Most medtech founders want to skip straight to building their product. Veronica Kingston has spent 30 years watching that approach lead to expensive recalls, failed regulatory submissions, and collapsed acquisition deals. As Senior Director of Quality Management Systems and Design Quality Assurance at Thermo Fisher Scientific, she's worked with startups, navigated mergers and acquisitions, and remediated global compliance disasters.
In this episode, Veronica breaks down the biggest misconception about design controls (that you can retrofit them later), explains why the most expensive mistake startups make is ignoring the framework upfront, and reveals the three compliance issues that consistently require remediation. She shares practical advice on when to bring in quality and regulatory expertise, how to build teams that can navigate gray areas, and what to do when you're facing your first FDA 483.
Timestamps:
[00:00:00] Introduction to Veronica Kingston's 30-year quality career
[00:03:10] The biggest differences between small and large company quality approaches
[00:05:10] What design controls really are and why they matter
[00:09:10] The biggest misconception: that you can retrofit design controls
[00:11:00] Forgotten elements: supplier controls and design for manufacturability
[00:13:05] Essential elements needed before you start building
[00:14:55] What to say to founders who claim they're too busy for planning
[00:16:15] The value of fractional quality leadership
[00:17:50] Hiring experienced vs inexperienced talent: when and why
[00:19:50] Key skills that make someone successful in startup quality roles
[00:21:35] Building and developing quality teams
[00:23:00] Crisis management: digging out of regulatory holes
[00:25:00] The top three compliance issues requiring remediation
[00:27:15] Advice for companies facing their first FDA 483
[00:30:10] How regulatory issues impact exit strategy and acquisition
[00:31:10] Rapid fire: essential advice for medtech founders
Follow Melita and Veronica:
Connect with Melita:
LinkedIn: https://www.linkedin.com/in/melitaball
Website: https://www.mbcaconsulting.com/about-us
Connect with Veronica:
LinkedIn: https://www.linkedin.com/in/veronica-kingston-377725b7/
Starting a medtech company without legal guidance is like performing surgery without sterilizing your instruments. Elizabeth Parsons has seen brilliant innovations die not from failed technology, but from preventable legal mistakes that founders never saw coming. As principal of Elizabeth Parsons, PLLC and an NBCA Board member, she's watched founders give away equity to fraudsters, lose their IP to co-founder disputes, face personal liability from pierced corporate veils, and spend hundreds of thousands fixing what could have been prevented with minimal investment upfront.
In this episode, Elizabeth walks through five critical legal areas where early-stage founders consistently stumble: founder agreements, entity governance, IP ownership, fundraising compliance, and trademark protection. She shares real stories of costly mistakes, explains why legal help is not a luxury but a necessity, and reveals exactly when founders should bring attorneys into the conversation (hint: it's earlier than you think).
Timestamps:
[00:00:00] Introduction to Elizabeth Parsons and her journey from Wall Street to startups
[00:02:35] Why Elizabeth is passionate about medtech founders
[00:04:05] The biggest misconception: legal help as a luxury
[00:06:15] Overview of the five legal mistakes that can kill a business
[00:10:10] Landmine #1: Failing to document founder agreements
[00:13:45] The 30% equity fraud story
[00:15:50] Landmine #2: Not understanding entity governance and piercing the corporate veil
[00:19:15] Real story of a founder who mixed personal and business expenses
[00:22:00] Landmine #3: Unclear IP ownership and assignment
[00:25:35] Landmine #4: Fundraising without understanding securities laws
[00:30:00] The dangers of crowdfunding for medtech companies
[00:32:10] Landmine #5: Neglecting trademark protection
[00:36:00] Warning signs that indicate you need legal help
[00:39:10] The reality of being a founder who can't do everything
[00:40:25] When and how to approach legal decisions
[00:43:50] Rapid fire: essential legal advice for founders
[00:47:10] Where to find Elizabeth and her practice
Follow Melita and Elizabeth:
Connect with Melita:
LinkedIn: https://www.linkedin.com/in/melitaball
Website: https://www.mbcaconsulting.com/about-us
Connect with Elizabeth:
LinkedIn: https://www.linkedin.com/company/elizabeth-parsons-pllc/
Website: https://parsonsadvisory.com/
AI is transforming clinical research faster than regulations can keep up. Olivia Longacre has spent over a decade on the front lines of global clinical trials, and she's watching MedTech companies make a critical mistake: treating AI as a replacement for human intelligence rather than a tool that requires constant oversight. With over 20,000 startups now working on software as medical devices, the stakes have never been higher.
In this episode, Olivia breaks down the most promising AI applications in clinical research, from patient recruitment to centralized monitoring, and reveals the dangerous pitfalls that founders must avoid. She shares real stories of AI hallucinations that made it to publication, explains the crucial difference between data access and data rights, and discusses why the intersection of technology and regulatory expertise isn't quite there yet.
Timestamps:
[00:00:00] Introduction to Olivia Longacre and AI's impact on clinical research
[00:01:00] How AI is outpacing governance and regulatory frameworks
[00:02:25] The shift from onsite to centralized monitoring
[00:03:50] What centralized monitoring means for speed and cost
[00:05:30] The most promising AI applications for small companies
[00:07:40] Where companies get overly excited about AI
[00:08:35] The danger of "set it and forget it" thinking
[00:09:25] Real story of AI creating a non-existent medical term
[00:12:15] Why human intelligence plus AI is critical
[00:14:55] Building teams that blend technical and clinical expertise
[00:18:15] What founders should ask when evaluating AI tools
[00:19:10] Data privacy and the difference between access and rights
[00:22:40] The gray area of laboratory samples and patient consent
[00:26:20] Looking ahead: the future of clinical research
[00:30:00] Skills clinical research professionals need to stay relevant
[00:31:00] Rapid fire questions
Follow Melita and Olivia:
Connect with Melita:
LinkedIn: https://www.linkedin.com/in/melitaball
Website: https://www.mbcaconsulting.com/about-us
Connect with Olivia:
LinkedIn: https://www.linkedin.com/in/olivia-longacre/
Rick Holecek walked into a quality nightmare: 27 open CAPAs from a botched audit report, a semi-paper-based system struggling to keep up with growth, and a small team stretched impossibly thin. As VP of Quality at Irrimax, a wound irrigation company that's grown from 30 to 76 employees in six years, Rick had to make fast decisions that would either save or sink the company's regulatory standing.
In this episode, Rick shares the intense triage process that separated legitimate findings from recommendations disguised as audit failures, the lightning-fast implementation of a full electronic quality management system in just weeks, and the leadership philosophy that tears down walls between engineering and quality. Plus, Rick offers his vision for AI-powered predictive quality systems and why the old "quality as police" model is dead.
Timestamps:
[00:00] Welcome and introduction to Irrimax
[02:10] Current regulatory priorities and QMSR migration
[03:00] The 27 CAPA crisis: what went wrong
[05:30] Triaging and closing unnecessary CAPAs
[06:30] Pivoting from paper to electronic QMS in weeks
[08:00] Exploring AI-powered quality management systems
[12:00] The magic wand: predictive AI for quality
[13:20] Breaking down walls between engineering and quality
[15:00] Building a quality culture from day one
[17:00] A collaboration story that changed everything
[20:00] Rapid fire: challenges, resources, and superpowers
[23:40] What MedTech teams should stop doing today
Follow Melita and Rick:
Connect with Melita:
LinkedIn: https://www.linkedin.com/in/rick-holecek-04b51b12/
Website: https://www.mbcaconsulting.com/about-us
Connect with Rick:
LinkedIn: https://www.linkedin.com/in/rick-holecek-04b51b12/
Website: https://www.irrisept.com/about/
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/
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.