Unlocking Insights with Kwame Ulmer: A Journey Through MedTech, FDA, and Venture Capital
This interview with Kwame Ulmer is part of a larger series of interviews where we discuss the intersection of healthcare and technology with subject matter experts from Adhera Health’s Advisory Board.
Kwame Ulmer leads MedTech Impact Partners (MIP), bringing over twenty years of experience evaluating medical technologies from both government and private sectors. In addition, Mr. Ulmer is a venture partner at Wavemaker Three-Sixty Health, the leading Southern-California based, early-stage venture capital firm focused on the healthcare industry. His career highlights include a 12-year tenure at the FDA in roles such as Deputy Director and Branch Chief, as well as serving as Vice President of Regulatory Affairs and Quality Assurance at Implant Direct, a subsidiary of Danaher Corporation. In addition to Adhera Health, Mr. Ulmer is a board member for Essenvia Inc. and Strados Labs Inc. He is a lecturer and researcher at the University of California, Los Angeles, and the founder of MedTech Color, a nonprofit aimed at enhancing the representation of persons of color in the medical device industry.
During your 12 years at the US Food and Drug Administration, you occupied leadership roles including deputy director and branch chief. How have the insights and challenges faced in these roles shaped your current approach at MedTech Impact Partners and Wavemaker 360 Health, specifically when advising startups on their journey through the FDA's rigorous evaluation process?
“There are a couple of ways my time at the FDA informed my decision-making afterward.” In his positions at the FDA, Mr. Ulmer was able to review a variety of products, “from medical devices to diagnostics, to digital health solutions – and a range of applications.” As Mr. Ulmer explains, the knowledge he gained at the FDA engaged him with “a sense of the core issues regarding establishing safety and effectiveness for any product and the basic processes and principles for evaluation that I could apply to a range of technologies when I left.”
Mr. Ulmer says that his time with the FDA taught him about the importance of knowing how to talk to the FDA. “What really became apparent after I left, was the impact of questions from the FDA and the activities that set off that accompany.” Companies put a lot of energy into “effectively responding to the FDA, and it really is a bit daunting.” When interacting with the FDA, “one has to be mindful, first of all, are the FDA asking the right questions, not having a whole laundry list of not critical or not germane or not necessary questions?” When you’re outside of the agency interacting with the FDA, you are working with companies “to effectively and efficiently answer their questions as quickly as possible, while using the right amount of resources in the organization and hopefully, not having the entire organization seize up.”
You have experience evaluating over 1000 medical technologies throughout your career. What patterns or trends have you observed in the evolution of medical technologies and how do these patterns inform your investment decisions at the venture capital level?
Mr. Ulmer explains how he has seen shifts in the medical technology industry over the last couple of decades.
“I’ll talk about the people and then the technology.” When Mr. Ulmer first began working in the regulatory space for medical technologies, he saw the same “teams” of individuals. “There was a leadership profile, and it was a clinician who had discovered a novel way to treat a pain point; sometimes they teamed up with a business-oriented person, and I would be sitting across the table with them talking about some safety or effectiveness issue. Now the profile is more diverse. It could be a former Google employee who found software to treat a mental health condition. It could be someone with no traditional medical device background at all who teams up with someone who came from pharma who wants to take a stab at the medical device industry.” While the type of entrepreneur has shifted somewhat, it still retains that traditional profile.
“The other thing that has changed over the years is the agency's focus and the industry's focus on all aspects of software-related issues. 10 years ago, the vice president at the time was in danger of having his defibrillator hacked. So, cybersecurity has been around for over a decade for medical devices. It is only in the last three or four years that there has been staffing for FDA experts in software, specifically in cybersecurity, so it has become one of the last elements of holistically established safety effectiveness. So, that is another megatrend: software as a medical device and software in a medical device, and the FDA having the capability to address it in terms of safety and effectiveness.”
What resources exist within the FDA, in terms of technical and technology knowledge, to address the rapid development of tech? For example, for generative AI applied to health care – how can they keep up with new advances?
“Yeah, it’s a challenge.” says Mr. Ulmer. “This is from reading the publicly available data about how the FDA is responding: number one, an unintended consequence of the pandemic is that there was a surge in staffing these for the FDA to get emergency-use authorizations through effectively.”
The staffing requirement is still there, “in the latest user fund negotiation, the FDA asked for additional staff. I think those staff are still coming online.” Specifically, explains Mr. Ulmer, “software experts are still coming online,” who can be difficult to find because those individuals have a lot of career options, especially in the private sector. “So that is a challenge. Getting that top talent who can address issues like cybersecurity.”
You have great experience overseeing various aspects of fund management, from deal sourcing to advising portfolio company management teams. What pitfalls do you observe startups taking in the MedTech space, and how do you leverage your experience to guide them?
“Over the years, I've been fortunate enough to establish relationships with the key stakeholders that are needed to build a high quality, safe, and effective medical device, med tech solution, and early on for rarely reasonable reasons, the founding team doesn’t always have access to all the experts that they need. So, a pitfall is not having, within arm's reach: the biostatistician, the clinician, the cyber expert, the biocompatibility experts – all the key team members you need to establish a proof of concept, and later safety and effectiveness. And that's obviously an issue of funding.”
Another pitfall is “companies not knowing, through really any fault of their own, not just that non-dilutive capital like NIH and NSF funding is there, but that most companies do not successfully get their grant approved on the first go around. It normally takes a couple of attempts to get that first a hundred thousand. And then for phase two, you know, for over a million dollars.”
As one of the founders of MedTech Color, you've made a significant effort to advance the representation of persons of color in the medical device industry. What challenges and gaps do you perceive that led to the establishment of this nonprofit? And how do you envision the future of diversity within the medical technology sector?
“The first gap, that was born out of my personal experience and the experience of other executives in the industry, was that it was a lonely experience – which impacted retention.” When people don’t feel a sense of community they tend to leave. “That was something I was dealing with professionally at the time. And so MedTech Ccolors originally was intended to build community, and we did that over the years. We have a network of over 43000 people from a range of ethnic groups and allies.”
In the time Mr. Ulmer spent as a consulting partner, he found that “early-stage companies with diverse teams, despite being more likely to have outsized returns, were not receiving commensurate capital – early-stage investment.” So, he helped to create a pitch competition “to serve as a magnet to attract additional capital from other sources like the NIH and the NSF, their partners for this pitch competition, but also large private companies who could buy strategically aligned companies to enter into their corporate accelerators.”
“So,” says Mr. Ulmer, “those are two examples, community and capital, that are a problem in the industry, and how MedTech Color aims to solve those problems.”
Adhera Health recently won an award specifically to address certain underserved populations in this U.S. and we understand that we still have a long road to a truly equitable future. Have you seen progress since you began MedTech Color?
“First, I think of four key stakeholders for this to be successful. One is the startups. And I'll give you a brief example. Over the last four to five months, we've seen at least five to six companies focused specifically on treating women going through menopause. That's great, the startup is trying to solve the problem there. The second element to success would be organizations in the government that could provide non-dilutive capital. Right now, there are a handful of sources of capital where you can focus on health equity. The National Institutes for Aging has a challenge where you can address health equity and receive a grand prize. And then, you have the venture capital community. If you look at just women's health investment, it's been flat, so we haven't seen a lot of activity there. And so, the fourth element is a nonprofit community and MedTech Color and MedTech Women are there to serve as a beacon for talent focused sometimes on health equity.” And while Mr. Ulmer believes these organizations are growing and thriving, “the hard truth is the venture capital dollars have not been increasing as much as they could be. And there are some early programs focused on health equity from the government side, but there's still a-ways to go for those two communities.”
Drawing from your experience as a lecturer and researcher at the UCLA Anderson School of Management, as well as your experience as a board member for the University of Virginia’s Licensing & Ventures Group, how do you see the role of academia in shaping and supporting the future of the med tech industry? And how do you ensure that the knowledge and innovations from these academic platforms transition effectively into real-world applications?
“There are two elements that I've observed for the successful translation of great ideas out of the university and into the private sector to reach patients. One is capital; larger research institutions like UCLA have wonderful innovation funds that can make significant investments to get companies to the prototype stage by de-risking regulations – sometimes even with reimbursement. Those early-stage questions that any company would need to face – they can get the capital before they even form a company through these innovation funds. So, at the University of Virginia where I went to school, there's a seed fund that plays that role. Sometimes they invest alongside angels. And then at UCLA, there's an innovation fund. So, the capital is one piece and that's the role that university should play.”
Mr. Ulmer explains further, “The other, beyond capital, is the university incentivizing professors to be able to work on these products beyond just a six-month sabbatical. This is hard,” laughs Mr. Ulmer, “but if it can be written, this should be written into the policies and procedures as to what is a factor for getting on tenure track or getting promoted; if part of the incentive for the factors that are considered to promote a faculty member could be formation of entrepreneurial projects, that would be the other major lever. And we talked about that some at the University of Virginia. How do we incentivize faculty to really be entrepreneurial? It's by saying this is a factor in your promotion.”
Why did you choose to join the Adhera Health Advisory Board and what do you see as Adhera Health’s top contributions to the current state of person-centric digital health platforms?
“Early on at the fund that I work at, and by nature of my work outside of the fund. We started thinking about megatrends, and one megatrend is personalized solutions. Some people call it personalized medicine. There are other terms, but fundamentally more and more software-enabled solutions are targeting the person, and it was really intriguing to be able to be associated with a company like Adhera Health which is focused on a personalized solution. As the company grew and established markets and patients to reach, I had a personal connection to the potential future ability to impact patients with autoimmune diseases because it has directly impacted my family. And professionally, I'm attracted to companies with diverse leadership teams, and that's immediately what I saw when I met you and got to know other members of the team,” he says, speaking to Ricardo Berrios, CEO of Adhera Health, “and I thought that that was going to be an advantage for you moving forward. So, for those reasons and many more, I'm delighted to be associated and work with you, Ricardo, and the company. There is going to be an amazing impact on patients, and I'm just delighted to be with you on this journey.”