What You Need To Know: Protective Packaging for Medical Devices

Medical device packaging is a crucial part of the medical device manufacturing process, ensuring that your product is safe and secure during transit and storage, and in perfect condition and ready to use when opened. Packaging is also important in terms of displaying key product information and marketing your brand.

Failing to properly package your product runs the risk of loss of sterility, product damage, diminished product performance or product recall. It can lead to costly market delays, financial penalties and reputational damage.

1 The options you have when packaging a medical device often feel innumerable.

1. Pouches

Pouches are low cost packaging options that allow for massive volume and quick lead times, which means they mostly remain relegated to commodity products. These “worker bees” of the medical industry may be cheap, but they’re indispensable and pragmatic. They can be stacked, thrown, flipped and sling-shotted around without adding much risk to the budget or supply chain.

Best of all: Pouches can be mixed and matched with various materials to suit any low cost device.

2. Bags

The medical device packaging market was valued at $29.32 billion USD in 2020, and is expected to grow to $41.91 billion USD by 2026. This aggressive expansion will be in large part due to the increased demand for low cost, high volume packaging. And with good reason.

Medical bags are another low-cost platform that provide superior opening options when compared to a basic tear pouch. Something as simple as a resealable opening, like a “ziplock” or mild adhesive, can add tremendous value to the end user.

3. Forming Films

Just as the type of clothing we wear determines our movement, so does medical packaging. For a medical device that requires versatility in its range of motion, a forming film solution may be best.

Polyurethane films are used industry-wide to protect prosthetic implants, surgical screws and other medical devices that need to be malleable and durable over the long term. Combined with breathability, flexibility, and durability, forming films have everything you need to keep your device safe and sterile at a relatively low cost.

4. Laminations

Layers are our defense against unwelcome forces; think of a brand new pair of sunglasses or a new smart phone - that protective film covering the delicate surface. In the medical packaging industry, we opt for laminations to protect devices from outside aggressors.

Laminations are composed of two or more individual films that are used within the structure of a medical pouch or bag. Each film adds an extra layer of protection, such as UV, moisture, or corrosion barriers, to name a few.

That final combination becomes unique to the device’s purpose and life cycle, adding a bespoke flair to what otherwise is just thought of as a piece of plastic.

Another benefit in using a stack of high-quality laminations is that most of the films are impermeable by gas, which enables their use as packaging for sterile products.

5. Die Cut Lids

How many gallons of pickle juice have been spilled due to the borderline-impossible task of opening the jar with ease? Accidents that messy cannot happen in the operating room. During a medical procedure, the end user must be able to open the device’s package without disturbing the contents inside. The die cut lid rises to that challenge.

This platform’s rigid structure, typically shaped as a tray, allows for a form that holds the device in place. “Clean peel” technologies then ensure a clean and particulate-free opening motion.

This one-two punch makes die cut lids a preferred package by nurses and surgical technicians due to their ease of use.

6. Thermoform Trays

After investing precious and countless hours and dollars designing and developing a medical device, the next thing you want to do create a package that adequately protects it. Thermoforming is an excellent protective and cost effective packaging platform that can be forged inside state-of-the-art certified Class 8 cleanrooms with high-speed machinery.

Many medical device designers choose thermoformed packaging due to it’s high impact resistance, glass-clear transparency, and its wide range of design and barrier options.

If you’re in the process of designing a high value item, the best way to go is a rigid thermoformed package. This solution is not the cheapest option reviewed today, but the protection and accompanying peace of mind more than justifies the price tag - and this is all before discussing it's sterilization capabilities.

2 Medical device packaging regulations

Medical device packaging requirements vary from market to market, depending on the class of device and transit and shelf-life requirements. So, if you intend to sell your medical device product in multiple markets, you must comply with any relevant legislation which applies in the countries in which it is to be sold.

3 How to ensure that your medical product has the correct packaging

Packaging your product correctly is vital for product safety and security, optimising the user experience and making sure that your manufacturing process is as cost-efficient as possible.

There are three key aspects to consider when making decisions regarding the packaging of your medical device:

1.Method of sterilisation

The sterilisation method appropriate to your medical product will determine the type of packaging you use

2.Shelf life 

Your product’s packaging needs to be appropriate for the length of time that it is likely to be in storage and in use

3.Transit validation 

Your product’s packaging needs to be able to withstand the rigours of transportation if you intend to ship it around the world to ensure it arrives at its destination undamaged.

4 What is Paper Fill Packaging?

Paper protective packaging products are the industry standard for environmentally friendly, recyclable, and compostable void fill solutions. Paper void fill material is easily managed by hand or can be used in an automated packaging machine for increased speed and efficiency. Paper protective packaging is rigid so when the product is packed.

Paper protective packaging can come in different forms but still serve the same result – protected products! Paper protective packaging can come on a roll with manual tear, pre-cut pieces, pre-crinkled pieces，and more.

5 What are protective mailers？

Protective packaging, especially mailers, typically fall under the large umbrella of shipping materials，partially due to the fact that mailers are often used as packaging materials for shipping. As one of Ontario’s leading distributors of wholesale protective packaging shipping supplies, we pride ourselves in having one of the widest selections in the region.

Protective mailers are envelopes that have some type of protective bubble packaging in them to reduce damage. Protective packaging mailers come in many different sizes and have the option of being eco friendly packaging.

6 Medical device packaging is more than just determining the dimensions of a cardboard box or pouch

These processes are crucial to safely and securely delivering a device to end users, while ensuring the sterile barrier stays intact.

Unfortunately, the packaging design process is all too often given little attention in the overall product development process. And with so much riding on the packaging process decisions at hand, manufacturers cannot risk letting packaging become some sort of afterthought.

When the design of packaging for medical devices is left to the final hour, shortcuts often utilized to save time and money can increase the risk of noncompliance. Instead, during this process different sterile barrier systems can be evaluated and manufacturing methods evaluated to best meet the needs and characteristics of a particular device.

For any shot at long-lasting success, manufacturers need to thoroughly define the requirements of the unique device’s packaging system much earlier in the product development process. For good cause, too, as prequalification of these kinds of discussions around packaging validation will only save money, time, and labor in a variety of ways.

7 Avoid over-packing in the supply chain

Another rationale for making the product box as compact as possible is to optimise space, improve efficiency & reduce cost in the supply chain. When transferring from the manufacturing to the packing process, additional packaging can often be used for transporting products to the packing facility.Shipment packaging must find the sweet spot between size and providing sufficient support to the product.

The awareness in this area has already encouraged changes in the industry. For security on pallet shipments, smart solutions have evolved, where a non-toxic, water-based cohesive is used to secure packages together, eliminating the need for large amounts of plastic shrink wrap.But there is still a way to go with avoiding over-packing.

Our packaging design process encourages the specification of recycled materials and sustainable manufacturing methods, alongside detailed assessment of product lifecycle to reduce environmental impact. If you’re looking to improve sustainability in your packaging design, we can help.