SUCCESS STORIES
IDS has successfully completed more than 100 innovation, industrialization, manufacturing/life cycle management projects for market leaders in the medical, diagnostic and pharma-/biotech, life-science industry.
Best Practices
Best Practice-Development and Industrialization Support in Pen Projects
Insulin pens and auto injectors are one of the most demanding devices in the development, industrialization, transfer and manufacturing due to the extreme complex design and functionality, the number of parts and finally due the quantities (sometimes > 100 Mio. devices per annum) manufactured over the live time. Consequently, the design and processes to manufacture the parts by injection molding and the assembly shall be extreme robust, reliable and reproduceable to fulfill the market requirements.
Therefore, prototypes parts are often already manufactured in 4-cavity molds to have a scalable tool design and the parts are assembled on a semi-automatic assembly line to review critical process steps before investing into a large scale assembly line. In addition, different feasibility studies are done to review the overall cost of owner ship of the device and the manufacturing to secure the success of the project and device.
For more information to the project and
the different services please contact:
Harald Grün
Dipl.-Ing, (FH), Wirt.-Ing. (FH), QMB | Managing Director
Tel. 0176 787 451 29
harald.gruen@360ids.de
Best Practice-Innovation, Industrialization, Transfer and Manufacturing of Medical Devices
Since the new regulations for Medical Devices and In-vitro-Diagnotics are approved the innovation, industrialization, transfer and manufacturing of medical devices is more complex than ever. Especially the development process according to the ISO13485 shall be extreme efficient to save costs and time to market without any compromises in regulator and clinical issues.
Regarding parts made of polymers, such as PP, COC or PEEK, manufactured by injection molding,
the focus is today on sustainable material solutions, smart manufacturing solutions incl. risk based approaches to qualify equipment and validate/re-validate processes.
Key to fulfill these requirements are experienced project manager, toolmakers and equipment manufactures with “medical” background, well designed processes and a reasonable budget and project timeline, to have a good project setup and to execute the different project phases incl. market launch.
For more information to the project and
the different services please contact:
Harald Grün
Dipl.-Ing, (FH), Wirt.-Ing. (FH), QMB | Managing Director
Tel. 0176 787 451 29
harald.gruen@360ids.de
Best Practice-Development, industrialization, transfer and manufacturing of an innovative Well incl. 96 Well Plate
Wells are use in the lab and diagnostics to store and to dose liquids substances to 96, 384 or 1.536 well plates. In this case a specific Well was designed out of a PP with an extreme high MVR (Melt Volume-Flow Rate) to have a good filling of the injection molding tool and a fast cycle time. In addition, a 96 Well Plate was designed to clip in the specific well into a plate system.
For the Wells a 1-cavity prototype injection molding tool and afterwards serval 4-cavity tools for series production were built to test the performance of the wells and to fulfill the market demands.
Since the demand for the 96 Well Plate were not so high, a 1-cavity mold with a hot runner and a needle valve gate to gate the part directly was built based on an extended mold flow simulation by the tool maker. In addition, in this project an automatic assembly cell with a turntable and SCARA robot was designed and manufactured to equip the 96 Well Plate with the specific wells in an automatic process. To complete the project, all tools and the assembly cell have been qualified and all processes have been validated to fulfill the requirements.
For more information to the project and
the different services please contact:
Harald Grün
Dipl.-Ing, (FH), Wirt.-Ing. (FH), QMB | Managing Director
Tel. 0176 787 451 29
harald.gruen@360ids.de