Billing itself as “the world’s first maskless, hoseless, cordless, micro-CPAP device,” startup Airing made a stir with its crowdfunding campaign this month, raising $800,000+ and attracting 4,000+ patients hoping to try the product as early as July 2017.

Watch Airing’s short videos at http://medgroup.biz/Airing

Abridged, from its site:
“Obstructive Sleep Apnea (OSA) is typically caused by a blockage of the airway when the soft tissue in the rear of the throat collapses during sleep… The standard treatment… is “Continuous Positive Airway Pressure,” or CPAP.

CPAP machines can mitigate this problem, but their poor design causes sleep apnea sufferers to give up on it: 50% of CPAP users stop using it within one year. Airing intends to change that with a revolutionary design that will work as well as any other CPAP machine, and patients won’t have to deal with cumbersome, uncomfortable masks.”

So will the Airing device be able to get sufficient airflow from a micropump for the average patient?

Will it be able to keep vibrational conducted noise acceptably low?

An industry insider told me, “It’s an interesting concept. I wonder if their intellectual property doesn’t violate existing patents. We’ll have to see if it’s ready for prime time.”

A lot can happen in two years and I wonder what the competitive response will be.

What do you think?

Will Airing disrupt the CPAP market?

P.S. An interesting Q&A with the 1980 inventor of CPAP technology at http://medgroup.biz/CPAP-history

++++++++++

Discussions You May Have Missed

The Right Amount of Regulation?
http://bit.ly/right-amt-of-reg

Using a contract manufacturer’s QMS
http://bit.ly/contact-QMS

Validation of Filling Equipment
http://bit.ly/valid-fill

FDA audits on device manufacturers?
http://bit.ly/FDAaudit

About the biomedical engineering technician community
http://bit.ly/biomec-eng

Scooters for disabilities?
http://bit.ly/scoooting

First 3-D heart printed using multiple imaging techniques
http://bit.ly/1st3d-heart

++++++++++

Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. Want to start your own discussion?
Here’s how: http://medgroup.biz/on-publishing

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
A pure guess based on energy required to do CPAP air assist, from my decades in respiratory care, says it is not possible to do what I read about.

David Hajicek
Owner / Luthier at Hajicek Guitars
Hard to say if they were naive or if it was a scam. It’s easy to come up with cool concepts. Making it work is a whole different matter.

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Jeff, I haven’t seen any news out of the company in the past few months.

Mike Reynolds
Director – Healthcare Economics & Advocacy at BIOTRONIK
Agree with above comment, moisture exchange is a key function of the nose ,also unsure device will meet peak flow demands should physiological demands change. Also resistance on exhalation. Appears elegant

David Hajicek
Owner / Luthier at Hajicek Guitars
Great video, I agree. But it sounds like they do not have a working prototype, just a concept and a shell for the device. When they explained their pump, and electrostatic bellows (basically), I said to my self that this cannot work in the real world environment. Any moisture (and you breath has a lot of moisture) will defeat the pump by clogging or shorting it out.

Evan Anderson
CEO at Luma Therapeutics
Great video that will notwork in real life because it defies the laws of physics. The Provent technology was a solid product but it failed despite huge investments (~100M) because of difficulties in market adoption. The micropump will not work and outside of that they will probably be in violation of Ventus Medicals patents (makers of Provent).

Robyn Barnes
Business & Real Estate Writer, Regulated Industry Business Development, GxP Lifeline Media Professional
As a wife who loses sleep every night to my husband’s snoring, I can only hope it will work. I signed up to test it! Thanks, Joe!

Jonathan Wacks
Vice President Of Quality at Flexan, LLC
As a veteran of multiple startups, as well as someone who has scars to prove the beatings taken at the hands of VC’s and investors, I think this a triumph of hope over physics. Hook a prototype to a $10 DC power supply and throw a meter on the power draw. Put a pressure gage on the output. Show it has any chance of working. CPAP units moves a lot of air under pressure, and a mask leak messes up that delivered pressure even more. Humidification? Titrating patients? Seal issues? I certainly wish them luck, because it would really be cool!

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Jane, I’m glad you brought this point up. Making better a better “salve” for a medical condition is not likely to save most people from an earlier death than if they remained healthy. It may be the best choice for the short term while longer term changes happen, but many times people don’t believe they have to change.

I don’t have any survey data to back up what I think, but I have anecdotal evidence with the rise in medical costs at all levels, that people are starting to pay more attention to health issues here in So.Cal. The level of mobile health Apps for smart phones both from medical providers and from device and drug makers and the rise of electronic communications between doctors and patients is encouraging. Lots of short articles summarize these sorts of events on MobiHealthNews.com.

Jane Evans
Therapy supported exercise for all members of the community
The main problem with CPAP machines is that they do nothing to rectify the underlying problems. More needs to be done to overcome and treat the underlying causes rather than propping up the individual. While sleep apnea can affect anyone of any age the vast majority of people are male, overweight and over 40. Use of SpiroTiger for respiratory training can retrain the respiratory muscles and assist in overcoming many of the factors that contribute to OSA.

Chris Ross
Product Design Expert ✔ Design Strategy ✔ Medical Device Design ✔ Industrial Design ✔ Biomedical Technology
I wonder what percentage of Apnea patients this will help and is that a sizable enough market to drive success.

Kyle Murphy
Consultant on the Japanese Health Care Industry
Not sure if the above comment by Mark is directed at my post. At least as far as Japan is concerned I think this idea is a little outdated. If there is strong IP Japanese companies will respect and utilize it similar to how it is used in the U.S. China is further behind.

Mark A Schlicht
Vice President of Business Development
@Kyle this devise is marketed at a three ($3.00) cost. Once Japan or China for that matter get there hands on it ( presuming it will work) they will have reversed engineered it and sold millions already. Maybe?

Anette van Reeuwijk
Owner, Cephomed
A similar idea has been on the market for a while (Provent, http://www.proventtherapy.com/index.php), but that has problems with adherence and success rate since OSA is not one type of disease but a collapse pattern of the airway with individual characteristics. So this could be a therapy for a subset of OSA patients, but all depends on documentation and publication in acclaimed international scientific journals. However, increasing the airflow resistance in the nose could mimic nasal obstruction which would lead to mouth breathing and thus decreasing the pressure within the airway, and resulting in increased (or less decreased collapsibility of the airway.

Michael H Gusky
Chairman at Maison DAVIDOR Paris
The digital photo rendered image appears to be just a concept. Many here have already noted the lack of meaningful technical information to provide an intelligent answer as to the likelihood of success. However, at 1 ounce(provided) it will be difficult to support without some type of fixation other than the prongs pushed deep into the nares(ouch). Our focus is on adoption and compliance of PAP therapy. We have made tremendous improvements with our Cloud9 device. From our clinical study, the patients perspective is overwhelmingly positive. Given our technological achievements in pressure and flow with a novel nasal interface, I for one remain skeptical whether Airing can ultimately deliver on their promises. Good luck to them though, it’s worth the effort.

Riccardo Gallone
Sales Manager
So small yet so powerful?!?! hard to believe, in related market 4ex Concentrators no size revolutions in these last years with many investments… I would be very impressed!

Kyle Murphy
Consultant on the Japanese Health Care Industry
This is very interesting. I look at everything from a Japan viewpoint. The issue is not approval but reimbursement. Without reimbursement in the Japanese market it will have limited sales. Even with reimbursement the system is designed to benefit the Doctor. Patients must visit the doctor every month and essentially pay a rental fee. Theoretically, this is a game changer but the rental fees are reduced every two years. Not sure if this technology would be able to receive premium pricing since it does not seem to even be a one for one replacement. There is a role but maybe not quite as big as they might think. Just some random thoughts.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Suded, that only works to raise pressure until the tissues separate and the pressure drops as the flow rate goes up dramatically which requires much higher flow to keep that pressure.

I am still very skeptical.