Hardware Podcasts

#413: Budgeting Blind Spots: What MedTech Startups Miss—and How Investors See It

Global Medical Device Podcast · 30 Jun 2025 · 35m · Episode 413

What this episode covers

Jon Bergsteinsson, founder of Smart Trial (acquired by Greenlight Guru) and investor at Leaf Ventures and Iceband, explains why early-stage MedTech startups frequently overlook budgeting for regulatory, clinical, and quality operations. He details how inexperienced founders lump compliance costs into single line items, ignoring essential software licenses (eQMS, CAD), testing fees, and post-market surveillance, which raises red flags for investors. Bergsteinsson advises founders to break out specific cost categories, use AI and networking to scout market rates, and build best/worst-case scenarios to avoid financial risk and ensure product quality.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, Smart Trial, Leaf Ventures, Iceband
Tools
eQMS, CAD
Also
510(k), ISO, UDI

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