WELCOME TO LUATH MEDICAL
About Us
My name is Seán Waldron, Senior Design Engineer and Managing Director of Luath Medical. Background education in Biomedical Engineering with over 10 years of experience in medical device design, development, and manufacturing, with a focus on implantable and minimally invasive technologies.
Through Luath Medical, we partner with innovators to turn concepts into safe, effective medical devices. By combining deep technical expertise with a practical, patient-focused approach, we help streamline development, ensure compliance, and accelerate time to market—enabling clients to grow with confidence while keeping patient outcomes at the forefront.
MEDICAL DEVICE DESIGN SERVICES
Concept • Design • Prototyping • Verification
Our Services
Luath Medical provides expert design, development, and compliance support for medical devices—tailored to startups and growing teams. Get in tough to discuss your needs.
Concept Development & Early Feasibility
➜ Concept refinement & problem framing
➜ Translating clinical insight into technical requirements
➜ Sketches, mockups, and early prototyping
➜ Concept benchmarking and risk-based design planning
Mechanical & Product Design
➜ Detailed CAD design and 3D modeling
➜ Design for manufacturing (DFM) and design for assembly (DFA)
➜ Design of implantable devices and delivery systems
➜ Mechanism design for minimally invasive tools
Prototyping & Material Selection
➜ Material selection
➜ Guidance on process capabilities
➜ Test fixture and jig design
➜ Rapid iteration and bench-level evaluations
➜ Design validation of prototypes against user needs
Specification Development & Acceptance Criteria
➜ Develop detailed device, sub-assembly, and component specifications
➜ Define mechanical, dimensional, material, and performance criteria
➜ Create specifications suitable for suppliers capabilities
➜ Outline requirements for DV Testing and regulatory documentation
Verification, Validation & Testing Strategy
➜ Test method development and documentation
➜ Design input/output traceability
➜ Protocol and report generation
➜ Design freeze preparation
Design Consulting & Team Support
➜ R&D support for startups
➜ Independent design reviews
➜ Cross-functional project support (design, QA/RA, manufacturing)
➜ Interim engineering leadership during growth phases
Ready to move your project forward?
