Notes From Jim...

HCC at 15: Why We Started and What Still Drives Us Today

Hart Clinical Consultants is celebrating 15 years of helping emerging MedTech companies turn innovation into clinical success. Founded to be more than a traditional CRO, HCC combines deep clinical research expertise with flexibility, responsiveness, and practical execution. Our founder-focused approach gives sponsors direct access to experienced professionals who understand both the science and business of medical device development. Fifteen years later, our mission remains the same: deliver exceptional clinical support and help innovators advance better patient care.

Jim Hart, President & CEO

September 11, 2026

More From HCC...

Success Stories

Beyond the Pivotal Trial: The Role of Real-World Evidence in MedTech

Real-World Evidence (RWE) is becoming an increasingly important part of medical device clinical development, extending the value of evidence beyond the pivotal trial. This article explores what RWE is, how it is generated, and how it can support regulatory, payer, physician, and commercial needs. It also highlights how HCC helps sponsors build comprehensive evidence-generation strategies through experienced clinical operations, trusted site and investigator networks, and strong Biometrics capabilities.

Sapna Ghuman, Director Biometrics

August 31, 2026

Success Stories

ISO 14155:2026: Right-Sizing Your Safety Oversight Model for Compliance

ISO 14155:2026 raises expectations for how MedTech sponsors structure, document, and defend clinical safety oversight. The update reinforces the need for a risk-based, integrated safety model that connects clinical risk assessment, AE and device deficiency workflows, DMC/CEC governance, stopping rules, monitoring strategy, and inspection-ready documentation. Hart Clinical Consultants helps MedTech sponsors strengthen safety oversight models, committee governance, AE/device deficiency workflows, and inspection-ready documentation.

Melanie Miller, Sr. Manager Clinical Safety Management

August 31, 2026

Success Stories

De-Risking Clinical Trial Design for Emergency-Use Product

HCC guided an international MedTech start-up through the regulatory, ethical, and operational challenges of an Early Feasibility Study (EFS) at U.S. VA Medical Centers, proactively addressing EFIC requirements with key stakeholders to mitigate risks early.

Jason Krzeszak, Executive VP Clinical Research & Operations

Success Stories

Building a Global Proctoring Network for a Breakthrough Medical Technology

Discover how HCC helped a global medical device company establish an international proctoring program for a novel breakthrough technology. Through strategic recruitment and training of local clinical experts across three continents, HCC provided real-time procedural guidance, ensuring successful device implantation, maintaining patient safety, and accelerating global study execution while reducing sponsor costs.

Jason Krzeszak, Executive VP Clinical Research & Operations

Success Stories

Early PMA Through Accelerated Trial Execution

This case study demonstrates how HCC's agile clinical operations accelerated trial execution, enabling a PMA submission 2.5 months ahead of schedule and expediting market access for a novel medical device.

Jason Krzeszak, Executive VP Clinical Research & Operations