In 2010 Kimal Medical Systems took ownership of all design and manufacturing rights for the ‘IVantage™ Ambulatory Infusion System’ from Colorado-based Delphi Medical Systems, thereby extending their product range into electronic instrumentation and treatment for the first time.
The IVantage™ infusion pump is small (14cm by 6cm), battery powered and runs extremely quietly. It is called an ‘ambulatory system’, which literally means the patient is free to move around normally while receiving medication intravenously or via a gastric tube – freeing them from the static restrictions of traditionally much larger infusion pumps.
Recognising that its current factory facilities could not support production of the electronic subsystems within the pump, Kimal took the decision to fully transfer manufacture to the UK. With medical device manufacturing processes now so inextricably linked to product qualification, this can present some significant challenges for the new manufacturing location to replicate.
Kimal engaged ITL with the challenge of completely transferring all technology, manufacturing equipment, IP and know-how from the US to their UK facilities in preparation for full scale manufacturing.
Initially ITL’s Operations Manager travelled to the Colorado plant with Steve Eccles, Kimal’s Business Unit Leader. ITL had two days to learn as much as possible about the line, identify the equipment and processes needed for the transfer and arrange for everything to be shipped to the UK.
ITL’s production engineering department then began the process of setting up the manufacturing cell in preparation for the transfer.
During this time, ITL identified three potential issues when validating the cell and also implemented an increased level of motherboard testing due to its fundamental importance in the correct operation of the device.
- 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. Lengthy investigation identified the cause to be batteries not receiving the necessary reconditioning during storage. ITL 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 absolutely critical that this does not introduce bubbles that could enter the patient’s blood stream intravenously as this could be fatal. Extremely strict ‘bubble testing’ processes existed in the manufacturing specification to control this however the mechanism to test for these was not 100% proven. As a result, ITL developed sophisticated new test processes which successfully identify bubbles down to micron dimensions.
Recognising that the operation of the on-board microprocessor is fundamental to the safe operation of the Kimal pump, ITL reviewed all the motherboard data available to fully validate the test procedure.
Even a simple software or control issue such as the pump not switching off as programmed could have disasterous consequences such as the build-up of fatal blood pressure within a sleeping patient.
While these issues were a challenge for the team, there was great value to be had from identifying and addressing them as they provided the ideal vehicle to test our qualification process. As a team, ITL was extremely aware that this was one of our most ‘safety critical products’ and we dealt successfully with every challenge.
With ITL managing all aspects of the transfer process, in less than three months the IVantage pump was transported from a product on a static line in a US factory, to a UK-based manufacturing cell capable of producing units. During the first nine months of manufacturing, the IVantage pump achieved EU Medical Device Directive Class IIb medical devices compliance, triggering a significant ramp up in volume with just two months of implementation.
During the process there were many issues, but the joint effort in the early days countered minimal engineering information and contact with the previous production engineering team.
ITL also invested a lot of R&D time into reverse engineering the manufacturing and process equipment and increased our experience in batteries, motherboards and test jigs.
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