Hardware Podcasts

259 - The Career Lesson I Learned the Hard Way in Pharma

Let's Combinate · 19 Oct 2026 · 5m

What this episode covers

Subhi Saadeh, a Quality Professional and host of Let's Combinate, recounts a career lesson from his time as a quality lead at a large pharma company managing a sterile, vial-based drug-device combination product program. He explains how he shifted from seeking personal visibility to focusing on his team's technical needs, specifically regarding sterility and bioburden, which earned their respect and influence. Saadeh emphasizes the importance of being coachable, asking questions, and adopting a 'their cookie, your crumb' mindset to build credibility and trust with technical experts.

Most relevant to

early-stage companies

Topics

Mentioned

Also
Combination Products Coalition, ASTM Committee E55, AAMI, ASQ

Related episodes from other shows

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 50m

    #352: Fundamentals of Quality & Regulatory

    Jennifer Mascioli-Tudor, CEO of JMT Compliance Consulting and former quality leader at Medtronic, Boston Scientific, and Johnson & Johnson, discusses the strategic role of quality and regulatory professionals in the medical device industry. She emphasizes that effective quality management requires strong project management skills, proactive stakeholder influence, and a deep understanding of human factors to prevent post-market failures. Mascioli-Tudor also advocates for building a culture of psychological safety and continuous improvement, arguing that quality teams must act as business partners rather than just compliance police.

    Leadership, teams & cultureValidation & product-market fit
    7 chapters

  • Global Medical Device Podcast · 53m

    #421: Mastering MedTech Influence: The Power of Communication in Quality

    Lesley Worthington, an executive coach with a background in psychology, law, and quality/regulatory affairs, discusses how quality professionals can build influence and a culture of quality through better communication. She argues that technical correctness often fails to drive buy-in because it ignores the listener's need to feel understood, advocating for active listening, paraphrasing, and plain language over jargon. Worthington highlights the limitations of traditional corporate training, which focuses on information rather than habit change, and suggests that personalized coaching or reflective writing (like 'morning pages') helps professionals overcome burnout and imposter syndrome by clarifying their thinking and building psychological safety.

    Leadership, teams & cultureCareers & education
    8 chapters

  • Global Medical Device Podcast · 44m

    #435: ICYMI (In Case You Missed It!) Becoming a Regulatory Affairs Professional

    Kavetha Ram, Regulatory Department Leader at Spectra Medical Devices and professor at Northeastern University, discusses the challenges new regulatory affairs professionals face, including overcoming imposter syndrome and building confidence. She emphasizes the importance of cross-functional collaboration through programs like the Bumblebee Innovation Nation and advises new hires to demonstrate a willingness to do the work rather than just oversee it. The conversation highlights how diverse backgrounds and asking 'dumb questions' drive innovation in MedTech.

    Careers & educationHiring & workforce
    7 chapters

  • Global Medical Device Podcast · 44m

    #354: Advice for MedTech Regulatory Affairs Professionals

    Kavetha Ram, Regulatory Department Leader at Spectra Medical Devices and professor at Northeastern University, advises new regulatory affairs professionals on navigating the MedTech industry. She emphasizes that confidence stems from understanding one's unique background and the value of diverse perspectives in cross-functional teams. Ram highlights the importance of bridging the gap between academic theory and real-world regulatory changes, such as the EU MDR, through active networking and continuous learning.

    Careers & educationLeadership, teams & culture
    7 chapters

  • Global Medical Device Podcast · 50m

    #440: ICYMI (In Case You Missed It!) Fundamentals of Quality & Regulatory

    Jennifer Mascioli-Tudor, CEO of JMT Compliance Consulting and former VP of Quality at Medtronic and Boston Scientific, discusses the evolution of quality and regulatory roles in the medical device industry. She emphasizes that quality professionals must act as strategic influencers and project managers, using storytelling to connect compliance requirements with business outcomes like cost of poor quality. The conversation covers the importance of human factors in design, the nuanced concept of 'design freeze', and the necessity of proactive quality management to ensure patient safety and regulatory agility.

    Leadership, teams & cultureMedical & health devices
    5 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Let's Combinate. The episode itself belongs to its publisher.