We explore the clinical need, generate and evaluate product ideas, and refine and select the concepts worth moving into design and development. We document and protect the intellectual property created along the way, including invention disclosures, patent support, and freedom-to-operate analysis.

We develop practical, human-centered device designs. We conduct human factors studies to drive requirements for ergonomics, aesthetics, and user experience, and we align design iterations with the product’s commercial strategy.

We bring together mechanical, electrical, systems, software, and process engineering to design and develop complex medical devices. We support Design for Manufacturability (DFM), along with packaging, labeling, and sterilization development.

We design, build, and test prototypes at every stage of development, from feasibility through verification and validation. We use each build to refine the design and resolve risks early.

We support the quality and regulatory needs of each program under design controls. We conduct formal design reviews, complete risk management activities, and maintain documentation in a project file or design history file.

We provide biocompatibility, feasibility, verification, and validation testing to support design and development. We use external testing laboratories when necessary.

We source, select, and manage suppliers for equipment and tooling, components and raw materials, and third-party services across every design and development program.