July 23, 2014
Everyone knows somebody who snores; sleep apnea affects a startling proportion of the population— about 1 in 4 men and 1 in 9 women; and if left untreated, it can disrupt relationships, cause depression and chronic fatigue, contribute to the onset of diabetes, and lead to dangerous heart conditions. All of which contribute to mortality rates higher than that of pack-a-day smokers. While CPAP therapy has been shown to be the most effective long-term treatment for the condition, clearly driven comfort and aesthetic issues it has one of the highest quit rates of almost any medical therapy.
Metamason, a 3D printing startup in Pasadena believes that the effectiveness of many medical products can be dramatically increased with a customized fit for each patient. Metamason is working on custom CPAP masks for sleep apnea patients via 3D scanning, smart geometry, and 3D printing; a process they call Scan Fit Print. Metamason's flagship line includes the Respere Secure™ CPAP Mask & the Respere Freedom™ CPAP Adapter, intended for patients suffering from Obstructive Sleep Apnea (OSA).
"We personally know several people who struggle with sleep apnea and CPAP therapy (including some members of our team), and quickly identified the opportunity that parametric design could yield a perfectly customizable product if coupled with 3D scanning and printing." says Leslie Oliver Karpas, Metamason Founder and CEO. "That's why we started Metamason, in order to make this idea a reality." The company has just perfected their prototyping process and is beginning the regulatory process; starting clinical trials in the near future. Currently they're fundraising to get through the FDA's 510(k) process, which should be complete by mid next year.
Metamason team is primarily a combination of Industrial Designers from Art Center College of Design; Leslie Oliver Karpas, Matthew Schreiber, & Ryan Oenning; Sleep Technology Specialist from Stanford Sleep Center, Oscar Carrillo; and the Director of the Sleep Disorder Center at Huntington Hospital, Dr. Ashish Patel.
We had a chance to speak with Mr. Karpas recently to know more about CPAP masks and help the 3ders community get more familiar with the company and their technology.
Leslie Oliver Karpas, Metamason Founder and CEO
3ders.org: Could you tell us a bit more about your back ground?
Karpas: My career started in architecture, where I encountered my first 3D printer at Washington University in St. Louis, back in the year 2000. Later, I worked as the lead mechanical designer at Performance Structures Inc. for Turner-winning artist Anish Kapoor, and collaborated on over a dozen large-scale modern art pieces, each requiring invention of completely new manufacturing and assembly processes, including the creation of custom large-scale C&C robots & machine tools, dyes, tooling and fixturing. I also spent some time on the UX & ID teams of the interactive holography company zSpace. I was a grad student at Art Center College of Design in Pasadena when I decided to start Metamason, which was initially funded by 'The Design Accelerator,' a partnership of Art Center and Caltech.
3ders.org: Are there any similar products on the market? What distinguishes Respere from others?
Karpas: None of the major CPAP mask players on the market today are currently using a customizable or one-off approach; and the only attempts in the past were cumbersome and expensive. Though market leaders have recently made huge strides in making masks that are lighter and minimize contact with the face, they are still plagued with issues of comfort and leakage. These two problems can be reduced to the fact that everyone's face is different, and if you apply the same geometry to everyone, you'll inherently have issues of fit (i.e. conformal geometry). 3D printing enables the individual customization that CPAP therapy so desperately needs. Additionally, conventional mask designs typically feature bulky and undignified front-facing tubing (commonly referred to by unhappy patients as the "elephant tube"), which limits freedom of movement in bed and isn't conducive to an attractive, unobtrusive design.
Metamason's Respere Freedom accessory revolutionizes CPAP airflow by directing it along the sides of the face and around to the crown of the head. Rather than a single, rigid tube, our design takes a unique approach to distributing the airflow, with a "Nike Air"-style bundled plenum of soft tubing. The plenum allows for shallower tubing, which actively pads the cheekbones and face, while moving the CPAP tube in line with the spinal axis where it is more snug. By doing this, the tube is now away from the body of the patient and their partner such that it no longer causes entanglement and cantilevers from the face where it is pulled off by tossing and turning in sleep. Instead, the airflow is directed discreetly off the top of the bed.
3ders.org: Could you explain the Scan Fit Print process in greater detail?
Karpas: Our proprietary Scan•Fit•Print process uses 3D scanning, patented parametric design algorithms, and on-demand 3D printing to create individually customized, ergonomic products that are perfectly fit for each patient.
SCAN: Aggregating 3D scan data of the patient's face (captured using low-cost scanners like the Fuel3D and Structure Sensor) and biodata from sleep studies (obtained from sleep clinics, or via mail-order sleep diagnostic kits), the API sends data from sensors, pushes them to the cloud, and hands them to simulation and product algorithms. We also plan to use thermal imaging to determine the elasticity of facial tissue.
FIT: We're currently building a cloud-based smart geometry platform for mask optimization in Grasshopper for manipulating algorithms which dynamically link flow simulation & deformable body simulation. Providers and patients can adjust aesthetic and performance features to find the perfect 'Fit.' Eventually, biomimetic algorithms will inform aspects of the mask's elasticity, which would be an exciting functional application of the work produced by designers like Neri Oxman.
PRINT: We're thinking smarter about what 3D printers are capable of. Far more than just prototypes, our disruptive production process, Investment Molding™, combines injection molding and lost wax casting for silicone and other thermoset plastics. We 3D print 'tooling' out of materials which can be dissolved/melted then sequentially replaced. We create parts which were previously considered 'unmoldable', breaking the traditional rules of molding informed by 'draft angle' and 'synclasticity' & 'part lines'.
3ders.org: Can you explain a little about how these are 3D printed?
Karpas: Our manufacturing partner Scicon Technologies is printing a custom mold for each mask using 3D Systems Visijet casting wax and ProJet CPX machines. The mold is then filled with medical grade silicone. Once the silicone cools, parts of the mold are then dissolved/melted away in stages and replaced with theromoset plastics; over half of the tooling is retained and reused. The result is a soft, custom fit silicone product that has complex geometries and multiple customizable aspects.
In our experiments we've explored the use of a number of different machines and approaches to Respere, including the use of elastic materials like Ecoflex PLA, Taubman 615, Ninjaflex, Polymakr Polyflex and Filaflex, as well as different resins such as MakerJuice SubFlex, which we've been running on a number of machines, including the Hyrel System 30, our Makerbot 2x, the Uncia DLP, and the Form1. We've also experimented with Objet Tango, 3D Systems Polyjet Flex, Envisiontec Eshell, and elastoplastic in exploring ways to create printed elastomeric products.
3ders.org: What's your current progress with the CPAP mask?
Karpas: Metamason has completed and successfully prototyped a number of designs for the Respere Secure CPAP Mask & the Respere Freedom CPAP Adapter. That said, there are very few precedents in the printing world for FDA approved medical devices, outside of Envisiontec & 3D Systems machines used for hearing aids, Invisalign, and prosthetics. Those machines are very expensive, but as the FDA approves more cost-efficient machines for medical device production our costs will substantially decline. We plan to play an active role in this process, starting with attending the FDA's "Public Workshop - Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing," this fall.
3ders.org: How are most CPAP masks priced?
Karpas: Conventional CPAP masks typically run in the $100-$300 range, and are usually covered by insurance. The Scan•Fit•Print process creates a cost efficient, medically certifiable alternative— and we have verified that we can keep our manufacturing costs at a competitive level. However, printing assembly lines like the one that 3D Systems and Google are building for Project Ara could dramatically increase our margins. That said, we're already witnessing lower-cost DLP-based solutions coming to market that also exponentially lower our costs. A recent example: MadeSolid was nice enough to send us one of the first batches of their FireCast Resin. We've just started running Investment Molding™ experiments with it in our Unica DLP at a fraction of the cost of our current production technique.
3ders.org: What are your plans for CPAP masks in the future?
Karpas: The custom masks market goes way beyond CPAP therapy, within respiratory space oxygen masks and pediatric/infant masks are a small side step requiring little change to our algorithms. Then in the medium term, Metamason plans to develop custom fit masks in other verticals—starting with military and municipal applications, extreme sports and athletic training masks after that. Further, Investment Molding and the Scan•Fit•Print process potentially enable the automation of mass customization of many different products. As such, create the potential for disrupting mass production as we've known it. We see a future where the Scan•Fit•Print platform grows into a ubiquitous tool, allowing anyone to be a "metamason" by using 3D scanning technology embedded in smartphones (already an imminent reality in Google's Project Tango and the like) to create custom products. Metamason has an essential role in that future, as we create the parametric algorithms for customization and provide new methods for 3D printing based manufacturing.
Posted in 3D Printing Applications
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frank moss, dds wrote at 11/5/2015 10:29:42 PM:
i am a dentist dealing with OSA and using oral appliances... if you are able to create a custom comfortable 3-D nasal piece, then i think the folks who go to our 5 sleep clinics on the west coast of florida ( clearwater-st. petersberg ) could greatly benefit. please respond so we can make plans to get this new idea going here. thanks, frank moss, dds
Jason R wrote at 11/5/2015 5:49:46 PM:
This would help so many people out, if the cost is reasonable, you will do very well. The Factor Mask normally are not fitted right.
renee cater wrote at 10/18/2015 6:37:16 PM:
Hurry, hurry, hurry!!!
Tony wrote at 10/3/2015 10:23:14 PM:
Please add my name to the list of people who need your product. Please notify me as soon as it is available thank you.
Jenny Stewart wrote at 9/30/2015 5:55:55 AM:
Hurry up and get this on the market please! I need this now!
Orville Simon wrote at 9/21/2015 6:07:41 PM:
Where can I get one? I can't stand the current mask which irritates the bridge of my nose and my forehead terribly.
Bruce wrote at 9/18/2015 1:24:51 AM:
I've been asking my specialist about this for years and was finally made aware of your operation by my DME provider today. Prayers answered.... please let me know when and where this option might be available in my area near Savannah, Georgia.
Jason wrote at 9/8/2015 5:15:26 PM:
Decades of typical CPAP mask use continue to result in facial traumas and horrible sleep and sleep patterns. I've known that there will be something far better than commercially available mask interfaces sold by bottom pyramid people whose job depends solely on making a sale -- forget the service. The bottom line is that this newer technology becomes available to the average apnea patient who struggles and that pricing is such that health insurance companies pick up the tab knowing clearly that finally getting therapy that works to these patients means far less expense down the road regarding nasty complications from improper sleep.
Dennis Bethke wrote at 8/3/2015 7:49:00 AM:
I would like to be on the mailing list and also, would like to ask if this would be covered under Medicare? The current mask leaks and has been leaking for over 5 years, no matter what mask we use. Also would be interested in any trial would help in the advertising.
Paul W. Schenk, Psy.D. wrote at 7/22/2015 2:00:31 AM:
Multiple masks (nose, full face, nasal pillow) either leak or irritate lining of nose; dental appliance led to headaches and multiple visits to the chiropractor; bed wedge.... And I don't even fit the physical profile for someone with sleep apnea. Please add my email to your list when you have masks available. Drpaulschenk@att.net
Joy in Virginia wrote at 7/2/2015 6:58:53 PM:
How are you fundraising? I would seriously consider a pre-order through Kickstarter to help get your business going!
P.C. wrote at 5/17/2015 7:09:09 AM:
Are you able to make oxygen masks? I just started on oxygen at night about a week ago and cannot use cannulas because they cause inflammation and infection in my nose and although the masks are not as bad they still don't fit very well and they are too stuffy and sweaty, not letting exhaled air out. I don't see much at all on the internet to address that. If you were to make an oxygen mask how much would one of those cost?
Jamie Jordan wrote at 3/23/2015 8:13:11 PM:
I've been struggling with comfort and panic attacks from trying to get use to my cpap mask. I've now been diagnosed with carbon dioxide toxicity from not being able to wear my cpap machine. This can be fatal. My husband and I have talked over and over stating they need to custom fit these mask to each individual. Coming across our site today gives me hope. I have had 2 cornea transplants, both have gone badly, one resulting in total loss of my eye sight. The masks I currently have either fit so I can breathe comfortably but are so crunched into my eyes that I get dry eye and or an air leak blowing into my eye. I can't have this due to it could result over time in blindness in the only eye I have left. I'm 36, please help me with custom fitting me for a mask please. Jamie Jordan = Pennsylvania
Robin Lyons wrote at 2/8/2015 3:34:49 AM:
OMG I want one! Add me to your email list. email@example.com
C.H. McGarry wrote at 2/1/2015 4:13:36 PM:
In reality, for ALL OSA patients, the mask is the weak link in the CPAP, BiPAP, ASV, and EPAP applications. The only way to get a mask that is comfortable and provides a leak-free seal, is one that conforms to the contours of one's face without excessive pressure. I am on my fifth mask in the short 2 years that I have been a CPAP patient. I am fed up with the lack of response the current suppliers of masks that are absolutely useless. Not even one of the works as it should. Not even the gel hybrid seal works. Waste of money($70 for my Fit Life full mask It is nice to see that there is finally someone who has taken the initiative to apply new technology to a problem that has been the Achilles's heal of such a simple process. When custom masks are available, I need one.
George Hampson wrote at 1/31/2015 10:48:04 PM:
I am currently a full face mask CPAP user do to previous surgery. I would be interested in a full face mask if available. Is it possible to find out if these type of masks are or will be available in the future.
klark wrote at 1/8/2015 4:47:17 AM:
Dean Kirkland firstname.lastname@example.org wrote at 1/8/2015 3:29:00 AM:
phone no 8643991111. HELP need custom, custom, cus made cpap mask. Daniel Kirkland
Paul wrote at 1/2/2015 8:30:24 PM:
I noticed the pictures just have masks over the nose. What about full face masks for mouth breathers?
Amy Rice wrote at 1/2/2015 6:50:47 PM:
Please email me when you have the solution available to the market. My mask slips, doesn't conform to my face and so I have to make it tight which leaves unsightly marks on my face for much of the morning. email@example.com
Terry wrote at 12/20/2014 3:19:58 AM:
I would love to try this custom mask. Please let me know when they are available Regards Terry
Adrienne wrote at 9/23/2014 9:50:16 PM:
Sounds like the perfect solution. I would love to be on an email alert list for when masks become available. firstname.lastname@example.org
Monica Salinas wrote at 9/18/2014 12:00:08 AM:
Please, let me know where and when I can buy a mask from your company. I am desperate! I have developed severe skin allergy/eczema from the ResMed device. email@example.com 310-573-9038
Rich p wrote at 7/31/2014 7:32:54 AM:
your idea sounds good but what are you going to do when a patient half way thru a cpap titration is not able to breathe thru there nose any more? and you have to switch to a full face mask? I like the idea if you see the patient after they have had a titration and have figured out nasal or full face mask for the patient. I have sleep apnea and have been doing studies on patients for along time now.
Mylan K wrote at 7/31/2014 3:29:29 AM:
I want to buy a mask and stock in your company
Monroe Williams wrote at 7/30/2014 2:13:42 AM:
Shut up and take my money! :)
Chris Seebald wrote at 7/28/2014 6:46:21 AM:
8 years since dx, and have been waiting for 3d custom fit mask. Would like to be on a mailing or news alert list. Thank you.
Chris Seebald wrote at 7/28/2014 6:46:19 AM:
8 years since dx, and have been waiting for 3d custom fit mask. Would like to be on a mailing or news alert list. Thank you.
ray wrote at 7/27/2014 7:12:33 PM:
where do I order one!?
yara havlicek wrote at 7/26/2014 2:26:17 AM:
Amazing!! A new world.
barbara c. duff wrote at 7/25/2014 8:43:19 PM:
I could certainly use a cpap mask that worked for me. I have been struggling for 15+ years.