May 1
58m 8s
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.
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
“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.
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.