The Five Biggest Stumbling Blocks Small Device Teams Hit in Study Start-Up and What to Do Next

In this Friday In-Focus session, Laura Van Vaeck (Co-founder & Director, Regulatory and Start-Up, Frankly Health) and Rob Bedford (Co-founder & CEO, Frankly Health) unpack the most common challenges small MedTech teams face when moving from idea to execution in clinical studies — and how to overcome them efficiently.

Drawing from first-hand experience supporting MedTech start-ups and emerging device innovators, Laura and Rob share practical strategies for avoiding costly bottlenecks, strengthening site engagement, and achieving faster first-patient-in milestones.

💡 You’ll Learn:
• How to structure study timelines that avoid “scope creep”.
• What delays early-stage device studies (and how to fix them fast).
• How to align regulatory submissions and contracting in parallel.
• When to outsource vs. build internal capability.
• Proven tactics for team coordination, site communication, and documentation.

🎙️ Featuring:
✅ Laura Van Vaeck – Co-founder & Director, Regulatory and Start-Up, Frankly Health
✅ Rob Bedford – Co-founder & CEO, Frankly Health

⏱️ Chapters
(00:00) – Welcome & introductions
(00:04) – The five biggest stumbling blocks in study start-up
(00:12) – Common issues for small MedTech study teams
(00:21) – Study planning & realistic timeline development
(00:33) – Managing regulatory submissions and site contracting
(00:45) – Resource limitations and team structure challenges
(00:56) – Communication breakdowns between sites and sponsors
(01:08) – Oversight and documentation pitfalls
(01:20) – Lessons learned from real-world study launches
(01:32) – Q&A and discussion
(01:42) – Closing insights and key takeaways

ℹ️ About Friday In-Focus
Friday In-Focus is MLVx’s weekly webinar series—always free, always interactive—spotlighting MedTech’s most experienced thinkers and doers.

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