Early FDA Engagement: The Single Biggest Lever to De-Risk Your MedTech Roadmap
The "FDA as a roadblock" mindset is outdated. It’s time to view them as a partner.
Early engagement with regulators is the single most powerful lever a MedTech leader can pull to de-risk their roadmap, accelerate approvals, and strengthen investor confidence. As Kwame Ulmer, Founder and Managing Partner of MedTech Impact Partners, notes, waiting too long to think about evidence generation or regulatory pathways is a common mistake. Understanding regulatory expectations early allows startups to make informed decisions about clinical trials, product design, and evidence generation.
Regulatory strategy is not just timelines or paperwork—it’s a coordinated set of actions that build company value.
Recorded at The MedTech Conference 2025, hosted by AdvaMed, Kwame explains how early engagement with regulators actually speeds up approvals and why most medtech founders underestimate how much evidence matters.
Regulatory strategy is not just "paperwork"—it’s what positions you for funding and market access.
Key Takeaways for Leaders:
Start Early: Engage the FDA at the concept stage. This is the single biggest lever a can pull to de-risk their roadmap.
Build Buffers: Your capital and schedule need realistic regulatory buffers.
Speak the Language: Fluency in regulatory strategy—understanding the different data requirements between a 510(k), De Novo, or 513(g)—signals an understanding of the critical driver of success.
In today’s MedTech landscape, regulatory strategy is a critical driver of success and value creation. Companies that engage regulators early and understand the landscape are positioned to navigate challenges, accelerate approvals, and deliver innovations that truly serve patients.-In today’s MedTech landscape, regulatory strategy is not just compliance—it’s a critical driver of success, value creation, and investor confidence. Startups that engage regulators early and understand the landscape are positioned to navigate challenges, accelerate approvals, and deliver innovations that truly serve patients.
Talk to the FDA before you talk to the FDA™