Solving the Complexity of Package Validation for the High-Growth Firm


It’s a topic of continual interest to us, as well as to firms in the orthopedic device industry. This year alone, we’ve looked at it from several angles: from what drives orthopedic-specific complexity to how tier 1 servicescan effectively counter it and four key ways to fuel velocity by reducing complexity.

The reason it’s so endlessly interesting is that complexity is a major villain in any business. Why? By ramping up the potential for error and amplifying inefficiency, complexity can escalate risk, cloud decision-making, and drive up cost. All of these things, you already know, affect business growth and profitability.

To high-growth manufacturers, velocity and profitability are paramount. Those firms that are focusing on driving rapid growth through new product launches, strategic resource utilization, and merger and acquisition activity are often keen to find any way to reduce inefficiency and speed time to market to keep pushing growth.

These firms might have already streamlined their loaner kit processing to turn kits faster and reduce their inventory footprint. They might have already made strategically sound decisions about facility buildout and staffing, choosing to consolidate facilities and opt for labor that can flex and scale with demand for better operational efficiency. They might have already seen the value of extending their shipping windows or choosing a partner for outsourcing their shipping and distribution. They might have already simplified their supply chain complexity and consolidated their vendor relationships to streamline communication and invoicing while also reducing risk.

Firms that have taken these drivers of complexity on and streamlined them certainly reap the benefits. After these challenges, though, what’s left?

The answer is an area with big opportunity for reduction of complexity: package validation.

As firms scale, package validation can become more and more complex. And, especially for high-growth manufacturers, package validation can be a particularly thorny challenge.

The reason is that inefficient processes for package validation can be a significant drain on the business, introducing risk and delaying time to market. Package validation expertise and pre-validated packaging solutions can effectively address this complexity, particularly for the high-growth firm. Here are three specific reasons why.

#1: Pre-validated packaging solutions can reduce time to market up to 50%.

Recouping investment in R&D (and often driving growth) hinges on getting products to market safely and quickly. Pre-validated packaging solutions can fit up to 80% of spine and orthopedic devices and offer flexibility, with both pouch and tray configurations. Because the sterile barrier system (SBS) is already pre-validated and the packaging has passed package stability and accelerated aging testing, time to market may be reduced by as much as 50%, cutting the often best-case package validation timeline from six or more months to as few as 13 weeks.

#2: Validation expertise can help OEMs embrace a more holistic approach to package design.

Some products can’t be accommodated by a pre-validated package solution. Failure to consider both package and product together, though, is a common mistake that can introduce significant delay in product launch timelines. Validation expertise can help steer a more successful, faster, less risky package design and validation process. An expert partner understands the package design and validation process inside out and can help an OEM consider package design from the very earliest days of product development.

#3: Expertise can resolve package remediation challenges.

Sometimes an OEM’s package design and validation encounters problems in the distribution or package stability testing phase. The sterile barrier system (SBS) must be able to bear the distribution stresses of travel between sterilization, the finished goods warehouse and the operating room, whether travel happens by truck or in the pressured cargo of an airplane. For package stability, OEMs must ensure that packaging can maintain a sterile barrier for the duration of the product’s specified shelf life. Often, to speed package stability testing, OEMs subject packages to aggressively accelerated aging stresses. Package failure can set product launches back again and again. Here is where package validation expertise can help specifically identify and address the reasons for failure and get products moving toward successful completion of validation testing.

Complexity rears its head at every stage in package design and validation, from the imposed complexity of regulations and compliance to the variety of multiple products and product lines to the complexity of systems within an OEM’s operations. Transferring processes and responsibility to an expert partner can often be the best way to counter one of the last bastions of complexity for the high-growth manufacturer.

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 reverse logistics services—all with an unparalleled focus on quality.

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