One of the phone calls that product managers fear most is a supplier notifying them that a material used in their product is being discontinued. The impending change forces a litany of time-consuming (and potentially expensive) procedures to identify and implement a suitable replacement material so production can continue. After all, one change creates a trickle-down effect for everyone on the project team: engineering, quality, manufacturing, and more.

If a supplier chooses to discontinue a material, this can create trickle-down effects for everyone involved. A medical device manufacturer can take steps to prepare for a potential material change.
If discontinuing materials is such a hassle for customers, why do suppliers do it? There are many reasons. Corporate mergers and takeovers often result in the consolidation of product lines, usually at the expense of less profitable materials. Some companies streamline or harmonize their product portfolio to focus on the materials with the most income potential, or they may decide to put minimum volume limitations on purchases to favor customers who buy in bulk. Further yet, they may close a production facility that manufactured a particular material.

Regardless of the reason, there are many steps a medical device manufacturer can take to prepare for a potential material change or mitigate the issues that could arise from one. Here are some that we’ve found most useful.

Communicate Often with Suppliers

Constant communication with your suppliers about their product portfolios can help alert you to imminent changes. It’s dangerous to assume that a particular material will be available year after year. Talk with them periodically about the future of the materials that you are using and tell them what your plans are for the material and what you see in the marketplace. The intelligence you share with your suppliers could be instrumental in their decision to continue manufacturing. Open and honest communication facilitates trust. The more the suppliers trust you, the more likely they are to inform you about an impending change — even before a formal announcement is made. A month or two of advance notification can make a big difference when trying to accommodate a new material.

Follow the News, Especially FDA Mandates

The FDA is constantly on the lookout for compounds in materials that could contribute to adverse side effects in patients. Of course, other countries have similar and sometimes more restrictive oversight bodies. Actions could range from an advisory to remove the material from particular devices, to instituting warnings on packaging. Latex, DEHP, and BPA are three recent examples of compounds that are under FDA scrutiny. Even though their use is still permitted within specified guidelines, the action coupled with public outcry could necessitate a change in materials. Early knowledge of potential issues with particular materials should compel manufacturers to start investigating alternatives that could deliver identical performance without the questionable side effects. In fact, converting to a material that’s not under regulatory scrutiny could provide a marketing advantage and put your enterprise in a leadership position.

Watch raw material market news, too. A rising price in a material’s precursor could portend a future price bump that might need to be addressed by changing to a lower-cost, more plentiful material. Additionally, a natural disaster (for example, the Japanese earthquake) or political unrest could constrain supply.

Protect Yourself in Your Supply Contract

Seek strategic purchasing contracts that mandate 18 months to three years of supply coverage if you can get it. While the material supplier may try to back down from their commitment, it’s better to start with extra time and accept less, rather than start with the minimum and hope they don’t give you less than you need. Some materials may take up to 12 months of testing to meet product specifications. For example, an accelerated five-year age test could take three to five months — and that’s after engineering development, prototyping, and other testing.

The alternative to a supply contract is to keep material in inventory. However, with the current focus on Lean Manufacturing and the desire to eliminate overhead, manufacturers may have to mitigate their risk through contracts rather than risk having extra material in a warehouse.

Prepare a List of Optional Materials and Suppliers

In a perfect world, every manufacturer would honor its contracts. Unfortunately, not all do. What happens when you’re given three months’ notice, but you need 12 to complete all of the testing necessary to requalify a product with a new material?

For device- or component-critical materials that would have a significant business impact, it may be worthwhile to invest the time and energy into preparing an optional material ahead of time. While it’s unlikely the new material will perform exactly like the original one, a rigorous pre-qualification process can avoid lengthy testing and compress the timeline for a conversion. Although most manufacturers are trying to condense their vendor lists, this is a case that argues for a strong and wide bench of alternative suppliers. Being able to avoid a material outage by moving nimbly to a new supplier could be the difference between the production lines rolling and shutting down.

Leverage Your Materials Expertise Across Your Team

As noted, material changes touch just about every facet of the project team, so it is critical to build material knowledge across team members. Time is precious. The more knowledge you have, the more quickly you can solve problems or at least narrow the range of solutions. Engineering needs to know how a new material will or won’t react with other materials. Production needs to comprehend how a new material may influence manufacturing speeds or assembly processes. Regulatory needs to review potential material options to determine regulatory impact. Sterilization processes need to be evaluated for impact, for example, whether EtO dwell times or aeration times will change. Product managers need to determine the impact on cost and delivery. Virtually every department is affected. Pulling together a cross-functional team to expedite the process and share information is almost mandatory.

Make Lemonade

After you get over the shock and uncertainty of an impending material change, try to view it as an opportunity to elevate the performance of the product. Perhaps you’ve always wanted to tweak the design or increase the tensile strength of a component after the product has been in the field. Without a change in material, the incremental improvement might not be worth the time or energy. But if a change is imminent, consider it an opportunity to reexamine the product and determine whether a new material can impart improvements.

Overall, it never hurts to play “What if?” with each material used. What if the FDA tightens its regulations? What if your primary supplier stops manufacturing? What if a civil war strikes the country responsible for producing an essential element? While the list of “ifs” can be exhaustive, the exercise can open the mind of your team — and hopefully, help prepare you for the phone call that everybody dreads.

This article was written by Valentina Stolarsky, Materials Laboratory Manager, and Jim Roma, Engineering Specialist for B. Braun Medical Inc., Bethlehem, PA. For more information, Click Here .