Three Reasons Validation Expertise Can Speed Time to Market Without Compromising Quality

Like a high-wire act, package design and validation can be fraught with risk. Not only does the process include multiple potential pitfalls, it can also involve setbacks that can continually push back market launch dates.

Time to market, of course, is crucial to success in this competitive industry. Yet, even under pressure to speed product launch timelines, manufacturers must always keep quality and patient safety as the top priorities in the process.

For all of those reasons, partnering with an expert when it comes to package design and validation can protect your investment in product development—and help assure you of your ability to recoup the investment you’ve already made in research and development. Here are the top three reasons to value expertise in validation engineering to minimize risk during the validation process.

#1: Ensure you get to market in the first place.

Let’s go back to the high-wire act analogy for a moment. Just as an aerialist isn’t guaranteed to reach the other side without falling, OEMs are given no guarantee of success in the validation process just by embarking on it.

The package design and validation process is intended to create a sterile barrier that can be maintained during distribution and shelf time so that a device can undergo a successful aseptic transfer to the surgical suite and into the patient’s body. Defining and validating a cleaning process ensures that a device is free of bacterial endotoxins as well as manufacturing residues. Ensuring a product is sterilized—by any method—and remains sterile greatly reduces the risk of infection, aseptic loosening, or other complications in the patient.

Getting to market safely also depends on being in compliance with regulatory oversight and global packaging standards. As these are complex standards with room for interpretation, OEMs benefit from working with expert partners that have a birds-eye view of the regulatory landscape and hands-on knowledge of the way these standards are being interpreted by the biggest players in the market.

#2:Ensure you get to market without unnecessary delay. 

Even relatively smooth package design and validation processes can take six months or more—with materials selection, package design, and testing protocols consuming valuable weeks (or months). Custom package design can often take much longer, delaying a launch when package considerations weren’t factored in until later in the product development process. Many package design and validation processes can easily balloon into a yearlong process—or even longer in some cases.

Expertise in validation engineering can help you consider product and package design together early on in the process. Certain universal or pre-validated solutions, too, can cut time to market by 50% for a large percentage of spine or orthopedic products while upholding safety and quality as top priorities.

#3: Ensure you don’t set yourself back unnecessarily. 

Expertise in validation engineering can head off unnecessary delays. Does your team understand all the complexities of distribution testing, for instance? How are you testing for the pressure changes of travel via air cargo, or the shock stress of travel by truck? Your device is likely to travel by both methods, so it’s key to know your product can withstand an array of distribution stresses.

Another potential pitfall lies in accelerated aging testing. Many OEMs try to speed the validation process by subjecting packaging to extremely high temperature ranges in order to shorten the aging testing window. It’s important to know what ranges to use and how aggressively to push accelerated aging testing to use the shortest window without setbacks.

Whether you choose custom package design or pre-validated packaging, validation expertise can help you ensure a smooth process that speeds time to market. Partnering with an expert can help you manage the risk of the validation process and ensure compliance, safety, and quality. Outsourcing can also help an OEM free up talent and in-house capacity to focus on core competencies and future innovation.

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.

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