Abstract
Sensile Medical AG, a Switzerland-based medical device company, develops innovative rotary pumps for highly precise dosing and delivery of liquids. As the company expanded its product portfolio and faced stringent medical device requirements, it needed an integrated digital development environment to manage complex geometries, simulation, manufacturing, product data, and regulatory compliance. By adopting Siemens’ Solid Edge, Simcenter Femap, NX CAM, and Teamcenter solutions, Sensile Medical established an end-to-end digital platform that improved product development, data management, collaboration, and manufacturing processes while supporting continued business growth and compliance with international medical device standards.
Key Takeaways:
- Integrated product development platform: Siemens software connected CAD, simulation, manufacturing, and product data management within a comprehensive digital environment.
- Complex medical device design: Solid Edge provided advanced surface creation capabilities required to model the complex geometry of Sensile Medical’s rotary pump components.
- High-precision manufacturing: The compact injection-molded components required manufacturing accuracy within hundredths of millimeters, supported by the company’s digital engineering processes.
- Advanced simulation capabilities: Simcenter Femap enabled simulation as part of the product development process, supporting engineering analysis of innovative medical devices.
- Streamlined manufacturing: NX CAM supported numerical control programming and provided a direct connection between product design and manufacturing activities.
- Centralized product data management: Teamcenter provided a scalable PDM/PLM environment, allowing different user groups to access product information from a centralized system.
- Improved regulatory compliance: Teamcenter helped Sensile Medical manage data in accordance with stringent medical device standards, including ISO 13485, FDA/cGMP 21 CFR 820, IEC 62366, and ISO 14971.
- Enhanced collaboration and traceability: Customizable workflows, controlled user authorizations, and user-specific views improved change and release management while enabling teams to share and access consistent information.
- Supported business growth: The scalable Siemens software environment positioned Sensile Medical for continued expansion, with the company planning significant growth in its engineering workforce and product development activities.
