By Amy Zakrzewski, MBA
In today's world, events such as global pandemics, force majeure events such as fires, floods, and hurricanes, or cybersecurity threats sound the alarm for suppliers to develop a robust, transparent business continuity plan (BCP) to ensure minimal supply chain disruptions.
As the saying goes, it’s not a case of if disaster strikes, but when. Proactive suppliers have already evaluated multidimensional scenarios to establish a BCP that mitigates disruptive events well
in advance and establishes detailed plans for what needs to be done to restart daily operations
When medical device manufacturers are evaluating suppliers of textile-based components, they should consider partnering with an organization that has invested in a robust strategy to mitigate risks and avoid costly supply disruptions—not only to the medical device manufacturers, but to the patients who rely on their devices for quality of life.
The Key Elements of a Business Continuity Plan
How is a strong business continuity plan for medical components established? Suppliers can plan using best practices outlined in ISO 22301:2019. Since no business, manufacturing site, or material is the same, a “one size fits all” solution falls short of the spirit of continuity planning. Effective planning takes a holistic approach to protecting a business from the inside out. Once established, BCPs contain detailed guidance on how to handle business-critical elements in case of a disruption, such as:
- Raw materials supply
- Change management via supply and quality agreements
- Operational capacity (Infrastructure)
- Critical manufacturing assets
- Information technology
This article discusses best practices on how medical component suppliers can mitigate risks for critical raw materials, change management, operational consistency, and manufacturing assets.
Ensure the Source and Quality of Raw Materials and Address Changes
Medical device manufacturers need reliable supply and consistent quality of raw materials. In the medical device space, these two aspects are vital to customer success, as scale-up requires device manufacturers to use the same materials repeatedly throughout the device lifecycle.
Late changes in materials can have a domino effect on the entire device development process, from R&D to commercialization. While the goal is to finalize raw materials as early as possible to avoid regulatory hurdles down the road, changes can become necessary, potentially increasing a project timeline due to unforeseen required testing. Suppliers should assure manufacturers that they can meet raw material specifications and critical parameters to minimize the time, cost, and work needed to implement changes well before a project build begins to avoid costly, time-consuming changes later.
How? The best way to set—and meet—expectations is to implement supply and quality agreements as early as possible. These agreements protect both the manufacturer and supplier in cases of unanticipated changes in raw materials, which, in addition to the aforementioned elements of a project, can also impact quality and regulatory requirements of the final components, and ultimately, the performance and functionality of a scalable medical device.
Materials changes are often unavoidable, even when suppliers identify and control quality of critical factors and requirements. However, understanding the requirements and performing a risk assessment ahead of time helps both parties effectively move through the implementation of a new material.
Establish Supply and Quality Agreements
More than reference documents, supply and quality agreements can be seen as planning documents that shape the manufacturer-supplier partnership from the start and ensure that any changes are communicated at the right time, ideally during R&D. Supply and quality agreements should go in hand in hand and remain inseparable. Although they each serve different purposes, both agreements are critical to the success of a medical device project.
The supply agreement should focus on four critical business elements: raw materials inventories, material consumption rates, machine redundancies, and forecast requirements. Transparency around this information ensures alignment on the device manufacturer’s short- and long-term goals. Together, both sides can proactively make informed decisions as they strive to meet established benchmarks on the path towards device finalization.
The quality agreement is key to controlling raw materials and component quality by capturing the requirements for uninterrupted supply during agreement terms (e.g., 3-5 years). Ultimately, a quality agreement is designed to mitigate the risk of supply chain events that impact materials and process changes tied to regulatory requirements.
An effective quality agreement should cover the following:
Maintain Operational Consistency
- Supplier change control management
- Record retention
- Storage, packaging, and shipping
- Non-conforming product
- Drawing/specification changes
- Recall/field corrective actions
Operational disruptions at a supplier plant can impact everything from manufacturing to quality to lead times to cost. Suppliers that adhere to the highest standards for operational consistency will be best equipped to run as smoothly as possible in times of uncertainty or disruption. A supplier should consider enacting the following to maximize consistency:
- Preventative maintenance programs
- Machine redundancies
- Cross-training operators on processes and equipment
Machine redundancies for critical manufacturing assets are essential for a strong supply chain. Suppliers should acquire backups for critical manufacturing assets or, at a minimum, hold spare parts in inventory for specific machines or equipment. Enhancing operational consistency and building-in machine redundancies may be costly up front, but in the long run the effort will save resources, promote a healthy supply chain, and decrease risk of extended operational disruptions.
No Project Is Complete(d) Without a Backup Plan
The best way to protect supply chain, quality, and operational consistency lies in the planning. Naturally, a supplier should always have the medical device manufacturer’s supply chain needs in mind under regular business conditions, ensuring raw material supply and quality, maintaining a high level of operational consistency, and engaging in transparent communication from R&D to commercialization.
While disaster may not always be lurking around the corner, the right supplier can see it coming a mile away. A supplier that has developed a strong business continuity plan to mitigate supply chain challenges during disaster or disruption will prove to be a far more valuable partner and resource than a supplier without a strategy. When interviewing supplier candidates, medical device manufacturers should always ask about the strength of a supplier’s business continuity plan—their ability to thrive in times of uncertainty just may depend on it.
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About the Author
Amy Zakrzewski is Sr. Strategic Account Director at Secant Group. She works closely with leading global medical device manufacturers in the cardiovascular, orthopedic, neurovascular, and surgical markets. Amy joined Secant Group in 2009, where she has worked in Engineering, Account Management, and Business Development. Amy has a bachelor of science degree in textile engineering technology and a master’s degree in Business Administration from Thomas Jefferson University. Connect with Amy on LinkedIn.