Validation and Contract Manufacturing – The Make or Break Relationship

Bob Marshall, chief editor of Med Device Online, recently published the fourth article in a series of five about medical device development and FDA approvals. In this article, he addresses the importance of validation and manufacturing transfer in the scheme of preparing for FDA inspections. “You have proven your concept, fully specified your design, and verified that the design output satisfies your design input requirements,” he states, “It is time for the most pivotal portion of the product development life-cycle. I like to call this fourth stage; validation/manufacturing transfer.” He calls this phase the dress rehearsal for commercialization.

KMC Systems Validation and Transfer to Manufacturing

It’s a critical phase in medical device development that can make or break FDA approval, time to market and the overall success of your medical instrument project. More than a phase in a process, Marshall stresses the importance of the relationship between your validation expert and your contract manufacturer. For installation qualification (IQ), he writes, “a process validation expert helps to ensure that manufacturing processes consistently produce devices that meet company specifications. The expert must have knowledge of manufacturing processes and equipment. Which is especially important for the first part of process validation, known as installation qualification (IQ).” Next, for operational qualification (OQ), Marshall points out, the validation expert must be able to understand the product risk analysis, requires “a good set of specifications to understand how to conduct the OQ” and he or she should have a working knowledge of statistics.

On to performance qualification (PQ) which Marshall says, “is performed by producing three production lots at nominal process parameters. The size of the production lots have to be determined by statistically modeling a confidence interval and the desired yield.” Because of the complexity required, Marshall urges medical instrument companies to have an adept validation expert on staff or find an outsourcing partner with the level of expertise required for a smooth validation and transition to manufacturing.

When choosing a contract manufacturing partner, Marshall says to make your selection based on “location, reputation, financial stability, specific manufacturing experience or skill sets, quality system certifications...and size.” He stresses the importance of choosing a CM with the expertise and ability to scale production based on your project and market needs. Choosing a financially stable CM who has a proven record of success in working with leading medical instrument companies will have the project management experience and global supply chain connections that will benefit your project. Marshall says, “be wary of low-priced bids. All too often, a CM may low-ball a project because they need work, only to later lose focus on your project because it does not generate as much revenue as other more lucrative contracts. There also is thinking that a low-ball offer will get the work, and later the CM can request a price increase. By then, the project will be too far along for you to consider moving the work elsewhere — our regulated industry exacts time and cost penalties when production is moved from one facility to the next.”

In conclusion, Marshall advises, “Think of the partnership as a marriage, not a date. Find a CM that has skills to compliment your own, a culture that fits your mindset, and the desire to help get your life-changing device into prime time — and stay there.”

Read the full article, entitled Lights, Camera, Validation – Preparing for FDA Prime Time, here:

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Manufacturing Readiness Checklist

Topics: medical contract manufacturing