WELCOME TO LUATH MEDICAL
About Us
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 marketenabling 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?
