The Role of Systems Engineering in Medical Device Packaging

According to NASA, systems engineering is a methodical, disciplined approach for the design, realization, technical management, operations, and retirement of a system. A "system" is a construct or collection of different elements that together produce results not obtainable by the elements alone. The elements, or parts, can include people, hardware, software, facilities, policies, and documents; that is, all things required to produce system-level results.

Vimal K. Puthiyadath

As they say, behind every successful man there is a woman; behind every state of the art medical device is a packaging system that ensures sterility, protection throughout the medical device distribution life cycle, enhanced user experience and valuable information to the user. This is the very reason I strongly believe that systems engineering concepts will play an important role in developing packaging for medical devices as it is important to have a thorough understanding of the device, the packaging material, end-user requirements, usability needs at the early stage of development of the medical device.
The design of a medical device package should not be considered an isolated activity, but a process of interdisciplinary tasks that will guarantee efficacy of a sterile barrier system (SBS), which will be maintained until the point of use of the medical device. In this highly competitive world where innovation lightning is causing the mushrooms of medical devices to multiply, medical device packaging is under lot of stress to be the differentiators offering enhanced device usability, product protection, and distribution.

In order to have a successful medical device packaging, it will be of great use and important to use systems engineering concepts. Starting with user requirements (needs) through the final delivery, packaging needs may be superimposed so as to ensure packaging development success. This will be of importance, considering the tough cost targets that are laid out for the packaging design engineers. System tests with packaging will definitely reduce costly recalls due to packaging errors which may prove detrimental to business reputation.


Another important aspect is that this approach will also help to stick to the stringent product launch timelines. It will not be an exaggeration that packaging can really affect the profitability of the product and it is equally important as the solution that the medical device is providing.

In an earlier blog about Nxtstage portable dialysis machines, Adele Graham-King points out the way the device is packaged in a suitcase form will make it popular among patients needing dialysis. It is also important to find the balance between packaging system price-to-performance with a systems engineering approach to gathering the design inputs that ultimately drive packaging.

What are your thoughts on the role of systems engineering in medical device packaging?

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Vimal K. Puthiyadath, Biomedical Electronics Engineer

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