Driving the Future of Pediatric MedTech: A Conversation with Janene Fuerch on Innovation, Collaboration and the CEO Summit

Emma Moran, Head of CobiCure MedTech, sat down with Janene Fuerch to discuss pediatric medtech innovation and the Pediatric MedTech CEO Summit, an exciting event designed to bring together the small community of innovators working on developing transformative pediatric medical devices. Janene is Clinical Associate Professor of Neonatology at Stanford University Medical Center, Co-Director of Impact-1 under the Stanford Mussallem Center for Biodesign, and an experienced entrepreneur and innovator.

Emma: Janene, while not a formally trained engineer, I would say you are an engineer at heart – how did you first become involved in medical device innovation?

Janene: Ten years ago, I never imagined I’d end up in medical device innovation, but great mentors—who knew me better than I knew myself—encouraged me to enroll in the Biodesign Program. Though I laughed at first, I eventually realized I was already doing the work: I built a digital health device and conducted clinical research to evaluate its effectiveness. My experience in adjacent areas, including human factors, helped me figure out the device worked, which led me to writing a paper and filing a patent. When people told me to just publish and move on, it felt deeply unsatisfying. That pushed me to apply for the Biodesign Fellowship. There, I discovered a love for needs-based innovation and the business side of healthcare. I’ve partnered closely with engineers to understand the nuances of building. It’s a team sport and I’m okay with not being the technical expert on a team.

Emma: What led you to spin out Impact-1 under Stanford Biodesign?

Janene: After finishing my Biodesign Fellowship in 2017, I teamed up with James Wall and Kunj Sheth to start Impact-1. James had just received the first Pediatric Device Consortium grant (at Stanford) and since this is exactly the kind of work I wanted to do, I joined the effort. After a while we realized that the Pediatric Device Consortium (PDC) program excluded the fetal population, as it didn’t fit into any existing pediatric categories. As a neonatologist, I know that it’s difficult to think about a baby’s health without also considering the mother’s health—they come together, as a dyad. We also noticed great innovations outside the U.S, which inspired us to create Impact-1, with the mission to advance pediatric and maternal health technology and impact lives from day one around the globe.

The way we do this is multi-faceted:

1.     We leverage the Stanford Biodesign needs-driven innovation process, used by all Impact-1 fellows and faculty.

2.     We accelerate technologies, guiding global programs, projects and companies with insights from our own successful experiences as founders.

3.     We incubate our own technologies with each fellow leading a project toward a potential company spin-out.

4.     We engage in legislative and policy efforts to drive more attractive funding and resources towards pediatric and maternal health innovation.

Emma: What inspired the first Impact-1 Pediatric MedTech CEO Summit in 2023 and what gap were you aiming to fill in the ecosystem with this forum?

Janene: At Impact-1, we kept hearing the same questions from our team and partner companies, especially around later stage device development and commercialization. Instead of everyone reinventing the wheel, we felt our small community needed a space to come together to exchange information. No one else was doing it, so if we don’t, who will? We gave it a try and it ended up being my favorite conference of the year.

Emma: What were some key takeaways or standout moments from the first summit that you found inspiring or unique?

Janene: Just the fact that everyone in the room was on a level playing field and focused on the pediatric space—that never happens. Our experience at most conferences has been people tuning out when pediatrics comes up—it’s seen as too small a market. At this summit, no one said it was too small. Instead, we heard, “That’s awesome. How did you do that?”

There’s something amazing about this community, and part of the reason why I’m a pediatrician and neonatologist, it’s this shared mission. People want to come together and see each other be successful because it means better outcomes for kids. Honestly, it wasn’t about the content or the panels we provided. It was about bringing the right people into the room together. By the end of the day, everyone was excited, and no one wanted to leave—that’s when I knew we had something here.

Emma: We were honored and excited that you asked CobiCure to sponsor the second CEO Summit this past fall - what were some of your personal highlights from the second meeting?

Janene: It was really exciting to have a second summit—after the first, you’re never sure there will be another. This time, it felt like coming home. We were reconnecting with people we’ve been working with, picking up conversations and continuing to develop a relationship. It’s becoming an annual gathering of a tight-knit community, with new faces joining in.

A big highlight for me was bringing our whole team and involving other Pediatric Device Consortiums, helping broaden the conversation around commercialization beyond early funding. On a personal note, I was especially proud to see some of my former Biodesign fellows up there—like Austin Sawyer, an entrepreneur and VC who is passionate about pediatrics, and Sophia Brodsky, a former NICU nurse turned design fellow, who absolutely shined on her panel. Watching them bring their talents forward and engage with the community in a valuable way was incredibly rewarding.

Emma: Most topics discussed at the summit didn’t have “pediatrics” in the title, but why is it so important to discuss them in the context of pediatric innovation? What makes it different?

Janene: Pediatrics is just different. It hasn’t received the attention of other markets and is often overlooked or deemed unnecessary in a business connotation. People don’t think about it until it affects their own child or family, but these are children’s lives and could affect anyone. If we don’t call out pediatric innovation specifically, it gets lost.  For example, I hear people give advice all the time to pediatric companies around reimbursement and telling them to look at the Medicare codes. Except for a couple of peripheral cases, children and pregnant women are not covered under Medicare, it’s Medicaid, which is not a federal program and is a completely different payment model. That’s why we need a dedicated space to bring this community together, highlight the unique challenges, and also raise awareness of the opportunities—like regulatory application fee waivers that many don’t know exist. These conversations will help build a stronger, more informed ecosystem for pediatric innovation.

Emma: Great points. It seems like every pediatric MedTech company is trailblazing some aspect of their journey, whether it is related to regulatory, reimbursement, or commercialization, and creating a “rule book”, if you will, that can be utilized by other innovators in the space. It is so important to share those experiences across the community so each innovator, each company, doesn’t need to reinvent the wheel each time.

Emma: There seemed to be a buzz at this summit around a changing tide in commercialization and the potential of these markets that hasn’t been there before – are you sensing more optimism around market potential and funding opportunities?

Janene: I am, especially in areas like pediatric cardiology and neonatology. I’m starting to hear more curiosity, such as “Is this a good area to be in?” rather than the skepticism about it being too small or narrow. You could even see it in the summit attendees—there were VCs, philanthropic groups and others exploring the space. It’s still early and not enough, but there’s a momentum that is being catalyzed. There’s been a real shift, compared to just a few years ago, more people are definitely getting interested in this space.

Emma: Now that there have been two CEO Summits, what direct impact have they had on your work at Impact-1 or within the Stanford-UCSF Pediatric Device Consortia? Have these summits translated into your day-to-day efforts?

Janene: Some of the companies we see at the CEO Summit, we’ve worked with and coached them for years. For example, Neola, we helped them with their pitch, they won a PDC award, and now we are launching a study at Stanford. This kind of long-term engagement is rare but impactful and the summit is one tool to help catalyze these relationships. The summit also elevates conversations. I’ve heard from attendees that there’s no other space like this—where the conversation is specific and focused on higher level, including further down the commercialization pathway. Even leaders of publicly traded companies were engaged, which showcases the value and impact of the conversation.

Emma: As a personal example, a CEO reached out to me to get connected with another CEO they met at the summit to get advice and share experiences on engaging with strategics. It’s fantastic to see those peer-to-peer connections getting made, especially as they are navigating the later stages of device development and commercialization.

Emma: Let’s talk about year three. You are planning for Austin in the fall of 2025—what can you share at this early stage of planning?

Janene: After hosting on the West and East Coasts, we felt it was important to highlight another innovation hub—so Austin made sense, especially with the great partners and sponsors we have there. We also keep hearing that one day isn’t enough, so we’re planning a two-day summit. One day will be exclusive to CEOs so they can have that engaging conversation with their peers and the next day will be open to everyone, including investors, philanthropists, regulators, and others who are part of the broader ecosystem. The goal is to build upon the momentum of the last two summits and create more space for meaningful interaction.

Emma: We are grateful for our partnership and collaboration with Impact-1. You are all amazing and I see you as a key driver of change in this ecosystem. I appreciate all that you do.

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