Shabani Fernando, who was diagnosed with severe pulmonary hypertension (PH) due to Eisenmenger Syndrome (irregular blood flow between the heart and lungs), needed to find a way to monitor her oxygen levels. While trying to solve this problem, she experienced several emergencies, such as a rapid drop in oxygen concentration leading to cardiac arrest, requiring self-administered CPR.
Fernando invented OxiWear, an accessory worn over the ear that monitors vital signs and sends emergency alerts. While other pulse oximeters (SpO2) take only a single measurement when the user is still, OxiWear continuously monitors throughout the day. Fernando's invention has the potential to monitor over 30 conditions where there is concern about decreasing oxygen levels, and it could bring peace of mind to patients' lives.
In this article, we spoke with founder Shabani Fernando about how she created this innovative new device, why multiple 3D printing materials were used, and the next steps for OxiWear.
Continuous Oxygen Monitoring
The OxiWear tracker was developed to withstand harsh environments.
OxiWear is an ear-worn oxygen tracker, the first device of its kind that can continuously monitor oxygen saturation and vital signs. The device fits snugly over the user's ear and can monitor vital signs without obstruction or discomfort. With a small, lightweight, waterproof, and customizable design, Fernando says, "We aimed for something smaller and more stylish. We want it to be something people want to wear themselves, not something that looks like a medical device."
OxiWear is a powerful device, working with a mobile application and providing real-time monitoring, allowing users to be aware of their health status and set alerts when vital signs fall below predefined thresholds. Fernando states, "Before the new coronavirus pandemic, we struggled to convince people of the necessity of continuous oxygen monitoring." However, after several years where public health and respiratory conditions have been prioritized, the benefits of this device are now clear.
Although OxiWear has just entered the market, it has already garnered support from highly competitive, top-tier partners. Athletes participating in the world's highest Obstacle Course Race (OCR) and Altitude OCR, held on Mount Everest, need to monitor oxygen levels for safety, but at the same time, they cannot allow equipment to obstruct participants. The company decided to partner with OxiWear to detect and prevent life-threatening conditions such as High-Altitude Pulmonary Edema (HAPE), High-Altitude Cerebral Edema (HACE), and Altitude Sickness, all caused by tissue hypoxia (low oxygen saturation).
- Dave Pickles (Co-Founder of World’s Highest OCR & Altitude OCR)
"We are delighted with this new partnership. We are eager to start testing the OxiWear product and believe we can contribute in a powerful, effective, and quality-assured way. Embeddable technology is clear to us and will help gather data in remote areas and harsh environments where we operate."
Prototyping Parts and Creating Jigs from ESD Resin
Printing multiple prototypes on a single Build Platform.
Like many hardware startups, when Fernando tried to develop OxiWear, the cost of prototyping and manufacturing became a significant barrier. Ultimately, the team decided to use one Form 3B, not only for prototyping the device but also for creating custom jigs for electrostatic discharge (ESD) printed with Formlabs ESD Resin.
Fernando stated, "Bringing 3D printing in-house allowed us to significantly reduce development cycle costs and also enabled testing multiple prototype designs simultaneously. Before 3D printing, each time we outsourced a prototype, it cost about $200, but with the Form 3B, the cost was reduced to a fraction of that."
Formlabs printers are versatile, capable of printing with more than 20 different materials on a single machine, allowing users to choose the most suitable material for their application. OxiWear used three different materials for prototyping and device production:
Elastic 50A Resin:
With a Shore Durometer of 50A, this is the softest material in Formlabs' Engineering Resin family and is ideal for prototyping parts typically made from silicone. For parts that need to bend, stretch, compress, and withstand multiple repeated operations without tearing, while quickly returning to their original shape, Elastic 50A Resin should be chosen. For this reason, OxiWear used Elastic 50A Resin to prototype the soft part of the ear-worn component to confirm its fit on the user's ear.
GreyPro Resin:
This is a versatile material suitable for a wide range of engineering applications due to its high precision, appropriate elongation at break, and resistance to deformation over time. The dark grey color is ideal for prototypes used for aesthetic verification. OxiWear used GreyPro Resin to prototype the hard carrying case for the OxiWear device.
ESD Resin:
ESD Resin is used for prototyping and verifying electronic device manufacturing workflows, creating parts with static dissipative properties to prevent dust or debris, and making enclosures that protect sensitive electronic devices from static electricity. OxiWear used ESD Resin to create custom manufacturing jigs.
Prototyping the charging case was critical for verifying the position of the charging port and the fit of the earbud components. When changes were made to the earbud component, the charging case also needed to be adjusted, but this was as simple as 3D printing a new case. During the charging case creation, Fernando joked, "My house was like a mini-factory," as numerous prototypes and parts were printed. Once the team was satisfied with the case, they sent the files for mass production using injection molding.
However, during the manufacturing process, a new problem arose: the internal circuit board short-circuited. Fernando then turned her attention to ESD Resin and created several custom jigs for their manufacturing partner in Korea. These new jigs allowed for static electricity dissipation, a crucial property of ESD Resin, and prevented damage to the circuit boards.
George Beckstein, Electrical Engineer and CTO of OxiWear, is overseeing OxiWear's transition to mass production. To prevent a decrease in manufacturing yield, he turned to ESD Resin for custom-fit jigs. Beckstein stated, "Because our parts are so small, it can make manufacturing difficult. Also, if we lose a mainboard to an electrostatic shock, that's $30 to $40 worth of material wasted. We couldn't find a print service that offered this type of material, but what Formlabs offered was a perfect fit."
Ear-worn Oximeter
OxiWear began its deployment in the United States this year for sports tracking, with future plans to seek FDA approval for medical use. Fernando has set the company's ultimate goal: "for everyone to wear OxiWear." The device has the potential to serve a wide range of people, from nursing homes and athletes, and someday even infants and toddlers.
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