Thermoformed Trays for Orthopaedic Applications
Is your orthopaedic device packaging ready for the whole journey?
Orthopaedic packaging decisions influence far more than device protection. Design, materials, compliance, supply and performance considerations can all affect validation, commercialization and long-term supply continuity.
Download the Orthopaedic Device Packaging Readiness Guide to assess your readiness and identify areas that may need attention earlier in development.
Packaging is part of the system
Orthopaedic device packaging goes far beyond the container. It's a crucial part of the system that keeps a device protected, sterile, compliant, traceable and ready for use, from production to point of use.
As orthopaedic devices become more complex and expectations around compliance, validation and supply continue to increase*, earlier packaging consideration gives teams time to address risks while changes are easier to implement, support more informed design decisions and maintain continuity as programs move to commercial order.
How Amcor Supports Packaging Readiness
Thermoformed tray expertise
built around orthopaedic device complexity
Tray, lid and material knowledge
to balance protection, fit and performance
Technical support, testing capabilities and quality-systems expertise
aligned with medical packaging requirements
Structured support
from concept development and prototyping through to validation, tooling and commercial production
From device-ready to system-ready
Our Orthopaedic Device Packaging Readiness Guide helps device manufacturers identify packaging challenges and key decision points before changes become more difficult to implement.
Inside this practical guide you’ll find:
- Guidance across five readiness dimensions: design, materials, compliance, supply and performance
- Five pressures reshaping packaging decisions: rising procedure demand, outcomes accountability, regulatory expectations, sterile barrier risk and supply complexity
- Orthopaedic Packaging Readiness Scorecard: an initial assessment tool to prompt reflection and planning
What you'll gain
A clearer understanding of the packaging decisions that influence validation, commercialization and supply continuity, before key development decisions are finalized.
The five pressures reshaping readiness
1. Rising procedure demand
Orthopaedic surgical procedures increased by 4.5% from 2023 to 2024.** That increases the pressure on dependable availability, consistent quality and repeatable supply.
2. Outcomes accountability
Longer-term outcomes are becoming more visible through registries and post-market data, raising the bar for packaging choices that affect device protection and confidence before use.
3. Regulatory and traceability pressure
ISO 11607-1 and ISO 11607-2 set clear requirements for materials, sterile barrier systems and packaging systems, and these frameworks require validation, documentation and stringent control.
4. Sterile barrier and point-of-use risk
Seal integrity, tray design and opening behavior all influence whether a device can be presented safely and consistently at the point of use. Packaging performance needs to be maintained across transport, storage, handling and sterile presentation.
5. Supply and operational complexity
A validated tray system depends on qualified materials and lids, production tooling, cleanroom capacity, technical support and reliable supplier routes. Issues such as manufacturing interruptions and recalls can disrupt device supply.
A recent review of three US FDA recall databases identified 791 seal-integrity-related product IDs among 27,799 recalled product IDs between January 2019 and January 2025. Of those with seal-integrity issues, 96.7% involved medical devices.***
The Readiness Framework: five connected dimensions
Packaging readiness is achieved when design, materials, compliance, supply and performance work together as one interconnected system.
Design readiness
Can the tray support fit, handling and point-of-use presentation in the intended use environment?
Materials readiness
Can the tray and lid materials protect the device and meet performance requirements across sterilization, storage and use?
Compliance readiness
Can the pack system be validated, documented and traced effectively?
Supply readiness
Can the validated tray system be produced and supplied reliably once demand scales?
Performance readiness
Has the tray system been tested across the conditions it will experience before use?
Together, these five dimensions help manufacturers identify packaging challenges earlier and prepare for validation, commercialization and long-term supply.
Let’s talk about your packaging readiness
Amcor combines orthopaedic thermoformed tray expertise with the knowledge of packaging engineers, materials specialists, quality professionals and healthcare packaging experts. From concept development and material selection through to testing, validation and commercial production, we help manufacturers address packaging requirements across the full product lifecycle.
Whether you're evaluating design options, preparing for validation or planning for commercial supply, our team can help you identify the packaging considerations that matter most.