Capital Readiness Program (CRP) #1: How Demo Days are Failing Founders and Why CRP is a Better Way, with Heath Naquin

Capital Readiness Program (CRP) #1: How Demo Days are Failing Founders and Why CRP is a Better Way, with Heath Naquin

After sitting through what he calls his "thousandth demo day," Heath Naquin walked away convinced that the entire model was broken. Founders were being polished for investors rather than prepared for the real work of building a company. In this episode, Heath Naquin, VP of Government and Capital Engagement at the University City Science Center in Philadelphia, joins Dan Mazzucco to unpack the philosophy behind the Capital Readiness Program — a week-long immersive boot camp for medtech founders that replaces pitch competition theater with real investor due diligence. They cover what investors actually look for before writing a check, how to build a real investor discovery strategy, what belongs in a strong deal room, and the red flags that end conversations before they start. This conversation is for medtech founders who are raising beyond friends and family and want to understand how investors actually make decisions — not how founders imagine they do. Heath Naquin is the Vice President of Government and Capital Engagement at the University City Science Center in Philadelphia, where he leads the Capital Readiness Program, the Investor in Residence Network, and federal commercialization partnerships. Over a 30-year career at the intersection of capital, innovation, and public impact, he has helped deploy more than $200 million in global venture funds focused on science and technology, served as Principal Investigator or Co-PI on more than $250 million in federal, state, and international funding programs, and coached hundreds of founding teams through the transition from grant funding to institutional investment. He invests his own capital as an LP and direct investor in medtech and other sectors.

Season 2 Epilogue and Season 3 Introduction

Dan yaps about his guests from Season 2 and introduces the theme for Season 3. This is not a full episode, but it is worth investing the eight minutes if you want to understand the whole season. Theme Music: Prelude, composed and performed by Benjamin Mazzucco, © 2026. Used with permission.

Everything you Need to Know about SBIR Reauthorization, with Jerry Hollister, BBCetc

From October 2025 through April 2026, the SBIR program went dark. Now that it's back, what is different? In this episode, Jerry Hollister, Co-Owner of BBCetc, joins Dan Mazzucco to pull back the curtain on the SBIR reauthorization fight, including the political dynamics that delayed it for months, the new foreign influence provisions now written into law, and the strategic breakthrough authority that allows awards up to $30 million without SBA approval. They also cover which of the 11 SBIR agencies is right for which stage of company, why NSF and NIH have fundamentally different expectations, the practical difference between SBIR and STTR for academics who are not ready to leave their university, and why the "solution in search of a problem" mentality is still the fastest path to rejection. This conversation is for life science founders and academic researchers who run toward federal funding and want to understand the system well enough to actually win. Jerry Hollister is Co-Owner of BBCetc, a 30-year-old SBIR support organization that grew out of the University of Michigan Medical School and now helps companies navigate the full SBIR program across all 11 federal agencies. Jerry began his career as a U.S. Navy Civil Engineer Corps officer, serving as a warranted contracting officer, and went on to lead the NIA Wave team to more than 45 SBIR awards. He joined BBCetc in 2017 and became co-owner in 2023. Both NIA Wave and BBCetc have received the Tibbets Award, the highest national recognition for SBIR awardees. Jerry serves as a reviewer for four different SBIR agencies, has been a trusted advisor to federal agencies and congressional staff, and was boots on the ground throughout the 2025 reauthorization fight, meeting directly with staffers and organizing the advocacy community that helped get the program relaunched. Theme Music: Prelude, composed and performed by Benjamin Mazzucco, © 2026. Used with permission.

Payers Don't Care what FDA Considers Safe and Effective, with Erik Harris

Getting FDA clearance is not a business goal. It is a milestone on the way to one. The goal is revenue in year one, year two, year three — and if a startup's pitch deck doesn't show how reimbursement dynamics support that revenue, sophisticated investors will notice before founders do. In this episode, Erik Harris, founder of Market Access Solved, joins Dan Mazzucco to demystify the market access and reimbursement landscape for early-stage medtech companies. They discuss the three pillars of reimbursement — coding, coverage, and payment — and when a product can legitimately fly under the radar of payer scrutiny, why payers don't care what the FDA considers safe and effective and what they actually care about instead, how coverage policies are really non-coverage policies in disguise, why label language drafted without a market access expert can be used against a company by payers, and how to design clinical trials that serve both FDA requirements and payer evidence standards without losing focus. This conversation is for medtech founders, executives, and investors who know reimbursement matters but haven't yet figured out when to start — and how much it affects everything else they're building. Erik Harris is the founder of Market Access Solved, a strategic and tactical market access and reimbursement consultancy specializing in U.S. and international medical device markets. With over 30 years of experience spanning device manufacturers including Zimmer, Wright Medical Technology, BioMimetic Therapeutics, and Moximed, as well as provider and payer organizations, Erik brings a rare 360-degree perspective to reimbursement strategy. He provides due diligence support to venture capital and private equity firms on M&A and investment activities, advises startups on pricing strategy within reimbursement, and conducts commercial payer coverage landscape assessments. He is a presenter and CEO mentor at ZeroTo510 Medical Device Accelerator, the 8400 Health Network's U.S. Market Access Symposium, and Peak Spirit Academy in the DACH region. Theme Music: Prelude, composed andperformed by Benjamin Mazzucco, © 2026. Used with permission.

An Afternoon with a Medtech Guru - Andrew DiMeo Sr., Ph.D. on Design Paradigms, Jars of Marbles, and SBIRs

NIH-funded researchers are brilliant scientists, but most are complete beginners when it comes to reimbursement strategy, design history files, and what the FDA actually cares about. By the time they realize it, they're months from a clinical study with no quality management system and a consultant asking, "Where's your design history file?" In this episode, Andrew J. DiMeo Sr., Ph.D., business advisor for the NIH C3i Program, joins Dan Mazzucco to talk about the commercialization gap in translational research. They discuss the origin of the NIH C3i program and how it evolved from Wallace Coulter Foundation training, the differences among Stanford Biodesign, the Coulter model, and the GAITS framework, why design controls are a framework of relationships rather than a stage-gated process, and why SBIR grants should be thought of as a partnership with taxpayers rather than a funding source. This conversation is for early-stage medtech innovators and academic researchers who suspect the gap between their lab and the market is bigger than they've admitted to themselves. Andrew J. DiMeo Sr., Ph.D., is a biomedical engineer and health innovation leader with over 20 years of experience at the intersection of design, entrepreneurship, and translational research. He is a business advisor for the NIH C3i Program and served as a Team Lead for the NIH RADx Initiative, ITAP, and Blueprint MedTech programs. He co-founded EG-Gilero, a medical device design and manufacturing company, and founded the NC Medical Device Organization, which became an NC Biotech Center of Innovation. For 12 years he was a Professor of the Practice at UNC and NC State, where his students launched multiple startups including 410 Medical, Contour Surgical, and Augment Medical. He is also a contributor to the second edition of the Stanford Biodesign book and the founder of Authbition (authbition.com), a podcast and publication exploring authenticity and ambition. Theme Music: Prelude, by Ben Mazzucco, copyright 2026.