Learn More About Our Medical Device Expertise

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

 

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

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 focus areas for companies seeking to launch or expand … Read More

Clarifying the Regulatory Road for Combination Products

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 pose numerous regulatory hurdles for sponsors, … Read More

Medical Device Development: A Pathway to Harmonization

The global medical device industry is facing strengthening competition, rapid technological innovation and increasing regulatory scrutiny while growing at an impressive rate. This paper provides an overview of the current premarket device development arena and global harmonization of medical device … Read More

Best Practices in Outsourcing Medical Device Clinical 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 flexibility of various outsourcing models and the … Read More