Jun 2025
35m 24s
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.
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.
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.
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.
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.
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.