Integrated Technologies Ltd.

Transfer to Manufacture

Kimal Medical Systems diversifies with an infusion of manufacturing skills from ITL
Technical case studies frequently focus on the development of a new product, and the challenges of moving from design concept onto successful production. Often less emphasis is placed on the qualification and manufacturing steps, which are considered ‘well-defined’ and handled either in-house or by judicious choice of a reliable manufacturing partner to turn the design files into a qualified, saleable volume product.

But what if business circumstances dictate that a product, ready for production, has to be shifted lock, stock and barrel to a completely different location? With manufacturing processes now so inextricably linked to product qualification, this can present some significant challenges for the new manufacturing location to replicate. Especially so if the product is for medical use or patient care, where the qualifications are inevitably even more demanding as patients’ lives will quite literally depend on product reliability.

We look at such a situation in more detail; at the potentially daunting technical challenges of
transferring a complete production package to an entirely new manufacturing location under different regulations and at a company needing help to make it a success.

Recognising they were not equipped to do this themselves, Kimal Medical Systems engaged in the search for a new manufacturing partner and their choice was a wise one when they awarded the business to Ashford, UK-based instrumentation design consultancy and manufacturer, Integrated Technologies Limited (ITL).

‘Bringing Instruments to Life’ is what ITL does. It has been doing so with great success for 35 years and its strength lies in its ability to support customers throughout every stage of the concept, design, development, prototyping and manufacturing cycle.

In this case their proven expertise in manufacturing and delivering qualified medical electronics products was what caught the attention of Kimal’s Business Unit Leader, Steve Eccles. He commented, “ITL’s detailed knowledge of the medical market, including a thorough understanding of the qualifications processes for Europe proved to be essential to our successful launch of the IVantage™ Ambulatory Infusion System.”

We look at how challenges in the process of transferring all the IP and the entire manufacturing line from US to UK were dealt with and the importance of ITL’s skills and knowledge throughout the process. We also see how the engagement developed into a solid partnership for the long term and successfully delivered on all the expectations for the IVantage™ manufacturing project.
The Kimal IVantage™ Ambulatory Infusion System
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 & 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.

The Challenge - Delivering on the commitment
Recognising that its current factory facilities could not support production of the electronic sub-systems within the pump, Kimal confirmed the decision to fully transfer manufacture to the UK, short listing and then choosing ITL - effortlessly.
“The choice was straightforward”, said Steve Eccles, “Kimal required an established medical instruments manufacturer and ITL was a clear leader from this perspective. ITL was also chosen based upon its broad skills, knowledge of regulatory controls and proven quality of current products. Of the three companies shortlisted, ITL easily gave us the greatest level of confidence that they would be able to support us through the life cycle of the project”.
So in March 2010, Steve Eccles and Kimal’s Project Manager, John Walters visited ITL and contracted all manufacturing of the IVantage pump to ITL’s UK production facilities. Furthermore the contract gave ITL responsibility for the complete transfer of technology, manufacturing equipment, IP and know-how from the US to their Ashford facilities.

Tony Butterfield, ITL Operations Manager, travelled to the Colorado plant with Eccles. “We 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”, said Butterfield

Kimal had purchased the whole technical package including work cell equipment and processes - on paper, everything needed to manufacture the product. Butterfield continued, “It was a fairly daunting prospect as, although we were shown the production line, technical package and how to find drawings and documentation, there was limited support available on site and with medical products, it’s just not that simple to transfer”.
Eccles added “All credit to the ITL team who prepared a dedicated manufacturing cell for us in Ashford, improved the process flow they inherited and had the entire transfer completed and the cell operational just two months later – a major achievement and a really solid start to our partnership”.
Qualifying the production cell is everything
When a patient’s life literally depends on a medical product’s reliability, qualifying its manufacturing process is a critically important activity. Having steps in the process triggered by real issues such as those identified by ITL, is an ideal way to exercise it to the full.
With existing qualifications in place, transferring to Europe under a different set of regulations is not entirely straightforward but, Eccles added, “With their support and extensive knowledge of the European medical market, ITL lead the way for us and was absolutely key to our success in transferring and qualifying the technology.”
ITL identified three potential issues when validating the production cell and also increased the level of motherboard testing due to its fundamental importance in correct operation:

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 had limited experience in battery testing so proactively identified testing methods for ‘battery drain & fail’ and learned how to test and resolve the issue. This was achieved, the reconditioning specification was updated and all existing stock refreshed or rejected as necessary.

Emitter functionality:
The rotating pump ‘emitter’ mechanism propels fluids through a tube to the patient. Obviously 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 exist in the manufacturing specification to control this and the mechanism to test for these was not 100% proven to ITL’s satisfaction. As a result, sophisticated new test processes were introduced, 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 for example, could have massive consequences such as the build up of fatal blood pressure within a sleeping patient.

Also the inherited motherboard tests must be followed to the letter because the functional tests are part of validation and because they implement an accelerated three year burn-in test. Kimal currently holds all existing component stock but when this runs out, they will look to ITL to procure and deliver future motherboard volumes.

Tony Butterfield added, “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 I’m proud to say that we have dealt successfully with every challenge – every one we faced, we have resolved”.

The Results
With ITL managing all aspects of the transfer process, the IVantage pump was almost literally transported from a product on a static line in a US factory, to a UK-based manufacturing cell capable of producing product in less than three months. The following nine months have seen the line achieve full product certification and the IVantage pump is qualified to EU Medical Device Directive Class IIb medical devices compliance. A ramp up of volume is currently underway for increased shipments in 3Q2011.

Steve Eccles comments, “We were very impressed with the speed ITL moved us forward with the transfer from Colorado to Ashford. The manufacturing cell was set up much more quickly than we expected, just eight weeks after the Colorado visit. They delivered technical support for the entire project including reverse engineering tests, procedures and the facilities to fully understand the design & capability of the product in the US.

“Whenever problems were encountered, ITL committed high quality resources to them and always assisted pro-actively, which helped us immensely. Our electrical and electronic engineering skills are limited and ITL’s design and development team always made the necessary electronics knowledge easily available and understandable. In fact they made the whole electronics process very easy for us.

“They did all these things extremely well and further into the project it became clear that the choice to go with ITL was very sound, as it was ITL’s skills that were pulling Kimal through the whole process rather than Kimal pushing ITL to deliver”.
Tony Butterfield added, “We put our best op’s and production engineers on the transition project and were pleased to ramp it up successfully in just two months. During that process there were many issues, but a great joint effort in the early days countered minimal engineering information and contact with the previous production engineering team. We also invested a lot of R&D into reverse engineering the manufacturing and process equipment – but this was very worthwhile as we completed detailed analyses of batteries, motherboards and test jigs, and we are the experts now.”
Future involvement for ITL
So what comes next for the partnership between these two companies? Well, ITL’s knowledge of medical products has helped to influence the specification of the next generation of device, making ITL even more invaluable to the future of Kimal.
From its experience so far, Kimal is completely confident in engaging ITL’s design and development services for new products of this type and clearly already views ITL as a close and strong manufacturing partner; very much more than just a supplier. Proof is that product planning and development discussions are already underway, at a time when Kimal might traditionally be going out to tender for a suitable partner for a new product.
Steve Eccles summarised by saying, “Personally we all got on with everyone at ITL extremely well, which made it very easy to progress effectively through some real challenges. They have been really good to us”. Both parties see potential for real success together and seem equally committed to delivering the next generation of the IVantage pump as a partnership. There is clear mutual admiration, which combined with all the skills, is a recipe for success.
Kimal Medical Systems and ITL look set to become ‘Partners for the long term’.