From supply chain disruptions to impromptu manufacturing modifications, the medical device industry has faced a whirlwind of complications in 2020. While many in the industry are working in overdrive to keep projects on track, the regulatory landscape can shift day-to-day, making it challenging to keep up with best practices for gaining or maintaining regulatory approval. To avoid setbacks with compliance, medical device manufacturers should strive to anticipate potential challenges and institute proactive measures.

Companies can begin to identify where a device may face risks by first looking into the sources that can cause complications and delays. Changes to device design, the manufacturing process, or the supply chain can present challenges when seeking regulatory approval. To achieve the highest level of quality assurance, companies should dedicate time to identifying each obstacle and develop precautions to stay ahead of any increases in risk.

Managing Material Needs
Backlogged supply deliveries in the past year have led to a widespread desire to move to onshore sourcing. From decreased capacity to transportation slowdowns, the limited availability of certain materials has made it difficult to maintain adequate supplies for production. These challenges, paired with the increasing scrutiny of materials with the publication of ISO 10993-18:2020, can create obstacles for device manufacturers trying to protect the quality, performance, and safety of their products during development and beyond.

Before material needs escalate, companies should consider a proactive approach to maintaining production. They can start by evaluating the risks of adding more safety stock compared to the likelihood of future shortages. If expanding safety stock presents fewer risks and is actionable financially, this should be a manufacturer’s primary step to managing future material needs. This is an especially important step for small to mid-sized manufacturers that might face increased challenges in purchasing due to their comparative lack of scale.

If safety stock doesn’t resolve issues with material sourcing, companies can brainstorm creative uses for work-in-progress materials. Utilizing what is available in unique ways could yield additional time to investigate future solutions more thoroughly. For example, if the same material is used across multiple products, discontinuing the manufacturing of a less profitable or in-demand product can allow for materials to be used for more critical devices.

Additionally, working with materials that have an established history in the device’s production process can reduce new variables of risk. In general, companies should encourage the use of proven materials with a history of testing with labs and regulatory bodies whenever possible. Novel materials may be at higher risk of scrutiny and unsatisfactory outcomes among regulators in risk assessments, where proven materials help minimize the likelihood of these setbacks.

Ensuring Production Quality
Whether scaling up, down, or maintaining production, most manufacturers have had to ask themselves tough questions about how best to utilize their investments and facilities, both now and in the long term. Not only is there interest in switching to domestic suppliers, but there’s also interest in the strategy of moving manufacturing sites onshore. Taking a more measured approach can help ensure the quality from development through the entire product lifecycle.

Evaluating the production process starts with a risk analysis to determine if changes will require additional testing. Changes to manufacturing, such as moving locations or changing cleaning agents, cannot be overlooked—no matter how seemingly insignificant they are. Identifying the risks associated with these changes before implementing them provides an opportunity to involve the right parties ahead of time to address necessary compliance precautions and avoid over-testing.

Capacity constraints aren’t limited to manufacturers but can extend beyond the supply chain to testing labs. For example, it’s possible that testing labs won’t have the ability to be as responsive to requests for quick turnaround times as they have in the past. Particularly with higher risk or more invasive devices, even minor changes can create the need for a full chemical characterization study. Having an ongoing dialogue and a strong relationship with testing partners can help level-set expectations for testing timelines and planning needs.

Special considerations for 3D printers
The use of 3D printers is becoming more widespread as a potential solution to help fill the gaps manufacturers experience with production. However, safety standards for this method of production are unclear. In the past, regulators faced challenges in developing consistent standards for 3D-printed medical devices or components. Manufacturers advocating for the use of 3D printers should consult with their regulatory body to ensure patient safety and quality assurance.

Without an exact blueprint to follow for 3D printing materials and the testing that follows, the process starts by taking steps such as selecting transparent material suppliers and gathering as much data on the materials as possible. Creating a paper trail helps build a solid foundation for reference during the risk analysis. Finally, this information can be useful to develop a testing plan customized to the risks at hand, as uniform testing is not yet an option. By working closely with a testing lab, compliance groups, and regulatory bodies, medical device manufacturers can ensure that everyone is on the same page and anticipate any potential setbacks.

Selecting Partners
The challenges manufacturers face in remaining streamlined and efficient apply to their partner organizations, too. Production partners should be selected carefully and thoughtfully. Companies engaging additional testing or manufacturing partners and/or working with regulatory agencies should start the process early, even if the product isn’t yet available, as shipping delays might occur.

In a largely “work-from-home” world, many manufacturers have had to become more inventive in conducting quality audits. Virtual audits are now more commonplace. For larger companies, there may be options to leverage previously approved partners used in other divisions. Utilizing audits completed by another division within the company could abridge the necessary vetting procedures and save valuable time and money.

Conversely, companies can also consider using current partners in new ways. For example, a manufacturer that relies on an outsourced testing lab for gathering biocompatibility data could get more mileage out of the partnership by also using the lab for an additional service like chemistry (if offered). With a previous facility audit already approved, this experience could lead to a more streamlined qualification process for other services or sites.

When working with any partner, new or established, it’s essential to understand their functionality in response to global conditions and how that could impact projects. One area susceptible to increased activity is information technology (IT) infrastructures, which could be under strain as teams try to adequately support new working conditions. In regards to testing in areas like chemistry, if the investment in the IT supporting this function isn’t significant, data processing and results could face delays. Finding partners with proven quality and updated technology can help ensure timely project delivery.

Understanding the Manufacturer’s Role
Staying ahead of quality assurance risks may seem like a daunting task but in the long run, it can save time and possibly avoid regulatory setbacks or patient safety issues. Discovering the cause of complications and involving the right parties is the basis for successful management. Still, there are some steps that must be taken to help companies adhere to product development timelines.

First, manufacturers should involve the procurement team in their development conversations, especially when discussing sourcing materials. Companies often won’t use a single source for all their materials and could be considering three or more vendors. The procurement team can help assess possible risks while evaluating the necessary capabilities in the production process.

Next, gather all information including test reports, field reports and material information to perform a new risk assessment. Regulatory standards are continually evolving, and the testing performed on a device even 12 months prior may not be up to standards. If a company isn’t using comparable data during a risk analysis, it could be evaluating apples to oranges.

Finally, taking note of process changes and their effectiveness is key to gaining the most value from potential change. Many in the industry are monitoring their responses to the current environment to inform future decisions. From discovering new capabilities with remote working, re-evaluating supply chains or navigating new partner auditing processes, there is potential to recognize opportunities for further efficiencies. Companies can take setbacks from recent events and use what they’ve learned to shape their business strategy going forward.

Bringing medical devices to market and maintaining the compliance of existing devices is a time-consuming responsibility, even when everything goes according to plan. Fortunately, involving the right partners early in the process and throughout development can help close gaps and expand team knowledge. If medical device companies dedicate time to identifying obstacles and proactive planning, achieving the highest level of quality assurance can be much more attainable. 

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Sandi Schaible is the senior director of analytical chemistry and regulatory toxicology at WuXi AppTec Medical Device Testing, located in St. Paul, Minn., specializing in extractables and leachables studies. She is a U.S. delegate and international delegate for ISO 10993 part 18 in chemical characterization, and also a U.S. delegate for ISO 10993 part 13 and the particulates committee (TIR42).

Peter Steen received his B.S. in chemistry and M.S in civil engineering from the University of Minnesota. His expertise includes chromatographic method development and validation, raw materials testing, medical device testing, and mass spectrometry. Since 2014 he’s worked in the area of extractables/leachables testing at WuXi AppTec Medical Device Testing and serves as a subject matter expert in gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS) analyses.