Food and Drug Administration (FDA) patents created in the process
line-down days during initial production due to plant closures or supply chain issues
reduction in unit cost during product iteration cycle, from EVP to mass production
Developing a new product with unprecedented technology that can collect clinically accurate patient data
Situation
Happy Health, a technology company with a mission to help bring better health to all, understood that the future of healthcare was home-based. With this vision in mind, the team wanted to change the market for wearable devices. The Happy Health team set out to develop a clinical-grade, real-time sensing product for patients.
The journey to bringing the Happy Ring to life came with several challenges, including the absence of a prototype and the requirement for a clear plan to design, develop and produce the product for market. Recognizing these hurdles, the Happy Health team collaborated closely with Surfaceink, part of the PwC network, to help bridge the gap between concept and execution. Together, they worked to transform the vision for Happy Ring into a tangible, market-ready product.
The teams envisioned Happy Ring would monitor both physical and emotional well-being using AI-driven sensors that can collect clinical-grade vitals, including heart rate and blood oxygen levels. Beyond these standard health metrics, the wearable goes further gathering data on stress, cognitive performance, steps, sleep, phone usage and sunlight exposure — all while fitting comfortably around a user’s finger.
Happy Health also was seeking help navigating the complexities of creating a medically viable product during the height of the COVID-19 pandemic as factories shuttered, production lines ground to a halt and the world went virtual.
Solution
Happy Ring’s form factor was a significant technical challenge — especially considering the need to shrink more than 20 sensors, including galvanic skin response (GSR) hospital-grade monitors. The team also needed the design to be strong yet lightweight and small enough to fit on any finger, including those of individuals with petite hands. Achieving this required deep experience in material science and engineering. Working collaboratively, the teams created innovative solutions — rooted in advanced engineering, test driven design — to bring the ring to life. The physical concept, inclusive of 15 product iterations, also resulted in multiple versions and colors in addition to easy charging capabilities and long battery life (twice as long as competitors). This rapid prototype development and proof-of-concept improvement also helped the company secure $60 million of additional venture-backed funding.
Pandemic era limitations prevented PwC and Happy Health teams from taking the traditional production approach of visiting overseas manufacturers and educating them about the product.
To reduce production disruptions, the team came up with an innovative solution to handle remote builds. They established an agile, and virtual, production scrum in the United States and China, each mirroring one another’s processes. Borrowing a typical software development project management technique, the hardware engineering team held daily morning and evening check-ins to address any issues.
The team also had to deal with increased lead times to secure battery components, which were longer than usual due to global supply chain slowdowns. To maintain continuity, instead of working with a single vendor, the team engaged multiple battery vendors capable of providing prototype quantities along with other necessary components.
Meanwhile, the engineering team qualified new adhesives and devised a new method for bonding and assembling the device — while developing in-line tooling standards for contract manufacturers to facilitate mass production. As a result, the ring now features an IP67 waterproofing distinction, an international rating that a device to be completely dust-tight and can withstand submersion in up to one meter of water for 30 minutes. As part of the commitment to continuous improvement, PwC also oversaw ongoing assembly process tweaks, that further enhanced production times.
To help create a successful and innovative product it’s critical to incorporate user feedback. The multi-disciplinary team sent out hundreds of rings to different universities to garner candid input, make sure the sensors and back-end algorithm worked correctly and perform Institutional Review Board (IRB) approved pre-clinical trials.
RESULTS
Health metrics from many of the wearables provide general, real-time data on vital signs and well-being, while precise digital biomarkers — like those in Happy Ring — offer highly accurate, clinically validated measurements used for diagnosis and treatment. With more predictive markers than any device that came before it — from heart rate to skin temperature — the ring can offer a highly detailed, holistic view of patient health.
Working hand in hand with the team at Happy Health, PwC’s design and engineering teams helped create a brand-new product that exceeded expectations in record time and reduced 10% of production costs during each phase of the development lifecycle. The innovations in product materials resulted in four pending patents and new innovations in manufacturing kept production ahead of schedule. As such, Happy Ring’s development opens a world of possibilities, not only poised to help improve patient care and enhance health outcomes, but also to shift the way that wearables are built.
Happy Ring is one of the first to reliably measure brain and body biomarkers simultaneously. This means it can track in-the-moment stress responses. Happy Ring is also one of the first device on the market to combine electrodermal activity (EDA) sensors to measure changes in skin conductivity caused by sweat gland activity, microtechnology that tracks respiratory rate and special temperature sensors to gauge changes in blood flow.
As the first FDA-cleared smart ring for whole body monitoring, Happy Ring is poised to offer wearers, medical researchers and clinicians more reliable data than ever before. Whether it's used in the development of new medications or helps to identify new stress or depression triggers, precision healthcare begins with better data — and Happy Ring provides just that, representing a new standard for remote patient monitoring. The FDA’s medical device designation translates to wider market access and enhanced credibility, further boosting Happy Ring’s commercial potential and the opportunities to improve the quality of patient care.
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