By Sean Fenske, Editor-in-Chief

The development of complex orthopedic systems is a sophisticated process. As such, it can be easy to neglect an aspect or wait too long to consider it within the larger scope of the entire program. When this occurs, benefits may be sacrificed or advantages that could have been realized are lost due to time and cost constraints.

One all-too-often neglected aspect of the development of a complex system is its packaging. While a critical consideration of the complete orthopedic product design, development of packaging can take place in the latter portion of the process. When this happens, opportunities are missed. In order to realize the greatest benefit from the system packaging, an expert needs to be included in the conversation early.

To help further explain the importance of packaging development and the benefits that can be enjoyed from doing so early is John Nino, CEO of Life Science Outsourcing. In the following Q&A, he speaks to when packaging should be developed, what impact it has on the orthopedic system, and what considerations come with a custom solution.

Sean Fenske: What should be the primary goals of orthopedic device packaging?

John Nino: The primary goals are protection, sterility, usability, and compliance—in that order. Orthopedic devices are often high-value and patient-specific, so packaging must safeguard that investment from the cleanroom to the operating room. But it’s not only about protection; it also needs to support surgical workflow and meet strict regulatory requirements.

Fenske: Do the device OEMs always recognize this early on?

Nino: Not always. Many are rightly focused on the device itself, and packaging becomes an afterthought. That’s where we come in. At LSO, we help reframe packaging as a critical component of product success, minimizing delays and preventing costly rework.

Fenske: While packaging is viewed as one of the final steps in a product development lifecycle, when is the best time to engage with a packaging partner on its design and fabrication?

Nino: Much earlier than most assume. If you’re waiting until the end, you’re already behind. We encourage orthopedic OEMs to engage us during design freeze or even earlier if the general form factor is known.

Packaging impacts sterilization, usability, labeling, shelf life, and logistics. These are not standalone steps but part of an interconnected process. Early collaboration sets the stage for smoother development, fewer surprises, and faster market readiness.

Fenske: When it comes to complex orthopedic systems, what are the most significant challenges involved with the development of appropriate packaging?

Nino: Complex systems—such as modular trays, multi-component kits, and patient-specific implants with intricate geometries or sensitive coatings—present several unique packaging challenges:

• Modularity: Maintaining component organization and sterility while enabling intuitive access during surgery is critical. Instrument and implant fit is especially important; packaging must strike the right balance between secure retention and ease of removal. A tray that holds instruments too loosely risks damage or disorganization; too tightly, and it can delay surgical workflows.
• Customization: Many orthopedic systems require low-volume or one-off configurations. These still demand consistency, compliance, and repeatable performance, even at scale.
• Size and Weight: As implants become larger or more robust, packaging must accommodate increased weight without sacrificing durability or ergonomics. Heavier components must be protected against the rigors of transportation and handling without creating a burden for sterile processing or surgical teams.
• Sterile Presentation: Regardless of complexity, packaging must ensure safe, intuitive access to the device at the point of use, supporting aseptic technique and minimizing unnecessary handling.

At LSO, we’ve engineered our packaging development capabilities specifically to address these challenges. By integrating design, prototyping, validation, and sterilization under one roof, we help orthopedic OEMs bring complex systems to market faster—without compromising safety, usability, or compliance.

Fenske: What regulatory hurdles come into play with orthopedic device packaging?

Nino: There are several. Packaging must meet ISO 11607 requirements for sterile barrier systems; pass validation testing for sterility, transit, and shelf life; and sometimes address combination product regulations from agencies like the FDA or EMA.

If the device includes a pharmaceutical component, such as an antibiotic coating, the packaging must also align with pharmaceutical GMP standards. These complexities often catch smaller OEMs by surprise. Our in-house regulatory and validation expertise helps clients navigate this landscape with confidence.

Fenske: Are there solutions available for orthopedic device packaging that are pre-fabricated, pre-validated, and/or considered off-the-shelf?

Nino: Yes, but with nuance. While there are off-the-shelf options—for example, stock trays, pouches, and blisters—those are typically best suited for standardized implants or instruments. When it comes to more complex systems like modular trays or combination kits, a custom approach is often necessary.

At LSO, we’ve developed a library of pre-validated sterilization cycles and packaging templates based on decades of experience across a wide range of orthopedic devices. This foundation allows us to dramatically reduce time-to-market, even when a fully custom solution is required. For example, by leveraging a pre-validated outer tray with a sterile perimeter, we can often pair it with a custom-designed backer card or internal configuration that fits the specific device. This hybrid approach combines the speed and regulatory confidence of pre-validated solutions with the precision and protection required for high-risk or non-standard products.

Our deep expertise in material selection and barrier systems also increases the likelihood of passing critical validation tests—shelf-life, aging, seal strength, and sterile barrier integrity—on the first attempt. It’s not just about faster packaging; it’s about smarter, more reliable outcomes.

Fenske: What is generally overlooked, forgotten, or neglected to be considered when it comes to orthopedic device packaging? Where do companies stumble?

Nino: The biggest mistake is treating packaging as just a container. It is part of the regulatory submission, part of the clinical workflow, and an extension of the product itself.

Many companies overlook the sterilization strategy, which should inform packaging materials and design. Others forget to account for labeling early in the process, leaving no room for critical elements like UDI or instructions for use. These oversights lead to delays, redesigns, and increased costs.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?

Nino: Yes. If you’re developing orthopedic devices, especially complex systems, packaging should be part of your strategy from day one. When approached early and executed well, it can improve surgical outcomes, reduce OR time, simplify sterilization logistics, and reinforce quality throughout the product lifecycle.

At LSO, we’ve built our business to integrate packaging, sterilization, and testing under one roof, so companies don’t have to coordinate across multiple vendors. That means fewer handoffs, faster timelines, and more control for our partners. This level of integration allows us to move quickly without sacrificing quality. Our goal is simple: to help you bring innovative orthopedic solutions to market safely, efficiently, and rapidly.

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