In this episode of The MedTech Talent Lab, Mitch Robbins sits down with Elena Mack, Chief Quality Officer at Sanisure, to discuss her career journey and insights into the world of quality and regulatory leadership in the medical device industry. With over 25 years of experience, Elena has held key executive roles at companies like Olympus, BD, and Teva Pharmaceuticals. Now, as part of Sanisher, she is leading the charge to build and maintain a world-class quality program for the bioprocessing and biomanufacturing sectors.

Elena shares her early career experiences, including her shift from medical technology to microbiology and how she got started at Wyeth in a regulatory compliance role. She reflects on pivotal moments in her career, including taking on a leadership role as a director at ACUPAC and the invaluable lessons she learned about leadership, delegation, and the importance of empowering her team.

Throughout the conversation, Elena also delves into the challenges of being a quality executive, emphasizing the responsibility of ensuring that quality is a shared value across all levels of an organization. She highlights the critical importance of having a robust quality system and talks about the ongoing efforts at Sanisher to move from ISO 9001 to ISO 13485, aiming to meet the highest standards of quality required by their customers.

With her unique perspective on quality as a critical but often underappreciated function in the industry, Elena offers valuable insights into the role of quality professionals and how they can drive real impact within their organizations.

Key Takeaways:

• The importance of leadership by example and empowering teams.
• The challenges and rewards of stepping into executive roles and delegating responsibilities.
• The need for robust quality systems in bioprocessing and biomanufacturing, especially in meeting regulatory standards.
• Elena’s personal connection to quality through her experiences with her son’s health challenges.

Links:

• Elena on Linkedin https://www.linkedin.com/in/elena-mack-bb57855/
• Sanisure Website www.sanisure.com

In this episode of The Med-Tech Talent Lab podcast, host Mitch Robbins interviews Mary McNamara-Cullinane, Vice President of Regulatory Affairs at ClearPoint Neuro, about her 25+ year journey in the medical device regulatory space.

Key Highlights:

• Mary shares her background as the youngest of eight children and how her early work ethic shaped her career path
• Learn how Mary transitioned from research to regulatory affairs through roles at Brigham and Women's, CRBARD, and a 17-year consulting career
• Discover what makes an outstanding regulatory professional in today's environment
• Understand the challenges regulatory executives face when balancing company goals with regulatory requirements

Practical Takeaways:

• Why proactive research and understanding the "why" behind regulations separates exceptional regulatory professionals
• The importance of managing leadership expectations around FDA timelines
• Why submitting complete FDA submissions is more efficient than rushing deficient ones
• Thoughts on remote work effectiveness in regulatory roles

Mary also discusses ClearPoint Neuro's exciting work with gene therapy companies and their recent partnership with PTC Therapeutics to address rare diseases in children.

Whether you're a regulatory professional looking to advance your career or an executive trying to better understand the regulatory landscape, this conversation offers valuable insights from a seasoned industry leader.

Mary McNamara-Cullinane on LinkedIn: https://www.linkedin.com/in/marymcnamaracullinane/

ClearPoint Neuro on the web:

https://www.clearpointneuro.com/

In this episode of The MedTech Talent Lab, host Mitch Robbins sits down with Carolyn Twomey, Global VP of Medical Affairs and Research at Iramax Corporation. Carolyn’s career path is nothing short of remarkable—from starting as an OR nurse and cardiac cath lab director to leading global clinical services and now shaping medical affairs strategy in the medical device industry.

She shares her personal and professional transformation, including:

How an early passion for music unexpectedly led her to nursing.

The pivotal career shifts that took her from clinical practice to corporate leadership.

The emotional impact of battling cancer while simultaneously losing her sister to the disease—and how it shaped her leadership and perspective.

The critical role medical affairs plays in bridging science, clinical practice, and commercial success in MedTech.

Lessons on resilience, adaptability, and building a meaningful career in the industry.

Why You Should Listen:

🎧 Gain insights into career growth strategies in MedTech and medical affairs.

🎧 Learn how to leverage clinical experience for leadership roles in the industry.

🎧 Hear an inspiring story of overcoming adversity and thriving in healthcare leadership.

🎧 Understand the evolving role of medical affairs in innovation and patient impact.

Don't miss this engaging and deeply personal conversation with a leader who’s making a difference in MedTech!

In this episode, host Mitch Robbins interviews Mickey Brown, Vice President of Access and Reimbursement at Cerapedics, discussing his 30+ year career journey and insights on healthcare market access.

Key Highlights:

• Mickey shares his transition from 15 years on the payer side (Blue Cross, United Healthcare) to manufacturer roles at Medtronic, Cochlear, and now Cerapedics
• Learn how stepping outside his comfort zone at critical moments propelled his career forward
• Discover the biggest challenges facing market access professionals in 2025
• Understand common reimbursement strategy mistakes companies make and how to avoid them

Practical Takeaways:

• Why waiting too long to develop reimbursement strategy hurts product launches
• The key differences between director and VP-level thinking
• What makes an outstanding market access professional
• How to effectively engage with increasingly inaccessible payers

Whether you're in medical device sales, reimbursement, or aspiring to leadership roles in healthcare, this conversation offers valuable insights from both sides of the healthcare ecosystem.

In this episode of The Med-Tech Talent Lab, host Mitch Robbins sits down with Erica Logan, Director of Talent Acquisition at Sequel Med Tech, to discuss the biggest hiring pitfalls companies face—and how to fix them.

With nearly two decades in staffing and corporate recruiting, Erica has seen it all. From hiring at fast-scaling startups to navigating high-volume recruitment in MedTech, she shares hard-hitting insights on what separates a great hiring process from a broken one.

In this episode, we cover:

✔️ The most common hiring mistakes companies make (and why they keep happening)

✔️ How bad candidate experiences damage employer branding & long-term success

✔️ Why hiring managers need coaching—and how TA leaders should step up

✔️ The truth about AI in hiring and how it’s actually being used behind the scenes

Whether you’re in talent acquisition, HR, or leading a team, this conversation is packed with actionable takeaways that will help you attract, hire, and retain top talent in today’s market.

🎧 Tune in now to level up your hiring strategy!

#Hiring #TalentAcquisition #Recruitment #MedTech #Leadership

In this episode of The MedTech Talent Lab, host Mitch Robbins sits down with April Spillane, VP of Market Access & Reimbursement at Intrinsic Therapeutics. With over 15 years in the industry—10 of those dedicated to spine—April shares her unique career trajectory, from clinical and business development to leading market access strategies at a high level.

She opens up about the challenges of balancing a demanding career with motherhood, the leadership lessons she’s learned along the way, and what it truly takes to thrive in market access and reimbursement. April also discusses the evolving healthcare landscape, the complexities of payer policies, and why persistence is key in the fight for patient access to cutting-edge technologies.

Whether you’re a MedTech leader, aspiring executive, or just curious about the behind-the-scenes battles to bring life-changing medical innovations to market, this episode is packed with valuable insights.

Listen now to hear how April is shaping the future of MedTech access and advocacy!

"There will be two types of recruiters: those who use AI, and those who don’t have jobs." 🤯

In this episode of The MedTech Talent Lab, I sit down with Noor Manji, Director of Talent Acquisition at Hearing Life, to unpack the realities of recruiting, job searching, and how AI is reshaping the hiring landscape. Noor brings over 20 years of experience across agency and corporate recruiting, and he’s got strong opinions on what works (and what’s broken) in talent acquisition today.

We cover:

✅ The truth about online applications—and why referrals win 80% of the time

✅ How top candidates bypass the black hole of job boards and command attention

✅ The biggest mistakes hiring managers make that cost them top talent

✅ Why AI won’t replace recruiters—but those who don’t adapt will get left behind

✅ What it really takes to move from recruiter to talent acquisition leader

If you're a recruiter, hiring manager, or job seeker looking for real, no-BS insights, this episode is a must-listen.

Noor on LinkedIn:

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

Hearing Life on the web:

www.hearinglife.com

Jason Bilobram, VP of Regulatory & Quality at Sekisui Diagnostics comes to The Med-Tech Talent Lab with over 20 years experience working across Regualtory& Quality in both Medical Device and Pharma. He has worked for companies like AstraZeneca, Smith & Nephew, and for the last 9 years Sekisui working his way up into the VP slot. Jason holds his bachelors of science in molecular biology & organic chemistry and a masters of science in biological & biomedical sciences.

Some highlights from what we discussed:

✅ How his early career pivots shaped his path into RA/QA

✅ The biggest misconceptions about regulatory and quality professionals

✅ What separates those who reach VP/C-suite roles from those who don’t

✅ The evolving landscape of AI, cybersecurity, and regulatory challenges in 2025

One thing that stood out? The best leaders take risks, put themselves in uncomfortable situations, and always find ways to stay relevant.

Jason Bilobram on LinkedIn:

https://www.linkedin.com/in/jason-bilobram-39288883/

Sekisui Diagnostics on the web:

https://sekisuidiagnostics.com/

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