From Animal Studies to First-In-Human Success
Welcome back to our three-part series on how MDS brought a mitral valve heart implant from concept to clinical-stage testing. In Part 1, we covered the design, development, and preclinical planning. Now, we turn to the next phase: rigorous preclinical testing and the transition to First-In-Human trials.
Testing and Evaluation: From Lab to Clinic
Before human studies could begin, the implant underwent an extensive preclinical evaluation program. Over the course of 150 animal experiments, we tested the implant’s biocompatibility, mechanical durability, and functional performance under realistic physiological conditions. These tests were instrumental in refining the implant’s design and optimizing its delivery system.
MDS was directly involved in managing not just the testing protocols, but also the handling and preparation of animal models used during clinical trials—ensuring animal welfare and scientific rigor throughout. At this stage, we also developed a comprehensive Clinical Evaluation Plan (CEP) to define the objectives, methodologies, and safety endpoints required for ethical progression to human trials.
Clinical Evaluation: From First-In-Human to Iterative Refinement
Following successful preclinical results, the implant progressed to human clinical studies. In close collaboration with our clinical partners, we evaluated the device’s performance in real-world procedures, focusing on both short- and long-term safety and efficacy.
This phase emphasized continuous learning: healthcare professionals provided critical feedback during live cases, while our clinical team monitored each procedure, ensured data quality, and oversaw ongoing risk management. The resulting insights were documented in a detailed Clinical Evaluation Report (CER)—a key part of our regulatory submission process.
Building a Compliant and Scalable Quality System
While developing the heart implant, we simultaneously built and implemented our company’s Quality Management System (QMS). This system was established in line with ISO 13485, ISO 9001, and ISO 14001 standards, and designed from the ground up to also meet MDSAP (Medical Device Single Audit Program) requirements.
In our next post
We’ll cover how our technical documentation, regulatory alignment, and global strategy are supporting our progress toward CE marking and global market readiness. If you’re interested in hearing more, you can also book a meeting with us to discuss how we could help your product design!
