3Aware and MED Institute Form Strategic Partnership to Enhance RWE Generation for MedTech

August 6, 2025 - 3Aware, a leader in real-world evidence (RWE) solutions for the medical device industry, today announced a strategic partnership with MED Institute, a full-service contract research organization (CRO) with over 40 years of experience in medical device testing, clinical trials, and regulatory services.

This alliance brings together 3Aware’s fit-for-purpose RWE platform with MED Institute’s deep industry expertise to offer medical device manufacturers a streamlined and robust path to clinical evidence generation – from early feasibility studies through post-market surveillance. Together, the organizations will provide customers with a seamless experience, enabling faster and more cost-effective clinical studies and regulatory submissions under evolving global frameworks like EU MDR and FDA guidance.

“This partnership reflects 3Aware’s commitment to building a new standard for regulatory-grade evidence,” said William (Bill) Moss, CEO of 3Aware. “Our collaboration with MED Institute gives MedTech sponsors a unique advantage – uniting device-specific clinical data discovery and analytics with full-service CRO support to enable efficient, scalable evidence generation.”

“We’re excited to team up with 3Aware to provide manufacturers a comprehensive solution for clinical evidence,” said Steve Charlebois, President of MED Institute. “From feasibility to submission and post-market stages, we can now help clients leverage real-world data alongside our core services in study design, execution, and regulatory support.”

About 3Aware

3Aware created a fit-for-purpose analytic platform for the MedTech industry, combining data science and clinical science, to automate highest-quality clinical real-world evidence for Post-Market Clinical Follow-up (PMCF), Label Expansion, Marketing Assertions and more.

• 3Aware integrates real-world data sources such as EHRs and processes vast amounts of patient data, transforming the data into easily assessed patient outcome information.

• 3Aware pinpoints specific devices via UDI numbers and provides access to full patient EHR records, including unstructured notes.

• 3Aware enables MedTech companies to find longitudinal data for Class III implants and procedure-specific clinical evidence for label expansion opportunities.

• 3Aware reduces time and resources dependency, thus accelerating study timelines.

About Med Institute

MED Institute is a privately held contract research organization (CRO) with over four decades of experience supporting medical device manufacturers from early development through regulatory submission. The organization offers comprehensive services including engineering design and analysis, nonclinical and clinical testing (with more than 250 ISO/IEC 17025-accredited methods), biocompatibility evaluations, clinical study execution, data management, and regulatory strategy.

With deep technical expertise and a flexible, client-centered approach, MED Institute helps sponsors accelerate product development while ensuring compliance with FDA, EU MDR, and other global regulations. Their multidisciplinary team supports device manufacturers at every stage of the product lifecycle, from bench testing to clinical trials, helping to generate high-quality evidence that meets regulatory and scientific standards.