{"id":884,"date":"2025-11-17T14:58:15","date_gmt":"2025-11-17T14:58:15","guid":{"rendered":"https:\/\/wptest.raylytic.com\/?page_id=884"},"modified":"2026-01-12T11:54:56","modified_gmt":"2026-01-12T11:54:56","slug":"case-study-dymicron-pmcf-2","status":"publish","type":"page","link":"https:\/\/www.raylytic.com\/en\/references\/case-study-dymicron-pmcf-2\/","title":{"rendered":"Case Study Dymicron PMCF"},"content":{"rendered":"\t\t
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Eric Lange \/\/ Dymicron<\/h4>\t\t\t\t<\/div>\n\t\t\t\t
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Conducting an international Post-Market Clinical Follow-Up (PMCF) study with the RAYLYTIC Platform<\/b><\/h1>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Challenge<\/b><\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Designing, setting up, and conducting a PMCF that highlights the unique biomechanical features of a cervical total disc replacement device.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Solution<\/b><\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Using the RAYLYTIC Platform as a comprehensive EDC system<\/a> combined with RAYLYTIC’s imaging core lab.<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Outcome<\/b><\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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High quality radiographic & clinical outcome data and happy site-level users.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Excerpt<\/b><\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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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.\u00a0\u00a0<\/p>

At the forefront of their total joint replacement innovation is the Triadyme\u00ae-C cervical total disc replacement device. For their PMCF study of the Triadyme\u00ae-C, they used the RAYLYTIC Platform and RAYLYTIC\u2019s imaging core lab services to gather safety and efficacy data as well as evaluate device performance with highly precise image analysis.\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Challenge: Designing and conducting a PMCF study <\/b><\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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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.<\/p>

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\u2019s regulatory predecessor, the MDR is considered to put device manufacturers under more pressure to maintain vigilance throughout a device\u2019s lifetime.<\/p>

Understanding the MDR\u2019s more stringent requirements, US-based spinal arthoplasty device manufacturer Dymicron needed a comprehensive PMCF data collection strategy for its flagship Triadyme\u00ae-C compact cervical disc replacement.<\/p>

\u201cTo 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,\u201d Eric Lange, VP of Research & Development at Dymicron, shared.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Solution: Imaging core labs services and the RAYLYTIC Platform for PMCF <\/b><\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Working with RAYLYTIC\u2019s 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\u00ae-C disc.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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\u201cIt was obvious that quality, consistency, and efficiency were the driving ideas behind each feature in the RAYLYTIC platform.\"<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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– Eric Lange, VP of Research & Development at Dymicron<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Working with RAYLYTIC\u2019s 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\u00ae-C disc.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Comprehensive radiographic evaluation protocol (REP)<\/h5>\t\t\t\t<\/div>\n\t\t\t\t
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This involved, on the one hand, creating the study\u2019s very robust radiographic evaluation protocol (REP) taking advantage of RAYLYTIC’s world-class imaging analysis software. To bolster the device\u2019s safety and efficacy profile, several new parameters \u2013 like heterotopic ossification, \u00a0changes in disc height, and movement of the discs center of rotation \u2013 were incorporated. All these measurements are conducted independently and in-house by RAYLYTIC\u2019s team of imaging experts and board-certified radiologists.<\/p>

As Eric puts it, \u201cIt has been exhilarating to witness the development of the study, from its initial design to the cutting-edge advancements in our REP. \u00a0By using RAYLYTIC\u2019s 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.\u201d<\/p>

Where the strategy really came to fruition was the RAYLYTIC platform. With the platform\u2019s front-to-back emphasis on data quality and security, Eric and Dymicron could approach data collection with confidence.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Site-friendly technology<\/h5>\t\t\t\t<\/div>\n\t\t\t\t
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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\u2019s intuitive approach to data capture\u2014where only complete data sets are savable\u2014this functionality helps Dr. Ardeshiri compile 360\u00b0-outcome data from his patients.<\/p>

As he says, \u201cThe main advantage of RAYLYTIC 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.\u201d<\/p>

Additional functionalities instrumental to realizing Dymicron\u2019s PMCF strategy have been:<\/p>