Respironics Comfort Curve Nasal CPAP Interface Interview
Product Overview
Introduction To The Comfort Curve
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The ComfortCurve Nasal Interface System is a breakthrough alternative to traditional nasal masks. It is
the first interface system to provide a less invasive, more complete and lifestyle-oriented form of airway
delivery. The ComfortCurve features an innovative cushion that gently cradles the nose and delivers a
dispersed flow of airway pressure. It comes complete with 3 cushion sizes, headgear, and an exclusive
tubing system. The ComfortCurve's low-profile and compact design allows for unlimited patient visibility
for watching television and reading before sleep and it is packaged in an attractive pouch for
convenient travel. It is also offered in 5 color options (sold separately) to customize the interface
for a fun, personalized expression.
cpap.com's Respironics ComfortCurve Nasal Interface Product Page
comfortcurve.respironics.com
Respironics Introduction and Background
History
Founded in 1976, Respironics is a leading developer, manufacturer and distributor of innovative
products and programs that serve the global sleep and respiratory markets. The Homecare Division
is recognized worldwide for its continuous stream of medical innovations and advancements in the
management of sleep disorders, integrating state-of-the-art technology in diagnostics, therapy
and monitoring with strategic programs to help homecare providers and sleep centers care for
patients efficiently and cost-effectively.
Respironics markets its products in over 125 countries and employs more than 3,400 associates
worldwide.
Respironics Homepage
Innovations
Respironics has demonstrated its dedication to the sleep therapy market with a proven track record of innovation and responsiveness to market needs. Widely considered a global leader in sleep therapy, Respironics introduced the first commercially available CPAP device in 1985 and was first to the market with BiPAP® bi-level therapy in 1989. Since then, many generations of increasingly advanced therapy devices and patient interfaces have been released. The company's latest technological introduction to the sleep therapy marketplace is C-Flex™.
The Interview
Getting To Know The Product Manager
Q: Please tell us a little about yourself. Are you married? Kids? What do you do when not attempting to change the CPAP industry? Is Respironics your first engineering gig?
A: Justin Crout, Respironics Product Manager, Patient Interface
I am a Product Manager within the Patient Interface segment of our Homecare Division. My wife and
I live in Pittsburgh and have a 2 month old son that keeps us very busy. I have been with Respironics
for 2 and a half years and have been involved with many product introductions in that time as part
of the marketing department. I started my career as a mechanical engineer then worked as a consultant
prior to earning an MBA then joining Respironics.
Q: Have you been involved in previous CPAP related projects? Is there a Respironics seal, clip or ventilation port with your name on it?
A: I was involved in the launches of ComfortGel, ComfortFull and ComfortLite. I also worked with our engineers to develop the Premium Chinstrap.
Concept, Design and Market Pull
Q: We would like to know about the creative process behind the Comfort Curve. Can you please tell us about the how this mask came to be?
A: The nature of the ComfortCurve stems from a continually strong patient demand for a better alternative to traditional nasal PAP masks. We challenged ourselves to create a more comfortable alternative that offered the benefits of a small and low-profile interface. We also relied heavily on input from real users that wore the ComfortCurve night-after-night to refine the design, performance and perception of the product.
Q: Are there any funny stories floating around the halls of Respironics that came from the process of bringing this mask from concept to production?
A: My favorite story came from a participant in one of our trials. When we introduced the opportunity to personalize the product with different colors, she stated: "These colors will work great for my husband. Red means 'no' and green means 'go'." We never ever considered this use for the color options and the whole room basically erupted.
Q: What did Respironics set out to do with this mask? Why have you moved in this direction?
A: Quite simply, we are providing a better alternative to pillows and prongs-based products. Through a less invasive, more complete and lifestyle-oriented form of airway delivery, the ComfortCurve represents a natural direction towards improving end-user compliance through a more readily-acceptable patient interface.
Q: This looks very different from masks and interfaces we have seen in the past. Do you consider this a new genre of interface? What advantages does this product offer over traditional nasal CPAP masks? What advantages over a nasal pillow or prong system?
A: Unlike traditional CPAP masks that cover the nose and obstruct visibility, the ComfortCurve is a low-profile, compact and minimal design. In fact, we consider the ComfortCurve a Nasal Interface System – not a "mask" due to the negative connotation of this term associated with something in front of your face. We definitely do not consider the ComfortCurve a pillows or prongs-based system. It does not insert into the nostrils and it uses the cheeks to support the seal (not the nose) which further eliminates unnecessary nostril irritation, pressure or pulling.
Q: Is this offering intended to replace other Respironics masks on the market or is it simply a new design? How does the introduction of this mask affect the rest of the Respironics product line?
A: The launch of the ComfortCurve will not affect the availability of the other products in our Comfort Series.
Q: Is this mask intended to cater to a specific patient demographic?
A: The ComfortCurve presents an excellent option for any patient that is struggling to find a better alternative to a traditional nasal mask.
Testing, Feedback and Trials
Q: How large a user base was this interface tested on? Were the patients being served by DME or online providers? Were they previously compliant on other masks? How many nights in a row did they use it? How many hours per night?
A: We did extensive patient trials at various stages of the development of ComfortCurve from early prototypes tested internally to at-home testing on real CPAP users. The testing that we perform depends on how far along we are in the progress of development and typically involves hundreds of participants. We test our products on real CPAP users (new and current) that wear the product night-after-night for extended periods of time. Most importantly, the feedback we get from these trials results in enhancements that are then re-tested and validated. The process takes a long time yet produces the best products.
Q: What were some of the changes that were made to the interface as a result of patient testing?
A: Every aspect of the product has changed as a result of the trials on the ComfortCurve. This is how critical the patient trials are to driving an excellent product. The most significant change we made was including the innovative tubing system as a lighter and more flexible alternative to standard gray tubing. This greatly improves system performance by reducing pull or torque on the interface that can disrupt seal.
Q: How did you test this on different sized faces?
A: We conduct our trials in multiple locations throughout the world which allows us to understand sizing, performance and preference based on a wide array of physiological differences and end-user lifestyles. Again, most importantly, these tests are done on real sleep apnea sufferers who are asked to use the product night-after-night for months at a time.
Q: Has this been tested for side sleepers?
A: Yes, most of the patients in our trials slept on their sides with little or no difficulty maintaining a seal. Early in our trials we gave patients the option of choosing a side for the tubing connection. Since they did not want to choose a side to sleep on, they preferred that the tubing system connect on both sides of the interface.
Questions, By Component
Cheek Pads
Q: Where on the face of the user is the cheek pad intended to rest? Do the pads have any "give" or way to counter patients with different sized and structured cheeks that move during the night?
A: The silicone cheek pads are designed to rest under the cheek bones. The "bridge" of the interface (which has the logo) connects the cheek pads and is a very flexible plastic material. It allows the cheek pads to flex for varying dimensions. Each cheek pad is also adjustable to 5 independent locations.
Q: How do the cheek pads adjust to the unique size and facial features of the user?
A: The Cheek Pad Supports rotate independently on both sides of the interface. The surface of each cheek pad support is also ergonomically designed to fit the contours of the face. By removing the cheek pads, you will see this ergonomic surface.
Q: Do the cheek pads rotate independently of the nose piece?
A: Yes.
Q: What are these cheek pads filled with? Air, soft silicone, or something different? Why was this material chosen?
A: The Cheek Pads are made of soft silicone for a comfortable, forgiving and dispersed contact with the cheeks.
Nose Piece
Q: How does the nose piece interface with your nose?
A: The ComfortCurve comes with 3 size nasal cushions (S, M, and L) that are designed to gently cradle and seal under your nose. It is important to note that the cushion should be placed under the nose therefore the tip of your nose should not be placed inside the cushion opening.
Q: What is nature of the way the nose piece seals around the nose? Does the nose piece require significant pressure on the nose to seal?
A: The cushion seals against the base of the nose and is supported by adjustable cheek pad supports (not the nose) which further eliminate unnecessary nostril irritation, pressure or pulling. The cushion has one opening that provides airflow to both nostrils – this allows the airflow to be more dispersed and more comfortable, particularly at higher pressures.
Q: Does the nose piece come in different sizes?
A: Yes, the cushion will be available in Small, Medium and Large sizes.
Q: Does the nose piece rotate independently?
A: The cushion does not rotate on its own although the 5 independent cheek pad adjustments on each side allow the cushion to rest at many different angles under the nose for a soft and secure seal.
Headgear
Q: Is the headgear adjustable only at the sides, or at another part of the headgear?
A: The Standard Headgear is adjustable on both sides.
Q: Is there a length adjustment in the lower strap of the rear halo or just the upper strap?
A: The halo component of the Standard Headgear is designed to stretch to accommodate varying head dimensions. The most important aspect of wearing the ComfortCurve headgear is to adequately separate the straps of the halo over the top and back of the head in order to provide optimal stability overnight.
Exhalation
Q: Does the nose piece exhaust at all? Is so, does it exhaust strait, up or down?
A: The exhalation on the ComfortCurve is located on both sides of the white "cross tube" of the interface. It includes dual diffusion ports that disperse the airflow widely in front of the face for a quiet and dispersed flow of exhalation.
Q: Is there an oxygen port available at the mask or will it require an additional connector?
A: An additional in-line attachment would need to be used in order to administer oxygen with the ComfortCurve.
Tubing
Q: Why did you incorporate two hoses into your mask design?
A: The ComfortCurve comes complete with 3 size cushions, headgear and our exclusive tubing system. The tubing system is much lighter and more flexible than standard tubing. Also, by attaching the tubing system on both sides of the interface, we are able to use a smaller diameter tubing with lighter weight applied to both sides. We asked patients in our trials where they preferred the tubing system to be connected. Since most of them sleep on either side during the night, they preferred the tubing connect on both sides with the smaller hose design.
Q: Can the tubes be routed up to facilitate comfortable turning from side to side?
A: Yes, the tubing system can be placed over the head by separating the short tubes. The optional stability strap can then be used to attach the tubing system to the headgear.
Q: I'm concerned that the tubes may tangle if the hose connections don't rotate the tubes away from the patient. Do the hose connections rotate the tubes away from you?
A: The tubing system includes a swivel (that also serves as a disconnect) that allows the tubing system to rotate freely.
Q: Do the elbows at small hoses rotate freely or are they semi-fixed?
A: Yes, the elbows of the tubing system rotate on both sides.
Q: Is this one hose that merges or two separate hoses?
A:The two smaller hoses merge to a larger hose. The entire tubing system is much lighter and more flexible than standard gray tubing. It is important to note that the tubing system comes standard with the ComfortCurve and cannot be used with other products. In addition, other tubing systems cannot be used with the ComfortCurve.
Sizing and Fit
Q: Is this product going to come in different sizes or is it a one size fits all?
A: The ComfortCurve comes complete with 3 size cushions – S (small), M (medium) and L (large).
Q: Which parts of this product are adjustable?
A: The primary adjustments on the ComfortCurve include the headgear straps and the left and right cheek pad supports which rotate to 1 of 5 settings.
Q: Which parts of this mask are replaceable? What is the suggested replacement rate for each disposable part?
A: All parts on the ComfortCurve are available as replacement parts. The tubing system replacement part includes the entire assembly (both short and long hoses).
Quietness
Q: How quiet is this mask?
A: The dual diffusion ports on the ComfortCurve provide for a very quiet and dispersed flow of exhalation. Some patients in our trials indicated that the ComfortCurve was so quiet that they had to check to see if the CPAP device was actually working.
Compatibility
Q: Will this mask NOT work with any widely produced and distributed CPAP or BiPAP Machine? Are there any machine configurations I should avoid using with this interface?
A: The ComfortCurve can be used with all Respironics devices.
Q: Are there any known APAP related pressure problems with this interface?
A: No.
In The Box
Q: Can you please list all components that will be contained in the Comfort Curve Nasal Interface package?
A: The ComfortCurve Nasal Interface System comes complete with 3 size cushions (S, M, L), headgear and the exclusive tubing system. We also have included an attractive pouch for convenient travel. Please note that the ComfortCurve website (www.comfortcurve.respironics.com) will have a considerable amount of information on the product such as brief instructional videos, detailed photos, testimonials and available literature.
Release and Purchase
Q: What's the expected release date? When will it be available for purchase?
A: The ComfortCurve will be available for sale beginning April 21, 2005.
Colors
Q: Many users on this board would like to see some color in our CPAP products! Does the Comfort Curve support different colors?
A: Yes! The ComfortCurve provides the option of 5 different colors through optional "bridges" (much like personalizing a cell phone). The color options include burgundy (light red), sage (light green), sky (standard light blue), bronze (light yellow) and platinum (light gray). Patients in our trials greatly enjoyed the opportunity to personalize the product for a fun expression. We also had 2 patients in a household that could better identify which ComfortCurve was which using the colors. Ultimately, it was evident in our trials that these options made participants feel better about their CPAP therapy. To that end, we welcome suggestions and comments about other colors, options or enhancements that can future improve the patient experience.
About The Interview
We are proud to provide the cpaptalk community with a means to communicate with the manufacturers of the newest and most innovative CPAP equipment. We have made an effort to keep questions posted by our community members in as close to their original form as possible, however, some gramatical and structural changes to community questions have been made in an attempt to improve the clarity and capture the spirit of the question. User questions, in their exact and originally posted form, can be found on cpaptalk's "Request for Questions" thread. We thank each and every one of you for your involvement in this process and look forward to gathering your questions for future interviews soon!
Thank You
A very special thanks to the cpaptalk users who participated in this interview.
snoozin', wading thru the muck!, Janelle, jdschooler, gailzee, SWS, SleepyTimeGal, luckylinda, rock and roll, rested gal, day for night, JudyAnn, imacpappro, sharonokc, unclebob, bill2 and limpy.