Jun 17, 2016 | By Alec

You could be suffering from it yourself, without even knowing it. If you’re male and over 40 years old, there’s a 50 percent chance you have sleep apnea. Medically known as Obstructive Sleep Apnea (OSA), it affects over 350 million people worldwide and causes snoring and daytime lethargy, even if you sleep eight hours every night. While it seems harmless, it is actually linked with depression, diabetics, high blood pressure, strokes, and early death. Fortunately, one Singaporean startup called Inspirate Medical might have a solution: 3D printed CPAP masks, that are made to fit using 3D face scanning technology and provide excellent breathing and sleep all night long.

It’s one of those issues that people don’t like talking about. “If I don’t notice it, why is it a problem?” many argue. However, you do notice it in your lethargy. Sleep apnea essentially prevents air from passing through your airways efficiently, causing your body to react and disturbing your sleep process. Even if you don’t notice it, sleep patterns can be disturbed up to 100 times a night, significantly affecting how well-rested you are. This, in turn, affects your overall health and performance.

Of course, it is treatable. While surgery options are available, the theoretically best solution is wearing a CPAP mask at night, which enables a steady airflow to reach your lungs. Unfortunately, these are infamous for their poor fit. Only coming in Small, Medium, Large and Extra Large sizes, they are known for being too tight, preventing you from falling asleep, or too loose – preventing proper airflow. It’s why 50 percent of all CPAP mask wearers stop using them.

Fortunately, 3D printing is coming to the rescue. Australian medical device company Oventus Medical is working on the 3D printed O2Vent, a special mouthpiece that could help breathing, while 3D printing startup Metamason has just revealed to have gathered $3 million in funds to develop 3D printed, custom-fitting CPAP masks.

But Inspirate Medical might beat them to it. The Singaporean startup was founded just last year, and have already developed an ingenious 3D scanning and 3D printing process to bring fitting CPAP masks to patients throughout Asia within the next year. Founded by 23-year-old Norman Wanto and 24-year-old Ivan Suriady, they first came up with the idea after Ivan was told he snores quite a lot during the night. The young entrepreneurs, who met during an NUS chemical engineering undergraduate course in Singapore, quickly set up a startup and were soon joined by accountant Felisa Tirtawinata. Building on the lessons Wanto learnt when setting up the successful Tee Inkers startup at the age of 19, they quickly built up their high-tech product and are looking for an early 2017 release.

What’s more, they have an excellent concept. As Suriady explained, they are essentially offering customized CPAP masks that can be worn all night. “The general consensus is that the first CPAP mask you buy will not fit you. Patients end up buying multiple masks until they find one that fits. Mass-produced CPAP masks on the market now are mostly designed for Caucasian facial contours, which might not suit many Asians,” he explains. “We decided to look into this because so many CPAP users complain about having to wear the mask - research shows that half the people who wear CPAP masks quit because of the discomfort.”

To solve this problem, they have designed an algorithm that uses 3D face scans to produce custom-fitting masks. “Based on this scan we create a mask that perfectly suits each person's face, so patients will not need to buy four or five different masks any more. We guarantee this one will fit,” they say. Scanning can take place at local scanning centers, pharmacies, or sleep clinics using hand-held 3D scanners, with the mask being 3D printed via a proprietary 12-step production process. Depending on your location, the mask can be delivered within as little as three days.

The concept itself was developed during the last year of their studies. “The development process took about half a year. It was intensive and we were trying new things every day. Research and development cost about $20,000 to $30,000 in total,” Wanto revealed. Fortunately, they also received help from mentors and advisers at NUS Enterprise and Spring Singapore.

Of course, 3D printing does push up production costs a bit. Where a conventional mask costs anywhere from $150 to $300, Wanto expects that theirs will be sold at the higher end of $300. But this shouldn’t be a problem, Suriady believes. “We're confident with this pricing because people who buy conventional masks often end up having to buy multiple ones anyway, and ours is guaranteed to fit the first time,” he says in an interview. Wanto even went as far as saying that 3D printed masks will become the new golden standard over the next few years, and a custom fit can certainly achieve that.

So far, development is moving forward quite quickly, despite the challenges that medical hardware bring to the table. It can take quite a while to receive regulatory approvals from health authorities, while manufacturing requires ISO13485 licenses as well. But the 3D printed CPAP masks are already undergoing clinical trials and could hit the market by late 2016 or early 2017.

To achieve that, the company is currently looking to raise about $1 million in investment, to scale up production and aid growth in the Singapore, Australia and Europe markets. But their ambition is reaching even further. “This is a very scalable business,” Wanto says. “Besides CPAP masks, there is huge potential in other customized medical wearables, like prosthetics. In the future, we might also go into anything that can be a customized wearable, even golf grips and tennis grips - anything that needs to be comfortable and fitting.” And with their custom fit algorithm, Inspirate Medical could become a company to look out for.



Posted in 3D Printing Application



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RepRapper wrote at 6/22/2016 1:44:05 PM:

The whole maker movement can scan and print their own parts :)

Anonymous wrote at 6/17/2016 10:05:36 PM:

It looks as though they have little to no understanding of the FDA approval process based on how they're manufacturing, using consumer grade FDM machines.

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