One of Dynamic Group’s current Medical Device OEM customers received a call from a different Division on the east coast stating they had a large program that would be cancelled soon. It appeared, after 3 years of attempts, their current molder/tooler could not arrive at quality parts. Without hesitation, that customer suggested an inquiry to Dynamic Group was in order.
When Dynamic Group received the call asking for help on the program they asked for databases, tool designs and part samples. Dynamic was more than willing to help, but they needed the proper history and education to determine how and when a solution could be provided.
Upon receiving the molds, Dynamic Group found they did not meet the database, changes had not been documented and quickly came to the realization that they would have to perform a complete refurbishment of the molds. Moreover, it had to be done using reverse engineering.
Dynamic Group began developing the molding process from scratch. This would now include insert molding of multiple components, assembly and testing of a complex medical device.
To maximize the success of this project, Dynamic encouraged their customer to come in-house and be a part of the validation process. Being so far behind already, the production timeline was at critical-mass; it was imperative that the project keep moving forward at a very quick pace.
Dynamic’s customer took them up on the invite and nearly lived at the facility for two weeks to get through a full IQ/OQ/PQ validation process. Together, vital decisions were made, documents signed, data reviewed; day and night they worked together to get the right processes and competencies for ongoing production to begin.
Dynamic Group’s competitor had struggled for three years to arrive at a viable solution for this customer. But, by utilizing the talent, dedication and perseverance of Dynamic Group, they refurbished the tooling, developed the process and ran a full validation, all approved for production in eight weeks from start to finish.
Since this initial success, this customer asked Dynamic Group to re-tool the entire program. Dynamic is now finishing full validations for three product lines including significant automation, testing and assembly.
Now is a good time to call upon Dynamic Group. Most likely, this kind of tenacity and drive can assist in identifying new paths to follow which will save time and dollars for your current or next mold building and molding project.