Device CDMO Design & Development Phase - IDP Process®
- Concept - Feasibility & strategy
- Product Design
- Manufacturing Process Design
- Primary & Secondary Packaging Design
- Design Transfer
Our CDMO teams take the concepting sketches and basic CAD designs to the next level by adding critical layers of device details.
The enhanced CAD drawings and data help to visually demonstrate the basic functionalities of the concept to the CDMO customer.
Potential device materials are selected in parallel with early design steps, also taking into consideration human factors, regulatory and technical requirements, in order to advance the product’s development plan.
Product design moves forward from highly-detailed CAD drawings, prototyping and the generation of crucial data through testing and analysis. For complex devices such as pens or autoinjectors, testing is performed to the relevant ISO standard 11608.
Sanner’s team of experts advance product design and tool engineering in parallel to deliver critical near-serial product samples. We optimize our tooling designs in digital formats, not only from a feasibility perspective, but also for manufacturing parameters such as cycle time.
This can avoid costly changes to the final tooling at later stages. Using techniques such as mold-flow simulations, Sanner engineers analyze mold cavity filling and temperature conditions in the planned tooling for optimal manufacturing quality. By conducting activities as part of an integrated development plan, subsequent approval loops can be minimized, with potential for time and cost savings.
Sanner’s manufacturing experts apply decades of experience in large scale manufacturing and their in-depth knowledge of a variety of different technologies, such as injection molding, injection blow molding or 2K injection-molding, to CDMO customer projects. We integrate efficient part manufacturing and ease of assembly considerations, using Design for Manufacturing and Assembly (DfMA) approaches, to minimize timelines and costs. Sanner engineers are always thinking ahead to the full-scale manufacturing of your successful commercialized product, while avoiding the costly rework and delays associated with typical scale-up processes.
Sanner can also apply its industry leading desiccant innovations into device design and secondary packaging, providing unique advantages for moisture sensitive products. We assess project risks in the design phase, which is critical for prototype development. Whether it’s device requirements or a complex packaging system that requires suitable desiccant to maintain the product over its intended shelf-life, Sanner has the experience to develop practical desiccant solutions that work at scale. Using our Failure Modes and Effects Analysis (FMEA) we proactively identify packaging risk areas, so that we can optimize parts manufacturing and final assembly for later stages of development.
Often overlooked, this critical step establishes procedures that ensure a device design is accurately translated into drawings and specifications that can be used to consistently manufacture the product. We apply our extensive device manufacturing experience to ensure critical data, designs and development learnings are captured in our design transfer process. Sanner can seamlessly transfer final designs and specifications to manufacturing team members located at any of our worldwide manufacturing sites. This includes our state-of-the-art manufacturing locations in China to support Asian market customer requirements.