De-Risking Clinical Trial Design for Emergency-Use Product

Situation

‍

An international MedTech start-up sought a partner to develop the clinical and regulatory strategy for an emergency-use medical device intended for the U.S. market. In addition to securing Investigational Device Exemption (IDE) approval, the sponsor needed to address the complex requirements associated with Exception from Informed Consent (EFIC), align with Department of Defense (DoD) grant stakeholder expectations, and engage a specialized network of clinical sites capable of supporting the study.

‍

‍Solution

‍

HCC leveraged its extensive experience supporting both start-up companies and international sponsors pursuing U.S. IDE and global clinical development programs. Acting as a strategic partner, HCC facilitated early protocol discussions with key stakeholders, including the FDA and Department of Defense, helping the sponsor refine the investigational plan and proactively address potential regulatory and operational challenges.

‍

Well in advance of IDE submission, HCC led site feasibility assessments and engaged experienced clinical investigators to evaluate the practical implementation of the protocol. These discussions informed critical aspects of study execution, including product readiness, emergency-use workflows, and subject enrollment and consent processes.

‍

Recognizing the unique ethical considerations associated with EFIC, HCC also leveraged its network to facilitate early engagement with a Central IRB. These consultations provided valuable feedback on the study design, investigational plan, and supporting documentation, enabling the sponsor to strengthen its submission strategy and prepare for future regulatory review.

‍

Impact

‍

By identifying and addressing regulatory, ethical, and operational risks early in development, HCC helped position the sponsor for a compliant and executable study design before trial initiation. Through proactive stakeholder engagement, strategic planning, and access to a specialized clinical and regulatory network, HCC reduced uncertainty, enhanced study readiness, and accelerated the path to regulatory approval.

‍

This partnership highlights the value of early clinical and regulatory strategy for emerging MedTech companies. By de-risking the development process upfront, HCC helped the sponsor avoid costly delays, optimize resources, and advance toward study approval with greater confidence and efficiency.

‍