From Concept to Preclinical Readiness
At MDS, we transform innovative ideas into market-ready medical devices. One standout example is our heart implant project—a journey that carried a complex concept from early design through verification, validation, and ultimately to First-In-Human use. This work highlights our dedication to technical excellence and showcases our capabilities in quality management, regulatory navigation, and clinical execution.
A Vision Turned Reality
The heart implant was born out of a clear clinical need: a safer, more effective solution for patients undergoing mitral valve repair. From the beginning, our cross-functional team—spanning engineering, regulatory affairs, and clinical expertise—worked in close alignment to develop a system that addressed both the technical and procedural challenges.
We didn’t just design the implant. We also created tailored sizing and delivery instruments to ensure anatomical fit and procedural precision. These tools included installation aids and a complete set of accessories, all designed in-house to support consistent and reliable delivery in the clinical setting.
Structured Design and Development Approach
Our development phase began with extensive research to identify the most appropriate animal model and delivery approach. Leveraging both customer-provided literature and broader scientific sources, we built a strong knowledge base to support our design decisions. We selected biocompatible materials suitable for long-term implantation and sourced qualified suppliers capable of working with them.
Ensuring that every manufacturing partner could meet our standards was critical. Through international supplier scouting, detailed technical assessments, and ongoing auditing—both initial and annual—we validated each subcontractor’s capabilities, maintaining strict compliance with standards such as ISO 13485.
In our next post
We’ll take you through how our implant transitioned from the lab to real-world performance—beginning with extensive preclinical studies and advancing into First-In-Human clinical trials. If you’re interested in hearing more, you can also book a meeting with us to discuss how we could help your product design!