Breast Pump

Process

ECT was in charge of the whole R&D process except the mechanical design. The client came with the basic idea and manpower for the mechanical design. ECT developed hardware and firmware, selected key components (incl. custom made components), executed regulatory approval tests, and implemented the product for mass production in a Danish ISO 13485 electronic factory. Since the product is Medical Class 2a, we were deeply involved in the entire process of regulatory approval.

Challenge

The client wanted to create a silent Breast Pump with a suction pattern simulating the suction pattern of the child as much as possible. The client took responsibility for the patented disposable pumping mechanism himself.

Regardless whether the pump should be used in a hospital or residentially, the user does not want to attract too much of attention – thus a very silent operation is important. Also an efficient and comfortable milking process was important elements of the R&D.

Challenge

The client wanted to create a silent Breast Pump with a suction pattern simulating the suction pattern of the child as much as possible. The client took responsibility for the patented disposable pumping mechanism himself.

Regardless whether the pump should be used in a hospital or residentially, the user does not want to attract too much of attention – thus a very silent operation is important. Also an efficient and comfortable milking process was important elements of the R&D.

Solution

Based on inventions and patents owned by the client, ECT developed special vacuum pump drivers on basis of stepper motors. The process included a special survey of potential suppliers of stepper motor, a selection of the most appropriate and the work with him to create a custom designed version supporting the claims of the product. The speed of the stepper motors was shaped to support silent pumping.

The firmware is controlling the pumping speed and the cycle frequency. These parameters were tuned and fixed in different settings for the user to select the most convenient and efficient operation in a very user friendly way.

Since the product is a Medical Class 2a device, we participated in clinical trials, and fine-tuned parameters of the product as a result of these trials.

A good part of the R&D process related to medical devices is related to the documentation. When developing medical products we have special rules with regards to documenting our work. Furthermore, a central document is the Risk Analysis, where the R&D team identifies the components in the highest risk for getting defective – and the consequence for the user hereof. As the Notified Body can be of any European nationality, ECT always generates all documentation in the English language to support a smooth validation process.

ECT also implemented the Breast Pump in an ISO 13485 certified factory for mass production. In this process, a lot of documentation and technology information was transferred.

A good part of the R&D process related to medical devices is related to the documentation. When developing medical products we have special rules with regards to documenting our work. Furthermore, a central document is the Risk Analysis, where the R&D team identifies the components in the highest risk for getting defective – and the consequence for the user hereof. As the Notified Body can be of any European nationality, ECT always generates all documentation in the English language to support a smooth validation process.

ECT also implemented the Breast Pump in an ISO 13485 certified factory for mass production. In this process, a lot of documentation and technology information was transferred.

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