Many MedTech companies focus heavily on FDA clearance but overlook a critical layer of U.S. market entry: state-level compliance. In this episode, Etienne Nichols speaks with Adam Steadman, CEO of MDD Options, to unpack the real-world challenges that derail commercialization after regulatory approval.

From navigating state-specific registration, sales tax laws, and distribution logistics to choosing between direct and distributor-based strategies, Adam shares hard-earned insights for avoiding the "second valley of death" post-clearance. Whether you're a domestic startup or an international company entering the U.S., this episode arms you with a tactical understanding of compliance landmines and scalable go-to-market strategies.

• 00:02 – Intro: The real MedTech “valley of death” after FDA clearance
• 04:45 – Why U.S. state-level registration is misunderstood and overlooked
• 08:15 – State-level definitions of medical devices and why they differ
• 11:20 – Strategic go-to-market options: Distribution vs. Direct
• 17:00 – How regulations vary drastically by state (CA, TX, etc.)
• 21:50 – The real risks of noncompliance: lawsuits, bad PR, and due diligence failures
• 26:15 – Why distribution agreements can stall your growth (and how to avoid it)
• 34:30 – Sales tax & use tax: The hidden compliance trap
• 39:10 – Logistics, warehousing, and long-term liabilities in contracts
• 44:55 – Overlooked pitfalls: Secretary of State filings and income tax in 36+ states
• 51:15 – Software as a Medical Device (SaMD): U.S. compliance still applies
• 55:30 – Selling to the U.S. government vs. private sector buyers
• 59:20 – Veterinary devices and why they still need regulatory controls
• 1:03:10 – What a winning go-to-market strategy actually looks like
• 1:10:25 – Adam’s final advice to MedTech startups (foreign and domestic)

"You're not entering one country—you're entering 50 states and D.C. Each with its own rules, definitions, and tax laws."

—Adam Steadman explains why U.S. MedTech entry requires a state-by-state strategy, especially for international companies.

"None of the strategics want your warehouse management system—they want your product, your sales, and your proof of market fit."

—Steadman on why building non-core infrastructure slows down commercialization and valuation.

1. FDA Clearance ≠ Market Readiness – State-level registrations, sales tax laws, and pharmacy board definitions often delay or block commercialization.
2. Distribution Isn’t Always a Shortcut – National distributors may have misaligned incentives and can lock you into exclusivity that hinders growth.
3. Sales Tax is a Regulatory Minefield – 46 states require separate sales tax registration, exemptions tracking, and monthly filings—even if you're tax-exempt.
4. Beware of Long-Term Contracts – Logistics and distribution contracts often lock companies into rigid terms that prevent pivots or acquisitions.
5. Speed to Market Is Strategic – Getting to market fast is often the difference between becoming #1 or #3—and #3 often gets nothing.

What Is “Nexus” and Why It Matters for Sales Tax?

“Nexus” refers to the minimum level of economic activity that triggers tax obligations in a given state. For example, selling $100,000 of devices or 200 transactions may establish nexus, requiring you to register for sales tax. Unlike VAT in Europe, U.S. sales tax laws are state-specific, making this a major compliance hurdle for MedTech companies.

• Adam Steadman on LinkedIn
• Etienne Nichols on LinkedIn
• MDD Options – Adam’s Company
• Greenlight Guru Quality Platform

Poll Question:

Which part of U.S. market entry do you feel least prepared for?

• State-level licensing
• Sales tax registration
• Distribution strategy
• Logistics & warehousing
• All of the above

Have you faced unexpected delays due to state-level regulations? Share your story—we may feature it in a future episode.

Enjoying the podcast or have ideas for future topics? We’d love to hear from you!

Send your thoughts to [email protected] – we read every message and often reply personally!

This episode is brought to you by Greenlight Guru Quality – a purpose-built QMS platform that keeps you always audit-ready. Organize evidence by requirement, flag gaps, and avoid the scramble before inspections. Don’t get ready—stay ready.

In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues take a critical look at the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. While intended to serve as a vital tool for post-market surveillance, the MAUDE database is fraught with issues—from late reporting and missing data to unclear mission alignment.

Mike challenges MedTech professionals to rethink how we engage with the system, exposing how widespread underreporting and data hygiene problems not only weaken safety efforts but also increase legal risk. This eye-opening discussion reveals where the breakdowns are occurring, who’s responsible, and what industry and regulators can do to fix it.

• [02:30] What is the MAUDE database, and why does it matter?
• [06:10] The critical difference between reportable and non-reportable adverse events
• [11:20] Limitations of MAUDE: Why FDA warns against using it for rate comparisons
• [17:45] Underreporting, late submissions, and missing data: The disturbing stats
• [25:00] High-profile companies dominating late reporting violations
• [32:10] Legal consequences: What expert witnesses look for in MAUDE data
• [38:50] Is it poor systems or lack of regulatory understanding causing failures?
• [46:00] Recommendations for manufacturers: What responsible reporting looks like
• [53:20] How FDA could modernize the MAUDE database to better serve patients
• [1:01:30] Carrots or sticks: Creating incentives vs. penalties for compliance
• [1:09:00] Final thoughts: The true mission of MAUDE and how to fulfill it

"A report in the MAUDE database is just a historical record. It doesn’t say why it happened or who’s at fault—just that it happened."

— Mike Drues

This quote underscores the limited utility of MAUDE reports and why interpretation requires caution.

"If you're not a medical device professional without your tools, then you're not really a medical device professional."

— Etienne Nichols

A poignant reminder that compliance and quality are human-led, not software-enabled by default.

Late Reporting is Widespread and Risky

• Nearly 30% of MAUDE reports are filed late, with 10% submitted more than six months past due. This creates legal exposure and potential patient harm.

MAUDE Is Misused—Despite FDA Warnings

• Manufacturers commonly use MAUDE for competitive analysis or trend detection, even though the FDA explicitly warns against it.

Three Companies Account for Over Half of Late Reports

• Large, well-resourced companies like Medtronic and Becton Dickinson are responsible for a disproportionate share of noncompliance.

Electronic Tools Help, but Culture Matters More

• Software can support MDR timelines, but organizations still need internal processes and urgency to act responsibly.

FDA and Industry Both Need to Evolve

• Suggestions include AI-driven cross-referencing, tiered reporting urgency, and incentive-based compliance recognition.

• FDA MAUDE Database
• 21 CFR 803.16 – MDR Reporting Requirements
• Etienne Nichols on LinkedIn

Think of the MAUDE database as a public logbook of adverse events involving medical devices in the U.S. Unlike peer-reviewed literature or formal recalls, MAUDE captures both mandatory and voluntary reports—from manufacturers, healthcare professionals, and even patients. However, it's not a perfect dataset. Think of it like Yelp for medical device failures: informative, but filled with inconsistencies, duplicates, and vague reviews.

Poll Question:

How confident are you in your organization’s ability to report adverse events to the FDA on time and accurately?

Have you ever tried to use the MAUDE database for competitive analysis or submission support? Share your experience—was the data helpful, misleading, or incomplete?

Have a topic suggestion or feedback on today’s episode? We want to hear from you. Email us at [email protected] and get a personal response from our team.

Today’s episode is brought to you by Greenlight Guru, the only MedTech-specific QMS software that empowers companies to simplify complaint handling, streamline MDR submissions, and improve audit readiness. If you're ready to evolve beyond spreadsheets and silos, visit greenlight.guru.

In this episode recorded live at LSI Dana Point, Etienne Nichols sits down with Ed Muzio, author of Iterate, to explore how iterative management helps MedTech companies move faster as they scale. Muzio breaks down the pitfalls of traditional management—including siloed execution and backward-looking metrics—and offers a proven alternative grounded in over 70 years of research.

With real-world analogies, like orchestras and dashboards, Muzio explains how leaders can create alignment, drive faster decisions, and unlock collaborative problem-solving by focusing on the future instead of the past. Whether you're part of a startup or an established MedTech firm, this episode delivers actionable strategies to help your team iterate with purpose.

• [00:01] Introduction and sponsor message from Greenlight Guru
• [01:13] Meet Ed Muzio and the premise of Iterate
• [03:15] Why most management meetings don’t drive real action
• [06:40] The “Alice” video case study and how it exemplifies iterative management
• [11:50] Common objections and barriers to implementing iterative processes
• [17:00] Using forward-looking data instead of status updates
• [22:08] MedTech example: anticipating 510(k) review delays
• [29:15] Making decisions early to gain planning time
• [34:20] How to get started if you’re a small or early-stage company
• [37:40] Cultural barriers in iterative team models
• [41:20] Handling matrixed environments and CEO-level priorities
• [47:10] Why clarity of decision-makers matters in early teams
• [51:45] The biggest mistake mature companies make in team meetings
• [55:05] Final advice: focus on behavior, not buzzwords

These quotes challenge conventional meeting norms and emphasize a proactive mindset crucial to success in fast-moving MedTech environments.

1. Backward-looking metrics kill momentum. Most leadership teams spend meetings reviewing past progress. Instead, focus on forecasting future outcomes and addressing variances before they become problems.
2. Accountability must be systemic, not personal. A team can only normalize issue-raising if the entire culture shifts to expect it—making it safe and standard to surface concerns early.
3. “Succeed or fail together” breaks silos. When departments align to shared goals, cross-functional collaboration becomes natural. Incentives that isolate progress undermine execution speed.
4. Don’t vote—decide. In small teams, designate a clear decision-maker and avoid democratic processes that lead to politicking instead of clarity.
5. Adopt flexible systems over rigid charts. Org charts don’t reflect reality. Iterative management embraces the messiness of matrixed teams and adapts meetings and collaboration structures fluidly.

• Iterate by Ed Muzio – Book on accelerating team alignment and decision-making
• IterateNow.com – Access free videos and practical management tools from Ed Muzio
• Etienne Nichols on LinkedIn – Connect with the podcast host

Iterative management is like adjusting your GPS route in real time—rather than simply reviewing where you’ve been, you keep making small course corrections to reach the goal faster. In a MedTech context, this means shifting focus from milestone recaps to real-time issue resolution, involving all departments in forward-looking planning. Visual tools like pragmatic dashboards (with projected vs. actual timelines) help clarify where corrections are needed.

Poll Question:

What’s the biggest obstacle your team faces in solving problems before they escalate?

• Status-focused meetings
• Lack of cross-functional alignment
• Fear of raising issues
• Unclear decision-making authority

Engagement Prompt:

Have you ever worked in a team where raising early concerns was encouraged—not penalized? Share your experience and tag a team leader who made it work.

Enjoying the podcast? We'd love to hear your feedback. Email us at [email protected] with your thoughts, questions, or suggestions for future guests. Every email gets a personal response!

This episode is brought to you by Greenlight Guru—the only quality management system built specifically for MedTech. Want your design history file audit-ready and effortlessly connected across departments? Learn more at www.greenlight.guru.

In this live episode from the LSI conference, Etienne Nichols sits down with Justin Bushko—known as the "MedTech Man" and author of Medical Device Fireside Chats—to dive into what separates thriving medical device companies from those that fail.

From costly engineering missteps like ignoring tolerance stack-ups to the human factors issues that derail usability in the OR, Justin shares battle-tested advice based on his experience reviewing hundreds of device designs. He also delivers a wake-up call to startups overly focused on licensing or acquisition as the endgame. Whether you're an engineer, founder, or CEO, this episode offers critical insights into how to build a product that works—and a company that lasts.

• 00:00 – Introduction & Greenlight Guru Sponsor Message
• 01:26 – Live from LSI: Introducing Justin Bushko
• 02:55 – Why Early-Stage Engineering Mistakes Derail Companies
• 04:12 – The Critical Role of DFM and Tolerance Analysis
• 06:20 – Real-World Usability Failures: FDA Warning on Cranial Fixation Devices
• 08:10 – Human Factors Oversights & Surgeon Behavior
• 10:25 – What CEOs Should Focus On vs. Engineers
• 12:20 – Economic Buyers, KOLs, and Commercialization Challenges
• 14:05 – Don’t Chase the Exit: Why Founders Should Build for Longevity
• 16:00 – Final Thoughts and Takeaways

1. DFM & Tolerance Analysis Are Non-Negotiable: Skipping detailed design-for-manufacturing and tolerance stack analysis often leads to failure right before tooling and commercialization—when funds are already tight.
2. Human Factors Must Be Built-In Early: Surgeons may not use your product as intended. Validate with a wide range of KOLs to uncover unintended use or misuse.
3. Test for High-Risk Use Cases Early: For devices like inserters, test mechanical thresholds that could lead to field failures. Don’t wait until post-market feedback.
4. Understand Economic Buyers, Not Just KOLs: A surgeon’s support doesn’t guarantee adoption. You need champions who can advocate to hospital boards and procurement teams.
5. Stop Chasing Exits—Build Real Companies: Investors and acquirers see through the “quick flip” mentality. A sustainable business model attracts more serious interest.

• Greenlight Guru – Sponsor and end-to-end MedTech quality management platform
• Justin Bushko on LinkedIn
• Etienne Nichols on LinkedIn
• Medical Device Fireside Chats – Justin Bushko’s Book (Amazon) (If mentioned/linked on-site)

Imagine building a puzzle where each piece is just slightly off in size—by the time you put it all together, nothing fits. That’s what tolerance stack-up is about. Every part in a device has a manufacturing variation. If those tolerances aren’t analyzed cumulatively, you can end up with a product that doesn’t assemble or fails under stress. Tolerance analysis helps predict and prevent these compounding errors before they happen.

Poll Question:

What’s the biggest product development risk in early-stage MedTech?

• Tolerance stack-up issues
• Ignoring human factors
• Economic misalignment with buyers
• Rushing to an early exit

Discussion Prompt:

Have you ever seen a product fail in the field due to a design assumption? Share your story and how it changed your approach.

Enjoyed the episode? Want to hear more from product engineers, founders, or regulators? Let us know!

Send your feedback, guest ideas, or questions to [email protected] — we read every email and respond personally.

This episode is brought to you by Greenlight Guru, the only MedTech-specific quality management platform. Whether you’re an engineer working through DFM or a CEO planning your go-to-market strategy, Greenlight Guru helps you manage compliance, risk, and innovation—all in one place.

Christian Espinosa, founder of Blue Goat Cyber and leading voice in medical device cybersecurity, joins Etienne Nichols to unpack the urgent and often misunderstood topic of cybersecurity in MedTech. From FDA’s 2023 regulatory overhaul to real-world hacking scenarios that could harm patients, Christian provides practical advice for innovators, RA/QA professionals, and software teams. He also shares why waiting until the last minute on cybersecurity could cost startups millions—or even kill a project entirely.

Whether you're a quality professional trying to build compliant systems or an innovator racing toward FDA submission, this episode lays out exactly what you need to know to stay ahead of cyber threats and within regulatory guardrails.

Key Timestamps:

• 00:01 – Intro to guest Christian Espinosa and Blue Goat Cyber
• 06:28 – Why medical device cybersecurity is different from traditional IT security
• 11:49 – Real-world hacking example: acne laser device turned skin-burner
• 13:57 – FDA expectations post-September 2023: what changed
• 17:12 – Secure boot: a microcontroller mistake that derailed a launch
• 20:35 – Common cybersecurity vendor mistake MedTech companies make
• 23:40 – SBOM: Software Bill of Materials and why it's legally critical
• 27:58 – Cyberattacks in hospitals: assuming a hostile network
• 35:44 – AI in medical devices: data bias and cybersecurity challenges
• 41:10 – Developers ≠ cybersecurity experts: the training gap nobody talks about
• 45:20 – What RA/QA professionals need to know now
• 49:30 – Why cybersecurity must be iterative, not a final-phase add-on
• 55:20 – Espinosa's final advice for MedTech professionals
• 57:52 – The story behind “Blue Goat Cyber”

Standout Quotes:

Top Takeaways:

1. Cybersecurity isn’t just about data—it's about patient safety. From burning skin to missed sepsis diagnoses, vulnerabilities in devices have real-world harm potential.
2. FDA now requires more than just a basic security plan. Post-September 2023 rules mandate testing (SAST, DAST, fuzzing), SBOMs, and risk assessments tied to patient harm.
3. Start cybersecurity planning during the requirements phase. Hardware like microcontrollers must support secure boot and other protections—retrofits can cripple product plans.
4. Iterate cybersecurity like any core development activity. One-time testing near submission is too late; build security into your pipeline just like QA or usability.
5. Traditional cybersecurity vendors aren’t enough. Many fail to meet FDA’s nuanced expectations for medical devices, causing costly submission rejections.

References & Resources:

• Christian Espinosa on LinkedIn
• Blue Goat Cyber
• Etienne Nichols on LinkedIn

MedTech 101 – Understanding SBOM (Software Bill of Materials):

Think of an SBOM like a nutrition label on food. Just as you want to know if a product contains allergens or preservatives, FDA wants to know what libraries and components are in your software. A clean, complete SBOM identifies both security vulnerabilities and potential licensing conflicts—like borrowing ingredients you’re not legally allowed to use. Want a visual explanation? Consider a flowchart showing third-party libraries linking into your main software repository, flagged with vulnerability scores.

Poll Question:

Is cybersecurity currently integrated into your product development process—

A) From Day 1

B) Only near submission

C) We outsource and hope for the best

D) What cybersecurity?

What’s your biggest challenge when it comes to building cybersecurity into your product lifecycle? Email us your thoughts at [email protected].

Feedback:

If this episode sparked new insights or raised questions, we’d love to hear from you. Send us your feedback or suggest a topic at [email protected]. We personally respond to every email and appreciate your ideas for future guests and discussions.

Sponsored by Greenlight Guru:

Most companies spend more time preparing for audits than in the audit itself. Greenlight Guru Quality lets you link cybersecurity and quality evidence directly to requirements, making you “always audit-ready.” Learn more at www.greenlight.guru.

In part 2 of a critical two-part series, Etienne Nichols and regulatory affairs expert Mike Drues explore the nuanced pathway of switching a medical device from prescription (Rx) to over-the-counter (OTC).

This episode dives deep into what triggers a new submission, how usability testing and human factors play an expanded role for lay users, and the regulatory logic that guides these transitions. The conversation highlights the importance of aligning regulatory strategy with business goals, and offers practical insights on leveraging real-world evidence, understanding the limits of FDA databases, and optimizing pre-submission meetings.

• 02:10 – Starting from a cleared 510(k): Do you need a new submission for OTC?
• 06:45 – Implications of removing the healthcare provider from the equation
• 12:00 – Risk management: Expanding risk profiles when lay users are involved
• 18:15 – When a 510(k) becomes a De Novo or PMA
• 22:50 – Usability testing and the risk of user error in OTC devices
• 31:20 – Clinical investigations and good clinical practices (GCPs)
• 36:00 – Real-world evidence vs. real-world data—what’s usable?
• 41:30 – Using Pre-Subs effectively and what “quality data” really means
• 47:10 – Labeling, cleaning, and UDI for OTC products
• 53:40 – OTC software and digital health—when is it a regulated device?
• 01:00:00 – Summary: Aligning regulatory logic with common sense and business strategy

“With an OTC device, we are taking the healthcare professional totally, completely, and utterly out of the loop.”

– Mike Drues

This quote encapsulates the core regulatory challenge in moving a device to OTC: every element, from labeling to usability, must assume zero clinical supervision.

“If the clinical trial won’t tell you anything you don’t already know from good real-world evidence, why spend the time and money?”

– Mike Drues

A powerful argument for using well-documented real-world evidence over unnecessary trials—provided the data truly meets evidentiary standards.

1. Label Expansion ≠ Shortcut: Moving from prescription to OTC usually requires a new submission—especially when removing the healthcare provider introduces new risks.
2. Usability Testing Is Critical: OTC usability studies must go beyond IFU comprehension to include risk of misuse, poor device selection, and user decision-making.
3. Real-World Evidence Can Help—If It’s Clean: Real-world data isn’t always usable. FDA will expect reproducibility, traceability, and strong justifications.
4. Labeling & Design Must Assume No Clinical Oversight: Cleaning procedures, warnings, and directions must all be validated for home use and layperson comprehension.
5. Use Pre-Subs Wisely: Especially for label expansions or gray-area digital health tools, pre-subs provide critical alignment with FDA and prevent costly errors.

• Etienne Nichols on LinkedIn
• FDA Guidance on Real-World Evidence for Regulatory Decision-Making
• Greenlight Guru Webinar: What is and Isn't a Regulated Medical Device (feat. Mike Drues)
• FDA Guidance: Clinical Decision Support Software

Analogy: Think of prescription vs. OTC devices like driving a manual vs. automatic car. Prescription devices assume a trained “driver” (the healthcare provider), while OTC devices must be intuitive and safe enough for anyone to “drive” without instruction.

Graphic Suggestion: A split diagram comparing IFU complexity, user training, and supervision levels between Rx and OTC pathways.

Concept Simplified: Usability testing for OTC devices isn’t just about making it “easy”—it’s about ensuring safety in the absence of clinical guidance.

Poll Question:

Have you ever considered transitioning a medical device from prescription to OTC?

• Yes, we’ve explored it
• No, but we’re curious
• We plan to stay prescription-only
• Not applicable to our device

What’s your biggest challenge in designing for lay users? Share your thoughts with us on LinkedIn or email us at [email protected]—we’d love to hear your story.

Enjoying the Global Medical Device Podcast? Help us improve! Leave a review on your favorite platform, or email us directly at [email protected] with feedback or topic suggestions. We personally read every message and love hearing from you.

This episode is brought to you by Greenlight Guru, the only MedTech-specific Quality and Clinical platform. Whether you're transitioning to OTC or optimizing your device's QMS, Greenlight Guru is your partner for faster development and safer products. Visit www.greenlight.guru to learn more.

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 Premarket Approval and De Novo Classifications”

Analogy: Think of a medical device like a power tool. A prescription device is like a chainsaw—powerful, but risky if misused, so it’s only operated by trained professionals. An OTC device is like a screwdriver—still a tool, still regulated, but safe and intuitive enough for the average person to use correctly at home.

Poll Question:

Do you think OTC medical devices should require a minimum standard of in-store or digital education before purchase?

Engagement Prompt:

Have you ever worked on a product that made the switch from prescription to OTC? What surprised you most about the process? Share your story with us at [email protected].

Enjoyed this episode? Help us keep the conversation going:

• Rate & review us on your favorite podcast platform
• Got a topic suggestion or question? Email us at: [email protected]
• We read every email and may feature your question in a future episode.

This episode is powered by Greenlight Guru, the only QMS platform designed specifically for MedTech companies. Whether you’re launching an OTC wellness device or navigating a PMA, Greenlight Guru helps ensure compliance and accelerate innovation. Learn more at www.greenlight.guru.

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
• Sara Adams on LinkedIn

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

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 [email protected].

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 [email protected]. We read and reply to every 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.

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 show it!

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Discover how Greenlight Guru Quality can unify your SOPs, documents, and product development process into a single living system — from idea to post-market. Learn more at greenlight.guru.

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kirk Petyo, Managing Partner at Talent Factory Recruiting, to explore the art and science of hiring in MedTech.

Kirk shares strategies for building magnetic employer brands, explains the difference between competencies and capabilities in candidates, and warns about the hidden costs of bad hires or delayed recruitment. They also discuss how to attract top talent from outside traditional MedTech backgrounds, and why companies must clearly define their values to thrive in today's competitive hiring landscape.

• [00:02:00] – Introduction to Kirk Petyo and Talent Factory Recruiting's unique approach
• [00:05:30] – What makes a company a "magnet" for top talent in MedTech
• [00:12:20] – How to recruit candidates from outside traditional MedTech backgrounds
• [00:20:00] – How to differentiate between a good worker and a good interviewer
• [00:30:10] – The ripple effects of a single bad hire in a MedTech company
• [00:35:50] – The cost of leaving key roles unfilled for too long
• [00:44:00] – Outdated hiring practices that repel top candidates
• [00:50:00] – Trends in hiring and workforce planning for 2025
• [01:02:00] – Final advice for MedTech hiring managers and company leaders

1. "If you treat hiring like a transaction, you'll get transactional results. But if you treat hiring as a critical strategy for growth, you’ll flourish." – Kirk Petyo
2. "Your candidate’s life must be better at your organization than it was at their last job—if you can't tell that story, you'll struggle to attract top talent." - Kirk Petyo

• Define your value drivers clearly: Understand what makes your company unique before trying to attract top talent.
• Focus on capability, not just competency: Prioritize what candidates can learn and contribute over time, not just what they know today.
• Structure your interview process: Build a consistent, benchmark-driven approach to avoid gut-feel hiring mistakes.
• Partner with strategic recruiters: Seek recruiters who genuinely understand your company culture and goals, not just resume matchers.
• Act early on critical hires: Don’t delay filling strategic roles; the opportunity cost and cultural risk multiply with time.

• Kirk Petyo’s LinkedIn Profile
• Talent Factory Medical Website
• Etienne Nichols' LinkedIn Profile

Competency vs. Capability (Simplified):

Think of competency like what’s already in a candidate’s toolbox—their current skills and experiences. Capability is their potential—the size of the projects they could build if you give them the right tools and environment.

Poll Question: What’s the biggest challenge you face when hiring MedTech talent?

• Defining clear job expectations
• Attracting candidates from outside the industry
• Avoiding bad hires
• Speeding up the hiring process

"Have you had a ‘good interviewer, bad employee’ experience? Share your story with us at [email protected] — we’d love to hear your lessons learned!"

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This episode is sponsored by Greenlight Guru, the only MedTech-specific QMS platform designed to speed up your product development without sacrificing compliance or quality. Learn more at www.greenlight.guru.