Optimizing Medical Device Product Development to Meet Regulatory Requirements and Avoid Costly Delays

The business of medical device manufacturing got considerably more complicated in 2010 when the U.S.Food and Drug Administration (FDA) began requiring manufacturers to conduct tests and provide more detailed information about extractables and leachables in their products. Since then, many product managers and engineers have learned about these new requirements the hard way. Extractables and leachables testing no longer means simply conducting inexpensive USP or ISO 10993 biocompatibility tests.

The FDA has begun asking manufacturers to conduct more extensive studies to determine the actual identity of individual extractables and leachables of medical devices as well as a determination of drug compatibility using model compounds representative of those that may be used with the device. If the launch of a new product fails to meet critical milestones and a manufacturer faces costly delays to market, it’s usually the product manager or engineer who takes the blame.

We’ve seen highly talented people run into considerable difficulty because they didn’t fully understand the new regulatory requirements and how the they would affect the launch of a new product or second-generation medical device. To avoid costly delays, product managers and engineers must understand the new requirements and how to optimize product development and testing strategies appropriately.

Through our experience working with both large and small medical device manufacturers, we’ve discovered many ways to avoid common impedances to regulatory approval. The following tips have proven helpful to many medical device product managers and engineers.
 
• Start at the Beginning: It’s critically important to begin thinking about the regulatory requirements and how you might be able to optimize your testing strategies for the greatest efficiencies at the earliest stages of product development. Too often, testing strategies take a back seat to product design, which can cause increased testing costs and delays in the latter stages of product development.
• Narrow the Scope of Your Product: If your goal is to gain regulatory approval and bring a new vascular access port to market in the shortest possible timeframe, you’ll want to limit the variability of the product you seek to launch into market. You ultimately may envision a product line of various sizes and colors for this port, but submitting the full range of sizes and colors for regulatory approval undoubtedly will increase your testing costs, complicate your submission package and may cause unnecessary delay in approval. Instead, focus on bringing one product to market and then introduce its variations at a later date.
• Be Prepared for New Testing of Second-Generation Devices: Under the FDA regulations, medical devices in the marketplace before 2010 are grandfathered into compliance and do not need to meet today’s more stringent regulatory standards related to leachables and extractables. But don’t underestimate the challenge of gaining regulatory approval for a grandfathered device once it’s time to make changes to its design. You’ll not only need to seek regulatory approval for the new components of the device, but all of the previously grandfathered components as well. It may be the second generation of a proven device, but the FDA will require you to conduct tests and provide information about it as if it were an entirely new product launch.
• Consider Global Access to Markets: Medical device manufacturers often develop products with a single geographic market in mind, but savvy product managers and engineers will look down the road and anticipate where the product might be launched next. For example, rather than developing your testing strategy to simply meet the current regulatory requirements in the United States, it’s wise to consider the requirements for European, Chinese and Japanese regulatory approval as well. By harmonizing the regulatory requirements for all of these markets, it’s possible to optimize your testing strategy at the earliest stages of product development. By conducting the appropriate tests and gathering the appropriate data to meet the regulatory requirements of multiple markets, you’ll avoid costly re-testing when it’s time to launch in a new market. Perhaps more importantly, you’ll also expedite your ability to bring your product to launch in new markets.
• Think About Scalability: When developing a testing strategy, it’s important to think about the range of products in which a particular component may be used. While your immediate objective may be bringing a single device to market, you may be able to optimize your testing strategy in a way that will provide useful data about specific components and materials that can be leveraged for future products.
• Understand What You Don’t Understand: As the regulatory environment changes for medical device manufacturers, many highly experienced product managers and engineers now find themselves navigating uncharted waters. It’s important to understand that “the way we’ve always done it,” is not good enough any longer. We all need to take an honest look at our strengths and weaknesses in this new environment and seek specialized assistance when necessary.

Addressing these issues can present significant up-front costs in a project, but these costs are minimal compared to the bottom-line impact of missed deadlines, design reworks, retests and delays to market. Like it or not, these new regulatory requirements are here to stay. In fact, additional regulatory requirements related to leachables and extractables in manufacturing equipment and filling-process equipment are likely on the horizon.

Nine Steps to Regulatory Approval
While every situation is different, the following ninesteps are generally appropriate in the development of almost every medical device product.
1.     Develop a testing strategy at the earliest stage of product development. Optimize your testing for scalability and global access.
2.     Conduct a materials assessment.
3.     Develop a study design.
4.     Perform an instrumental analysis.
5.     Interpret the data.
6.     Prepare a final report.
7.     Conduct a toxicology assessment, if needed. Depending on what compounds have been identified in the final report, a toxicology assessment may be necessary.
8.     If necessary, modify product design to address toxicology assessment findings.
9.     Submit your application package to the appropriate regulatory agency.
 
NSF Medical Devices helps clients through the critical steps on the path to regulatory approval. The firm often engages with clients after they’ve already traveled far down the product development path and encountered regulatory pitfalls. In either case, NSF encourages clients to follow these basic steps but also think strategically about their products and the regulatory inhibitors they are most likely to encounter. NSF Medical Devices is developing a series of training workshops to help product managers and engineers cope with the changing regulatory environment. For more information, visit www.NSF-DBA.com.

About the Authors
James Pink is a partner at NSF-DBA Medical Devices, part of NSF Health Sciences, a division of NSF International. He has audited medical device manufacturers worldwide as a medical device lead auditor with the British Standards Institute and is considered an expert in medical device quality and risk management. He can be reached at [email protected].
 
James R. Scull, Ph.D., is general manager of NSF Pharmalytica, a GLP and GMP contract laboratory offering a wide array of independent testing and analytical services as part of NSF International’s Health Sciences Division. He has more than 25 years of pharmaceutical and medical device development experience, including expertise in conducting extractable and leachable studies and oliognulceotide analysis. He can be reached at   [email protected]  .