The Tug-of-War Between Time to Market and Quality Processes

Let’s be honest: how much time are you factoring into your product launches for package design and validation?

For manufacturers, success in launching new devices and product lines depends heavily on being fast (and sometimes first) to market. After all, even once product development is underway, it can take significant time to determine the right packaging design and proper packaging validation process to ensure patient safety. Even then, package validation doesn’t come with guarantees: manufacturers can become mired in a validation process that stretches from weeks to months—or at worst, years.

And, despite the pressure to get to market quickly, OEMs must of course always prioritize product and process quality. Given the continual tug-of-war between getting to market quickly and getting to market with a quality product and robust process, what can a manufacturer do to ensure success?

Understanding the high stakes

To understand what’s at stake, it’s crucial to take a step back. The products OEMs design and manufacture are, of course, intended to improve patients’ quality of life. And with continual technological advancements, such as patient-specific implants and the application of 3D technology, the pace of product development is continually increasing. Getting to market safely and quickly is key to recouping significant R&D investments to, in turn, feed future innovation. It’s also essential to be in compliance with FDA regulatory oversight and the global standards that govern packaging in order to get to market safely and quickly.

Failure to prioritize safety and compliance can put manufacturers at risk of continual product launch delays or—in the worst cases—jeopardize their ability to ever reach the market at all.

Understanding package design and validation

The package design and validation process ensures the integrity of a sterile package for a device’s journey from the manufacturer to the patient. Without a successful aseptic transfer, patients are at risk of infection, which can lead to aseptic loosening, or other complications. To ensure patient safety, devices must withstand transportation into the operating room with an effective aseptic transfer into the surgical site and, ultimately, the body.

Traditional package validation involves several steps, including:

  • Package design, which involves choosing packaging materials and creating a package configuration.
  • Sealing validation, or proving that a sterile barrier can be created and maintained
  • Distribution testing, which concerns whether or not the chosen design protects the device so that it survives distribution with an intact sterile barrier—from distribution through the arrival into the surgical suite
  • Accelerated aging, a time-related process validation which entails proving that the packaging can maintain its integrity for the full shelf life of the product as determined by the manufacturer. Accelerated aging testing can simulate the aging process over the specified timeframe and provide the necessary proof.

Taken together, traditional package design and validation can take 26 weeks or longer (or even stretch to a year or more), a considerable horizon in a competitive industry. And that’s not considering the potential for setbacks. Repeated failures in accelerated aging testing, for example, can push a product launch back 40 days or more for each failure. It’s easy to see how package validation can balloon and put manufacturers—and their investments in new product design—at real risk.

Three ways to speed time to market

Accelerating the package design and validation process is possible—without amplifying risk or compromising patient safety.

First, OEMs can take a holistic approach to product design and validation during the product development process. This approach involves considering product and package as two halves of a whole and proactively undertaking package design earlier in the product development process.

Second, in an alternative approach to traditional package design and validation, manufacturers can choose from robust pre-validated and universal packaging solutions. These solutions, which can fit up to 80% of spinal implants, give manufacturers the assurance of an effective sterile barrier and package. Additionally, the package has been proven to withstand distribution stresses and aging testing. Pre-validated or universal packaging solutions can cut time to market by 50% in many cases.

Third, manufacturers can reap the advantages of working with an industry-expert partner with proven market expertise in packaging design and validation. Outsourcing with such a partner can alleviate a great deal of the risk of the validation process and ensure that regulatory constraints or delays do not hamper product launch timelines. Additionally, outsourcing can often be an optimal allocation of resources for greater efficiency—and to free up talent on an OEM’s team to focus on product design, marketing, and sales to fuel next-level growth.

At Millstone, we get it. We believe quality drives patient success. That’s why we’ve perfected all the capabilities medical device manufacturers need to get to market. Today we offer post-manufacturing and aftermarket services to more than 50 customers, including some of the top 10 orthopedic companies in the world. We are constantly evolving our processes and services to help OEMs achieve sustainable success. We offer clean room packaging, medical device specific warehousing, finished goods distribution, loaner kit management, advanced inspection and after-market services—all with an unparalleled focus on quality.

What could we help you do better? Learn more at


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