In Part 1 of this two-part series, Etienne Nichols sits down with regulatory strategist Dr. Mike Drues to explore the nuanced differences between prescription (Rx) and over-the-counter (OTC) medical devices. They demystify key terms, regulatory classifications, and the growing trend of label expansions from Rx to OTC—highlighting real-world examples like CPAP machines and continuous glucose monitors (CGMs).

This episode unpacks how intended users, environments, and risk tolerances shape device categorization, and why usability testing is far more complex than many realize. Whether you're developing a consumer health product or preparing a label expansion strategy, this is a must-listen for your regulatory roadmap.

• [03:05] – What defines an OTC vs. prescription medical device?
• [06:45] – Market size of OTC devices and major product categories
• 10:00 – Label expansion: moving from Rx to OTC status
• 13:22 – The role of intended use environment in OTC classifications
• 20:40 – Examples of devices in each FDA class that are OTC
• 26:30 – Prescription devices used in home settings vs. true OTC
• 31:15 – Characteristics that qualify devices for OTC status
• 37:55 – Self-diagnosis, self-selection, and patient usability challenges
• 43:00 – “Reasonably foreseeable misuse” and how to interpret guidance
• 49:05 – Do you design for the lowest common denominator?
• 56:10 – Representing diverse user populations in usability testing
• 1:01:45 – Can a device launch OTC first? The case for wellness-to-Rx strategies
• 1:08:15 – FDA’s perspective on device safety: OTC vs. Rx

“The best regulatory professionals don’t just know the rules—they know the exceptions.”

Dr. Mike Drues reminds us that exceptional regulatory strategy lies in understanding nuance, especially in OTC classifications where edge cases can redefine categories.

“Just because a device is used at home doesn’t mean it’s over the counter.”

This insight challenges a common industry assumption, underscoring the importance of carefully defining intended use and environment early in development.

1. OTC ≠ Low Risk by Default – Many Class II and even rare Class III devices can be OTC; it’s more about intended user, use environment, and risk mitigation than class alone.
2. Label Expansion Requires Strategy – Transitioning a device from prescription to OTC isn’t just about removing a doctor’s role—it may involve new usability studies, labeling changes, and potentially a 510(k) or de novo submission.
3. Understand the "Intended Use Environment" – FDA doesn’t just care about where the device is used, but how those environmental parameters (like light, humidity, and user training) affect safe operation.
4. Usability Testing Must Reflect Real Users – For OTC devices, human factors validation must account for diverse educational backgrounds, not just ideal users.
5. Don't Rely on Labels Alone – Whether or not users read (or understand) instructions must be tested, not assumed. Intuitive design is critical for OTC success.

• Etienne Nichols on LinkedIn
• Greenlight Guru Medical Device Classification Webinar with Mike Drues (for explanation on device classes)
• FDA Guidance: “Factors to Consider When Making Benefit-Risk Determinations in Medical Device...

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.

• Etienne Nichols on LinkedIn
• Chris Rush on LinkedIn

In this episode of the Global Medical Device Podcast, Etienne Nichols speaks with renowned regulatory and reimbursement expert Karandeep Singh Badwal to uncover the complexities of medical device reimbursement across the US, EU, and Asian markets.

From the influence of governmental systems to the nuances of coding, coverage, and payments, Karandeep shares real-world insights for MedTech companies developing their global market strategies. Learn why early planning for reimbursement is just as crucial as regulatory approval, and how future-proofing your strategy against political and economic changes can safeguard your device's success.

00:00 – Intro and Sponsor Message (Greenlight Guru Quality)

02:30 – Why Reimbursement Must Be Considered Early

07:15 – US Reimbursement System: Medicare, Medicaid, and Private Insurers

13:10 – EU Reimbursement: Challenges with Fragmented National Systems

17:45 – Asian Market Differences: Japan, China, and South Korea

23:20 – The Importance of a Reimbursement Expert

28:05 – Navigating Political Changes in Global MedTech Markets

33:30 – Special Challenges for AI and Software as a Medical Device

40:00 – Direct-to-Consumer vs. Prescription Strategies

46:20 – Integrating Real-World Evidence and Post-Market Surveillance

52:00 – How Management Reviews Can Align Business and Quality Goals

01:03:10 – Pros and Cons: US vs. EU Reimbursement Models

01:18:20 – Final Takeaways and Closing Thoughts

"Reimbursement isn’t just the final step after regulatory approval — it is a core business strategy."

Why it matters: Many companies fail by not building reimbursement into their earliest development and design decisions.

"You can have the most innovative medical device in the world, but without a reimbursement pathway, you won't have a viable business."

Why it matters: Innovation alone isn’t enough; financial strategy is crucial to survival and growth.

• Start with reimbursement in mind: Align your product claims, indications, and market strategies with potential reimbursement pathways early.
• Tailor by region: US, EU, and Asian markets all have distinct reimbursement landscapes — success in one doesn't guarantee success in another.
• Hire jurisdiction-specific experts: Use consultants experienced in your target markets to avoid costly mistakes.
• Leverage post-market surveillance: Integrate real-world evidence gathering into your QMS and management reviews to support reimbursement claims.
• Build strategic flexibility: Political and regulatory landscapes shift — maintain backup jurisdictions and alternative market strategies.

• Etienne Nichols on LinkedIn
• Greenlight Guru Quality Management System
• Medtech Podcast hosted by Karandeep Singh Badwal

What is "Reimbursement" in MedTech?

Reimbursement refers to how a company gets paid for a medical device after it’s cleared for use. This usually involves navigating government programs (like Medicare) or private insurance, and it determines how easily hospitals, clinics, or individuals can buy and use a product.

Simple Analogy: Think of it like getting a movie produced: regulatory clearance is getting your movie rated, but reimbursement is making sure theaters agree to pay you to...