Breaking new ground in purchasing and procurement

The customer’s price specifications alone precluded the purchase and procurement of, for example, stamped or metal parts as well as spring baskets to hold the electrodes or components of the device connectors from well-known European suppliers. Within a very short time, we searched for and found suitable suppliers around the world with the appropriate qualifications. But even here, realising the target prices was only possible by calculating with sizable purchase quantities. The solution here was a volume agreement with the suppliers.

GPE developed mechanical masterpieces
Since the customer did not specify which version needed to meet the increased voltage requirement in advance, we incorporated it into the design of every version. With injection moulds featuring a sophisticated design – perfectly tailored to the handle sleeve and the soft component – we succeeded in developing an ergonomically optimised curved design. With a keen eye for the essentials, GPE and the client agreed to design the spring assembly with a holding force that at least meets the standard – and how this should be tested. While the customer had defined the insertion and extraction force for the device connectors in advance, the device socket as an interface was still undefined, which meant that it was not yet possible to design the various connector geometries at that time. In this case, we here at NICOLAY conducted in-house development – working closely with the customer , of course, in order to find an OEM solution that could be used by all manufacturers. With a very simple but cleverly balanced cable construction, it was possible to both meet the stringent alternate bending tests and comply with the equally stringent price specifications.

Electrifying solutions found for high-voltage challenges

While conducting high-voltage electrical tests, we found that different frequencies sometimes caused the handpiece to heat up. At this point, we put the testing conditions to the test ourselves and ultimately solved the proof of dielectric strength with the customer’s generator. In the process, we tested all available parameters to ensure that the handpiece meets the required 10 kVp according to IEC 601-1/44.7.

Responding with flexibility to regulatory changes

If the rules change in the middle of the game, it takes flexibility and creativity to still score the point. In this case, it was regulatory changes that led to a cleaning validation towards the end of the project – and to a revision of the initially selected design of a closed housing. In this case, we found a solution which delivered results in the laboratory that satisfied all parties involved: subsequently added openings. The monopolar electrode handpieces even successfully withstood the required 350 sterilisation cycles in a test carried out by the customer themselves at their own premises. Biocompatibility was demonstrated through testing conducted using the finished handpiece. However, due to the open design of the handpiece, critical components could have been dissolved without patient contact, which would have led to a negative result. Through adapted, real-world testing conditions and taking risk management into account, this requirement was approved by the customer.

All ducks in a row, quickly and flexibly assembled

Our production-optimised line concept enabled the efficient assembly of all components into the housing parts – well-arranged, fast, flexible and cost-effective. The housing parts were sealed by means of soft overmoulding. It hides parting lines and prevents the possibility of disruptive discharge. This assembly concept could be realised by a sophisticated injection moulding tool concept. The pre-assembled unit and the soft overmoulding were harmonised with each other over several rounds.