Life Science Insights

Third Eye Associates
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Dan Mazzucco interviews experts in the biotech and medtech industries.

  1. Aug 7

    CRP#5, When Do You Need Regulatory Help, with Shaherah Yancy

    Most early-stage founders know they need regulatory help. What they don't know is that by the time they think they need it, they're already two years behind. The submission is not the strategy — and confusing the two is one of the most expensive mistakes in medtech. In this episode, Shaherah Yancy, founder of Research Lifecycle Solutions, joins Dan Mazzucco to talk about what regulatory strategy actually means for early-stage founders. They discuss the five milestones every medtech company must hit, why regulatory is the anchor to your entire commercialization plan, how FDA has become more collaborative when you bring quality questions, and why the founders who win are playing chess while others are playing checkers. This conversation is for medtech founders and innovators who suspect their regulatory thinking is a checkbox exercise and are ready to find out what it actually should be. Shaherah Yancy is the founder and CEO of Research Lifecycle Solutions (RLS), an internationally recognized clinical scientist, award-winning regulatory strategist, and global keynote speaker. With over 20 years in life sciences, she has led regulatory, clinical, and commercialization strategies behind hundreds of MedTech and BioTech innovations launched across the U.S., Canada, Europe, China, and Australia. Before founding RLS, Shaherah held leadership roles at Medtronic, Smith + Nephew, and Stryker, where she directed global clinical affairs and market access for Class I–III medical devices, robotics, and enabling technologies. She has been named Best Regulatory Consultant by Consulting Magazine and nominated for Best Regulatory Strategy Consultancy of the Year by MedTech World. Theme Music: Prelude, composed andperformed by Benjamin Mazzucco, © 2026. Used with permission.

    CRP#5, When Do You Need Regulatory Help, with Shaherah Yancy

  2. Jul 24

    CRP#4: Show a Child what Success Looks Like: The Science Behind Wide Therapy, with Rinat Hitelman, BCBA, Co-Founder and CEO of Wide Therapy

    Eighty percent of adults on the autism spectrum are unemployed or unable to live independently. We spend more on autism than on diabetes, but most of those individuals still can't cross the finish line on basic life skills. Rinat Hitelman spent 20 years watching that gap from the inside, and then built a company to close it. In this episode, Rinat Hitelman, BCBA and Co-Founder and CEO of Wide Therapy, joins Dan Mazzucco to explore how personalized digital self-simulation helps neurodiverse children master real-world life skills. They discuss the behavioral science behind "changing the prediction," how Wide Therapy navigates the regulatory landscape as a non-device behavioral tool, and the company's B2B model selling to ABA therapy centers, schools, and hospitals. The conversation also covers the unexpected resilience required to build a startup through active conflict in Israel, including how Wide Therapy opened its platform for free to Israeli families after October 7, and what Rinat learned at the Capital Readiness Program about how investors really think. This conversation is for life science founders and entrepreneurs who want to understand how a clinician-turned-founder identified a systemic gap, built a novel solution around behavioral science, and is navigating the commercial path into the U.S. market. Rinat Hitelman is the Co-Founder and CEO of Wide Therapy, a patented digital health platform that enables neurodiverse children and adults to independently practice and master real-world life skills through personalized self-simulation. A Board Certified Behavior Analyst (BCBA) with over 20 years of experience in early intervention and autism therapy, Rinat spent her career working directly with hundreds of families, therapists, and educational teams before founding Wide Therapy. The company works with ABA therapy centers, therapeutic schools, non-profits, and leading hospitals including Children's National Hospital in Washington, D.C. Wide Therapy is headquartered in Israel with a growing U.S. presence and has been recognized as a finalist for Best in Class in the Kids Health Category of the Digital Health Hub Foundation Digital Health Awards. Theme Music: Prelude, composed andperformed by Benjamin Mazzucco, © 2026. Used with permission.

    CRP#4: Show a Child what Success Looks Like: The Science Behind Wide Therapy, with Rinat Hitelman, BCBA, Co-Founder and CEO of Wide Therapy

  3. Jul 10

    CRP#3: 90% of Patients Don't Do Their PT. Band Connect is Fixing That, with co-Founder Abby McInturf

    $380 billion is spent annually on musculoskeletal care in the United States — more than cancer, diabetes, and cardiac care combined. And 90% of patients don't follow their plan of care. Physical therapy has an adherence problem, and the model built around three in-clinic visits per week isn't solving it. In this episode, Abby McInturf, co-founder of Band Connect, joins Dan Mazzucco to talk about building a hybrid physical therapy platform from a class project at the University of Cincinnati. They discuss how customer discovery led to a pivot before the product even existed, why Band Connect put clinical evidence ahead of revenue, how sensor-enabled home equipment lets physical therapists extend care beyond the clinic wall, and why reducing visit frequency actually improves completion rates. They also get into co-founder dynamics, raising a seed round in Ohio, and what it means to problem-solve across every role in a resource-constrained startup. This conversation is for medtech founders and healthcare entrepreneurs who are pre-revenue and wondering whether they have enough to start — and whether the problem they're solving is real enough to bet on. Abby McInturf is the co-founder of Band Connect, a patented hybrid physical therapy platform that augments in-person care with a virtually supervised at-home experience through sensor-enabled exercise equipment. She holds a B.S. in Industrial Design from the University of Cincinnati's DAAP program, where she completed five co-ops with medical and consumer brands and developed a concussion mitigation tool for female soccer athletes before pivoting to physical therapy. Since founding Band Connect, McInturf has led product development, clinical trial preparation, UX design, and go-to-market strategy. Band Connect has completed IRB-approved clinical trials with major health systems and raised a seed round led by Jumpstart Ventures with participation from Techstars.

    CRP#3: 90% of Patients Don't Do Their PT. Band Connect is Fixing That, with co-Founder Abby McInturf

  4. Jun 26

    CRP#2: How a Robot Became a Shoe: Cadense Adaptive Footwear, with Tyler Susko, Ph.D. and Johannes Sauer

    During a feasibility study at MIT, patients walked on a robotic treadmill that removed the floor during the swing phase of gait. The result was simple and striking: people just walked better. One patient said, "I wish I could take it outside the lab." That sentence became a company. In this episode, Cadense co-founders Tyler Susko and Johannes Sauer, join Dan Mazzucco to talk about translating a decade of MIT and UCSB robotics research into a variable-friction adaptive shoe for people with neurological conditions. They discuss the engineering behind passive variable friction technology, navigating FDA registration through customer reviews, securing an NIH R01 grant, the founder duo dynamic and why humility matters more than hustle, and why awareness, not technology, is their biggest challenge with 40,000 pairs sold and 60 million potential customers in the U.S. This conversation is for medtech founders and academic inventors who are sitting on something that helps people and aren't sure how to get it out of the lab. Tyler Susko, Ph.D., is the CTO and founder of Cadense and a professor of teaching at UC Santa Barbara, where he has taught product and machine design for over a decade. He completed his Ph.D. at MIT, where he developed the Skywalker — a robotic gait rehabilitation treadmill — and holds patents on the variable friction technology that became the foundation for Cadense footwear. Johannes Sauer is the CEO and co-founder of Cadense, bringing over a decade of consumer brand and direct-to-consumer e-commerce experience to the company. He holds an MBA from the University of Graz and previously served as CEO for consumer and high-tech brands before joining Cadense in 2022. Together they have built Cadense into a registered medical device company with NIH-funded clinical research underway at the Shirley Ryan AbilityLab, the top-ranked stroke rehabilitation hospital in the U.S. Theme Music: Prelude, composed andperformed by Benjamin Mazzucco, © 2026. Used with permission.

    CRP#2: How a Robot Became a Shoe: Cadense Adaptive Footwear, with Tyler Susko, Ph.D. and Johannes Sauer

  5. Jun 12

    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.

  6. Jun 5 ·  Bonus

    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.

    Season 2 Epilogue and Season 3 Introduction

  7. May 29

    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.

  8. May 15

    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.

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

Dan Mazzucco interviews experts in the biotech and medtech industries.

Information

  • Creator
    Third Eye Associates
  • Years Active
    2025 - 2026
  • Episodes
    26
  • Rating
    Clean
  • Copyright
    © Third Eye Associates
  • Show Website
    Life Science Insights