By Sean Fenske, Editor-in-Chief

Process validation is vital to virtually every component fabricated for a medical device. It helps ensure quality in the manufacturing process, but takes careful planning. In addition, when an orthopedic device manufacturer is working with a contract manufacturer, the activity involved with process validation becomes a collaborative effort.

“Customers definitely play an important role in the validation of manufacturing processes for their device,” explained Raghu Vadlamudi, chief research and technology director for Donatelle. Vadlamudi explained that since the manufacturer is ultimately responsible for the device, they must be involved in the process, but they also need to enlist a contract manufacturer who has a solid track record for quality and success.

Vadlamudi took time to speak with ODT about process validation, the complexities of it, and what best practices should be incorporated into the protocol to ensure best results. In the following interview, he offers his experience in fabricating thousands of medical device components for an array of customers.

Sean Fenske: Can you explain the differences between the two types of process validation—prospective and retrospective—and how you handle each?

Raghu Vadlamudi: Process validation in general is a critical part of medical device manufacturing as it helps ensure devices are manufactured to produce the outcome for which they are designed and intended to serve. Prospective validation is performed prior to releasing the product to market, as well as when the product manufacturing process is changed and those changes may alter the product characteristics. Retrospective validation is performed for a product already on the market based on historical manufacturing process data (e.g., process records, inspection and testing data).

Both types of process validation should incorporate regulatory guidance from the International Organization for Standardization (ISO) standard 13485 and the FDA’s Quality System Regulation (QSR) regulation 820.75.

Fenske: Are there specific considerations for process validations with respect to the orthopedic industry?

Vadlamudi: There are no specific considerations for process validations required for the orthopedic industry. However, especially considering the critical nature and complexity of many orthopedic devices (e.g., high-risk, long-term implants and other products that enhance or save patient lives), a robust process validation program is essential to mitigating serious risks.

Further, in any market, before launching any new medical device onto the market, medical device manufacturers should seek a high level of certainty that their manufacturing processes have the proper controls in place to produce safe products that meet specified user, technical, and regulatory requirements. Also, any device distributed in the United States must be manufactured in compliance with FDA’s Quality System Regulation (21 CFR 820).

Fenske: Do you include the customer on a process validation? Are they part of the validation team?

Vadlamudi: Donatelle’s customers review and approve process validation protocols and reports. Ultimately, the customer is responsible to manufacture a device that is compliant with applicable statutory and regulatory requirements. As a best practice, it is very important for medical device companies to partner with a contract manufacturer that has a proven record of creating devices of the highest quality, while getting their product to market in a timely fashion. A high-quality contract manufacturer will have a methodology and strategy for validating processes, as well as clear evidence of success and consistency executing these processes, such as by demonstrating these processes through a site visit, or by having a strong FDA inspection record with no observations, among other means.

Fenske: Is the process validation independently verified, such as by a third party?

Vadlamudi: The process validations are not usually verified by third parties. However, third parties can be used to audit the company’s quality management system to ensure they are compliant with applicable regulatory requirements.

Again, the medical device manufacturer is ultimately responsible to be compliant with Quality System Regulation. As such, the manufacturer should partner only with contract manufacturers that have appropriate validation resources and a proven capability to produce accurate, repeatable products.

Fenske: Can it be tricky to balance FDA requirements against customer demands? If so, how do you handle this?

Vadlamudi: We specialize in Class II and Class III medical devices, and have produced thousands of different orthopedic device components (including micro, insert, and overmolded) over the past 20-plus years from implantable-grade plastics, metals, and exotic materials. These types of products are inherently complex to produce and must meet stringent regulatory requirements. In other words, we understand what’s at stake, and welcome the challenge. It’s what we do!

We work closely with our customers to understand their specific program needs, often collaborate on design for manufacturability, and use specially designed systems throughout our vertically integrated facilities. As a contract manufacturer serving the orthopedic (as well as entire medical device) industry, we must maintain absolute quality standards to achieve extremely tight tolerances and manufacture our customers’ products consistently and repeatedly.

As a matter of practice and principle, this is how our highly qualified and experienced team ensures we meet customer specifications and regulatory requirements.


Fenske: If a customer approaches you with a process validation strategy, will you work with them to identify potential improvements or suggest revisions?

Vadlamudi: Yes, we are happy to help our customers improve their process validation strategies. As mentioned previously, Donatelle brings decades of experience in manufacturing device components and devices with implantable grade materials. As a result, we have substantial expertise in manufacturing process development, validation, and maintenance of the validated processes, which we’ve used time and again to help our customers mitigate manufacturing risks and avoid surprises. For example, in numerous instances, our team has suggested changes in part design to achieve better yields and improved processes. In addition, we put manufacturing controls in place to demonstrate and prove products perform to their design and intent, and work together seamlessly end to end through vertically integrated capabilities.

Fenske: Once a process is validated, how do you ensure it remains in compliance?

Vadlamudi: Planning is the most important aspect for the success of a medical device program. Thoughtful care and attention must be taken in defining the requirements up front in the device development lifecycle. When conducted properly, the initial process validation will have anticipated production conditions, account for acceptable and normal production variations, and establish thorough processes in order to consistently and repeatedly manufacture the product with precision in spec.

As for Donatelle, we take compliance very seriously and have long adhered to the industry’s highest standards and best practices. Donatelle is an FDA-registered contract manufacturer and follows Good Manufacturing Practices. We use proven, rigorous processes and continually invest in learning and utilizing best-in-class technology, including real-time statistical process controls to ensure part and product consistency. Further, as I mentioned earlier, our team fully understands what is at stake, and is committed to doing what we can to help ensure our customers’ critical medical devices are brought to market with confidence.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed?

Vadlamudi: We appreciate the opportunity to discuss the importance of process validation, which often doesn’t get the attention it deserves and requires. For medical device manufacturers, process validation is a powerful tool to be confident your program will produce high-quality devices that comply with standards, specifications, and guidelines. They’re a critical step in the lifecycle of a device and help prove the manufacturing processes selected will give expected outcomes.

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