In this episode of Mastering MedTech, host Melita Ball sits down with Marie Wesselhoft, President and Co-founder of ZelosDx, to discuss what it really takes to build and scale a medtech startup on the bleeding edge of innovation. With more than 35 years in healthcare innovation and diagnostics, Marie shares hard-won lessons on navigating pivots, understanding the true value of strategic partnerships, and staying laser-focused on the patient. You’ll hear how she turned a regulatory setback into a new product pathway, what she learned from launching her first product to Harvard, and why "fast, focused, and flexible" has become her mantra.00:00 Introduction to Long-Term Partnerships00:34 Welcome to Mastering Med Tech00:55 Guest Introduction: Marie Russell Hoft01:32 Marie’s Journey in Healthcare Innovation02:44 Founding ZelosDX and the Quest for Brain Biomarkers04:45 The Role of Incubators and Ecosystems13:41 Challenges and Changes in the Startup Landscape17:01 The Importance of Pivoting in Entrepreneurship23:08 The Essence of Long-Term Consulting Partnerships26:08 Evaluating and Choosing the Right Partners27:30 The Importance of Early and Extensive Partnerships29:02 Transitioning from Client to Board Member30:47 Advice for Founders on Managing Partnerships32:20 Balancing Vision and Control in Partnerships35:02 Supporting Entrepreneurs through Ecosystems37:29 Common Mistakes in Early-Stage Life Sciences Companies39:18 Regulatory Strategy from Day One43:26 Excitement for the Next Generation of Healthcare Innovators47:12 Rapid Fire Questions and Final TakeawaysFollow Melita and Marie:Connect with Melita: LinkedIn: https://www.linkedin.com/in/melitaball/Website: https://www.mbcaconsulting.com/Connect with Marie: LinkedIn: https://www.linkedin.com/in/marie-wesselhoft-9926731/Website: https://zelosdx.com/
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Mastering MedTech - Trailer
Bringing a medtech device to market is complex—but it doesn’t have to be chaotic. On Mastering MedTech, regulatory strategist and MBCA Consulting founder Melita Ball helps founders navigate the path from concept to clearance. This podcast demystifies the regulatory maze, offers proven startup frameworks, and unpacks real stories from founders, engineers, and compliance experts. Whether you’re building SaMD, diagnostics, or physical devices, each episode gives you the tools and clarity to avoid costly mistakes, meet compliance, and scale faster. If you’re ready to bring a breakthrough product to market smarter, faster, and fully compliant—this is your compass.
Bringing a medtech device to market is complex—but it doesn’t have to be chaotic. On Mastering MedTech, regulatory strategist and MBCA Consulting founder Melita Ball helps founders navigate the path from concept to clearance. This podcast demystifies the regulatory maze, offers proven startup frameworks, and unpacks real stories from founders, engineers, and compliance experts.
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