It’s the final week of materials month, and we want to end it with a bang!
We sat down with our team of chemists and engineers to talk about something that continues to be an obstacle for established medical device companies and startups alike—material changes.
The Problem
Although it may seem rare, medical device companies around the world face the material change problem every year. There are a number of reasons why a manufacturer would make a material change after a product has been granted a 510(k). Some of the most common events that force a material change are:
- Discontinuation – Material discontinuation happens when the supplier/producer of a material completely shuts down the supply/production of a specific material. This typically occurs when businesses/product lines are consolidated or a raw material is discontinued further up the supply chain.
- Policy Change – When a supplier/producer or regulatory body restricts the use of a material in the medical device market, it is considered a policy change. Examples include recent changes by DuPont, Bayer, and LyondellBassell.
- Price Change – Sometimes, the cost of upstream raw materials can increase significantly, forcing the price of medical materials to spiral out of control. When this happens, manufacturers often seek out suppliers, producers, and materials that are equivalent, but less expensive.
- Device Improvement – Medical device manufacturers are constantly on the lookout for ways to improve device functionality and use. Sometimes, a change to the material allows the device to serve more markets and/or applications.
- Force Majeure – Often referred to as an “act of God,” force majeure is the entrance of a force or occurrence that is beyond the control of a material supplier/producer. Force majeure incidents often cause production lines to shut down, which can result in a shortage of material throughout the market. This occurred in 2012 when Evonik suffered an explosion in one of its European plants. (See Reference 1)
Sooner or later, every medical device manufacturer will face the material supply/change problem. When the problem occurs, the manufacturer has two viable options: (1) discontinue production of the device(s), or (2) go through the material change process and determine the correct route to take.
The Solution
As a leading contract manufacturer and innovative polymer solutions provider for the medical device industry, we are often asked why a material change is necessary and how to go about it. In its document, Deciding When to Submit a 510(k) for a Change to an Existing Device the Food and Drug Administration (FDA) of the United States laid out its guidance for properly completing a material change.
At this point we would like to note that although this blog post is meant to provide basic information on completing and handling a material change, only the FDA and other regulatory bodies (depending on where your device is designed, manufactured, and marketed) control the regulation and guidance on this process. We recommend that any manufacturer wishing to perform a material change follow the guidance provided by the FDA.
It is the manufacturer’s responsibility to determine whether or not their change requires a new 510(k) or extensive documentation (hereby referred to as a “Note to File”). Determining whether or not a material change requires a new 510(k) or a Note to File is, arguably, the most difficult part of the material change process—and it is undoubtedly the area in which we receive the majority of questions regarding material change. Thankfully, the FDA has published guidance on this process. According to the FDA:
“When making the decision on whether to submit a 510(k), the manufacturer’s basis for comparison of any changed device should be the device described by the cleared 510(k) or to their legally marketed preamendments device… In effect, manufacturers need to submit a new 510(k) only when a change, or the sum of the incremental changes exceeds the §807.81(a)(3) threshold, ‘could significantly affect the safety or effectiveness of the device.’” (See Reference 2)
To determine whether a change, “could significantly affect the safety or effectiveness of the device,” the FDA has provided several flow charts to answer the question. Because we are focusing solely on a general material change, we will only be highlighting two of the flow charts: Main Flowchart – When to File a 510(k) After Change to a Legally Marketed Device (See Reference 3) and Flowchart C – Is It a Material Change? (See Reference 4)
To begin, we must decide whether or not the change is due to recall or corrective action. If it is, the FDA’s 510(k) Requirements for Proposed Fixes to Devices Undergoing Recall document must be consulted. As this is a separate and distinct issue altogether, we will not be talking about it in this post, we will be assuming that the change is not due to recall or corrective action.
Once it is determined that the change is, in fact, a material change that is not due to recall or corrective action, we move onto Flowchart C – Is It a Material Change?. Flowchart C – Is It a Material Change? requires the manufacturer to address a series of questions to determine if the material change requires a new 510(k) or a Note to File (please see the questions and flowcharts in the FDA guidance document for the details).
Tips from our experts.
When asked about completing a material change, our experts provided the following tips and advice:
“Use a team approach,” recommends Travis Sessions, CEO of Biomerics. “Cross-functional input from management, engineering, quality, and regulatory affairs is the best method for making sure risk is mitigated.”
According to Dan Brittingham, VP of Engineering at Biomerics, “When embarking on the material change process, companies should evaluate the impact of the material change on design function, process validations biocompatibility, packaging validation, and sterilization/stability validation. A change to any or all of these things can impact the path you take.”
“We recommend that companies establish standard operating procedures, based on the FDA guidance, to deal with material changes,” advises Nate Henriod, Sr. Program Manager at Biomerics. “This will help resolve issues before they arise and provide a clear path for the organization to follow.”
How can Biomerics help you?
Looking at the FDA’s guidance and the corresponding flowchart, we can see that the material change process is extremely complicated and full of different variables. Fortunately, a material change doesn’t have to be as arduous a task as it seems. At Biomerics, we’ve familiarized ourselves with regulatory requirements through years of material change requests. When we partner with a customer to perform a material change, we not only establish the steps that follow the FDA’s guidance, we work with the customers’ quality and regulatory departments to determine their threshold of comfort with such a change. The result of our work and the material change process is a document showing why a new 510(k) or Note to File must be completed.
Typically, we provide the expertise, tools, and experience to supply our customers with:
- Formulation Information and Test Protocol
- Material Specification and Physical Test Protocol
- ISO-10993 Biocompatibility Testing and Rational
- Operational Qualification (OQ) and Production Qualification (PQ) Services
There are a myriad of processes and components within each of the steps laid out by the FDA that may make the material change process seem impossible—luckily, we’re here to guide you through everything. Once all of the protocols are created and tests are completed, we’ll generate a well-documented report of our findings and the recommended course of action.
It is up to our customers to choose the path they will take—after all, every application is different and every firm has different internal policies, risk assessments, and internal requirements. Although we are always willing to consult and provide advice, we ultimately work to support our customers down any path they choose, and we partner with them to produce their desired outcome.
Are you looking to perform a material change now or sometime in the future? If so, please do not hesitate to reach out to us by phone (801-895-2578) or by email (csr@biomerics.com).
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References
- Reference 1: https://www.ihs.com/country-industry-forecasting.html?ID=1065966710
- Reference 2: 510(k) Memorandum #K97-1, pp. 1-2.
- Reference 3: Deciding When to Submit a 510(k) for a Change to an Existing Device, p. 28.
- Reference 4: Deciding When to Submit a 510(k) for a Change to an Existing Device, p. 31.
