Sanner works with customers through phases covering exploration, development, transfer, scale-up, and on-market support.
In Plain English: The Clinical Takeaway
Engineering continuity between development and manufacturing prevents knowledge loss at handoff.
Testing data mirrors actual manufacturing conditions because design verification and validation (DV&V) takes place in settings equivalent to the final production site and operates under commercial controls.
From Concept Feasibility to Design Inputs
Sanner collaborates with clients during the exploration stage to formulate concepts, evaluate technical and business viability, and convert user requirements into precise design inputs, evaluating ideas early on against regulatory standards, expenses, and production feasibility.
Design Verification and Validation Under Commercial Controls
Once concepts move into active development, requirements become a proven design. Sanner’s engineering team produces design outputs, locks down the design, and conducts verification and validation builds to confirm the device functions properly. The route to transfer is already established, test data mirrors actual manufacturing conditions, and design verification and validation (DV&V) takes place in environments equivalent to the future production site under commercial controls.
This method ensures that the device performs as intended, while simultaneously laying down a pathway for subsequent design transfer.
Managing Design Transfer and Manufacturing Scale-Up
Products arrive at a Sanner production plant via manufacturing transfer from an external partner or design transfer executed by Sanner’s internal development group. By maintaining engineer continuity through every tech transfer task, pilot build, and the commencement of commercial production, the handoff avoids any loss of institutional knowledge.
| Development Phase | Core Activity | Operational Environment |
|---|---|---|
| Exploration | Feasibility & Design Inputs | Concept and Regulatory Stress-Testing |
| Development | DV&V Builds & Freezing Specs | Commercial-Equivalent Facilities |
| Transfer & Scale-Up | Pilot Builds & Automation Integration | Iterative Volume Expansion |
Following successful transfer, the focus shifts from entering the market to growing within it. To boost output and unit economics, the same group steers ongoing design and process refinements while Sanner executes a step-by-step strategy to ramp up production volumes and deploy both semi-automation and full automation.
On-Market Support and Quality Management Systems
Sanner aids commercial-stage products through regulatory monitoring, engineering change management, inventory warehousing and stockholding, and supplier coordination.
Furthermore, complaints, device returns, and investigations are handled under its QMS, reviewed collaboratively with the customer.
References
Sanner. Exploration, Development, Transfer, Scale-Up, On-Market Support.
