The Incipio Devices contract development model is to assemble a core team of experienced design and development resources focused on the orthopedic space.
The core team approach allows Incipio Devices to provide a self-sufficient group resource that internally manages personnel and skill sets to most effectively deliver on stated objectives. Each member of the team has the background and talent to drive all aspects of product development and launch. For any given project, Incipio Devices will leverage the combined resources of the core team to support the project needs.
• All elements of Design Assurance within a variety of quality systems
• 3D modeling, component, and assembly drawings
• Engineering design with consideration of human factors
• Mechanical testing and finite element analysis simulation
• Project management
• Test method development and statistical analysis
• Internal manufacturing resources for prototyping, design for manufacture, and production
• Regulatory clearance including 510(k) and CE marking
• Implant and instrument projects for hip, knee, spine, extremity, and sports medicine solutions
• Project partnership directly with surgeons, entrepreneurs, and small to large orthopedic companies
• Combined experience taking hundreds of devices from concept to clearance for sale within the US and internationally
• Familiarity with large OEM procedures and systems