I must admit to having a bias, but, at a minimum, I would ensure that the company has appropriate certification. Hypertronics is certified to ISO 13485, which sets a standard guideline.
ISO 13485 is designed to produce a management system that facilitates compliance to customer requirements with an emphasis on meeting regulatory and risk management requirements and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices. It’s important to note that being certified to ISO13485 does not fulfil regulatory requirements, but it does help to align an organisation’s management system with many regulatory schemes around the world including US FDA’s Quality System Regulation (QSR).
These interconnects must power the systems and transmit signals to the main system for accuracy. This can be a life-critical function.
In the past, implantable leads were attached through a captive set screw. In other words, there is no female contact in the device; instead, the lead is inserted into an opening on top of the device and screwed into place by the physician. This procedure requires a specific tool, because torque is very important when attaching the lead. If there is not enough torque, the lead could create intermittent electrical contact, since it has only one point of contact with the set screw, or it could disengage completely. If the physician over-torques the set screw, the lead and possibly entire device could be damaged. Having to discard the device and start with a new one adds significant cost.
Other areas of concern include the possibility of losing a screw, cross threading, damaging the screw head, and even nicking the lead. Implantable devices require uncompromised functionality within highly sensitive and demanding environments.
Improvements in portability and patient comfort cannot translate into trade-offs in accuracy and reliability. Accuracy and reliability often need to surpass that of the larger devices they replace. Because of space and weight constraints in these devices, embedded components need to be smaller and weigh less. A more efficient use of the system footprint can be realised with a smaller form factor contact/connector system that allows more space for critical functions.
Components are scaled-down or “miniaturised” but still need to perform with the best quality and highest reliability. New challenges in manufacturing arise with this trend. The connectors used in medical devices need to be more dense and more compact, and be made from materials that are best suited for smaller spaces.
Manufacturing hurdles result from:
- The connector’s mechanical geometry–moulding, machining and handling small parts with small features
- The electrical requirements–smaller distances between electrically charged parts can create challenges in voltage transmission and have an impact on the connector’s current carrying capability, driving the potential for compromises in accuracy and reliability.
These manufacturing challenges can be overcome by considering new materials, more extensive testing, and more accurate moulding and machining processes. Connectors featuring smaller components with 0.3-mm contacts, for example, meet the density, size and weight requirements of new medical devices coming on the market.
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