Mechanical Assembly (vPoke)

For medical devices and instruments, mechanical assembly is a manual process prone to variability and inconsistency, even when operators use technology such as online visual assembly aids. As operators become more familiar with the assembly of a unit, they are more likely to ignore instructions, take shortcuts, or simply become careless. High volume manufacturers in other industries—automotive, for example—have been very successful in virtually eliminating manufacturing defects through the use of poka-yoke, a Japanese term loosely translated as “mistake-proofing,” that uses techniques such as locking keys, fixtures, and robotics to help human operators avoid making mistakes and, in some cases, to reduce the need for operators altogether.

In contrast, manufacturers operating in a low volume environment have faced numerous challenges trying to design a sophisticated solution that works consistently for complex medical devices and instruments. Paramit has developed a patent-pending computer-directed assembly technology called “vPoke” based on poka-yoke principles that provides a dramatically higher level of control and validation. We are confident that vPoke is a game changer for the system level assembly of medical devices.

vPoke Mechanical Assembly

vPoke is a programmable computer system that contains assembly sequences and images of parts, tools, and completed examples. The vPoke system utilizes custom parts trays that hold the precise parts, in sequence, required for a single unit. No slot in the tray is left empty so the operator is confident there are no missing parts at the start of the job. When the operator successfully completes a step, vPoke validates the work and creates a visual image, automatically storing the information electronically for use in the device history record. vPoke allows the operator to continue with the assembly process only when the current sequence is successfully completed and the computer audibly confirms validation. By engaging the operator through interactive activities and multiple senses of sight, sound, and touch, vPoke improves the operator's concentration and enhances their involvement.

vPoke Advantages

vPoke ensures that each unit is built the same way as every other unit, using the same sequences, the same tolerances, the same parts—regardless of the operator. vPoke exercises control on all inputs into a basic element of work, forces conformance to established criteria and sequences, and automatically and securely documents everything for easy future reference during internal reviews and FDA inquiries. vPoke’s precisely repeatable sequences are infinitely scalable for volume and product complexity and the system can be configured as an inline process, a single workstation process, or an in-place system fed by subsystem processes. In addition, vPoke allows supervisors to train and certify operators online and at-station in real time. See vPoke in Action.