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Success Story

Efficient lithotripsy in the smallest of spaces

An operational system to remove urinary stones was to be miniaturized. Zühlke integrated all the functions required into a battery-powered handheld device – the Swiss LithoBreaker®. The development followed the strict international standards for medical devices.

Task

In lithotripsy, urinary stones are destroyed with shock waves and subsequently removed. Today’s surgical instruments consist of application components that are connected to an external power supply and control units via cable or tubing. Compact versions are also available on the market, but they only release individual pulses.
EMS, a manufacturer of medical devices for shock wave therapy and endoscopic lithotripsy, wanted to develop a miniaturized system: Operations were to be carried out with a wireless handheld device that generates continuous shock waves. Zühlke assumed overall responsibility for the development – from the feasibility study to the product launch of the serial device.

Implementation

Zühlke checked the technical feasibility with a comprehensive series of lab tests and developed a rough system architecture as the basis for the industrial design concept.

With a functional model, the team analysed the feasibility of the miniaturized system and verified the critical functions. The results of the performance and endurance tests were very positive; the insights gained were integrated directly into the system specifications.
The team developed an efficient, compact drive system with a multi-stage transmission. For the prototype series, Zühlke minimized the weight and consistently took the user’s requirements in a sterile environment into account. This helped ensure optimal usability. In cooperation with the client, the prototype series was subjected to a range of different tests.
The development was carried out in accordance with the customer’s development process. This was subject to the Design Control requirements of the European Medical Device Directive 93/42/EEC and FDA Quality System Regulation (21 CFR 820).

Customer benefits

  • The interdisciplinary cooperation created innovative solutions for integrating functions in a highly confined space with optimum ergonomics.
  • Thanks to Zühlke’s experience in medical technology, it was possible to comply with the regulatory requirements in a very short time.
  • The risk-driven approach ensured that the most critical functions were verified at a very early stage.
  • Production costs are minimal. Consistent target costing helped achieve the ambitious goal.

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