Medical device & diagnostics research case studies

Explore our library of case studies for medical device and diagnostics research solutions.

Explore this library to learn how our dedicated team at ICON can assist with all phases of your clinical trial development and testing by supporting you in designing, implementing and managing clinical trials for your devices, diagnostics and combination devices, to successfully bring your product to market, faster.

Supporting an ANDA submission for a drug-device product

A Canadian mid-size pharma company partnered with ICON to support FDA approval of a generic injectable for opioid overdose treatment. ICON’s Regulatory Affairs team guided the sponsor through the ANDA process, including pre-submission, filing, and responding to FDA review queries.

Streamlining clinical operations

ICON successfully streamlined clinical operations during a post-market registry study by adapting sponsor SOPs mid-study, enabling a seamless transition to ICON-led project management while maintaining operational continuity and site performance.

Partnering to provide vital regional support on a global medical device study

ICON was selected as a European partner CRO for a drug-coated balloon device study, supporting regulatory services, study start up and monitoring activities, and safety reporting service for study sites located across Europe. The device consequently received CE Mark certification and FDA approval.

Ensuring consistent source data monitoring for a global cardiology study

This global, double-blind cardiology study evaluated an atrial shunt’s impact on quality of life and heart failure symptoms in 260 patients. Conducted over 4.5 years at 66 sites, it included a crossover option and five-year follow-up.

Collaborating to improve monitoring visit trip reports

A global, multi-centre trial is evaluating cardiac radioablation (CRA) vs. repeat catheter ablation for high-risk VT patients. Spanning 7.5 years, the study involves 380 randomized patients across 20+ sites in the U.S., U.K., and Germany.

Resolving patient recruitment issues in an oncology study

A large multi-year IVD colorectal cancer study faced enrolment challenges across 180+ sites and 28,000 participants. The sponsor turned to ICON’s Medical Device and Diagnostic Research team to uncover root causes and implement effective recruitment solutions.

Immune assay for thyroid diseases

A top medical device maker partnered with ICON to validate a new immune assay. The study aimed to collect serum samples from up to 760 U.S. patients with various thyroid and autoimmune conditions to demonstrate assay performance.

Overcoming under-enrolment for an assay study on neonate sepsis

A two-year non-interventional study evaluated an interleukin assay for diagnosing neonatal sepsis. Over 500 samples were collected across 24 U.S. sites, using control and treatment cohorts to assess biomarker accuracy and diagnostic performance.

Optimising resources on a portfolio of large scale oncology studies

ICON supported five global IVD studies on rapid colorectal cancer diagnosis, enrolling over 29,000 patients across 250+ sites. Each study had unique needs, and ICON managed key functions including project management, monitoring, data handling, and site oversight.

Eliminating enrolment delays to bring an AI-enabled SaMD to market

A medical device developer faced clinical evaluation timeline delays due to under-enrolment. Discover how the collaborative partnership between the sponsor and ICON’s Medical Device & Diagnostics Research team steered the study from patient enrolment to FDA submission and approval.