Key Takeaways

• Sterilization Compatibility – Robotic packaging must align with sterilization methods to ensure sterility at the point of use.

• Durability – Packaging must protect complex, high-value instruments through shipping, handling, and reprocessing.

• Sustainability – Reusable and eco-friendly packaging solutions must maintain sterility and withstand repeated use.

• Regulatory Compliance – Packaging must meet ISO and FDA integrity, labeling, and traceability requirements.

• Human Factors – User-friendly packaging supports aseptic presentation and efficient handling in the OR.

Robotic-assisted surgery (RAS) has revolutionized the modern operating room by providing unmatched precision, flexibility, and improved patient outcomes. However, these advancements introduce various packaging challenges for manufacturers and healthcare facilities. The instruments and components used in robotic surgery are often sophisticated, delicate, and high-value, necessitating packaging that effectively protects these items while facilitating sterilization, compliance, reusability, and aseptic presentation in real-world surgical environments.

In this discussion, we will examine five key challenges in packaging for robotic surgery and explore how original equipment manufacturers (OEMs) and healthcare providers are working to address these issues.

1. Sterilization Compatibility and Maintaining Sterile Integrity

Sterilization is essential in surgical settings, but robotic devices complicate this process. Many robotic components are factory-sterilized using ethylene oxide (EO) or gamma radiation and sealed in sterile barrier systems (SBS) that must maintain their integrity until used. The packaging materials must allow sterilant penetration without degrading, and their barrier properties must withstand storage, transit, and handling.

From the perspective of medical device OEMs, this means rigorous material selection and validation according to ISO 11607 standards. Pouches, trays, and outer cartons must maintain sterility, while components—particularly reusable—may require hermetic sealing or protective housings to withstand repeated sterilization cycles. Electronics present additional challenges for steam sterilization, prompting OEMs to incorporate protective features into the product and packaging design. Cleanroom assembly is also critical in maintaining sterility, ensuring that instruments and components are prepared, handled, and packaged in an environment that meets stringent contamination control standards.

On the hospital side, reprocessing becomes complex. To effectively penetrate long, delicate robotic instruments, we must package them in reinforced pouches or rigid trays that allow steam or hydrogen peroxide gas to reach them. Non-sterilizable parts, such as robotic arms, are covered with sterile drapes, adding another layer of sterile packaging to manage. Staff must follow the Instructions for Use (IFUs) to ensure reprocessing and packaging choices align with the validated methods. Any missteps can compromise sterility or damage the equipment.

Ultimately, ensuring sterilization compatibility is not just about materials. It involves aligning packaging, device design, and assembly workflows to support reliable and validated sterilization across diverse clinical workflows.

2. Packaging Durability and Protection for Complex Components

Robotic surgery systems are intricate and expensive, necessitating packaging that safeguards both sterility and functionality. Every touchpoint presents a risk, whether shipping high-value robotic consoles or reprocessing delicate instruments.

Manufacturers must design durable packaging systems that resist vibration, shock, and moisture. Achieving adequate packaging and storage involves multi-layer configurations that include inner sterile pouches and outer cartons for smaller instruments. Custom-molded trays and rigid sterilization cases, sometimes featuring proprietary brackets or inserts, are standard for reusable tools. Position these secure devices correctly to minimize movement and prevent damage during autoclaving, transport, or storage. The assembly process plays a key role here, ensuring that each component is correctly loaded into trays or holders, fastened brackets, and protected delicate features before final packaging.

Durable packaging must endure daily handling in a hospital environment, from decontamination to the operating room. Sterile processing departments depend on reinforced pouches, such as robotic instrument pouches and rigid trays that are puncture-resistant and maintain shape. Features like heavy-duty seals, easy-peel designs, and dust barriers enhance protection and user-friendliness.

Protection is essential at every stage, from the OEM’s factory floor to the nurse opening the tray mid-procedure. The packaging must be robust enough to secure sensitive devices while remaining simple enough to avoid delaying surgical workflows.

3. Reusability and Sustainability of Packaging

Robotic-assisted surgery generates significant packaging waste, including single-use sterile instrument kits, disposable drapes, and wraps. In an era where sustainability is a priority, OEMs and hospitals are reevaluating strategies to reduce, reuse, and rethink sterile packaging.

OEMs are adopting greener practices by offering reusable trays instead of disposable wraps, minimizing plastic volume, and exploring recyclable or biodegradable materials. Some manufacturers create “reposable” systems that replace only part of the device while keeping the core reusable. However, these solutions necessitate extensive validation to ensure they can withstand multiple sterilization and handling cycles without degrading. OEMs must meticulously assemble reusable and reposable components in validated configurations to ensure proper functionality, protection, and regulatory compliance throughout multiple uses. This attention to detail during assembly is critical to maintaining the integrity and longevity of these sustainable systems.

Hospitals experience the waste burden firsthand, often opening numerous sterile packs for each procedure. To mitigate environmental impact, facilities are implementing recycling programs, reprocessing systems, and individualized instrument pouching, which allows unused items to stay sterile and avoids unnecessary reprocessing. However, reusable packaging demands maintenance, training, and infrastructure to clean and track items effectively.

The overarching goal is to reduce waste without compromising sterility, safety, or workflow. OEMs and hospitals must collaborate to balance ecological responsibility and clinical reliability.

4. Regulatory Compliance and Labeling Requirements

Sterile packaging for robotic devices must adhere to a complex set of regulatory requirements, ensuring physical integrity and accurate labeling.

RAS OEMs are subject to stringent international standards such as ISO 11607 and FDA regulations. These standards govern packaging validation, seal strength, transit durability, and shelf life. Additionally, labeling requirements introduce another layer of complexity: lot numbers, sterilization indicators, expiration dates, UDI barcodes, and symbols (as defined in ISO 15223-1) must be clear, accurate, and durable throughout sterilization and transport.

For hospitals, regulatory compliance is crucial in daily operations. Operating Room (OR) staff require clear labeling to confirm sterility and expiration dates quickly. UDI barcodes must be scannable by inventory systems for effective traceability and recall. Poorly designed or missing labels can lead to serious risks, including misused devices, lost documentation, or safety incidents.

Moreover, the Instructions for Use (IFUs) accompanying robotic tools are essential. These instructions must clearly outline opening procedures, sterile presentation, and reprocessing steps, especially for complex, multi-component systems.

In conclusion, packaging compliance fulfills requirements and ensures safety, usability, and traceability from the warehouse to the operating room.

5. Human Factors and Aseptic Presentation in the Operating Room

In the high-stakes environment of robotic surgery, packaging needs to accomplish more than just protection; it must also facilitate flawless aseptic presentation. The design should consider how human hands will interact with the packaging.

To assist surgical staff, OEMs engineer packaging systems with double-barrier layers, easy-open tabs, and intuitive visual cues. For instance, a sterile peel pouch may allow an inner tray to drop into the sterile field, presenting the robotic instrument in a ready-to-grasp position. Features such as sealed corners prevent fiber tears while holding fixtures helps avoid inadvertent contact with sterile areas.

In hospitals, scrub techs and circulators depend on consistent and reliable packaging to safely present and transfer instruments. Issues related to human factors, such as oversized wraps that sag, difficult-to-peel lids, or unclear labeling, can lead to contamination or delays. Compact, organized, ergonomic packaging enhances safety and efficiency, especially in crowded operating rooms.

It is not enough to protect a device during transit; the packaging must be easy to open, intuitive to handle, and straightforward to use when precision is critical.

Conclusion: Packaging Innovation Must Align with Surgical Innovation

Robotic-assisted surgery requires more than just advanced tools; it also necessitates packaging that meets their complexity. Key factors such as sterilization, durability, sustainability, compliance, and usability all play crucial roles in ensuring patient safety and the success of surgeries.

Both manufacturers and hospitals should adopt a multidisciplinary approach to packaging for robotic systems, carefully balancing protection, performance, and environmental impact. By investing in innovative materials, validated systems, and human-centered design, the industry can ensure that the packaging supporting robotic innovation is as precise and reliable as the robotic systems themselves.

Millstone Medical Outsourcing provides a fully integrated approach to simplify the complexities of robotic packaging for OEMs, including complex assembly, cleanroom packaging, sterilization validation, regulatory expertise, and custom kitting solutions. With extensive experience in RAS device packaging, Millstone ensures that each component—single-use, reusable, or reposable—is protected, compliant, and ready for aseptic delivery. From early collaboration to final assembly, Millstone delivers the precision and reliability that robotic-assisted surgery demands.