An Introductory Letter From the BONEZONE Packaging Special Section Sponsor



Millstone 200x75

Special Section: 

Spine, Trauma Companies
Focus on Sterile Packaging

Vital Validation Considerations for Your Company's Next Packaging Project 

Medical Device Packaging is Shaped by Increased Regulations

*Sponsored by
Millstone Medical Outsourcing

Device packaging is a critical stage of product commercialization that cannot be underestimated, given its impact on your device long after implementation. Mitigating patient risk and developing confidence in packaging remains a priority for you and your orthopaedic colleagues, as packaging plays a vital role in the success and lifespan of your implants and instruments.

From design and manufacture, all the way to the end user, proper packaging ensures asset protection during transit, end-user traceability, brand promotion, reliability of device performance and, most importantly, patient safety.

Millstone Medical understands the criticality of proper packaging. We also recognize the significance of each step that must be considered to ensure your product is delivered to market safely and efficiently. From the selection of an effective package configuration to validations, sterilization methods and production process controls, thorough consideration must be given at each step in the process. Any setback or forced design change in the midst of validations or production has the potential to inflict significant delays to market—and additional costs.

Additionally, regulatory standards surrounding device packaging continue to evolve, with requirements becoming increasingly stringent. The critical nature of packaging does not subside with successful validations and production launches. Continuous, comprehensive process monitoring requirements that ensure package stability and assurance continue to gain prevalence throughout the industry. Establishing quality-centric, statistical and risk-based controls around each of your processes—and maintaining those controls throughout the lifespan of your device—is imperative for your packaging success.

Many orthopaedic manufacturers find adherence to new regulations challenging as they concentrate on minute details while facing tight timelines to market. Advice on ways to handle these challenges is highlighted within this special packaging section. It is important for device manufacturers of all sizes to ensure they tap into the right expertise and identify the best solutions for their business.

Partnering with a veteran packaging supplier is a viable solution for creating durable designs and thorough, robust validations. Our goal is to ensure peak performance of your devices and heighten patient safety.

Karl Neuberger



Chief Executive Officer
Millstone Medical Outsourcing