A medical device contract manufacturer recently approached us with an interesting challenge. They were trying to develop a high volume, semi-automatic assembly and testing solution for a medical device that would be part of a FDA submission for product launch in the United States. This system needed to emulate the current manual operation that was being used for low volume, production outside the United States. Also, in order to beat competitors to the market, this system needed to be completed in a time frame roughly one-third of that we would normally expect for a line of this size.
We started this project by working with the customer, up front, to understand the existing manual operations, device function and test requirements. The delivery date was a significant driver for success in this project, so we used our experience to note the technical challenges that could impact the timeline. By addressing these concerns early on, they were solved before they affected the project’s schedule. These included incorporating design features to aid in scrap reduction and sequencing resources ahead of time to meet the aggressive completion dates.
This product was relatively new to the market and even newer to automated manufacturing, so product design changes were another challenge in this project. Many of our medical device customers are still in the process of fine-tuning their products while they are preparing equipment for mass production. To get the product to market as fast as possible, they need us to be flexible while they are making these last minute changes. This project was no different. INVOTEC integrated these changes and maintained the deadlines by staying flexible throughout the process and continuing as much progress as possible while awaiting the final decision points on these changes.
In the end, INVOTEC was able to exceed the customer’s expectations and deliver this manufacturing system in the necessary time frame. The customer was impressed with the amount of progress we made, in the face of so many changes throughout this project. Our cooperative effort with the customer gave them the opportunity to be first to market with this new product.
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