Package and Product Integrity Blog

Here is part 3 of our 7 part series on Medical Package Design, from Life Packaging Technology‘s Karen Greene. In part 3 we look at why medical device manufacturers should be evaluating how their competitor’s medical device packaging is performing for their customers, both positively and negatively.

Packaging Essential #3: Evaluation of similar or competing devices

The value of evaluating similar or competing devices may appear to be obvious but is not rigorously put into practice.    Identify your key competitors and/or comparable devices and get yourself out into the clinical setting and determine what your target customers love and hate about these packages.  Inquire about every facet of the packaging design and request your customers to prioritize their top 3 requirements for the package.

Considerations

• labeling for product identification, directions for use, bar coding and inventory management requirements
• examination of existing storage systems for integration
• ease of use of package/device
• package size as it relates to storage and use
• packaging materials utilized(primary, secondary, tertiary packaging systems)
• Is it imperative that the package is see-through and why?
• Does the primary sterile barrier package impede removal and aseptic technique?
• Does a coiled device present a significant hurdle to good clinical application because the device has taken an unacceptable “set”?
• Does the package facilitate one-handed opening and removal?
• If the device is a procedural kit, are all the expected and necessary components contained within the kit package?

You will not have the time or resources to gather a statistically significant data set on these package design considerations but the value of a first hand experience in the clinical setting including a dialogue with the clinical staff on their input and the reasons for their opinions will prove invaluable towards a successful package design.  As a packaging design professional, you will be able to quickly discern what will or will not work based on first hand clinical input.

In continuation of the 7 Essentials for Successful Medical Package Design, contributed to the Package and Product Integrity Blog by Life Packaging Technology‘s Karen Greene, here is the 2nd essential to be concerned with when it comes to designing your medical device packaging.

Packaging Essential #2: Packaging System Hazard Analysis

The goal of a thorough packaging system hazard analysis is to eliminate all high-severity hazards and reduce as many medium and low severity hazards as possible¹.  Two prime high severity hazards are breach of the sterile barrier (for sterile barrier package) and damage to the medical device which is not easily detectable and may impact the safe and effective use of the device.  Annex A (medical devices) and Annex B (in vitro diagnostics) of ISO 14971 provide a set of questions to help illicit the identification of hazards.  The package/device system can be reviewed by a number of analysis techniques, including top-down and bottom-up approaches.² A typical bottom-up approach is an FMEA, failure modes and effects analysis.   An FMEA facilitates focus on a specific component or element, e.g. a sterile barrier system.   A typical top-down approach is an FTA, fault tree analysis.  You start with an undesired consequence, such as breach of the sterile barrier, and then identify the initiating and contributing events that must occur to produce it³.

In summary, perform a packaging system hazard analysis early on after the package design requirements have been established and then move through the next few essential activities of defining the clinical storage, handling, and use environments as well as the distribution and handling environments so that you can begin the valuable activity of prototyping the packaging system design.

¹ Ozog H, “Risk Management in Medical Device Design, “ Medical Device and Diagnostic Industry, October: 112, 1997.

² Ozog H, “Risk Management in Medical Device Design, “ Medical Device and Diagnostic Industry, October: 112, 1997.

³ Ozog H, “Risk Management in Medical Device Design, “ Medical Device and Diagnostic Industry, October: 112, 1997.

The article series, 7 Essentials for Successful Medical Package Design was written by Karen Greene, Vice President of Sales and Technology at Life Packaging Technology LLC.

Testing for package integrity is often times one of the most important factors for many medical device manufacturers getting FDA approval for their products. There are many considerations to make by the packaging engineer in determining the best way to design, test and get approval for medical device packaging. In part 1 of a 7 part series on packaging essentials, we will take a look at packaging design requirements.

Packaging Essential #1: Packaging Design Requirements

It is imperative to define the packaging system in order to produce a successful package design .  The packaging engineer/designer must collaborate with project team members to create a packaging design requirements document which provides a clear expectation of the function, limitations, special features, aesthetics, product/company branding, cost limitations, size limitations, sterilization method, labeling requirements, hospital/clinic storage requirements, case count and possible adverse conditions of use and/or distribution and storage.   Do not limit your consultation to your Marketing and product development representative.    Valuable and detailed input can be obtained from the clinical team member, the end user, such as the clinical nurse, the O.R. technician, the Cath Lab technician, and the physician.  Also, consult your field sales representative for insight into competitive products.  Plan a trip to a local clinical site to see first-hand the environment in which your packaged device will be deployed.  Pre-arrange a visit and you will find a warm reception from the clinical staff as people love to provide their opinions.

Do you collaborate with all of the necessary parties involved in producing your package design?