G&H | ITL Case Study: Kimal

Overview

Kimal is an innovative and trusted manufacturer and supplier of specialized procedure packs and vascular access devices to hospitals worldwide. The IVantage™ volumetric ambulatory infusion system is their latest device introduction. It is designed to support patients’ ambulatory needs and can be used for patient-controlled analgesia, intermittent infusion, continuous infusion therapy, and parental nutrition.

Requirements

Recognizing that their current manufacturing facilities could not support the production of the electronic subsystems within the pump, Kimal decided to transfer all manufacturing activities to the UK.

Kimal approached G&H | ITL with the challenge of transferring all technology, manufacturing equipment, intellectual property (IP), and know-how from the US to their UK facilities in preparation for volume manufacture. We had two days to learn as much as possible about the device, identify the equipment and processes required for the transfer and arrange all logistics.

Our production engineering team began setting up the manufacturing work cell in preparation for the transfer. During this time, we identified three potential issues when validating the work cell, including:

• Battery performance
• Emitter functionality
• Motherboard

Battery performance

To feed or treat a patient continuously overnight, batteries must last for at least 8 hours. Tests carried out identified some falling below this level, and so the battery testing process was fully reviewed. A lengthy investigation identified the cause to be batteries not receiving the necessary reconditioning during storage. We proactively identified testing methods for ‘battery drain and fail’ and learned how to test and resolve the issue.

Emitter functionality

The rotating pump ’emitter’ mechanism propels fluids through a tube to the patient. It is critical that this does not introduce bubbles that could enter the patient’s bloodstream intravenously as it could be fatal. Extremely strict ‘bubble testing’ processes existed in the manufacturing specification to control this; however, the mechanism to test them was not 100% proven. As a result, we developed sophisticated new testing processes and procedures that could successfully identify bubbles down to micron dimensions.

Motherboard

The operation of the on-board microprocessor is fundamental to the safe and correct operation of the Kimal pump. We reviewed the motherboard data available to fully validate the test procedure and implemented enhanced PCB testing. A simple software or control issue such as the pump not switching off as programmed could have disastrous consequences such as the build-up of fatal blood pressure within a sleeping patient.

Results

With G&H | ITL managing all aspects of the transfer process, in less than three months, the IVantage™ pump was transported from a US manufacturer to the UK, where we had a designated work cell set up and ready to assemble units. During the first nine months of manufacturing, the IVantage™ pump received EU Medical Device Directive (MDD) Class IIb medical device compliance, triggering a significant ramp-up in volume with just two months of implementation.

During the process, there were many issues. We were extremely aware that this was a safety-critical system, so although the issues were challenging, there was great value in identifying and addressing them. They provided the ideal vehicle to test our qualification process. R&D invested a lot time into reverse-engineering the manufacturing and process equipment, allowing us to expand our knowledge and experience of batteries, motherboards, and test jigs.