"Developers of medical technology products are under great time pressure in the time-to-market situation. At the same time, the variety of functions is increasing, packaging density is growing and miniaturization is on the rise. This is where a manufacturing service provider can save valuable time through processes and procedures, ensure quality and also reduce costs,” says EMS service provider Tonfunk.
The Tonfunk Group received its first medical technology order from Philips Medical Systems in 1995. Today, as service provider for Electronic Manufacturing Services (EMS), Tonfunk serves customers from a wide range of medical technology sectors such as visualizing diagnostics, homecare & hospital, emergency, ventilation and defibrillation. "Despite increasing time and cost pressure, our customers from the medical technology sector have to meet the once again increased requirements of the Medical Devices Ordinance. As an experienced EMS service provider, we have adapted our processes to shorten the time span from the initial product idea to the product launch. In particular, we have optimised our in-process quality controls and our testing technology," reports Mathias Haase, Managing Director of Tonfunk GmbH.
On the subject of five starting points for the quality and testing strategy, Fred Lindeke adds from the perspective of Tonfunk Entwicklungsgesellschaft, "Medical technology manufacturers focus their development on the best possible functionality of the products. Suitability for production and testability can quickly fall short here. Correcting this after the fact costs unnecessary time and money. We can avoid this by getting involved at an early stage."
Mathias Haase and Fred Lindecke therefore name five starting points for a quality and testing strategy:
- Consulting and co-engineering to consider design-for-X aspects such as manufacturing and testability already during development.
- High flexibility and moderate testing costs even with initially unclear quantities.
- Large test coverage and test depth to ensure high product quality.
- Suitable test solutions for complex assemblies and systems. - Early fault detection before overall acceptance by the customer.
Read the whole article from page 34 in the meditronic Journal of beam verlag >>>