartCard does not directly improve patient comfort, the memory card itself has been instrumental in encouraging compliance for CPAP users. The device tracks apneas, hypopneas, leaks and snoring to provide both HME providers and physicians with hard facts on clinical efficacy. It's that type of data that has helped physicians track their patients' usage and circumvent problems with CPAP, such as incorrect pressure and lifestyle interferences. "You hope that the patient is sleeping most of night," says Gretchen Jerzerc, director, U.S. marketing, sleep-disordered breathing. "So, the patient is not going to be in the position to say, 'I think I had a massive mask leak at approximately 3 a.m.' That's just not the kind of information that you're going to get verbatim from the patient." SmartCard can report that information, however.

The card integrates easily into a providers' business model. Patients simply pull out the card and mail it to the provider, and the provider's farthest trip will be to the post office to collect and send SmartCards.

This article originally appeared in the Respiratory Management Jan/Feb 2008 issue of HME Business.

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