Are you new to the medical device industry—or mentoring someone who is? In this foundational episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Sara Adams and Chris Rush from Greenlight Guru to deliver a MedTech 101 masterclass.

They unpack the roles, regulations, and realities of medical device development in a heavily regulated space. From defining what actually counts as a medical device to navigating FDA classifications and global regulations, the trio offers practical insights, industry analogies, and personal war stories that make this episode as entertaining as it is educational. Whether you’re in R&D, marketing, clinical, or quality, this is the episode to bookmark and share with every new hire.

Key Timestamps

02:20 – What counts as a medical device? Intended use and labeling

06:48 – Differentiating roles: Quality, Regulatory, Clinical, R&D, and Marketing

15:40 – Understanding regulatory bodies: FDA, EU MDR, Health Canada, and more

20:15 – FDA Classifications: Class I, II, III, and what determines risk

26:00 – Standards to know: ISO 13485, 14971, 14155, 21 CFR Part 820

33:05 – FDA pathways: 510(k), De Novo, PMA – when and why they apply

41:55 – The design control matrix explained (User Needs through Validation)

49:00 – Reverse engineering design controls: pitfalls and best practices

55:30 – Clinical trials vs. preclinical studies: When each is required

1:00:45 – Manufacturing & supplier controls: operations meets compliance

1:04:15 – Final advice for MedTech newcomers: Read the regs and know the problem

Quotes

“Just because you don’t call it a medical device doesn’t mean the FDA agrees with you.” – Sarah Adams

This quote highlights a key regulatory pitfall: your marketing claims, not just your label, determine if the FDA considers your product a medical device.

“A 510(k) is like someone checking your wristband at the door—you’re cleared to go in. A PMA? That’s a locked door and you need full approval to enter.” – Chris Rush

A memorable analogy that demystifies the difference between FDA clearance and approval pathways.

Top Takeaways

Labeling + Intended Use = Regulatory Trigger

Whether it’s software or a simple tool, if your product makes medical claims or supports medical decision-making, it may fall under FDA or other international regulatory oversight.

Regulatory Pathways Are Tied to Risk and Novelty

Know the difference between a 510(k), De Novo, and PMA. Class II “me-too” devices may avoid clinical trials, while Class III and novel devices usually require significant evidence.

Understand Design Controls Early

Reverse-engineering documentation late in development is risky and inefficient. Start early with user needs and build forward through the five pillars: inputs, outputs, verification, and validation.

Cross-functional Understanding Prevents Compliance Gaps

Marketing, clinical, and R&D all influence regulatory standing. Even social media likes can trigger off-label scrutiny—every department needs to understand their regulatory impact.

Reading Regulations Is Not Optional

A strong regulatory foundation is key to faster development, better audits, and smoother market access. Resources like 21 CFR Part 820 and ISO 13485 are surprisingly readable and essential.

References & Resources

MedTech 101: Key Concepts Explained

Design Controls = Your Blueprint for Safe Innovation

Think of design controls as a recipe:

User Needs = what the customer is hungry for
Design Inputs = what you plan to give the customer
Design Outputs = the finished dish (specs)
Verification = checking the dish matches the recipe
Validation = confirming the customer loves it

FDA Classes: Think Risk Levels

Class I – Low risk: toothbrushes, bandages
Class II – Moderate risk: catheters, infusion pumps (often 510(k))
Class III – High risk: pacemakers, implants (typically PMA)

510(k) vs. De Novo vs. PMA – Simplified

510(k) – You’re like someone else
De Novo – You’re new, but not high-risk
PMA – You’re new and high-risk = prove everything

Audience Engagement

Poll Question:

Where do you currently need the most clarity in the medical device development process?

Understanding FDA classification
Clinical evidence and trial design
Design control implementation
Global regulatory expansion
Post-market surveillance

Discussion Prompt:

What’s the most surprising thing you’ve learned about medical device regulation that you wish you knew sooner? Share your stories with us at podcast@greenlight.guru.

Feedback & Reviews

If this episode helped demystify the MedTech industry for you or someone on your team, we’d love to hear about it. Share your feedback, topic ideas, or guest suggestions at podcast@greenlight.guru. We read and reply to every message.

Sponsor Message

This episode is brought to you by Greenlight Guru, the only QMS purpose-built for the medical device industry. From design controls to post-market surveillance, our platform helps you stay audit-ready and accelerate product development with confidence. Learn more at www.greenlight.guru.

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