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...