In our 400th episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Greenlight Guru’s Sara Adams to unpack the findings of the 2025 Medical Device Industry Benchmark Report. From the rise of family office investments to QMS upgrades and the impact of regulatory uncertainty, this episode delivers a candid and comprehensive look at the current MedTech landscape. Sara brings her quality expertise and industry anecdotes to life, while Etienne adds sharp insights on strategic planning and product development.

Whether you're facing supply chain complexity, preparing for QMSR, or trying to navigate market shifts, this episode is your roadmap for the year ahead.

• 00:03 – Introduction to the 2025 Medical Device Industry Report
• 05:00 – Market growth outlook: $800B by 2030
• 09:40 – Family office investment trends in MedTech
• 13:15 – Hiring freezes and headcount reductions: what's behind the numbers?
• 20:22 – Supply chain challenges and supplier qualification issues
• 28:35 – Why only 11% of companies rate their supply chain management as “excellent”
• 33:30 – QMS upgrades and the strategic focus on quality systems
• 39:00 – Fundraising and clinical trials: top priorities for pre-commercial companies
• 44:55 – Regulatory complexity: QMSR, EU MDR, and FDA staffing pressures
• 53:50 – FDA Form 483s: top causes and how to avoid them
• 1:04:00 – Action plan for 2025: technology, collaboration, and performance
• 1:12:00 – Making quality your competitive edge

1. Global MedTech market expected to hit $800B by 2030.
2. Quality systems and operational efficiency are becoming top priorities.
3. Regulatory uncertainty is affecting hiring and supply chain strategy.

1. Start preparing for QMSR (FDA’s Quality Management System Regulation) now.
2. Prioritize supplier qualification and traceability early in development.
3. Choose purpose-built tools to reduce headcount needs and streamline processes.

• 2025 Medical Device Industry Report – Greenlight Guru
• Etienne Nichols on LinkedIn
• Sara Adams on LinkedIn
• Episode 360: Is it Possible to Buy a QMS? with Sara Adams

QMS (Quality Management System): A structured system that documents processes, procedures, and responsibilities for achieving quality and regulatory compliance.

QMSR: FDA’s new quality regulation aligning with ISO 13485:2016.

483 Form: Issued by the FDA when investigators find conditions that may violate the FD&C Act.

Family Office...