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.