Device Design

Medical Device Concept Development & Design

Sanner transforms your ideas into market-ready medical devices with early-stage design and concept development services. Our solutions are purpose-built for manufacturability, regulatory compliance, and scalable production—reducing development risks and accelerating your path to commercialization.

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Our Design Centers of Excellence drive early-phase innovation across diagnostic devices, combination products, drug delivery systems, and medical devices. We blend user-centered design with engineering rigor to ensure clinical effectiveness, technical feasibility, and regulatory compliance.

Concept Development & Feasibility
 

Turning a medical device idea into a manufacturable solution begins with focused research, creative exploration, and rigorous technical evaluation. Sanner applies user research, early sketching, prototyping, and technical reviews to transform early concepts into validated, production-ready designs. Our process aligns with key regulatory frameworks such as ISO 13485 and FDA Quality System Regulations from the outset.

 

Early-Stage Design Services

Sanner offers a full range of early-phase design services to help bring concepts to life. These offerings support efficient product development from initial exploration through to manufacturing readiness. Key areas of focus include:

Successful devices start with the people who use them. At Sanner, usability is built into every design stage to ensure safe, intuitive use in clinical and home settings. Our human factors and industrial design teams work together from the start to align form and function across all device types.

We create intuitive user experiences that connect device interaction with supporting digital tools, improving continuity across treatment and increasing patient adherence.

Our sustainable-design strategies reduce environmental impact while meeting performance, usability, and compliance goals. We evaluate materials, production practices, and packaging from both regulatory and sustainability perspectives.

Our teams include physics, electronics, software, and materials science specialists. This technical depth enables rapid, cross-functional evaluation of early concepts and feasibility.

Sanner integrates scientific rigor, robust design controls, and regulatory alignment into every project. We conduct early testing, such as bench testing and formative usability studies, alongside technical reviews to proactively identify and resolve risks. Our process is fully aligned with ISO 13485 and FDA standards, ensuring a smooth transition from concept to engineering transfer.

We support product portfolio planning, technology scouting, and early technical reviews across drug delivery systems, diagnostics, combination products, and connected health devices.

Integrated Industrial Design

Industrial design is fully integrated into Sanner’s development process. From early sketching and prototyping to feasibility studies and refinement, our design and engineering teams work in parallel to balance user needs with technical requirements. The result is streamlined development with fewer redesign cycles and solutions ready for manufacturing.

 

End-to-End Design for Manufacturability

Concept development is a core part of Sanner’s CDMO model. Every design reflects manufacturability, scalability, and regulatory approval from the start. With design, engineering, and manufacturing all within one global system, we help clients move from concept to clinical trial with fewer handoffs and greater efficiency.

Learn more about Engineering Development 

Learn more about Human Factors 

 

Ready to Accelerate Your Medical Device Development?

Whether you're launching a new concept or preparing for clinical trials, Sanner's design, engineering, and regulatory experts help you move faster, reduce risk, and get manufacturing ready. Contact us today to discuss your project and discover how we can support your next phase.