Triple Ring’s team has extensive experience with drug/device combination products spanning ideation through large scale manufacturing. Our drug delivery domain expertise includes minimally invasive delivery methods such as needle-free injectors; infusion pump drug delivery systems; and pulmonary delivery via DPI’s, nebulizers, pMDI’s, and critical care systems for breath coordinated delivery of systemic and topical therapeutics.

Our team can also help you solve compatibility challenges between the device, drug formulations, and materials safety. Our regulatory experts help our customers navigate the complex approval pathway for combination products, prepare content for IDE/NDA filings, and assemble your device and product characterization content for regulatory filings.

• Feasibility Analysis
  • Technical and competitive analysis
  • Modeling and simulation
  • Risk analysis
• Proof of concept engineering
  • Prototype device and dosage form
        design and fabrication
  • Product definition development
  • Test and product characterization
        equipment design
  • Formulation compatibility guidance
  • Materials safety and selection

• Product requirements documentation
• Product design
  • Mechanical and electromechanical
        design
  • Human factors and industrial design
  • High volume plastic and metal
        components
  • Disposables design
  • Design for Manufacturing
• Complete risk management
• Validation and verification

• FDA OCP regulatory strategy
• ISO 13485-compliant documentation

• IDE, 510(k), PMA and CE mark submissions
• IDE/NDA filing content