2025 Retrospective: Strategic Regulatory Milestone
In the world of Large MedTech, the primary objective is managing the risk of global portfolios while ensuring clinical milestones are met. As 2025 concludes, MedTech Impact Partners (MIP) reflects on the substantive progress made by our partners.
This year, our collaborations focused on de-risking the innovation lifecycle. We worked as an extension to high-level regulatory teams, providing the research-backed advice necessary to navigate evolving FDA software guidance and complex therapeutic pathways.
2025: Global Breadth and Clinical Impact
Our work this year reflected the increasingly interconnected nature of the MedTech industry. In 2025, MIP’s engagements:
Spanned 4 continents and 9 countries, supporting global market entry.
Covered 12+ clinical specialties, providing deep-dive expertise from cardiovascular diagnostics to orthopedic advancements.
Generated an estimated $1.5M+ in value creation per client through optimized pre-submissions and clinical trial cost-avoidance.
High-Impact Partnerships
Substantive Progress
We celebrate a long-term partner’s achievement of Substantial Equivalence (SE) for their cardiovascular software. This milestone was the result of a persistent, multi-year regulatory journey where we served as a trusted advisor, ensuring the clinical evidence met the highest levels of FDA data requirements.
Peer-Reviewing Innovation
For our partners at the University of Virginia and Washington University, we provided regulatory snapshots and complete strategies for novel soft electrode and AI imaging technologies—supporting Translational Velocity.
Strategic De-Risking
Our focus remained on creating company value through multiple FDA interactions, to accelerate market entry and reduce the burden of clinical trial costs.
At the enterprise level, the goal remains: Talk to the FDA before you talk to the FDA.™ We greatly value our 2025 partnerships and the trust placed in us to stress-test your most critical strategies.
Ready to de-risk your path to market for 2026? Schedule a strategy session with our team.