People Resting Easy Thanks to 3D Printing

Posted by Fred Kaplan On April - 24 - 2017

People Resting Easy Thanks to 3D Printing

Medical start-up turns to 3D printing for customized CPAP masks

By Fred Kaplan

Since the dawn of 3D printing when the first primordial plastic oozed on a build plate, 3D printing has offered the possibility of individually customized production. The promise of the technology is that it will alter traditional shipping and manufacturing methods on a scale we can yet barely imagine. Metamason is a Los Angeles-based medical industry start-up contributing to the landscape of on-demand devices by manufacturing personalized, custom-fit respiratory masks using 3D scanning and printing.

Sleep apnea is a disorder disrupting a person’s breathing during sleep. It is usually treated with Continuous Positive Airway Pressure (CPAP) therapy. Though CPAP is highly effective, generations of sleep apnea sufferers have struggled with poorly fitting and uncomfortable generic masks at night. Now, Metamason has introduced “Miia,” a mask designed for the unique contours of an individual’s face. Created using virtual scanning and 3D printing, Miia is a soft, flexible mask with a digitally accurate fit.

People Resting Easy Thanks to 3D Printing

Metamason’s online app walks the user through the creation of a custom-fit CPAP mask, incorporating 3D scan data of the patient’s face. After the process is completed, the manufacturing files are instantly printed on 3D printers and shipped to the customer.

We spoke with Leslie Oliver Karpas, founder and CEO of Metamason, to discuss the process of using additive manufacturing to produce an FDA-approved product by starting-up a digital manufacturing company.

3D Printr Magazine: How did you get started in 3D?

Leslie Oliver Karpas: I started using 3ds Max (Autodesk) and Poser (Smith Micro) to create 3D models in junior high school. I got good enough that after high school, I was hired by a local architectural firm to model building designs. One day they printed one of my 8-inch models on their StrataSyS Dimension printer. I was awestruck. The power of seeing that first 3D print still inspires me and is why I am doing what I am doing today.

3D Printr Magazine: How did Metamason get started?

Leslie Oliver Karpas: My late father struggled with conventional CPAP therapy, and during my education at Art Center College of Design, it struck me as one of many medical devices that would profoundly benefit from 3D customization. I founded Metamason in 2013 with two friends who brought a lot of invaluable industry experience to bear. The first two years of the company were furious R&D. We stretched our knowledge and imaginations in the very beginning. We had an idea of where we wanted to go but we had no idea how we were going to get there.

We tried every 3D printer we could get our hands on; we tried every soluble printing material in the catalogue. In order to get FDA approval, the 3D-printed material has to be as similar to the existing products as possible. We knew that we would eventually be custom-casting medical-grade silicone, a process we had to develop ourselves. Fortunately, Metamason is now being incubated by 3D Systems, which has one of the most advanced 3D printing labs in the world.

3D Printr Magazine: Getting FDA approval sounds difficult.

Leslie Oliver Karpas: Our original idea was to print the masks directly in PVA or HIPS materials, which are commonly used as FDM (Fused Deposition Modeling—a standard extrusion 3D printer) support materials; we developed a process for dissolving one of the materials away and using the remaining material for a mold to pour the silicone in. The problem ended up being that the print had too low a resolution, and getting the PVA or HIPS support materials to print the way we wanted was nearly impossible. The difference in temperatures required to print the materials was too extreme.

We then worked with Scion Technology on our next attempt, using 3D Systems’ multi-jet wax printers, CPX 3600. Our plan was to use the wax as mold material in which medical grade silicone is to be formed. The process was successful and had incredibly high print resolution, but it was too expensive for our application. However, it gave us a true proof of concept and a prototype, which got us funded.

We ended up using the ProX 950 SLA at 3D Systems’ 70,000 square foot facility in Golden, Colorado, which was built specifically for 3D printer Class I (minimal risk) to Class III (highest risk) medical devices in accordance with FDA and MDD regulations. The facility is climate controlled and air-locked and each printing technology such as SLA, SLS, multi-jet modeling and color jet has its own controlled environment. We SLA (stereolithography) print a shell with a process we co-developed with 3D Systems. The final masks use multiple SLA components and SLS (selective laser sinter) printed parts.

People Resting Easy Thanks to 3D Printing

Metamason’s scanner for custom-fitting CPAP devices

3D Printr Magazine: Tell me about your 3D scanning workflow?

Leslie Oliver Karpas: Of course, the 3D scanning aspect is its own ball of wax. We are using Intel’s RealSense scanner. The RealSense scanner libraries, which are built into the developer kit, allow the scanner to interact with the JavaScript on our site. Then the JavaScript communicates with our backend which processes all our data. It has been a challenging process and an extremely valuable learning experience. Landmark identification is what we are concerned with—identifying the nose, mouth, and nostrils—so we can orient our product correctly on the face. Our code goes from a 3D scanner to a 3D customization runtime to a HIPAA-compliant packet. Since we are working with a medical device, our data needs to be encrypted and tightly controlled from a security standpoint, which adds another layer of complexity.

3D Printr Magazine: If you were starting now with the knowledge you gained, what would you do differently?

Leslie Oliver Karpas: We spent a lot of time trying to make an FDM printer work in the process. I still believe that FDM’s potential is underrated, and our experimentation with it resulted in high-quality FDM parts we are using as components of our product today, but to use FDM effectively to create a complete product like ours, we would need to build customized multi-nozzle printers and 5- and 6-axis printers. It was exciting to learn about the possibilities for using FDM in these advanced ways, but our situation is more complicated because whatever process we commit to has to be approved by the FDA. The printer itself has be ISO-certified with tight controls on where the printer is and who is operating it. So we want to be able to use existing medical-grade-certified printing facilities if possible, rather than developing our own proprietary printers.

3D Printr Magazine: How have your investors reacted to the 3D-printing aspect of your company?

Leslie Oliver Karpas: 3D printing used to be a draw for all types of investors, but now it’s scaring a lot of them away. The consumer 3D printing market collapsed aggressively for investors last year, and a lot of start-ups went down with it. It might have been healthy for the industry as a whole, but a lot of people lost money when companies who had promised the moon failed to deliver. Medical and aerospace [production] is where we find the money is being made, and even in those fields, it takes a certain kind of investor to recognize which projects are using the technology in ways that are truly innovative and cost-effective. At Metamason, we are looking for investors who are comfortable with medical devices, not scared of 3D printing, and understand the advantages of 3D digital asset workflow. We are uniting Machine Vision with web-based 3D customization and a HIPAA-compliant, FDA-approved manufacturing pipeline for silicone goods which, when put together, become a platform to make individualized silicone objects for medical devices and other functions. Once we get to market in this medical vertical, we are looking forward to expanding into other verticals.

One of the things we are most excited about is the promise of the 3D Systems Figure 4 technology, which combines robotics with high-speed SLA printing. Figure 4 will be ideal for our process since a robotic arm will take the completed print into any number of processes that are robotically controlled.

3D Printr Magazine: What first step would you recommend to someone just starting out with a 3D printer?

Leslie Oliver Karpas: If someone is just starting in the 3D space, I would encourage them to learn a scripting language like JavaScript 3D or WebGL, or both preferably, and pick up a plug-in for Rhino called Grasshopper 3D. Grasshopper 3D is a visual programming language which allows you to do generative design and algorithm-based design. The future is going to be programmatic design, script-generative design and algorithm-based design where scanned input goes into a 3D space, and a design process reacts and formats itself based on the input—meaning, the design resizes itself to user preferences, or in our case, user anatomy. I suspect that the utility of static 3D models will quickly be eclipsed by that of dynamic models built by algorithms. I find that Grasshopper3D is the best sketch tool for this purpose, because it gives you figuring information during the design process. I find it to be useful for everything from a skyscraper to a CPAP mask.

3D Printr Magazine: Where does coding come into play with 3D printing?

Leslie Oliver Karpas: Using Rhino as the CAD program we call “command with code.” We need to do a lot of JavaScript-based commands for Grasshopper3D to behave properly. I recommended basic computer science fundamentals with geometry fundamentals. As a company that is hiring, we have had a hard time finding enough people who combine these skills.

3D Printr Magazine: Do you think there will ever be a 3D printer that will allow you to directly print a CPAP mask?

Leslie Oliver Karpas: That’s difficult to answer. The printer would have to be a multi-material printer, probably purposefully built for our process. Carbon 3D offers excellent materials that possesses the characteristics to directly print our masks, but how do you get the support structure—the mold—off of the printed product? The support will be as durable as the part itself. You could cut it off, but you can’t sand down silicone, which will make it difficult to remove the support and give the part a finished surface. The only way to 3D-print a CPAP mask directly would be to combine a sacrificial support structure with the silicone material. The support structure would have to be biocompatible. Maybe the 3D manufacturing company Collider could do it. If someone came up with a dissolvable sinterable material, that would help. Its seems to me that the fixation of manufacturers on producing end-user parts directly off the print bed does a disservice to technology which would be better served focusing on specific functional tools that work better. I think making parts that are printed to be tools or fixtures or jigs are the best use of 3D printing—especially when you get into sacrificial materials for molds like the ones we are using—which enable fabrication techniques that can’t be done with traditional manufacturing.

For more on Metamason, its job openings and investment opportunities, visit http://www.metamason.com. For more on the combined machining of 3D-printed molds and individually-produced silicone parts, see our story on Chattanooga, Tennessee-based company Collider.


Fred Kaplan is a 3D-printing material specialist, who has worked with SLA, SLS, FDM, ColorJet, ADAM, DLP, LOM, FFF, MultiJet, Polyjet, and SDL 3D printers. Specializing in matching the best technology to a particular 3D printing application, he has also worked with many brands of 3D scanners and many CAD packages.

Prior to his work in additive manufacturing, Fred received a Los Angeles area Emmy and other awards for documentary filmmaking.