10 critical considerations for medical device packaging

Jennifer Eiker, Product Manager for Tekni-Plex’s flexible packaging products, shares her expertise in creating the right kind of packaging for the medical devices market.

Engineering the right package for your medical device is critical for many reasons, including the fact that it is the first interaction your customer has before they even touch the product. 

If you ask either a patient or a healthcare professional, they will likely tell you that accessing medical device package contents while preserving sterility is at the top of their criteria list. If you don’t get it right, they won’t properly access your product and it becomes unusable. As a result, medical device companies and their suppliers are paying more and more attention to usage environments in order to create patient- or end user-centered packaging to improve functionality. 

With the market continuing to grow for medical devices and wearables, it is understandable that optimal accessibility and ease of use for these products is even more important than ever before.

Here are some factors that should be considered when determining an optimal package for your product:

Use location

It is important to understand how or when your product is likely to be used.  For example, use in an ambulance is different than accessing it in an emergency room. The former may mean that there isn’t enough time or space to ensure an aseptic opening (ISO 11607 certification requires that a package can demonstrate aseptic use to the end).

Accessibility

How easy is it to access your medical device product when the patient needs life-saving intervention? For example, if you are struggling to get to the contents located in a snap-fit tray, it most likely is not an ideal packaging solution when you are attempting to treat a cardiac arrest.

User profile

The problem is magnified in a home environment, where a trained clinician will likely not be performing the function. The user can run the gamut from a healthy individual to one who is in palliative care. Age is another factor that should be considered. Not only are people living longer, but nurses are also delaying retirement. On the other side of the age spectrum, young medical professionals are entering the workforce. Your package needs to consider all of these user attributes and be up to the challenge.

Larger devices

With increasing emphasis on minimally invasive procedures, such as laparoscopies, orthopedics, and others which require a longer journey through the vascular system, medical device manufacturers are designing larger devices to accommodate the latest practices. As a result, these new devices also require larger thermoformed trays and lidding to contain them.

Comprehension

You may think you have designed a package that is intuitive for the user to open, but that is not always the case. The goal is for the user to open it correctly and quickly. If your package features are hard to understand or can’t be opened correctly, it can be very frustrating for the user. Even worse, incorrect opening can compromise the sterile contents.

Left or right-handed use

Because pouches are typically opened from the center, the user’s dominant hand preference is typically not an issue. However, packages such as thermoforms that feature a peelable seal are typically designed for a right-handed person. This makes it challenging for a left-handed person to open and still maintain the aseptic field. This issue can be addressed by including a peel option on both the left and right side of the package.  

Language/regulatory information

Frequently, medical device packages sold in North America need to have English, French and Spanish use instructions. If package space allows, companies may opt to put the various languages on one label or print separate labels depending on language requirements for a specific geographic area. In addition, mandatory symbols, product information, product codes, lot numbers and barcoding all lobby for valuable package space. What is most critical, however, is that all of this information is legible and quickly understood, particularly for products that may be put to use in emergencies.

Storage

It is also important to take into consideration the storage method(s) for your product. Will it be stored hanging on hooks, in bins or in drawers? If the medical device is long – five feet, for example – how will that be stored? Is your packaging material slippery which would limit its stacking ability? Do you need to keep the package away from UV lights to minimize change of product degradation? It’s critical to understand these various physical attributes and how they impact storage so that the packaging can be designed appropriately.

Package evaluation

With so many people working out of their homes during the pandemic, whenever possible, healthcare has shifted to personal spaces and away from doctors’ offices and hospitals. Medical device companies now have reduced opportunities to actually observe how their package is being used. The critical voice of the customer is being muted. It’s important for medical device designers to make an effort to figure out ways to learn from actual implementation scenarios.

Recycling

Although packaging materials that come in contact with biohazards are not recyclable, there are medical device packaging materials that can be recycled. Consideration needs to be given to recycling when your package is being specified. For example, coated medical grade paper is a commonly used packaging substrate that can be recycled if there is an appropriate recycling stream available within the end user’s waste management program.

Jennifer Eiker is a product manager for Tekni-Plex’s flexible packaging products which provide solutions for medical applications worldwide. Additionally, she has more than a decade of experience engineering medical device packaging. Eiker has a Bachelor of Science degree in packaging from Michigan State University.