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

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.