Insights on Medical Device Development. Digital Health Interviews: Lisa Voronkova

Welcome to the latest episode of Digital Health Interviews! This episode is particularly special as it features a Ukrainian founder for the first time, alongside the host Alex Koshykov. The guest for today’s show is Lisa Voronkova. Both Alex and Lisa are committed to raising awareness about the ongoing war in Ukraine and the egregious acts being committed there by russian federation. So we highly encourage everyone to stand with Ukraine until the victory!

A Visionary’s Journey: Lisa Voronkova

With a decade of expertise in medical and wellness devices, Lisa Voronkova stands at the helm of OVA Solutions, an R&D shop she runs in New York. Her team, spread across New York and Ukraine, mirrors her dedication to innovation in the health sector. Lisa’s journey wasn’t always directed towards medical technology. Initially drawn to digital security, her curiosity soon pivoted toward the human body and its signals. “I wanted to know more about the human body and also about capturing the signals from the human body,” Lisa recalls.

This fascination with biometric signals spurred her to explore myography, particularly the signals emanating from hand gestures. It was a burgeoning field in 2014, and it propelled Lisa into entrepreneurship. She co-founded her first startup, Force, alongside university colleagues. Their venture’s success led them through the Alchemist accelerator, an experience Lisa describes as “amazing” and “exciting.”

The Startup Accelerator Path: Lisa’s Insights

Lisa Voronkova’s entrepreneurial spirit was nurtured through her participation in two renowned accelerator programs: Alchemist in 2017 and Tech Stars in 2023. These programs, one at Stanford and another in Fort Worth, are designed to propel startup founders toward success. Lisa credits them with providing a comprehensive understanding of integrating technology into the healthcare pathway, which is crucial for medical startups. “It’s not only about innovation but about fitting this innovation into the care pathway,” she emphasizes.

The most significant takeaway for Lisa from these experiences was the importance of building a customer advisory board. Alchemist’s focus on B2B startups highlighted the necessity of early customer feedback to grasp the true value of the products being developed. Lisa candidly shares, “I thought if I’m going to build amazing technology, I’m going to succeed — and it’s wrong.” This realization has been pivotal in her approach to creating value in the medical device industry. Her journey through the accelerators has been transformative, with mentors like Ravi Belani opening her eyes to new perspectives and possibilities.

The Touch of Innovation: Lisa’s Creative Endeavors

Lisa Voronkova’s career is marked by her work on a diverse range of medical and wellness devices, each with its unique challenges and rewards. Among these, the development of a pre-screening mammography device stands out as a significant contribution to cancer diagnostics. Yet, it’s the creation of wellness and niche sex-related devices that brings an unexpected joy to her work. Lisa shares a vivid memory from the production line, “I think it’s one of the best experiences in the world to dig your hand inside this plastic, it feels just so good!” This tactile pleasure is akin to the satisfaction she derives from seeing a product evolve from a mere sketch to a tangible device over months of dedication.

For Lisa, the process of bringing an idea to life is deeply fulfilling, comparable to the profound experience of holding one’s child for the first time. Her passion for innovation and her ability to find delight in the nuances of product development are what make her journey through the world of medical and wellness devices truly exhilarating.

From Concept to Market: The Lifecycle of a Medical Device

Lisa Voronkova’s expertise shines as she delineates the intricate journey of a medical device from inception to market launch. Not all startups approach OVA Solutions merely with ideas; some arrive with tangible proofs of concept, ready for refinement. Lisa stresses the distinction between a prototype and a production-ready design, noting that first-time founders often conflate the two. “Once you have a prototype, it would be the same in the production. It’s wrong!” she clarifies.

The transition from prototype to manufacturing is fraught with regulatory pitfalls, a lesson learned through firsthand experience with a client who faced significant delays due to material compliance issues. This stage demands vigilance over regulatory requirements, especially concerning materials approved for use in different countries. The design for manufacturing must be meticulously crafted, considering factors like FDA compliance and the creation of a quality management system.

Lisa’s guidance doesn’t end with the production phase; she extends her support through logistics and ongoing support, encapsulating the full spectrum of device development. Her commitment to aiding startups is further evidenced by her offer of a free guide, available through her LinkedIn, providing invaluable insights to budding entrepreneurs in the medical device field.

The Crucial Focus: Lisa Voronkova’s Perspective on Startup Success

Lisa Voronkova believes that the key to a startup’s success lies not in the product itself but in the value it brings to human lives. She advocates for a strategic focus on client relationships and understanding the real-world impact of solutions. “It’s not the product. What I would focus on is working with hospitals and clients to understand how my solution is going to affect human lives and bring them value,” Lisa asserts.

In her view, many founders falter by losing sight of this crucial aspect. She suggests outsourcing hardware and software development to concentrate on the core mission — delivering value and saving costs for payers. Lisa also emphasizes the importance of networking and securing early-stage customers, such as insurance companies and hospitals, to validate and pilot innovative solutions.

When it comes to mass production, Lisa hasn’t observed significant issues, provided that founders have robust agreements with their subcontractors. She underscores the irreplaceable role of networking and engaging with stakeholders in the healthcare ecosystem. Lisa’s advice to fellow entrepreneurs is to be open to piloting with health systems that are receptive to innovation, as it can lead to unexpected opportunities and insights.

Reflecting on the timeline from concept to market, Lisa notes the extended journey for medical devices due to regulatory requirements. “According to the FDA, it takes 7 years from the idea to hitting the market for medical devices,” she remarks, highlighting the patience and dedication required to navigate this field.

Empowering Health: Lisa Voronkova’s Drive and Vision

Lisa Voronkova’s inspiration in the medical device industry stems from a profound sense of empowerment. She is driven by the ability to enact positive change in healthcare, enhancing recovery processes, preventing conditions, and helping individuals understand their bodies. “I feel power. Power over a human body. Like the power to change something for the better,” Lisa expresses, encapsulating her motivation to innovate for a healthier life.

Looking ahead, Lisa anticipates significant advancements in the medical device sector. She identifies two emerging trends: opioid control intake devices and metabolism control tools. The former includes various devices aimed at medication delivery and pain reduction, addressing the growing opioid crisis. The latter focuses on combating obesity and personalizing dietary needs through advanced wearables that monitor glucose, ketone levels, and other metabolic indicators. These trends reflect a shift towards more personalized, data-driven healthcare solutions, promising a future where medical devices play a pivotal role in managing and improving patient health.

Service as a Catalyst: Lisa’s Commitment to Medical Startups

Lisa Voronkova has chosen to dedicate her expertise to the service side of the medical device industry, believing it to be her niche where she can offer the most value. Her goal is to guide startups away from common pitfalls and towards swift success. “I just don’t want them to make common mistakes and I want them to achieve the results as soon as possible,” she states, highlighting her role as a crucial ally for medical device startups.

When it comes to the ideal time for startup founders to seek her guidance, Lisa is flexible, and accommodating to startups at any stage. She recounts assisting a friend at the very inception of his idea, facilitating a conversation with an FDA expert to weigh the options between at-home diagnostics and laboratory analysis. This level of support exemplifies her approach: proactive, strategic, and regulatory-savvy. Lisa likens the process to a game of chess, where thinking several moves ahead is essential. Her advice underscores the importance of early risk assessment and management, setting the foundation for a successful venture in the complex landscape of medical devices.

Strategic Piloting and Long-Term Passion: Lisa’s Final Advice

Lisa Voronkova, with her extensive background in medical devices, offers a clear stance on geographical pilots for startups aiming for the U.S. market. She advises against starting pilots outside the U.S. if the primary target is the American healthcare system, due to its unique landscape and values. “If you want to do the same work from zero — then yes, start with another country, then go to the U.S. But if you’re targeting the market in the U.S., you should be here doing everything from the beginning. It’s a must,” Lisa emphasizes.

For startup founders in the medical space, Lisa underscores the necessity of passion and long-term commitment. She cautions against underestimating the time it takes to succeed, suggesting that founders seek mentors who have navigated similar paths, even among competitors. Understanding the market and learning from those who have been in the industry is crucial. Lisa’s journey as an outsource provider in the hardware space was informed by observing successful companies and recognizing the potential for her success.

The ultimate reward, Lisa believes, is witnessing the real-world impact of one’s work. The pride and inspiration drawn from seeing a medical device in use, improving lives in a hospital setting, is unparalleled. “However, if you’re going to succeed, it would be so inspiring for you to go one day to the hospital and see your device in use for all these people and you would feel so proud of yourself! I think it’s literally the best feeling in the world!” With these parting words, Lisa imparts a vision of fulfillment that transcends financial success, rooted in the profound influence on human health and well-being.

Our previous episode was with Amir Lahav: Evolution of Pharmaceutical Innovation