Last year, we shared a three-part series on the development of a heart implant, following the journey from early design through clinical evaluation and regulatory preparation.
In this series, we turn our attention to another critical part of that work: catheter-based development and the delivery systems that enable minimally invasive treatments in practice.
While the implant itself often receives the most attention, its success depends just as much on how reliably and precisely it can be delivered.
Designing as a complete system
In catheter-based projects, development cannot be approached as a single-component task. From the beginning, this work was treated as a system-level challenge, combining the implant, delivery catheter, and supporting instruments into a unified solution.
MDS was involved directly in the design process, contributing not only to the device itself but also to the accessory components required for controlled and consistent deployment. Material selection formed a central part of this work, balancing biocompatibility, mechanical performance, and manufacturability while ensuring alignment with regulatory expectations.
By addressing these elements together, the project was able to move forward with a clearer connection between design decisions and clinical use.
Establishing a validated development foundation
Early in the project, significant attention was placed on building a reliable supply and production foundation.
All subcontractors were carefully selected and validated through structured assessments and audits. The focus extended beyond technical capability to include quality system maturity and the ability to operate within regulated environments. This ensured that each partner could support both development and future production requirements.
At the same time, MDS contributed to designing the broader production chain, aligning materials, suppliers, and processes into a coherent structure that could support scaling later on.
Iterative development with clinical perspective
Development progressed through iterative cycles, where design refinements were continuously informed by both technical evaluation and clinical considerations.
Rather than separating engineering and clinical thinking, these perspectives were closely aligned throughout the process. This helped ensure that usability, delivery precision, and device performance evolved together, reducing the gap between development and real-world application.
MDS supported this work not only through design activities but also as an active partner in shaping the overall development approach.
Preclinical work as part of development
Following initial development, the project moved into preclinical studies.
MDS was involved throughout this phase, supporting study planning, participating in the execution of animal studies, and contributing to the regulatory preparations required for preclinical work. These studies were arranged in line with Good Laboratory Practice (GLP), ensuring both scientific rigor and regulatory acceptability.
Importantly, the role was not limited to observation. Technical and procedural feedback was actively collected during these studies and fed back into development. This made preclinical evaluation a continuation of the design process rather than a separate validation step.
Building toward clinical readiness
By the end of this phase, the project had established a strong and validated foundation. The device and delivery system had been refined through iterative development and tested in preclinical environments, while the supply chain and production structure had been carefully aligned.
Just as importantly, development had been approached as a continuous process, linking design, manufacturing, and clinical use from the outset.
Stay tuned
In the next post, we will look at how this work progressed into process validation, clinical studies, and regulatory interaction, and what is required to move from development into real-world use. You can also reach out to explore how MDS can support your next medical device breakthrough at Kristian@mdsdenmark.dk or via Book a Meeting.