MedTech World Magazine: When patients build medicine

Patient-led innovation is reshaping how medical technologies are conceived, built, and used in real-world care. When lived experience exposes the gaps between clinical settings and everyday life, it can become a powerful driver for meaningful medical solutions. Shavini Fernando, Founder and CEO of OxiWear, explores this and more in the cover story of MedTech World Magazine’s second edition, to be released in conjunction with MedTech World Middle East | Dubai 2026. Fernando explores how her experience living with pulmonary hypertension led to the creation of a wearable medical device designed to deliver reliable, real-time oxygen monitoring during everyday activity, addressing a need long overlooked by traditional monitoring tools.

OxiWear did not begin as a startup idea, a research grant, or a market opportunity. It began as a survival strategy. For Shavini Fernando, medicine was not an abstract system or a professional domain. It was something she depended on, something that had already failed her in critical ways. Living with pulmonary hypertension, her oxygen levels could drop dangerously low without warning. There were no symptoms to rely on, no signals her body could offer before it was too late. The consequences were devastating: four cardiac arrests and three strokes, often occurring before anyone, including Fernando herself, realized something was wrong.

Doctors advised her to avoid living alone, climbing stairs, exerting herself, or doing many of the things that defined her independence. The implicit message was clear: safety required limitation. For Fernando, that was not an acceptable trade-off.

“OxiWear was born directly from my experience living with silent hypoxia,” she explains. “My oxygen levels could drop dangerously low without any warning symptoms. Because of that, I suffered four cardiac arrests and three strokes – events that often happened before anyone, including me, realized something was wrong.”

Faced with the choice between letting her condition define her life or finding a way to live safely on her own terms, Fernando chose a third path. She decided to build what did not yet exist. “I didn’t want false reassurance or a lifestyle gadget,” she says. “I wanted agency.” That word – agency – sits at the center of OxiWear’s story. From day one, OxiWear was designed to give patients real-time visibility into silent, life-threatening oxygen drops during everyday activity, so they could make informed decisions in the moments that mattered most.

This patient-first origin is what fundamentally differentiates OxiWear from much of the wearable technology market. Fernando did not approach the problem as a clinician, researcher, or engineer trying to optimize an existing category. She approached it as someone living inside the gaps of the healthcare system, gaps that are often invisible from the outside.

“The biggest lesson is that patients live in the gaps of the healthcare system every day,” she says. “Those gaps are often invisible to clinicians, researchers, and companies unless they’re willing to listen deeply. As a patient, I wasn’t thinking in terms of publications or market categories – I was thinking about survival, quality of life, and peace of mind.”

Those gaps are not theoretical. They exist between clinic visits, outside controlled environments, and during movement, precisely when many traditional monitoring tools fail. Most pulse oximeters and oxygen-monitoring systems are designed and cleared for patients at rest. But for many cardiopulmonary conditions, the most dangerous oxygen drops happen during activity.

That insight shaped every technical and strategic decision behind OxiWear. It also led Fernando into unfamiliar and unforgiving territory: regulated medical hardware. Her background spans software, design, and immersive technologies, but entering med-tech meant starting over. Electrical engineering, sensor design, biomedical signal processing, algorithm development, much of it she studied herself, determined to understand the system deeply enough to challenge it when necessary. Over time, she assembled a team of specialists who shared the same commitment to rigor and purpose, not just execution.

What surprised her most was not the complexity of the technology, but the rigidity of the regulatory framework. “When we entered the FDA process, we quickly learned that many regulatory testing requirements are applied almost uniformly – whether you’re building a CT scanner or a wearable device and protocols for testing are not inclusive of skin tones” Fernando says. “The framework hasn’t fully evolved to reflect the nuances of modern, body-worn technology.”

Rather than accepting those constraints at face value, OxiWear engaged directly with regulators, explaining not just how the technology worked, but why it mattered. Why motion mattered. Why the ear – long dismissed as a viable measurement site – could provide more reliable physiological data during activity. Why testing across all skin tones for accuracy was essential, And why certain legacy tests, while appropriate for stationary equipment, were not meaningful for a wearable designed to function in real life.

At the same time, the company faced another structural challenge: funding. Hardware is notoriously difficult to finance. Regulated medical hardware even more so. And for Fernando, who was neither a U.S. citizen nor a permanent resident at the time, everything depended on external investment. Many potential investors expressed interest, but on one condition: change the mission. “That was never an option,” she says. “Compromising patient safety or impact was never on the table.”

Instead, OxiWear took a deliberate and often overlooked path. When the first version of the device launched in 2022, it was positioned closer to the wellness space, not because the vision was smaller, but because survival demanded proof. The company needed to demonstrate that accurate oxygen measurement during movement was possible, that people genuinely needed it, and that the technology worked outside the lab. What followed validated the original premise. Patients for whom oxygen monitoring was a safety requirement, and not a nice-to-have, actively sought out the device. That real-world adoption generated meaningful usage data, refined the product, and demonstrated impact across multiple verticals, from chronic disease management and post-acute care to aerospace, military, and high-risk occupational settings.

Crucially, it also enabled OxiWear to secure the funding necessary to complete the FDA process. In August 2024, OxiWear received FDA clearance, becoming the only FDAcleared wearable capable of measuring blood oxygen levels during physical activity with proven accuracy across all skin tones. For Fernando, the milestone was deeply personal. “From the very beginning, many people told us it couldn’t be done,” she recalls. “We were told repeatedly that we would fail. Instead of discouraging us, that skepticism became fuel.” The team worked through years of uncertainty, often for minimal compensation, driven by belief rather than guarantees. FDA clearance was not just validation of the technology, it was recognition that a patient-driven vision could meet the highest medical standards.

“As a patient, FDA clearance felt like validation that taking control of my own safety – and refusing to let my condition define my limits – was the right decision,” Fernando says. “What began as a way for me to protect myself had grown into a medical device held to the highest standards of safety and effectiveness.” Professionally, clearance transformed OxiWear’s role in the healthcare ecosystem. Clinicians began to see it not as an experimental or supplemental device, but as a legitimate medical tool. Partners saw credibility and long-term viability. And patients saw something even more important: trust. That trust rests on a fundamental distinction between OxiWear and most consumer wearables. The difference is not form factor or user interface, but the very intent of the device.

“Consumer wearables are designed for trends, averages, and lifestyle insights,” Fernando explains. “OxiWear is designed for clinical decision-making, prevention, and safety. We don’t smooth over data to make it look reassuring – we preserve clinically meaningful signals, even when they’re uncomfortable.”

Today, OxiWear is being used across a wide range of clinical settings, from pulmonary hypertension and COPD to post-surgical recovery, oncology, and emergency care. It has proven especially valuable for patients who are difficult to assess with traditional finger-based sensors, including those with poor peripheral perfusion or autoimmune conditions. Beyond healthcare, adoption is growing in environments where real-time physiological insight can prevent catastrophe rather than respond to it.

Looking ahead, Fernando’s vision extends beyond oxygen alone. The next-generation OxiWear device aims to deliver deeper, real-time cardiovascular insight, capturing how the heart and lungs respond together during everyday life. The goal is to shift care from reactive to proactive, giving clinicians and patients earlier signals that something is changing, before symptoms escalate.

At its core, however, the philosophy remains unchanged. OxiWear exists because one patient refused to accept the limits imposed by a system not designed for real life. It is a reminder that some of the most meaningful medical innovation does not come from optimizing what already exists, but from listening to those who live with its failures.

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