In this episode of the Med-Tech Talent Lab podcast, host Mitch Robbins interviews Jeff Gensler, the Vice President of Quality at Kindeva Drug Delivery, about the innovative 'Frame by Frame' approach to manufacturing processes. Jeff's background spans over 20+ years of experience in Med-Tech Regulatory & Quality having held prominent positions with companies like Dentsply, Zimmer Biomet, and others prior to joining Kindeva. Jeff explains how this method revolutionizes process development by breaking down procedures into micro-steps and utilizing AI for risk assessment and training. The conversation covers the origins of this approach, its implementation in aseptic processing, and the significant time and cost savings it offers. Jeff also discusses the impact on roles within the industry, the feedback received from peers, and his personal journey in quality assurance.

Tune in to learn about this revolutionary way of developing & implementing processes. Your views & approach will be forever changed....for the better!

Jeff Gensler on LinkedIn:

https://www.linkedin.com/in/jeff-gensler-67a54a1a/

Kindeva Drug Delivery on the web:

https://www.kindevadd.com/

In this episode of the MedTech Talent Lab podcast, host Mitch Robbins interviews Garrett Johnson, the new CEO of Quantus Cardiovascular. Garrett shares his journey from a mechanical tinkerer in his youth to a leader in the medical device industry, having had experiences leading R&D programs for companies like Edwards Lifesciences, Foldax and inQB8 Medical Technologies. He discusses his early influences, the transition from medicine to medical devices, and the importance of hands-on experience in R&D.

Garrett reflects on his leadership evolution, the challenges of building a strong team, and the risks associated with career growth. He also shares insights on balancing work and family life, the exciting developments at Quantus, and the value of mentorship and continuous learning.

Tune in for all of Garrett's nuggets of wisdom!

Garrett Johnson on LinkedIn:

https://www.linkedin.com/in/garrett-johnson-medtech/

Quants Cardiosvascular on the web:

https://www.quantuscardio.org/home

In this episode of The Med-Tech Talent Lab, we dive into the complex world of Laboratory Developed Tests (LDTs) with Julie Ballard, a clinical laboratory expert with over 25 years of experience in operations, quality systems, and regulatory compliance.

Julie shares her journey from working at Stanford Health Care to leading roles in startups like GRAIL, Genomic Health, and Guardant.

We unpack the implications of the FDA's groundbreaking LDT ruling, discussing its potential impact on patient care, lab operations, and the broader industry.

Julie explains the distinctions between LDTs and FDA-approved tests, the challenges labs face in adapting to the new regulations, and the critical steps they should take now to stay compliant.

Julie also sheds light on how these changes create opportunities for talent in regulatory, quality, and consulting roles, offering insights into how labs can navigate this regulatory rollercoaster.

Don’t miss this expert analysis on one of the hottest topics in clinical labs today!

Connect with Julie: https://www.linkedin.com/in/julieballardcarrotclinical/

Learn more about Carrot Clinical: https://www.carrotclinical.com/

In this episode, we talk with Talent Acquisition professional, Allie Patterson, about how job seekers can stand out in today’s ultra-competitive, employer-driven market. Allie shares her own journey, tips on building a strong personal brand, and the importance of networking and targeted outreach. Her advice is essential for those navigating an intense hiring landscape.

Allie has a background in recruitment across multiple industries (Med-Tech, Renewables, etc.) She holds a bachelor’s degree in Human Resources Management and has honed her expertise through diverse industry roles. Allie also runs Elevate and Bloom Consulting, where she supports nonprofits with recruitment and marketing services.

Key Takeaways:

Are you leveraging LinkedIn to its fullest potential?

You won’t believe the impact a tailored approach can have, especially when it comes to outreach and standing out in applications.

Plus, we explore the power of personal branding and how storytelling can transform your connections with hiring managers.

With resilience being key in a competitive market, are you ready to adapt?

Tune in for actionable tips and insights to elevate your career.

Allie Patterson on LinkedIn:

https://www.linkedin.com/in/alliesheley/

In this jam-packed episode, Mitch Robbins sits down with Dr. Greg Critchfield, a titan in molecular diagnostics and biotech. This is a leader who’s done it all—from spearheading Myriad Genetics into global prominence to raising over $300 million for groundbreaking women’s health innovations. But that’s just scratching the surface!

🔬 Why You Need to Tune In: Dr. Critchfield shares how his early passion for diagnostics was sparked by his father, a physician, who once said: “The hardest part is the diagnosis.” Since then, Greg has led pioneering efforts in genomics, transforming the landscape of molecular diagnostics and helping shape the future of personalized medicine.

🌟 The Ultimate CEO Insights: What does it take to build powerhouse teams? How do you scale a company from a biotech hopeful to a market leader with 54% annual growth for 12 years? Dr. Critchfield shares priceless advice on surrounding yourself with relentless problem solvers and the importance of challenging the status quo. His Formula 1 analogy on biotech performance sums it all up.

💡 Challenges and Triumphs: Taking a company public? Greg did it virtually during the pandemic and shares the inside scoop on how they pulled off a successful IPO without a single in-person meeting. Plus, hear about the toughest decisions he’s made as a CEO—when loyalty to long-serving employees meets the harsh realities of growth.

🌊 Bonus: Passionate about the environment? Greg’s work with Bear Lake Watch will inspire you to think about conservation in a whole new way.

This episode is a masterclass in leadership, biotech innovation, and building lasting impact—don’t miss it!

🎙️ Hit play now to dive into a world where diagnosis meets data and biotech pushes the boundaries of what’s possible.

In this episode of The MedTech Talent Lab, host Mitch Robbins sits down with Mike Winterling, Chief Operating Officer at Junkosha USA. Mike shares his journey from spending nearly three decades at WL Gore & Associates to making the leap into a leadership role at a much smaller company, Junkosha.

He discusses the challenges of transitioning from a well-established corporate environment to a more agile, fast-growing organization, and offers valuable insights for leaders navigating similar changes. Whether you’re scaling a team or managing cultural differences in a global company, Mike’s experience offers a blueprint for building a high-performing team in a lean environment.

Tune in to hear about the importance of company culture, the impact of hiring right, and the adjustments needed when leading a small, dynamic team in today’s competitive marketplace.

How do you successfully recruit top-tier engineers in a location no one’s heard of?

Summary:

In this episode, Mitch Robbins dives deep with Julia Campbell, Talent Acquisition Manager at Terumo Medical Corporation, to explore the art of recruiting technical talent in the MedTech space. Julia shares her journey from falling into recruitment by chance to becoming an integral part of Terumo’s hiring strategy.

They discuss the unique challenges of hiring for highly specialized roles, managing hiring manager expectations, and Julia's secrets for identifying top candidates.

With over 14 years of experience, Julia offers invaluable insights into building teams that propel innovation and growth.

🎧 Why You Should Listen:

If you're involved with recruiting for technical roles, or you're a candidate in a technical role, this episode is packed with actionable advice.

Julia’s strategic approach to building trust with hiring managers and candidates alike will leave you rethinking your own recruitment processes.

Joining us for episode #109 was Ms. Kathy Jeffery, the Chief People Officer at Element Science. Kathy comes to the show with over 20 years experience as a Senior leader overseeing People Operations, Talent Acquisition, Organizational Development. She’s had the opportunity to scale five start-ups across industries, including Pear Therapeutics in the Digital Health space. She holds her Bachelors in Human Resources from DePaul University in Chicago & her Masters in Managerial Communication from Northwestern University.

For those unfamiliar with Element Science, the company is a Medical Device & Digital Health start-up that leverages data science & machine learning to develop lifesaving wearable solutions designed to deliver an outstanding experience.

Some highlights:

-What exactly is culture & how do you define it?

-In a rapidly scaling organization, how do you balance culture while ensuring you retain core vision & values

-How Kathy & Element Science are attracting sought-after Med-Tech Talent in one of the most competitive hot beds, the San Francisco Bay area

-How to keep the focus on employee development as the organization continues to scale

-How start-ups can support internal Diversity, Equity & Inclusion

....and so much more!

Kathy Jeffery on LinkedIn:

https://www.linkedin.com/in/kathyjeffery/

Element Science on the web:

www.elementscience.com