Controlled Supply Chains Crucial for Medical Device Manufacturing

In medical device manufacturing, when recalls happen, device manufacturers are often called upon to show documentation of their supply chain and manufacturing processes. Medical device supply chains can be lengthy, with multiple tiers of suppliers. The quality and functionality of the device can be impacted by any one of the components. When issues arise and documentation is requested, having a reliable, high-functioning, and well-managed supply chain is crucial to the response.

Detailed Supply Chain Management

The ECM you partner with for your medical device manufacturing should have a detailed supply management system in place that they are willing to share with you. All medical device components should come from vetted suppliers to best avoid the potential for unregulated or counterfeit components. The risk of counterfeit components is one that will need to be completely avoided. Counterfeit parts are always a problem, but the importance of quality components in medical devices can’t be understated. The risk of faulty and unreliable counterfeit parts can be avoided by a quality control plan that prioritizes part and product traceability. With this traceability system in place, you will be able to determine what raw materials were used, and details about how long, where, and under what conditions they were stored. Being able to easily trace where all parts came from is important when you’re building medical devices that our healthcare systems will rely on to keep patients healthy and alive.

A Domestic ECM is Vital to Controlling Supply Chain

Choosing an onshore ECM partner for your medical device manufacturing is vital. A domestic ECM partner will have the right certifications and registrations, including ISO 9001, ISO 13485, and FDA registration. With a domestic ECM, communication throughout the process will not be a struggle, as it can be when working with offshore ECM partners. Juggling time differences and language barriers can be detrimental to the build, and often you find out too late that there was an error that could have been avoided.

Communication is essential to controlling the supply chain and making sure that all the components used in the medical device are legitimate, registered, and meet or exceed industry standards. A domestic ECM who is qualified to build for the medical device industry understands the regulations and will ensure that all the supply chain transfers are documented and controlled throughout the process. Most ECMs who work with medical device manufacturing have continuous improvement processes in place to hold themselves to the highest standards.

Cutting Corners Can Be Your Demise

The bottom line is important. However, cutting corners at any point in the process of medical device manufacturing can spell doom for the final product. The best choice is to choose a domestic, turnkey facility with an on-site engineering team who is experienced and ISO 13485 certified that can oversee the process throughout the design and manufacturing. An on-site engineering team can handle reverse engineering, prototyping, testing, design services, including Design-for-Manufacturing, all the way to packing and shipping. By keeping everything in house and under one roof with one point of contact, there is far less risk of miscommunication or lack of documentation. You will have a project manager to keep the entire process running smoothly, and a whole team capable of producing a superior medical device for your end users.

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There is a high demand for medical device manufacturing. The technology in medical devices is growing and has driven the demand exponentially over the past decade. This increased demand will put additional stress onto the manufacturers. The process is unique, regulated, and complex, but a domestic ECM with the right certifications, experience, expertise, and quality control processes is up for the challenge. Let us help. If you’re planning your next medical device build and you’re looking for an ECM to partner with, contact Levison Enterprises to learn more about how we can help you build a better medical device.