The neoGuard, a first-of-its-kind wearable device vital signs monitor, launched in 2021 in Kenya, Africa. Designed specifically for regions with unreliable electronics and limited resources, neoGuard monitors vital signs in newborns and can alert nurses and doctors of signs of distress, thereby decreasing infant mortality. The neoGuard is the product of a pair of scientist innovators, Sona Shah and Teresa Cauvel.
An interview with Sona Shah soon after their launch revealed some of the revealing truths and essential wisdom that guided their successful journey. First and foremost, a human-centric approach to medical device design is necessary to adapt to the changing needs of the world. Secondly, mentors pave the way for innovators and change makers. In brief, getting a device to global markets takes time and patience, and a team of mentors. Read more below about Neopenda’s journey from start-up to first global launch.
Sona Shah founded Neopenda with Teresa Cauvel to bring affordable, responsive care to patients who need it most. In fact, the mission and vision of Neopenda began a decade ago in Kenya where Ms. Shah travelled after college as a teacher. There she discovered many unexpected inequities including inadequate equipment and healthcare–which many of us take for granted in the United States.
Upon returning from Kenya, Sona met Teresa Cauvel in the bioengineering program at Columbia University and together, they created a wearable device to answer the need Sona saw so clearly in underserved communities. The two scientists and innovators designed and built a prototype, a product, and in time, a company.
Neopenda’s first product is a wireless wearable neonatal vital signs monitor designed for resource-constrained healthcare facilities. The affordable system enables more responsive, appropriate care for critically ill newborns, and ultimately helps reduce preventable newborn mortality.
After the success of neoGuard, Neopenda continues innovating needs-based medical technology for the massive untapped opportunity in emerging markets. They create end-to-end solutions that enable high quality patient care and nuanced data insights for stakeholders.
Sona overcame many obstacles along the way. She’s honest about the challenges of bringing neoGuard to market and what it takes to build a successful company. She finds educating external stakeholders is absolutely necessary. Sona’s spent a lot of time thinking about how to educate people–something her teaching background in Kenya supported. Because of the obstacles she’s gained valuable insight and experience she readily shares with other entrepreneurs in the medical device industry.
Sona above all else learned the value of a quality system in medical device development. “Whenever I talk to other entrepreneurs I always tell them how it’s expensive but start your quality system as early as you can. We had to retroactively create documents–and a FMEA which we should have done early on–but we didn’t know we had to do it. It’s something I recommend to other entrepreneurs is to spend time and get [your quality system] right from the beginning—it’ll set you up for success later on.”
Sona understands that while it may take time and money on the front end, a quality system prevents headaches and hassles later on.
In summary, Neopenda introduced a life-saving device to the world. The company is innovating needs-based medical technologies where they’re needed most. It took six years, numerous accelerators, investors, trusted advisors, mentors, and an expert team dedicated to their work. What makes Neopenda truly successful though are its leaders. Sona calls herself “CEO”: Chief Empowerment Officer—a title well-earned.
Sona’s final words of wisdom? “Remember why you’re doing what you’re doing, and what problem you’re trying to solve. You’re doing this because you’re saving patients’ lives.”
MAE Group is honored to be part of Neopenda’s journey, offering quality management systems, services, and training. In Sona’s words, “I want you to know how much we appreciate MAE—it’s such a relief that we have this team of experts that we can fall back on when we have questions. It’s a big relief for us. Without that it’s really hard to understand all that complex content. We certainly love it, thank you.”