We guide the development and launch of biomedical innovations through our product strategy. We explore the clinical need, generate product ideas, refine and select product concepts, and integrate them into a cohesive product brand strategy.

• Brainstorming & Ideation
• Concept Generation
• Concept Evaluation
• Concept Refinement & Selection
• Product Brand Strategy

We support the development and protection of intellectual property. During our work, we describe device concepts in a memo with sufficient detail to serve as an invention disclosure, and we support patent applications. When necessary, we conduct or support a freedom-to-operate analysis to help determine limits on device concepts.

• Invention Disclosures
• Patent Application Support
• Freedom-to-Operate

We develop practical and successful device designs. When necessary, we perform or oversee human factors studies to help drive the device's requirements, including ergonomics, aesthetics, and user experience. We align our design iterations with product brand strategy refinements.

• Human Factors
• Industrial Design

We bring together the engineering concentrations necessary to design and develop medical devices successfully. This includes mechanical engineering, electrical engineering, systems engineering, software engineering, and process engineering to support Design for Manufacturability (DFM).

• Mechanical Engineering
• Electrical Engineering
• Systems Engineering
• Software Engineering
• Process Engineering
• Materials Engineering
• Packaging & Labeling Design

We design, build, and test prototypes to support our design and development work. This includes prototype builds for feasibility, design, verification, validation, and appropriate testing.

• Feasibility Prototypes
• Design Prototypes
• Verification & Validation Prototypes

We support the quality and regulatory needs of each program under design controls per our quality management system. We conduct formal design review meetings throughout each program, complete risk management activities, and control all documentation in a project file or a design history file, depending on the quality system used.

• Design Review
• Risk Management
• Quality Management Support
• Regulatory Support

We provide testing to support the design and development of medical devices, including biocompatibility, feasibility, verification, and validation testing. We will utilize external testing laboratories when necessary.

• Biocompatibility
• Feasibility Testing
• Verification Testing
• Validation Testing

We provide complete sourcing support for design and development programs. This includes sourcing, selecting, and managing suppliers for equipment and tooling, components and raw materials, and necessary third-party services.

• Equipment & Tooling
• Components & Raw Materials
• Third Party Services

We support the development, sourcing, and validation of sterilization services. We work with external partners to develop new sterilization cycles or adopt existing cycles into our programs.

We ensure project success through our program management methodology and team. Our program management team is responsible for project planning and execution, proactive communication, and day-to-day task management.

• Project Plan
• Development Plan
• Reporting
• Documentation