Understanding Medical Device Packaging Requirements

By Mike Terry

Producing a medical device means understanding and communicating medical requirements before bringing your product out of design. Done right, addressing medical requirements early can benefit your operations, help you package and deliver a better device, and build valuable trust between your business and those you mean to serve. Done right, requirements can very often be the fine line between producing a viable product and closing your doors for good.

But what are these requirements? What do they mean for your material, packaging, and compliance choices, and how can you harness them to optimize your product and process?

We’ll explore the best ways to understand this necessary data and show how you can reimagine your medical device production to save time and money and preserve the all-important trust you have built with your valued users.

Begin at the End

For all their gravitas, medical device packaging considerations have traditionally come at the end of the design and development phases. They carry enormous weight in both processing and product viability, yet, device packagers have continued to follow a linear thought path, integrating packaging, labeling, and quality control requirements in the latter planning stages of their roadmap instead of at the onset.

But the reality is incorporating medical requirements and packaging as early as possible will always yield the best benefits.

Regulations, validation, and testing pervade the medical device industry. As a medical device packager, understanding your end users’ needs and medical packaging requirements simultaneously helps you stay perpetually compliant, pass current and future validation testing and reporting, and deliver a better product and process overall.

Think about your end-user. Who are they? How do you define them? How will they be using your product? In what settings and under what conditions? Do your product and packaging live up to the claims provided in the printed labeling?

The answers to these questions will influence and determine the package format and design on various vital fronts, including materials, sterilization, shipping and transport, ease of use, overall user experience, and more.

Governmental & Organizational Medical Device Packaging Requirements

End users are not the only ones who dictate product requirements and design. Depending on the registered class of your medical device – Class I, II, III – you will also have requirements from governmental and standardization entities such as the Food and Drug Administration (FDA) and the International Organization for Standardization (ISO).

While there are voluminous requirements to meet for every medical device class, such as 21 CFR Part 801, ISO 15223, ISO 11607, and others, these governing bodies seek to satisfy established guidelines and regulations that permeate the industry. These can include standards for labeling and data integrity, usage, sterilization, age testing, shelf life, and international distribution overall.

However, cataloging and staying current with these various guidelines is often outside your responsibilities as a direct medical device manufacturer. Almost every manufacturing company has people to track, apply, and integrate all these established requirements and any changes.

Most organizations employ internal or even third-party regulatory departments to keep current on the FDA’s and ISO’s standards and practices. These teams are responsible for dictating these requirements to the engineering, design, and production teams.

What is more, these expert teams and personnel are always included on any registered device changes and can conduct impact analysis on any changes, including packaging format changes, production rates, materials, the veracity of device capability claims, and more.

Medical Requirements & End-User Advantages

Regardless of where they live, incorporating established medical requirements as early as possible means minimizing the risks of product defects, eliminating costly surprises, alleviating the stress of expensive potential recalls, and creating a more efficient product. In addition, determining medical requirements early from end-users AND governing bodies gives you the tools you need to properly plan and execute the next stages of your packaging strategy. It provides a clear path through the various facets, formats, and medical packaging applications and creates a beneficial domino effect for your business.

How does reordering your process achieve such results? Consider all the ways beginning with medical requirements and packaging design can conserve essential resources overall:

  • Better Market Adoption: Your product will be safer and easier to use, get to market faster, and provide you with improved market adoption among your essential end users.
  • Steady Sales & Production Costs: Thorough planning and additional consideration will never hold up your timeline, decrease sales, or increase production costs.
  • Fewer Design Errors: Solving for medical requirements will preclude you from going back and redesigning for packaging problems and usage issues later – even helping you avoid costly recalls.

A Qualified Packaging Partner

As you establish your unique medical device packaging requirements, that data will be shared with film vendors and a chosen, reputable packaging partner. This requirement data is then used to develop pertinent questions regarding your product, identify any packaging gaps, and discern where packaging equipment and applications best fit in those scenarios.

While your essential product requirements are predetermined, your packaging partner can now offer expert insight on the optimal packaging formats and rate speeds that best match your needs – all based on a variety of production factors, including:

  • Time
  • Temperature
  • Pressure
  • Sterilization
  • Advanced Printing & Labeling
  • Inspections
  • Data Integrity
  • Throughput
  • And more

For instance, you have a terminally sterile medical device, and you want to incorporate a peelable inspection area. That will eliminate almost all flow wrapping equipment options. You could then opt for the advanced alternative capabilities of a thermoformer machine for your medical packaging to achieve the desired results.

Key Considerations for Medical Device Packaging Requirements

Your packaging partner does not dictate your medical requirements but monitors them to offer you essential packaging insights based on your unique product specifications. Generally, this monitoring will yield three main areas for which you should have predetermined requirement data to provide an optimal production process and user experience:


Package characteristics and film type determine the machine model, application, and unique sealing elements’ characteristics. If you want rigid or flexible medical packaging materials, sterilized Tyvek medical paper, or coded or non-coded labeling, your packaging partner will work with your designated film vendors. Using the provided product parameters and technical specifications, your partners can select an optimal film based on seal time, pressure, and other important features.Thermoformed Medical Kit

Therefore, it is crucial to state package preferences and material caveats at the earliest opportunity when determining package characteristics. These can include looks vs. function preferences, material backlogs, price increases, etc.

For example, learning that a preferred material is unavailable, discontinued, or exceeds your operating budget could mean starting design and development again. If you are under a tight deadline to deliver your product to market, this is an undesirable outcome.

During conversations concerning materials, be prepared to answer essential questions like:

“What materials are you currently using?”

“Can your packaging partner accommodate your desired rate for forming and sealing?”

From these questions, other tributaries open concerning other issues such as “Do you want recyclable materials?” and more.


You can address packaging sterilization after choosing your preferred material and optimal packaging rate.

For instance, choosing an Ethylene Oxide (EO) with breathable Tyvek medical packaging paper will make sterilization is a must. Gamma and e-beam sterilization require alternate configurations, as do steam-sterilized equipment.

All sterilized products must be tested, aged, and officially validated to ensure safety and efficiency. That choice in sterilization options and methods will dictate product design.

Sustainable Medical Packaging

There are also choices to be made concerning packaging sustainability. More and more, modern packagers are seeking sustainable packaging materials, such as recyclable Polyethylene Terephthalate (PET). Your packaging partner will collaborate with you and your chosen film vendor to discern if your materials are a forming film and integrate it into your system for better savings and green options.

Package Depth

Finally, you have various product depth options with modern packaging innovation provided by advanced flow and thermoformer sealing technology. You can choose multiple packaging depth options up to and including 210mm (8.3”) on most equipment.

Hermetic vs. Non-Hermetic Sealing

“Hermetic” is defined as a gas-tight seal or a seal that is impervious to gas flow. A properly formed hermetic seal with a sufficient, low-leak rate can prevent water vapor from accessing any components inside your medical packaging, keeping it dry and moisture-free for years. Conversely, if a seal is non-hermetic, it can allow liquid droplets to form on the device’s surface, causing corrosion and degrading the device’s performance, possibly leading to failure.

This distinction is important as safety is paramount when discussing the seal type for your medical device. Products must be pristine and ready for use, often in high-pressure emergencies. However, hermetic parts are not listed as requirements from the governing entities for medical packaging. Moreover, hermetic parts cost more to build and test.

Choosing hermetic vs. non-hermetic seals based on your product’s requirements will determine your equipment’s chosen sealing technology. Subsequently, that technology can affect the machine’s cycle time overall.

Inline Printing, Labeling & Inspections

As much as materials, printing, labeling, and inline product inspection equally affect throughput and machine design, as these factors allow for the highest levels of data integrity and traceability. UDIs, bar codes, inline printing, and labeling all require inspection to ensure data meets industry standards and inspection and rejection capabilities in secondary packaging.

Product Inspection & Secondary Packaging

Product in seal, missing product, and seal wrinkles can all be detected with inline printing and inspection capabilities. In addition, with sophisticated printing options, you can auto-reject products that don’t meet requirements and take advantage of advanced quality control (QC) sampling rather than simply applying a label after the fact.

Medical Device Labeling & Manufacturing Claims

Does your medical device labeling address all regulatory requirements?

Have you included unique device identifiers and the required labeling symbols to ensure your device stays compliant?

Answering these questions and proactively integrating proper labeling elements ensures the highest accuracy, verifies product capability claims, and helps you avoid costly recalls. Not including these labeling elements or having inaccuracies that counter your product’s claims can negatively impact your device’s market introduction, success, financial viability, and even your patients’ health and lives.

In fact, labeling inaccuracies consistently rank as one of the three to five causes of FDA-issued product recalls. While larger corporations may be able to correct these issues quickly, survive the recalls, and continue to thrive, smaller manufacturers may miss the market opportunity and be unable to recover.

Consider if your company mislabeled a lot number on your product. It would set off a series of necessary steps to correct that issue. A recall will be issued, product must be shipped back, and your company will have to launch an internal investigation. These steps are costly in terms of shipping times and lost sales, and they also erode end-user trust and may terminate future funding.

Safeguarding Your Investment through Printing & Labeling

To counter these outcomes and ensure your printing and labeling are correct, it is essential to familiarize yourself with the FDA’s standards on device labeling and work closely with your regulatory, quality assurance, and manufacturing teams. In addition, be sure that the labeling is incorporated in the manufacturing process BEFORE testing at the design output phase to correct any issues that may arise early to prevent any damage to your organization.

Using Medical Device Packaging Requirements to Better your Products & Process

As a medical device packager, you must understand many medical requirements before bringing a device to market. However, familiarizing yourself with these requirements and bringing precise product data to conversations with film vendors and packaging partners makes sense from a financial and product viability standpoint.

When you have the required information that satisfies your unique production, end-users, and the governing industry entities, the complete medical device production picture, from design and labeling to testing and user experience, comes quickly into focus in dynamic, helpful ways.

These required predetermined numbers, facts, and figures eliminate the guesswork in both material selection and the packaging process. They provide a strategic path to product success and help you avoid costly pitfalls, delays, or product redesigns.

Talk to the experts at Harpak-ULMA Packaging about your medical device needs. As your packaging partner can utilize your medical requirement information to guide you through the process, make the best recommendations for your unique device, and optimize essential production features, such as speed, automation, labeling, product quality, and speed to market.

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