De-Risking Innovation: A MedTech Impact Partners & Boulder Clinical Science Case Study
The Challenge: A High-Stakes Pathway to Market
An ARPA-H funded innovator had a groundbreaking 3D laparoscopic imaging platform, but faced critical gaps threatening its path to market. Lacking a defined Minimum Viable Product (MVP), a clear regulatory strategy, and a defensible IP position, their timeline and commercial viability were at significant risk. They needed a partner who could provide a seamless, integrated solution covering the entire development lifecycle.
The Solution: An Integrated Regulatory & Clinical Approach
This is precisely where the strategic partnership between MedTech Impact Partners (MIP) and Boulder Clinical Science (BCS) created immense value. By combining MIP’s expert regulatory strategy with BCS’s capital-efficient clinical execution, we provided an interconnected team to address the client's challenges head-on.
Our integrated approach delivered:
Robust Regulatory Strategy: We navigated the complex 510(k) vs. De Novo pathway decision.
Capital-Efficient Clinical Development: Leveraging the BCS virtual CRO model, we designed the first-in-human clinical trial, established key opinion leader (KOL) connections, and built detailed financial models for all pre-clinical and clinical work, ensuring maximum value and budget efficiency.
Stakeholder & Go-to-Market Readiness: We provided targeted pitch coaching to sharpen their investor presentations and initiated foundational work on pricing and commercialization strategies.
Our integrated approach delivered (cont’d):
Pre-IND Package Development: Collaborated on the creation of a comprehensive pre-Investigational New Drug (IND) package, which facilitated a highly productive pre-IND meeting with the FDA, resulting in complete agreement from FDA on all critical aspects.
First-in-Human Clinical Trial Design: Orchestrated the strategic design of the initial clinical trial in human subjects, laying the groundwork for subsequent phases of drug development.
INTERACT Package Assistance: Provided support in the drafting of the Investigational New Drug Application for Research and Collaborative Trials (INTERACT) package, ensuring all necessary documentation was accurately prepared for submission.
The Impact: From Uncertainty to a Clear Competitive Advantage
Our collaborative effort empowered the company to make informed, strategic decisions across regulatory, clinical, and commercial pathways.
"We transformed their complex regulatory environment from a potential roadblock into a clear competitive advantage."-Kwame Ulmer, Managing Partner (MedTech Impact Partners)
This newfound clarity significantly accelerated the device’s journey to market and established a robust foundation for long-term success, paving the way for sustainable growth and substantial value creation.
Key Takeaway for MedTech Leaders
For MedTech leaders, the path from innovation to revenue is fraught with specialized challenges. Integrating external, cross-functional expertise isn't a cost—it's an accelerant. The success of this 3D imaging platform demonstrates that a proactive, unified regulatory and clinical strategy is the new standard for de-risking development, accelerating market access, and unlocking the full value of your technology.
About the MedTech Impact Partners & Boulder Clinical Science Partnership
This strategic alliance offers a seamless and comprehensive approach to drug and device development. It combines MIP’s deep regulatory expertise with BCS’s proficiency in capital-efficient clinical trial design and execution to help clients accelerate their path to market while managing risk.
MedTech Impact Partners (MIP) is a regulatory strategy consulting firm leveraging executive-level FDA and MedTech operational experience to deliver tailored solutions that create company value.
Boulder Clinical Science (BCS) is a specialized CRO that helps start-ups with capital-efficient clinical trial protocol design and execution through all phases of development.
To learn how this integrated approach can benefit your project, contact our team.