Finding a Sustainable Path Forward in Medical Device Regulation

A Conversation with Amelia Hufford, PhD, 3Aware Co-founder and SVP of Clinical and Regulatory

At the RAPS Convergence Conference, I sat down with Amelia Hufford, PhD , Co-founder and Senior VP of Clinical and Regulatory Science Operations at 3Aware , to explore a breakthrough approach to post-market clinical follow-up (PMCF). 3Aware is pioneering the use of real-world evidence (RWE) by leveraging electronic health records (EHRs) to streamline regulatory compliance for medical devices. Dr. Hufford shared the company’s mission and the transformative potential of their novel method, which is poised to reshape how manufacturers collect crucial post-market data.

Addressing a Critical Need

With over 20 years of experience in research and the medtech industry, Dr. Hufford has focused extensively on medical devices' regulatory and clinical science aspects. 3Aware was born from the challenges faced by manufacturers during the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) in the EU.?

Dr. Hufford explained, “We were struggling to find efficient, cost-effective ways to collect data for legacy devices, especially given the new MDR requirements.”

3Aware was founded to address this need by utilizing real-world data (RWD) collected from electronic health records (EHRs), allowing manufacturers to bypass traditional retrospective chart reviews and surveys. The company’s unique approach provides access to de-identified patient records, giving manufacturers deeper insights into the real-life performance of their devices.

A Unique Approach to PMCF Data Collection

Unlike traditional methods, 3Aware partners with health systems like the Mayo Clinic to collect structured and unstructured patient data, including operative notes, discharge summaries, and follow-up reports.?

“It’s like logging into the medical record itself, but everything is de-identified and connected to the specific device and procedure,” Hufford explained.?

This access allows manufacturers to analyze real-world data in a way that’s never been possible before.

By focusing on unstructured data, 3Aware ensures manufacturers receive the level of detail needed to meet regulatory requirements.?

Dr. Hufford emphasized, “You won’t get the kind of detail we’re interested in—such as device deficiencies or anatomy-specific safety signals—from payer codes or lab scripts. This is where unstructured data becomes critical.”

EHR-Based Real-World Evidence (RWE)

As Dr. Hufford emphasized in our conversation, the current regulatory landscape under the MDR has posed significant challenges, particularly around the sustainability of post-market surveillance for medical devices.?

“Finding a sustainable pathway forward is essential,” she said.?

For 3Aware, EHR data offers a viable solution to gather real-world evidence (RWE) more efficiently, which is crucial for maintaining regulatory compliance while minimizing the burden on clinicians and manufacturers.

She explained that while EHRs are not a one-size-fits-all solution for every device, they hold immense promise for a broad range of products, particularly class IIa and class IIb devices.?

“For a large swath of IIa and IIb devices, EHR data will be instrumental in creating sustainable, compliant pathways,” Dr. Hufford noted.

This is especially true for the larger manufacturers who dominate the market. “Most of the commonly used devices come from a few major players,” she explained. By integrating EHR-based data collection, these manufacturers can streamline their compliance processes, prioritizing innovation and safety.

Dr. Hufford also pointed out that, while class III implantable devices often require more rigorous clinical trials, the approach taken by 3AWARE can still play a significant role in post-market surveillance.?

“Class III devices will always require more hands-on data collection, but for many other devices, EHR-based real-world evidence is the key to a more sustainable path forward,” she added.

Access, Analysis, and Alerts

The name “3Aware” reflects the company’s core focus areas: Access, Analysis, and Alerts.?

“First, we provide access to a treasure trove of real-world data. Then, we help manufacturers analyze this data to identify trends, safety signals, and off-label use. Finally, we alert manufacturers to these findings, ensuring timely and informed decision-making,” Hufford said.

This streamlined process removes many of the barriers manufacturers typically face, such as the time and cost associated with contracting clinical sites, obtaining patient consent, and coordinating studies across multiple locations.

A Sustainable Path Forward for European and U.S. Manufacturers

While 3Aware is currently focused on U.S. health systems, the company plans to expand into Europe, though the fragmented nature of the healthcare systems there presents challenges.?

“There’s a misconception that MDR requires data to come from Europe. In reality, data from the U.S. can meet European needs as long as it’s relevant, reliable, and transferable,” Dr. Hufford noted.

3Aware’s plans also include expanding beyond large academic institutions to include data from more rural community hospitals, where most real-world medicine occurs.?

“We want to enrich our data set to include patients from non-academic institutions because that’s where medicine really happens,” she added.

The Future of Real-World Data in Medical Devices

Dr. Hufford is optimistic about the future of real-world data in medical device regulation.?

She believes that 3Aware’s approach to data collection is key to making PMCF sustainable for manufacturers, particularly as regulatory requirements continue to evolve.?

“We’re providing manufacturers with a sustainable, scalable solution to meet post-market surveillance requirements without overburdening clinicians or the healthcare system,” she said.

In an industry grappling with unsustainable regulatory demands, 3Aware offers a pathway forward, ensuring both compliance and innovation can thrive.

To learn more about 3Aware , visit RAPS Booth 731 or contact Amelia Hufford, PhD , to request her slide presentation and case study.