Learn More About Our Medical Device Expertise

For your convenience, our white papers, overviews and fact sheets can be accessed here.

 

Unlocking Regulatory Complexities for Combination Products

The Key to Combination Product Success The shifting borders among traditional drugs, biologics and medical devices are poised to produce safer and more effective combination products that offer new diagnostic and treatment options for patients. But such novel combination products … Read More

Innovations in Heart Valve Technology

New Device Technologies Influence Treatment Options and Clinical Trials Choosing valve repair or replacement for most patients relies on the clinical judgement of their cardiologist and cardiac surgeon based on factors including overall health, the valve in question, and the … Read More

Clinical Study Requirements: Drugs vs. Devices

Understanding the Key Differences in the Clinical Trial Process Whether developing a new drug or medical device, designing and running clinical trials can be daunting. How drugs and devices are developed differ dramatically. Study design and regulatory pathways differ; requirements … Read More

Success Criteria for Small Cardiovascular Medical Device Sponsors

Seven Tips for More Effective Cardiovascular Device Trials The increasing cardiovascular patient population, regulatory and payer demand for improved and cost-efficient patient outcomes and evolving technologies are driving innovation, especially among small and mid-sized cardiovascular device companies. This paper examines critical … Read More

Medical Device Overview

As a specialty medical device CRO, we have gained a comprehensive understanding of the distinct needs and requirements of clinical device development programs. Our approach provides medtech companies both personalized regulatory consulting – critical early in the development phase – as … Read More

Best Practices in Outsourcing Medical Device Clinical Trials

The Roadmap to Outsourcing Medical Device Trials Consider this a roadmap for both large and small medical device companies looking to outsource clinical trials. Utilizing external resources can be attractive to device manufacturers due to both the financial and operational … Read More

Medical Device Cardiovascular Overview

Novella Clinical’s core competency and therapeutic specialty is in cardiovascular device trials — comprising more than 50 percent of our medical device portfolio. Our specialized project teams consist of device-industry trained professionals with experience in sponsor, hospital and regulatory agency … Read More

Medical Device Orthopedic Overview

Our specialized project teams consist of device-industry trained professionals. We understand the unique nuances of orthopedic and neurological device development programs. Download this resource to understand why Novella has earned preferred vendor status with several of the world’s largest medical device companies.