Denise Bronner, PhD, CEO of Empactful Ventures: Clinical Trial Best Practices and The Importance of Patient Representation

Denise Bronner, PhD, CEO of Empactful Ventures: Clinical Trial Best Practices and The Importance of Patient Representation

As CEO of Empactful Ventures, Denise Bronner leverages a data-driven approach and over 15 years of industry expertise to empower organizations to redefine their strategies and implement innovative solutions. Drawing on insights from real-world data, she helps companies uncover hidden potential, adapt to evolving landscapes, and position themselves as industry leaders. Prior to founding Empactful Ventures, Denise earned her PhD in microbiology and immunology from the University of Michigan in 2015. Most recently, she held roles at Johnson & Johnson as Director, Senior Global Feasibility Lead, and Director of Diversity, Equity, and Inclusion in Clinical Trials for their Immunology portfolio. During our conversation, Denise shared her best practices for designing clinical trials and her perspectives on the importance of diverse patient representation within these trials. She emphasized involving all key stakeholders—patients, clinicians, advisory boards, and trial site staff—in the design phase because their input can help identify potential design flaws, improve patient recruitment, and create a more robust, patient-centric trial that is also more likely to satisfy regulatory considerations from the FDA. 00:30:20 - Best Practices for Clinical Trials 13:19:08 - Patient Representation in Clinical Trials 27:35:02 - The Benefits, Costs, and Value of Diverse Patient Data 31:27:58 - Clinical Trial Outcomes 34:51:57 - Empactful Ventures 38:14:05- Conclusion

Kwame Ulmer, Managing Partner at MedTech Impact Partners: Perspectives on The FDA and The Importance of Regulatory Experts and Strategy

As Managing Partner at MedTech Impact Partners, Kwame Ulmer leverages over twenty years of experience evaluating medical technologies in the government and private sector to answer regulatory questions, develop comprehensive regulatory strategies, and support complex submissions (e.g., de novo, PMA, 510(k)) for companies working with the FDA. He has personally evaluated more than 1,000 medical technologies in his career, and he spent 12 years at the FDA in progressive leadership roles, including Deputy Director and Branch Chief.  In addition to his work at MedTech Impact Partners, Kwame is a venture partner at Wavemaker Three-Sixty Health - the leading Southern-California based, early stage venture capital firm (Seed and Series A) focused on the healthcare industry - and is a lecturer and researcher in MedTech Innovation at the University of California, Los Angeles.  During our conversation, Kwame shared his perspectives on the recent and significant changes at the FDA, particularly regarding staffing cuts, operational disruptions, and their impact on medical device companies, investors, and the broader medtech ecosystem.  The FDA is experiencing a period of disruption and these disruptions are not business as usual, affecting all stakeholders across stages. As a result, FDA-risk has increased, demanding a greater allocation of time and resources from companies and founders. With continued turnover in the organization, companies should anticipate and budget for possible delays for different application types. Despite regulatory uncertainty, Kwame believes investors will continue to fund medtech companies, with longer timelines and greater emphasis on de-risked regulatory pathways. 00:06:21 - The Current State of The FDA 09:07:10 - Investor Perspectives on FDA Changes 14:51:19 - MedTech Impact Partners 18:11:18 - Perspectives for Founders Navigating Changes at The FDA 37:05:14 - Conclusion

Matthew West, Founder and CEO of Boom AI: An AI-powered Mental Health App for College Students

Matthew West, Founder and CEO of Boom AI, has experienced periods of severe anxiety throughout his life. As a child, he never seemed to seamlessly integrate with peers from similar ethnic backgrounds. His independent mindset and love for soccer acted as barriers to connection within his proximal environment, but he developed a strong sense of self through academic and athletic accomplishments, maintaining an ambition to play at the highest levels. Unfortunately, an injury during his junior year of high school reduced his chances of playing professional soccer to zero and led to his first battle with debilitating anxiety. Matt was able to overcome his initial experience with severe anxiety, but challenges in college and, later, a divorce catalyzed recurring battles with anxiety over time. After earning a master’s degree in clinical psychology from Pepperdine University, Matt began working with college students to help them manage anxiety and depression during the school year. Personally, he discovered mindful journaling and introduced the practice to the students he served. Students immediately shared overwhelmingly positive feedback about the effects of mindful journaling on their mental health. Once Matt saw how transformative mental health tools could be for these students, he and his co-founder decided to launch Boom AI to expand the resources available for students to manage their mental well-being. Boom AI is building an AI-powered mental health app specifically designed for Gen Z college students, where users can track their moods, connect with peers, and access personalized insights and resources. Through mood tracking, mindfulness exercises, and goal setting, users can proactively manage their mental well-being. The app fosters a supportive community atmosphere, promoting empathy, understanding, and solidarity among its users as they navigate the challenges of college life. With Boom AI, technology becomes a catalyst for emotional resilience and balance, empowering young adults to prioritize their mental health and thrive. 00:00:00 - Matthew's Mental Health Story 18:26:13 - Mindfulness and Mindful Journaling 22:21:05 - Converting from Islam to Christianity 30:15:08 - Boom AI 41:54:10 - Millennials v. Gen-Z 50:00:13 - Boom AI for Universities 57:00:26 - Conclusion

Chelcie Taylor, Investor at Notable Capital: Investing in AI and Vertical Voice Agents

As a multi-stage investor at Notable Capital, Chelcie Taylor spends her time thinking about a future transformed by AI-native and AI-enabled software. She focuses specifically on vertical AI applications, as well as B2B and enterprise software, evaluating deals from inception through later-stage opportunities. Additionally, she co-created the annual SMBTech 50—a list showcasing the most promising private companies building for SMBs. Her journey to venture capital has been highly decorated: she earned her undergraduate degree from Princeton, her MBA from Harvard Business School, and held strategic and operating roles at Google, CBS, and MediaLink before joining Notable Capital in 2021. In addition to her work as an investor, she contributes to organizations supporting underrepresented investors, including AllRaise and BLCKVC. In 2024, Chelcie was selected as one of five recipients of the National Venture Capital Association’s Rising Star Award. During our conversation, Chelcie shared her belief in AI as a transformational technology and offered her perspective on the rapidly evolving AI ecosystem. She identified the biggest change in the last 18–24 months as the increased velocity of top-line growth for AI companies. As time to milestones have compressed to unprecedented levels, AI-native startups that are going from zero to five or ten million in ARR are adapting their capital allocation and fundraising strategies. As a result, Chelcie and other investors are re-underwriting how they assess these businesses across different stages. In particular, Chelcie is very bullish on the AI voice agent space, and she spent a meaningful portion of our conversation deep-diving into the nuances and potential impacts of these agents across verticals such as banking, healthcare, and SMBs. You can read her blog post, “Vertical Voice Agents Are Taking Off: Here’s Why,” for a detailed exploration of the key factors driving their adoption and growth: https://www.notablecap.com/blog/vertical-voice-agents-are-taking-off-heres-why [https://www.notablecap.com/blog/vertical-voice-agents-are-taking-off-heres-why] During our conversation, Chelcie and I discussed: 00:00:54 - Chelcie's Observations, Perspectives, and Thesis on AI Markets 00:05:19 - AI-Native Startup's Shifting Capital Needs 00:12:05- Vertical Specific AI Tools and Voice Agents 00:27:34 - Competition and Differentiation for AI-native Companies 00:30:16 - Conclusion

Eldrick Millares, Co-Founder and CEO of Illuminant Surgical: The First Real-time Anatomical Projection System for Spine Surgery and Interventional Access

Illuminant Surgical (YC S22) is building the world’s first real-time anatomical projection system for spine surgery and interventional access-displaying imaging directly onto the patient to give surgeons a view of what’s beneath the skin. It uses artificial intelligence, computer vision, and dynamic projection mapping to make image-guided procedures seamless and accessible for all care settings and specialties. Led by Co-Founder and CEO Eldrick Millares, the company is safely and swiftly developing the system to improve patient outcomes in spinal fusion procedures, its initial beachhead indication. Spinal fusion has a relatively elevated revision rate, meaning patients often require additional surgeries due to misplacement or other consequences of imprecision. By projecting real-time imaging, instrument tracking, and anatomical mapping directly onto the patient with sub-two millimeter accuracy, surgeons gain enhanced visibility during procedures, improving precision and reducing the likelihood of revision surgeries. Eldrick was incredibly gracious in providing us with an in-person demo after our conversation at their office in Culver City, and I was absolutely blown away by their transformational technology. 00:00:00 - Eldrick's Background 17:18:11 - Founding Illuminant Surgical 27:25:14 - The World's First Anatomical Projection System 37:27:17 - Potential Applications Beyond Spine Surgery 42:42:27 - Near-Term Roadmap 46:03:21 - Conclusion