Monika Lehmann // Mathys AG Bettlach
Clinical data management with the UNITY Platform
Challenge
Collecting and managing patient-reported outcomes (ePROs), case report forms (CRFs), and radiographic imaging data in a single clinical data management platform.
Solution
Mathys uses the UNITY platform as a comprehensive clinical data management solution.
Outcome
Mathys is expanding their commitment to evidence-based medicine with remarkably complete data sets.
Excerpt
Mathys AG Bettlach, a Swiss-based orthopedic implant manufacturer, is dedicated to improving patient outcomes by designing solutions to complex clinical problems.
Challenge: Capturing patient and radiological outcomes in a single clinical data management platform
Medical device manufacturers, and especially orthopedic implant manufacturers, face a unique challenge: efficiently gathering data that demonstrate the scientifically backed performance, efficacy, and safety of their product as well as sustainable implant performance.
Many clinical data management systems on the market today can’t do both. They specialize in narrow subsets of clinical and patient-reported data and often lack the functionality to capture and manage the diverse types of data device manufacturers require for product development and regulatory compliance. It is not uncommon for clinical study coordinators to have to manually transfer data between multiple clinical data management systems, which poses risks to data integrity and can cause countless administrative headaches.
Mathys' requirements
Mathys was therefore looking for an all-in-one EDC system and imaging core lab services that would generate insights into the relationship between hip implant positioning and patient outcomes.
By handling patient questionnaire data as well as highly precise radiological analyses, they needed to do what most EDC systems cannot.
Additional criteria for the Swiss implant manufacturer were a solid reputation in the medical technology industry, an outstanding degree of regulatory and patient data protection, and an intuitive user interface.
Solution: UNITY platform as a comprehensive clinical data management tool
Mathys found a solution to this challenge in RAYLYTIC’s cloud-based UNITY platform. Today, UNITY’s questionnaire collection and medical imaging analysis modules allow Mathys to gather the diverse data they need.
Capturing patient outcomes
With the module “UNITY Outcome”, clinic sites can easily conduct and evaluate standardized ePRO questionnaires, while the Questionnaire Designer feature allows Mathys to develop unique CRFs. The questionnaires can then be administered via a user-friendly interface, and scores are automatically tabulated and integrated into neatly arranged overviews.
"RAYLYTIC is a partner we can grow with."
– Monika Lehmann, Mathys Bettlach AG
Fully automated analysis of radiographic parameters
Sites also have the option to upload imaging data from their clinic’s picture archiving and communication system (PACS) directly to the cloud-based platform. Once the DICOM files are uploaded, Mathys can then rely on RAYLYTIC’s Imaging Core Lab to conduct highly precise and accurate measurements of complex radiographic parameters of hip arthroplasty.
For instance, Mathys utilizes RAYLYTIC’s RayMatch method to measure anteversion and inclination in their hip endoprostheses in order to evaluate the result of cup positioning on the outcomes of hip arthroplasties.
With CAD data provided by Mathys, RayMatch automatically assesses the position and orientation of implant components using a 2D-3D registration technique.1 These results are highly precise and accurate, so Mathys receives the best possible overview of implant performance.
When it comes to other complex radiographic parameters Mathys wants to have measured, like leg length difference and hip-stem migration, the images uploaded to UNITY are processed with RAYLYTIC’s Functional X-Ray Analysis (FXA) software.
Outcomes
Complete data sets and study reports
With UNITY, Mathys has access to highly complete data sets and 1:1 study reports.
The study overview module makes it simple for Mathys to track results in real time. Here they can easily identify if and where any questionnaire or imaging data are missing. Maintaining this overview helps ensure that data sets remain complete and organized.
The data can then be compiled into quarterly study reports that can be directly distributed to clinical sites, where they can be used to identify and correct missing data points, images, and questionnaires.
Building a commitment to evidence-based medicine
In increasingly competitive markets and stringent regulatory landscapes, device manufacturers need a way to easily collect data that demonstrate the long-term safety, efficacy, and performance of their products. UNITY simplifies building a commitment to evidence-based medicine, helping Mathys fulfill strict regulatory requirements and gather valuable data to use in product development.
1 Haversath, M., Klebingat, S., die VITAS-Gruppe. et al. Abriebanalyse mit virtuellen CAD-basierten Röntgenaufnahmen in der Endoprothetik. Orthopäde 47, 811–819 (2018).