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Mastering MedTech
Melita Ball
3 episodes
6 days ago
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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Technology
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All content for Mastering MedTech is the property of Melita Ball and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
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.
Show more...
Technology
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Building a MedTech Startup from the Ground Up
Mastering MedTech
48 minutes 23 seconds
1 month ago
Building a MedTech Startup from the Ground Up

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 Partnerships

00:34 Welcome to Mastering Med Tech

00:55 Guest Introduction: Marie Russell Hoft

01:32 Marie’s Journey in Healthcare Innovation

02:44 Founding ZelosDX and the Quest for Brain Biomarkers

04:45 The Role of Incubators and Ecosystems

13:41 Challenges and Changes in the Startup Landscape

17:01 The Importance of Pivoting in Entrepreneurship

23:08 The Essence of Long-Term Consulting Partnerships

26:08 Evaluating and Choosing the Right Partners

27:30 The Importance of Early and Extensive Partnerships

29:02 Transitioning from Client to Board Member

30:47 Advice for Founders on Managing Partnerships

32:20 Balancing Vision and Control in Partnerships

35:02 Supporting Entrepreneurs through Ecosystems

37:29 Common Mistakes in Early-Stage Life Sciences Companies

39:18 Regulatory Strategy from Day One

43:26 Excitement for the Next Generation of Healthcare Innovators

47:12 Rapid Fire Questions and Final Takeaways


Follow 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/


Mastering MedTech
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.