The focus of this podcast episode is the critical importance of evaluating Electronic Quality Management Systems (EQMS) platforms at the appropriate stages of product development rather than waiting for a crisis to prompt action. I explore how proactive medtech teams that prioritize early evaluation of EQMS platforms position themselves for success, ultimately enhancing their capacity to bring safer and more effective medical devices to market. Joined by industry expert Andy Rogantino, we delve into the intricacies of when and how teams should consider EQMS solutions, emphasizing the necessity for a foundational quality system that supports regulatory compliance and operational efficiency. Our discussion also highlights the essential collaboration among product development, quality assurance, and leadership to ensure that the chosen EQMS aligns with the unique needs of each organization. By understanding these dynamics, we aim to equip medtech professionals with the knowledge to make informed decisions that will positively impact patient outcomes and organizational success.

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Takeaways:

• The most effective medtech companies evaluate EQMS platforms early in their development process to avoid regulatory headaches later on.
• Quality management systems should be viewed as the backbone of medical device development, essential for improving patient outcomes and compliance.
• Companies need to adopt a proactive mindset in quality management, as waiting for issues to arise can lead to dire consequences.
• A successful EQMS implementation requires collaboration across various departments including regulatory, quality, and product development.
• It is crucial for medical device teams to consider the user experience of the EQMS software, ensuring it is intuitive and effective for everyday use.
• Evaluating the ROI of an EQMS should encompass not only financial metrics but also improvements in efficiency and compliance readiness.

Links referenced in this episode:

• www.greenlight.guru
• podcastreenlight.guru

Companies mentioned in this episode:

• AbbVie
• Signal Therapeutics
• Second Nature
• Greenlight Guru

In this insightful episode, Mike Drues joins host Etienne Nichols to dissect the FDA's most frequently cited compliance issues, challenging the notion that many are strictly "pre-market" concerns.

They delve into the nuances of software changes, design creep, and off-label marketing, providing a critical look at how companies can avoid common pitfalls.

This discussion is vital for MedTech professionals seeking to understand the true nature of FDA expectations and build more robust quality systems.

• 00:04 – Introduction to common FDA compliance issues
• 02:02 – Discussion on FDA's policy of not naming individuals
• 05:45 – Mike Drues challenges the "pre-market" classification of common issues
• 09:20 – Documentation requirements for different device classes
• 11:35 – Mike’s take on the most common FDA issues (beyond the presented three)
• 15:40 – Root causes of common compliance problems and industry responsibility
• 20:00 – The role of regulation and FDA's responsibility in clarity
• 27:05 – Deep dive into design change and design creep
• 31:40 – Software changes and the "bug fix" mentality
• 35:45 – Marketing beyond authorized intended use with a real-world example
• 41:00 – Key takeaways and proactive compliance strategies

• "If the regulation makes sense, we shouldn't need it. If the regulation doesn't make sense, we shouldn't have it." — Mike Drues. This quote encapsulates Mike's philosophy on regulatory compliance, emphasizing that true professionalism means understanding inherent needs rather than just following rules.
• "You have a piece of software, you have a bug, you fix the bug… Is your job done? Absolutely not." — Mike Drues. This highlights a critical oversight in software development within MedTech, stressing the importance of holistic post-fix validation to prevent unintended consequences.

• Regulatory Misclassification: Many issues labeled by the FDA as "pre-market" (e.g., marketing beyond intended use, design creep) are fundamentally post-market compliance challenges. This distinction is crucial for companies to allocate resources effectively.
• Beyond Administrative Review: While administrative incompleteness accounts for a significant portion of 510(k) rejections (around 38%), the scientific and substantial equivalence reviews are major hurdles, with approximately 75% of 510(k)s rejected initially, primarily due to lack of substantial equivalence (85% of those rejections).
• Top Post-Market Violations: Historically, the most common reasons for FDA 483s and Warning Letters relate to CAPAs (12.5%), design controls (12.5%), and complaint handling (10.5%), collectively accounting for roughly 35% of all post-market issues. Companies should prioritize these areas.
• Software Change Management: Fixing a software bug is only the first step; a holistic review is essential to ensure no new problems are introduced and the device's safety, efficacy, and usability remain uncompromised.
• Intentionality vs. Compliance: Marketing a device beyond its authorized intended use, even if the device functionally performs beyond its cleared claims, carries significant regulatory and product liability risks. Companies should seek appropriate clearance for expanded claims rather than relying on off-label promotion.

• Etienne Nichols' LinkedIn
• Greenlight Guru

In this episode, Etienne Nichols and Matt Stratton, Director and Principal Consultant at Coalition, delve into the dynamic and complex world of neurotechnology.

They discuss the expansive definition of neurotech, the significant challenges in accelerating innovation—particularly concerning regulatory frameworks and cross-functional collaboration—and how a united industry voice can overcome these hurdles to bring life-changing devices to patients faster.

• 00:04 - Introduction to the episode and Matt Stratton
• 02:21 - Matt Stratton’s journey into neurotechnology and passion for acceleration
• 04:30 - Defining neurotech beyond traditional boundaries
• 07:11 - Major challenges preventing acceleration in neurotech
• 10:16 - The internal and external barriers to collaboration
• 13:40 - The "generalist vs. specialist" dilemma in neurotech expertise
• 17:03 - Optimizing existing neurotech and the future of advanced neuroscience
• 19:34 - What neurotech can learn from other medical device verticals
• 22:50 - The complexity of the brain: "What is normal?"
• 24:50 - Ethical considerations of neurotech advancements
• 26:27 - Overcoming competitive intelligence in collaborative communities
• 29:05 - Bridging the language gap between pharma and medical devices in neurotech
• 31:40 - Matt Stratton's call to action for the neurotech community
• 33:10 - Political challenges and maintaining focus on shared goals

• "I think the neurotech space is a bit broader than that because there are so many interrelated areas that are relying and using very similar technologies and ultimately aiming for the same patient groups...and will come across the same regulatory structures." — Matt Stratton
• Matt's expansive view highlights the interconnectedness of neurotech, emphasizing that a holistic approach to defining the field is crucial for effective collaboration and regulatory navigation.
• "If what ties us together is greater than the soil we stand on, then yeah, we can remain standing together." — Etienne Nichols
• Etienne's profound statement underscores the power of shared purpose and patient-centric goals in transcending political and competitive barriers within the medical device industry.

• Broadening the Neurotech Definition: Neurotech extends beyond neuromodulation and BCIs to include neurodiagnostics, neuromonitoring, neurological drug delivery, and neurosurgical devices. This broader perspective fosters greater collaboration and addresses common regulatory and patient needs.
• Challenges in Acceleration: Key hurdles include complex regulatory environments, the need for increased collaboration among diverse experts (neuroscientists, biologists, engineers), and adapting to emerging technologies like AI.
• The Power of External Collaboration: Bringing together different industry players helps establish a unified voice for regulatory changes, benchmark best practices, and break down barriers to faster progress, especially as neurotech pushes ethical and technological boundaries.
• Learning from Other Verticals: While neurotech faces unique challenges, insights from established fields like orthopedics and CRM, particularly regarding rapid product development (e.g., "Moore's Law" in tech), offer valuable lessons for accelerating innovation.
• Navigating Complexity and Ethics: The brain's inherent complexity and the fluid concept of "normalcy" introduce unique challenges for neurotech. This includes addressing profound ethical considerations, such as the potential for enhanced human capabilities to exacerbate societal inequalities.
• Fostering Open Dialogue: Community platforms that focus on "mundane"

As global clinical trials become more competitive and data-driven, Latin America is stepping up with a new global standard in clinical trial quality. In this episode, Etienne Nichols speaks with Julio Martinez-Clark, CEO of BioAccess and a key advocate for clinical site certification in Latin America.

They discuss the launch of the GCSA certification and IAOCR accreditation now available in the Americas, exploring how these standards improve site credibility, de-risk clinical trials, and offer faster pathways for medtech market access. From regulatory advantages to site selection strategies, this episode is essential listening for sponsors, CROs, and MedTech leaders navigating global trials.

00:02 – Introduction to Julio Martinez-Clark and episode overview

02:10 – What is GCSA and IAOCR certification?

06:00 – Why certification is emerging now: volume, complexity, and patient safety

09:42 – Certification structure: site vs. individual requirements

13:45 – The Colombian model: First mover in Latin America

17:55 – Global harmonization vs. local certification pitfalls

21:30 – Measuring ROI of certified vs. non-certified sites

26:15 – Future of global site certification and Latin America’s role

30:00 – Regional differences: speed vs. patient pool in trial site selection

36:15 – Final thoughts on FDA trends and LATAM’s emerging position

1. GCSA Certification Elevates Site Credibility: Clinical sites with GCSA certification are fast-tracked for sponsor consideration, leading to better trial access and more robust patient recruitment.
2. IAOCR Accreditation Validates Individual Competency: For investigators, coordinators, and site managers, individual accreditation under the UNESCO-backed IAOCR framework offers a portable, verifiable skillset.
3. Latin America Offers Dual Advantages: With rapid recruitment and cost-effective data generation, LATAM is uniquely positioned to lead in globally certified trials—especially Colombia, which already mandates certification.
4. Global Harmonization is Critical: Fragmented local certifications can deter sponsors. A unified global framework like GCSA simplifies compliance, increases efficiency, and builds trust.
5. The FDA Bottleneck May Shift Market Entry: With regulatory delays in the U.S., more medtech firms may turn to Latin America for first-in-human trials and initial commercialization.

• Julio Martinez-Clark on LinkedIn
• Bioaccess LATAM
• IAOCR – International Accreditation Organization for Clinical Research
• Etienne Nichols on LinkedIn

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with seasoned MedTech founder and investor Jon Bergsteinsson to unpack a critical—but often overlooked—topic: budgeting in early-stage medical device startups. Drawing from his deep regulatory, clinical, and investment experience, Jon shares the red flags investors look for, the cost categories that founders routinely miss, and why a line item called “compliance” just doesn’t cut it.

Whether you’re a startup founder, a regulatory lead, or a project manager, this episode offers a sharp lens into the financial planning realities that can make or break product development and commercialization in MedTech.

02:34 – Why QMS, regulatory, and clinical are budget afterthoughts for startups

06:45 – What separates experienced vs. inexperienced MedTech founders in budgeting

10:20 – Why software and compliance tools get left out of early budgets

14:12 – How missing budget detail impacts product quality and time-to-market

19:04 – Red flags investors look for in MedTech startup budgets

23:30 – How to improve budgeting accuracy without a CFO

28:10 – Critical cost categories MedTech founders often overlook

35:55 – Advice for recovering from a budgeting oversight

39:40 – Comprehensive checklist of overlooked line items (manual translation, UDI, ISO licenses, and more)

45:00 – Final advice: why networking trumps isolation for smarter budgeting

"Relying on the status quo is never good. There are always ways to do things better."

Jon reminds founders and compliance professionals alike that innovation doesn’t stop at the product level—it also applies to budgeting, systems, and team empowerment.

"Getting a 510(k) through is just the starting point. Budgeting like everything ends there is a massive red flag."

This quote highlights the investor’s perspective on sustainability and long-term thinking—crucial traits in any fundable founder.

1. Broad Budget Buckets Signal Inexperience

Lumping all compliance-related costs under one line item may look tidy but signals to investors a lack of operational depth. Break out line items for QMS, clinical, regulatory, and software tools.

1. Software and Tools Are Not Optional Extras

Founders must factor in essential systems—like eQMS, CAD, risk management, and clinical data tools—early in budgeting. Assuming a single hire covers everything is a critical mistake.

1. Budgets Must Reflect Time and Scale Realistically

Flat budgets over 2–3 years, or those that assume regulatory costs end at market clearance, raise red flags. Investors expect dynamic budgeting that reflects the realities of growth, post-market surveillance, and team evolution.

1. Outsourcing ≠ All-Inclusive

Many startups underestimate the actual costs tied to consultants and CROs, assuming “someone else is handling it.” Always clarify what’s included—and what’s not.

1. Recovery Is Possible—If You Own It

If your budget’s off-track, clear communication with your board and investors, a willingness to revise, and a plan for worst-case scenarios are your best tools for regaining credibility.

• Jon Bergsteinsson on LinkedIn
• Etienne Nichols on LinkedIn
• Greenlight Guru – QMS and Clinical platform for MedTech companies

In this live episode from the LSI conference in California, Etienne Nichols is joined by Ashkon Rasooli to break down what it really takes to build a high-performing quality management system (QMS) in medtech—from startup chaos to post-market scale.

Ashkon shares a phased approach to aligning QMS implementation with product development, explains the concept of "enforcement points," and reveals how founders can reduce the burden of compliance by starting small and planning ahead. If you're navigating regulatory requirements while trying to stay innovative, this episode is your roadmap to smarter, leaner quality.

• 00:02 – Introduction to Greenlight Guru and medtech process integration
• 01:15 – QMS evolution from startup to commercialization
• 03:00 – Phase-based product development overview (Phases 0–6)
• 06:35 – Why QMS should follow product needs, not just regulatory triggers
• 09:10 – Agile vs. proceduralism in quality systems
• 11:50 – Building a quality culture during the feasibility phase
• 15:25 – When to implement QMS controls and how to prepare for “enforcement points”
• 18:40 – Investor-driven and regulatory QMS triggers
• 21:10 – How early QMS planning saves time and reduces future remediation
• 26:20 – Ashkon’s final advice for startups: start small and stay proactive

"You’ve got to take the BS—being burdensome—out of QMS."

Ashkon Rasooli redefines QMS as a project management tool, challenging the notion that compliance must be a burden. This quote encapsulates his philosophy of proactive, phased implementation that actually enhances product development.

"Start small and do a little bit at a time—it won’t seem like a burden."

A practical mantra for startups, this advice underscores how a gradual, well-aligned QMS rollout can prevent last-minute fire drills and wasted effort.

1. Use the "Phase 0–6" Model to Guide QMS Rollout – Align QMS implementation with the stages of product development to ensure each step supports the next.
2. Don’t Wait for Enforcement Points – Start building your QMS before regulators or investors demand it to avoid remediation-heavy implementations.
3. Prioritize Culture Before Controls – In early feasibility, focus on aligning your team with medtech’s safety responsibilities, rather than formal procedures.
4. Procedures Should Support Outcomes, Not Just Check Boxes – Avoid proceduralism by tying every process back to its intended quality objective.
5. Regulatory Strategy = Investor Strategy – QMS maturity is increasingly scrutinized during due diligence. Treat it as a value driver, not just a cost.

• Ashkon Rasooli on LinkedIn
• Greenlight Guru – Quality management software for medical devices
• Etienne Nichols on LinkedIn – Connect with the host
• ISO 13485 vs. ISO 9001 – Explains how medical device quality systems build on general standards
• ISO 14155 Overview – Relevant for clinical validation procedures

In the context of QMS, enforcement points are moments when external stakeholders (regulators or investors) require proof of formalized processes. Think of it like a driver’s license checkpoint—you may be cruising just fine, but at that moment, you must prove you’re compliant. The earlier you prep for them, the smoother your...

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.

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