Time to Transition from Premade Medical Pouches? 7 Signs that say “Yes.”

By Mike Terry
Pre-made Pouch vs. Thermoforming

Choosing thermoforming as your primary medical packaging method makes sense. From custom, right-sized packaging capabilities to advanced inline printing, opting for thermoforming can improve production and efficiency and reduce total cost of ownership (TCO).

Once that decision is made, you also know the right ways to implement modern thermoforming to get the most from your production lines. Optimizing system design based on unique criteria then conducting validation testing allows for optimal, customized operations and a strong return on investment (ROI).

Knowing all this information still leaves you with one essential question you must answer before you implement your medical thermoformed packaging method:

“When is the right time to transition from premade medical pouches to thermoforming?”

While every packaging operation is unique – with specific requirements, operational parameters, budget, and facility space – there are telltale signs to indicate the time is NOW to take your medical packaging capabilities to the next level.

Capacity Expansion

In the wake of COVID-19, the demand for sterile medical packaging is skyrocketing, projecting to reach $68.49 billion by 2028 with a compound annual growth rate (CAGR of 8.1%). This dramatic rise in demand signals a necessary capacity expansion for many producers.

However, despite this expanding capacity trend, each producer has a selling cost and a margin on their products. They need to package as much of that product as possible without increasing the piece price costs. Trying to maintain that margin requires investment, which may be cost-prohibitive.

There are also several factors to consider when increasing capacity, including cycle rates, machine design, web width and draw depth, and overall line balance. Along with the piece price costs, optimizing these elements requires additional investments – both monetary and labor.

The efficiency, materials, and labor savings from a thermoformer can help offset these costs and make that essential capacity expansion possible.

Labor Concerns

Worker turnover rates in modern manufacturing have reached record highs over the last two years. Trained workers, who have legacy knowledge of packaging systems and production, leave and producers must train and retrain new personnel to take their place.

These modern workforce realities can leave you with efficiency gaps on your production line. The gaps can often require you to keep production up with a reduced staff, cut production to remain commercially viable, or opt for other solutions to manage pressing labor concerns.

Production automation on thermoforming equipment can alleviate these issues, as you can integrate it at every packaging stage. As a result, product loading, primary and secondary packaging, inspection, and palletizing are all more efficient – running at a 50% rate of Overall Equipment Effectiveness (OEE) from the onset while workers learn the system then rising to a world-class rate of 85%.

This solution not only alleviates labor and efficiency concerns but helps you realize a solid ROI to recoup your investment in automation within less than five years.

Supply Chain Issues

Labor issues, materials, and the hinderance of the global supply chain threaten to negatively impact the manufacturing sector well into next year. Medical thermoformed packaging is no exception.

As a producer, you must validate your packaged medical product through an extensive testing process. If the premade pouch you validated is no longer available due to materials or supply chain limitations, that leaves you searching for a new package.

Conversely, if your premade pouches are still available, but you must make various changes to internal features (i.e., added padding) or labeling, there could be extra costs in procuring these additional materials and integrating them effectively.

These scenarios will almost inevitably lead to in-depth analysis and comparison of packaging costs vs. investment for a thermoformer. You will ascertain the piece price cost, the cost of customizing that process, and, most importantly, the savings obtained through modern thermoforming and automation.

Testing on Calibrated & Validated Equipment for Medical Thermoformed Packaging

All equipment must be properly calibrated according to your production needs and validated using installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ). Having the equipment onsite to conduct this required testing can be capital intensive to a point that exceeds your operating budget.

Additionally, validating equipment – conducting validated test methods and using the product in-house – requires time as well as capital.

For example, you have identified peel testing as your zero-barrier system requirement testing method. Now, you must test, achieve your desired product and process accuracy, and implement that data into your production to optimize your lines.

Conducting these tests in-house with your own machinery can cost up to $100,000 in some instances. It also costs your Quality Assurance Team time to validate the equipment (up to six months) and your engineers time to keep it calibrated.

Third-party Calibration & Validation for Medical Thermoformed Packaging

Calibrating and validating equipment in-house is a strong indicator that automated thermoforming may be a better option for your production. But that doesn’t mean that you must shoulder the burden of time and monetary expenses conducting the testing in-house alone.

In these instances, you can save more by opting for third-party assistance. These trained specialists execute all validation testing for you, keep all your equipment calibrated, and provide detailed process reporting with data you can implement to improve your production at a lower cost.

While the savings vary from operation to operation, considering third party assistance does beg certain questions:

“Can you be more efficient?”

“What is your time worth to you?”

“What does it cost your in-house staff to calibrate and validate machinery?”

The answers to these questions can help you analyze your operating costs and determine whether there are significant savings you can take advantage of. Additionally, this automation of your calibration and validation processes allows you to return to your true mission: producing better packaged medical products in greater quantities for your eager customers.

Rate of Return for Medical Thermoformed Packaging

Every packaging company looks for a high rate of return when investing in modern packaging equipment. The monetary investment alone for thermoforming starts in the tens or even hundreds of thousands of dollars and continues over the machine’s lifespan.

In addition, there is not only monetary investment but also investments of time. Implementing thermoforming equipment for medical packaging can take up to 18 months to deliver measurable results. This process often requires six months for design, six months for validation testing, and three to six months for detailed data collection, depending on your unique operational requirements.

When you factor in both time and monetary spending, the rate of return will ultimately come down to savings vs. overall capital costs.

Factors in Rate of Return

The great news is, according to the experts, adopting thermoforming for your medical packaging can offer you 30% or higher rate of return for savings vs. capital costs.

But the path to those savings can be a long and winding road that is completely customized to your needs. There are careful considerations for every aspect of your unique process and complex calculations you must consider to help you see dividends.

What factors into these calculations?

For medical packagers, elements that influence the rate of return the most can include:


  • Material Savings
  • Efficiency
  • Production & Throughput Rates
  • Plant Space

Varying Production Goals

You may not even want to focus on the rate of return for your operation. Many medical packagers focus less on the monetary rate of return and concentrate on fulfilling other commercial needs that dictate a necessary investment, successful transition to thermoforming, and commercial viability:

Maintaining Production

The pandemic has made skilled and unskilled human labor a rare commodity, with about 941,100 unfilled openings for hand laborers and material movers. As a result of workplace health and safety concerns and lateral career shifts, companies are experiencing exorbitantly high turnover rates among their workers.

Adopting a thermoformer machine with fully automated loading and production offers a solution to their needs. The focus strays away from the bottom line and becomes all about the production line.

Consistent Product

Other packagers transition to a thermoformer for medical packaging to offer their customers a more consistent product. Medical packaging with premade pouches involves manual labor. That handling can lead to variations in product packing and overall results and more opportunities for contamination. In an industry that demands sterility at every production, transport, and utilization stage, deviations from the ideal can be unwelcome.

Transitioning towards a Brighter Tomorrow

As a packager, you may have an array of reasons to transition from premade pouches to the benefits and security offered by modern automated thermoforming. Whether those reasons include capacity or labor concerns, supply chain certainty, or rate of return, you know that beneficial changes must be made. But you’re unsure that a thermoformer machine for medical packaging is the right answer.

Harpak-ULMA can be there to provide that surety and make your transition to thermoformed medical packaging a seamless one.

As your trusted packaging partner, we do an in-depth analysis of your production lines and offer tailor-made solutions to help you meet your present and future goals. We have the expertise, resources, and equipment to help you understand your medical packaging limitations, transcend them, and transition to better medical packaging at a time that’s right for you.

We invite you to talk to our packaging experts for more information and discover a better medical packaging system designed around you.

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