Full-Service Resin Compounders Streamline Medtech Supply Chains

Global supply chain challenges facing the medical device industry range from increasingly stringent regulations to raw material shortages and shipping disruptions. All these issues can inhibit a device maker’s ability to develop novel products and bring them to market ahead of competitors. As supply chains become more complicated and geographically dispersed, there is a greater risk of spot shortages, order fulfillment delays, quality impacts and cost increases—any of which can affect a device’s ultimate success.

To cope with supply chain uncertainty and volatility, device makers are exploring different approaches. They include reshoring or near-shoring of production; investing in digital technologies like predictive analytics for visibility, monitoring, and risk mitigation; entering into stocking agreements at local warehouses to improve lead times and supply reliability; and collaborating with material suppliers to optimize device designs and production efficiency. 

Full-service resin compounders can play an important role in streamlining and strengthening the supply chain. By offering a full range of products, services, and expertise, these compounders minimize the need to coordinate with multiple material providers. A proactive compounder that has established alternative sources of materials and has invested in robust customization capabilities can avoid the last-minute rush to find acceptable substitutes in the event of a shortage or disruption. A full-service compounder can also qualify new polymers to help a customer meet changing compliance or performance requirements, as well as formulate resins that are optimized for specific types of molding or for advanced assembly methods like laser welding.

Adaptability and Value-Adds

Device manufacturers can benefit from engaging with adaptable, full-service compounders that provide a wide range of materials, backed by value-added services and healthcare industry expertise. In contrast, some polymer manufacturers are only equipped to fill orders for standard types and quantities of resins and compounds.

A compounder with the flexibility to quickly shift production can be invaluable during development of new medical devices. Major polymer manufacturers typically produce very large quantities of a particular material. They must spend significant time and effort to switch a production line to a different grade or color. However, custom compounders design their plants for fast and easy conversion of lines because they cater to each customer’s needs. This agility makes them responsive to requests for fast turnarounds and small quantities, such as for prototyping. 

In addition, a full-service compounder will often take additional steps to identify the resin with the best combination of properties, performance, and processing for a given application, and further customize its formulation in-house to meet every requirement. 

If a supply chain disruption occurs, access to raw materials from alternative polymer suppliers and control over production can equip a compounder to assist customers quickly and effectively, as the following example demonstrates. 

In 2021, a severe winter storm on the U.S. Gulf Coast led to blackouts that shut down polymer reactors at major producers for several days. According to one report, production of all epichlorohydrin was offline, as was most of the production of ethylene glycol, polypropylene, and epoxy resins. In addition, ports in Texas were shut down, preventing delivery of materials from overseas. Lead times for resin orders stretched to 20 weeks, and in some cases, more than 40 weeks. A device manufacturer seeking a specific material turned to a full-service compounder for help. Since the compounder had prudently stockpiled material from various global sources, it was able to produce and deliver a truckload of the desperately needed grade to the device company within two weeks. 

Now, let’s explore some of the top capabilities and benefits of a customer-driven compounder. 

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One-Stop Shopping 

The ability to obtain materials, services, and knowledge from a single source can benefit medical device manufacturers in important ways. 

Extensive Product Portfolio

A full-service resin compounder’s value begins with a broad array of medical-grade resins, blends, and alloys with agency certifications. These products are typically sourced from a number of producers in different geographies to provide alternatives in the event of regulatory changes or supply chain disruptions. Following is a case in point.

Flame-retardant (FR) acrylonitrile-butadiene-styrene (ABS) typically uses antimony trioxide (ATO), a halogenated additive that is experiencing a global shortage due to export restrictions in China and limited processing capacity in the rest of the world. Resin compounders that offer similar materials, such as FR polycarbonate/acrylonitrile-butadiene-styrene (PC/ABS) blends, can help device makers work around ATO shortages. Further, replacing ABS with a resin that uses a non-brominated, non-chlorinated FR chemistry addresses regulatory restrictions on halogens. 

By working with a full-service compounder, device designers can benefit from the opportunity to evaluate and compare multiple materials, with different combinations of properties and processing characteristics, for a given application. They can also consolidate the process of sourcing different materials for various components of the same device, simplifying logistics. To support material selection, leading compounders enhance their product offerings with industry expertise and deep material knowledge. This guidance can help the device company choose the best material for the application’s performance, aesthetic, and regulatory requirements. 

To help customers meet their sustainability goals, a compounder’s portfolio should include grades that incorporate high percentages of recycled content or are formulated with bio-based feedstocks. In addition, resins with enhanced durability—such as resistance to harsh healthcare disinfectants, UV light, multiple sterilization cycles, and physical impacts from day-to-day operation—can help extend the useful life of a device to avoid premature disposal.

Creative Customization 

While a resin’s data sheet lists anticipated performance metrics, within those parameters, there is room for adjustment. A skilled compounder can tailor a resin or blend using additives, modifiers, and reinforcing agents to meet precise application requirements. Among the customization possibilities are increasing performance properties such as dimensional stability and impact resistance, improving processing characteristics like melt flow and mold release, and adding desirable attributes such as antimicrobial performance.

A resin compounder can customize materials for both existing and new applications. In the first case, adjustments are typically aimed at solving a performance or processing problem or addressing a regulatory requirement. A service-oriented compounder may send technicians to the device company’s production site to observe the molding process and troubleshoot the issue. Based on the findings, the compounder can make recommendations about adjusting equipment settings or the material’s formulation and provide samples for trialing. 

When a new application is involved, the compounder can provide advice and recommendations about selecting and customizing materials to meet the part’s regulatory, performance, and processing requirements. The compounder can suggest alternatives that are compatible with the device maker’s budget. When the compounder is engaged early in the application development process, they can also advise on tooling design and process optimization. 

In-house color services, including color labs and technicians, enable customers to obtain polymers in custom shades for branding, usability or safety purposes. Leading compounders offer advanced technologies to expedite the color-matching process and ensure precise, consistent results. 

Compliance and Certifications

A full-service compounder that supports medical device companies usually employs global regulatory experts who can help streamline approvals and accelerate time to market for new products. Advice from these experts regarding materials can increase the likelihood the device will pass tests and experience a smoother agency approval process. 

Obtaining material certification according to Underwriters Laboratories (UL), the National Electrical Manufacturers Association (NEMA), and the Canadian Standards Association (CSA) enables the compounder to address electrical performance requirements for connected medical devices. 

Responsive Fulfillment

Optimizing order fulfillment is essential in streamlining the supply chain. A full-service compounder can save time by producing the requested amount of material, instead of receiving and repackaging bulk quantities of resin, as a distributor does. Some compounders offer local or regional warehousing to ensure product availability, as well as regularly scheduled deliveries for an uninterrupted supply of material. In a time crunch, expedited order shipping enables customers to meet deadlines. 

Flexible order sizes also help device manufacturers successfully meet production goals. As mentioned previously, many large producers only ship substantial quantities of resin, forcing customers to over-purchase or pay for on-site warehousing space. In alignment with the Just-in-Time model, a service-focused compounder can quickly produce and ship small quantities needed for prototyping or limited production runs, sparing the customer from incurring inventory and storage costs. 

Beyond the Supply Chain

Medical device manufacturers face more than supply chain volatility. Aggressive global competition, rapid technological changes, rising costs, and tightening regulations are also creating issues. Collaboration with a full-service polymer compounder can help device manufacturers react quickly to these challenges. From a proactive standpoint, a strong relationship with a trusted compounder can help customers achieve strategic goals, such as ensuring quality and compliance, controlling material and production costs, and accelerating delivery of new medical devices to the global market.

William Galla is the vice president of Sales for Polymer Resources Ltd. In this position, he is responsible for commercial strategy and execution and for managing the company’s sales, business development, marketing, and communications processes. Galla joined Polymer Resources from SABIC, where he worked for 12 years. He most recently served as senior manager of SABIC’s Compounding Business, where he was responsible for leading commercial teams across the eastern half of the United States and managing global accounts and South America commercial teams. Before that, Galla held positions of increasing responsibility with SABIC, including region general manager – South, product marketing manager/asset utilization leader, distribution commercial director, and market development manager – Blow Molding.