The Pioneer of Modern Leak Testing

Trends in the Medical Device Manufacturing Industry – a three-part series

This article is a 3-part series

Part 1 – Product innovation is moving at an unbelievable pace in the medical device manufacturing industry

Product innovation is a key performance indicator (KPI) for the medical device industry. Medical device companies are driven to continuously innovate their processes, to ensure quality, regulatory compliance, and short time-to-market for new products, and the speed of product innovation seems faster than we have seen it before.

We’ve identified several areas where the speed of innovation is creating challenges for our customers in the medical device manufacturing field.

1) Product performance requirements are becoming more stringent.
Because of stricter performance requirements, testing requirements are also becoming more complex. Our customers have been looking for the ability to analyze real-time test result trends to anticipate necessary changes before a full-line stoppage is necessary. Additionally, test specifications are changing. Low-pressure requirements are becoming even lower in terms of test parameters, and high-pressure requirements are becoming higher.

Leak testers need to be able to accommodate multiple steps in the testing process, while maintaining high repeatability with optimal resolution and sensitivity. They must have two-way communication to the network, to send real time test results and analytics.

2) Each part of a product requires unique criteria for design and testing.
It is pretty common for medical devices to have unusual geometries, including tubes, valves, stopcocks, transducers, enclosures, and components within components. Because each part of a product needs to be tested, the testing process can become complex. Often, multifunctional testing is required, with leak testers being able to accommodate a wide variety range of tests, including pressure, vacuum, flow, occlusion, burst, and crack. Part integrity testing is also often a requirement, to ensure performance by verifying welds, assembly, and builds.

It’s important to make sure your leak tester accommodates a wide range of multifunctional testing, while maintaining the highest levels of performance, fast cycle times, and high repeatability.

3) Patient comfort is an important consideration in product development.
Medical devices are becoming smaller to reduce patient pain and accommodate a hospital-to-home treatment model. Smaller devices, however, require higher pressures to get the same amount of flow or performance. Leak testers should be able to handle increasing pressures of >500 psi, as well as lower leak rates.

4) The cost of regulatory compliance is high, with product validation and revalidation costing between $80-$100k USD.
Because product validation is expensive, medical device manufacturers want to avoid a requirement for revalidation. This means that processes cannot change once they have been validated. Leak testers must be able to be duplicated with the same parameters and software, and the operation must take place in a highly controlled environment.

It’s important to use a leak tester with a very long lifecycle, with cradle-to-grave support. The leak test solution needs to be high quality, scalable, and globally supported, with many language options.

This article is a 3-part series


Joe Pustka

Director Applications Engineering

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