Eric Lange // Dymicron

Conducting an international Post-Market Clinical Follow-Up (PMCF) study with the UNITY platform

Challenge

Designing, setting up, and conducting a PMCF that highlights the unique biomechanical features of a cervical total disc replacement device.

Solution

Using the UNITY platform as a comprehensive EDC system combined with RAYLYTIC’s imaging core lab.

Outcome

High quality radiographic & clinical outcome data and happy site-level users.

Excerpt

Dymicron is an American medical device manufacturer focused on minimizing the generation of harmful wear debris in spine and orthopedic arthroplasty devices by utilizing their proprietary formulation of polycrystalline diamond for the implant bearing surfaces.

At the forefront of their total joint replacement innovation is the Triadyme®-C cervical total disc replacement device. For their PMCF study of the Triadyme®-C, they used the UNITY platform and RAYLYTIC’s imaging core lab services to gather safety and efficacy data as well as evaluate device performance with highly precise image analysis.

Challenge: Designing and conducting a PMCF study

In the European Union, post-market clinical follow-up (PMCF) is an integral part of post-market surveillance (PMS) activities for manufacturers of certain classes of medical devices.

The now effective Medical Device Regulation (MDR; EU 2017/745) sets out detailed requirements for PMS and PMCF. Compared to the Medical Device Directive (MDD), the MDR’s regulatory predecessor, the MDR is considered to put device manufacturers under more pressure to maintain vigilance throughout a device’s lifetime.

Understanding the MDR’s more stringent requirements, US-based spinal arthoplasty device manufacturer Dymicron needed a comprehensive PMCF data collection strategy for its flagship Triadyme®-C compact cervical disc replacement.

“To realize such a significant project, it was critical to find a partner that combined subject matter expertise in medical imaging, excellent data collection technology, and unwavering client support,” Eric Lange, VP of Research & Development at Dymicron, shared.

Solution: Imaging core labs services and the UNITY platform for PMCF

Working with RAYLYTIC’s experts, Eric and his team at Dymicron were able to design a comprehensive data collection strategy that highlighted the unique biomechanical advantages of the Triadyme®-C disc.

“It was obvious that quality, consistency, and efficiency were the driving ideas behind each feature in the UNITY platform."

– Eric Lange, VP of Research & Development at Dymicron

Comprehensive radiographic evaluation protocol (REP)

This involved, on the one hand, creating the study’s very robust radiographic evaluation protocol (REP) taking advantage of RAYLYTIC’s world-class imaging analysis software. To bolster the device’s safety and efficacy profile, several new parameters – like heterotopic ossification, changes in disc height, and movement of the discs center of rotation – were incorporated. All these measurements are conducted independently and in-house by RAYLYTIC’s team of imaging experts and board-certified radiologists.

As Eric puts it, “It has been exhilarating to witness the development of the study, from its initial design to the cutting-edge advancements in our REP. By using RAYLYTIC’s highly precise image measurement software, we have been able to collect biomechanical data on our disc that have never before been measured in this type of study.”

Where the strategy really came to fruition was the UNITY platform. With the platform’s front-to-back emphasis on data quality and security, Eric and Dymicron could approach data collection with confidence.

Site-friendly technology

On the clinical site level, Dr. Ardeshir Ardeshiri, a neuro-spine surgeon at Wilhemsburger Hospital Gross-Sand in Hamburg, Germany has praised the uncomplicated upload of images without the need for additional third-party software. Combined with the platform’s intuitive approach to data capture—where only complete data sets are savable—this functionality helps Dr. Ardeshiri compile 360°-outcome data from his patients.

As he says, “The main advantage of UNITY is the ability to automatically sort images to the correct follow-up time points. This feature saves medical staff, such as study nurses, countless hours of sorting images to different folders before upload.”

Additional functionalities instrumental to realizing Dymicron’s PMCF strategy have been:

Easy-to-use patient-reported outcome measures
Secure and accurate imaging data collection
Seamless connection to RAYLYTIC’s imaging core lab for image analysis
GDPR-compliance
AI-based image classification and analysis

“It was obvious that quality, consistency, and efficiency were the driving ideas behind each feature in the UNITY platform. The relentless focus on quality, both in the UNITY platform and through RAYLYTIC’s team, has been nothing short of impressive,” Eric remarked.

Outcomes: Efficient outcome data collection for PMCF

For Eric, collecting clinical and radiographic outcome data in a singular platform has been a major relief. The adoption of the UNITY platform for Dymcron’s PMCF study has resulted in high-quality data, excellent patient participation, and efficient imaging data collection and analysis.

Together, these individual successes have culminated into a complete depiction of device safety and efficacy. Radiographic data can be used to support clinical outcomes, patient satisfaction – a testament to the power of innovation — and data-driven technology when harnessed for the betterment of healthcare practices.

Furthermore, Eric and Dymicron have been particularly impressed with the tailored support they have received from RAYLYTIC.

“The UNITY system itself is fantastic, but what makes it so much better are the people behind it."