Top Essentials for Medical Package Design and Validation

The experts that design and validate the medical device packaging systems have the responsibility of providing an effective and safe packaging system that is capable of delivering the enclosed packed product to the end-user with no defect or any risks to the safety of the patient. There are several guidelines and regulations set to ensure that that is always the case. For starters, you can buy mylar bags here to have an idea of the standards set in the medical industry. Some of the packaging essentials are highlighted below.

Packaging Design Requirements

Defining the packaging system is imperative to enable the production of a successful package design. A packaging designer or engineer, in collaboration with other team members, need to come up with the packaging design requirements document. The document should indicate the clear expectation of function, special features, company branding, aesthetics, size limitations, cost limitations, labeling requirement, sterilization method, hospital storage requirements, possible adverse conditions of use, and case count. Consultation should not be limited to only the product development and marketing teams. Clinical team members should have an input as well.

Analysis of Packaging System Hazard

One of the main goals for analysis of the medical packaging system should be to eliminate all the hazards that have high severity and minimize the low and medium-severity hazards. The high-severity hazards include a sterile barrier breach and damage to the device, which may not be easy to detect. Different techniques can be used for the analysis, which includes the bottom-up and top-down approaches. Analysis of the packaging system hazard should be done early on after establishing the design requirements.

Evaluation of Competing or Similar Devices

There is a lot of value found in evaluating competing or similar devices. Start by identifying the leading competitors and start figuring out how you can improve on what they already do. Consider everything from the perspective of the company and that of the target customer. Some of the things to consider include labeling, ease of package use, packaging materials utilized, package size, sterile barrier, and ease of unpacking, among many others.

Distribution, Handling, and Storage of the Medical Device

As the packaging designer, you have to take into account the anticipated distribution, handling, and storage of the medical devices. You can run some trial packages to determine all the effects that shipping, handling, and storage will have on them and adjust the packaging accordingly to minimize the effects. Factor in other factors such as prolonged storage, increased shipping frequency, extreme temperature changes, and exposure to weather elements, among many others.

William Darnell

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