Reliable Medical Device Manufacturing Starts with the Right ECM
Posted On January 19 2022
The demand for quality medical device manufacturing continues to rise and there are no signs of it slowing down anytime soon. With the increasing need for devices, developers are seeking out electronic medical device manufacturers to partner with for production.
A domestic, turnkey electronic contract manufacturer (ECM) with medical device industry experience and capabilities is your best defense in combating the challenges medical device companies are dealing with right now like supply chain issues and faulty products.
There are many advantages to working with a turnkey shop who can manufacture a high-quality medical device for you, but not all ECMs are created equal. You want to find a partner who has the right capabilities, certifications, and experience in this industry. When you’re building a new medical device, time is money. You need an efficient process with a high quality product your end users can count on.
A DFM (design for manufacturing) analysis ensures that your design is optimized for manufacturability. Partnering with a turnkey ECM with on-site engineers can help you utilize this convenient design service. An ECM who understands how the design can affect the entire manufacturing process will be invaluable to your bottom line.
Turnkey Domestic Partner
The greatest benefit of working with a turkey domestic partner for manufacturing is working with one service provider. Having only one point of contact to service all your needs is beneficial to the entire project. Errors can be handled and fixed efficiently, the entire project is completed under one roof so your project won’t be bouncing between different shops for different phases of the build, and because you have a project manager to oversee every step, communication errors are less likely.
Design for manufacturing (DFM) analysis helps you design your components with manufacturability in mind. This helps to get your design and product to market faster, while still ensuring a high-quality product. When the design and manufacturing teams can communicate, design errors can be found early in the manufacturing process when they are less expensive and time-consuming to fix.
Vetted Supply Chain
All component suppliers need to be vetted to ensure there are no counterfeit or imperfect parts being used. Using a medical device manufacturer with quality certifications will already have supply chain management processes in place. Not only will this mitigate counterfeit parts, but will also aid in your ECMs forecasting ability since they will have a firm grasp on component inventory, know what components are in short supply, and whether or not parts obsolescence will be a concern for your build.
PFMEA in Place
Process Failure Mode and Effects Analysis carefully analyzes and identifies anything that could go wrong during the manufacturing process. This helps electronic manufacturers build in safeguards so they can plan for potential failures for every scenario. It also helps to avoid errors during changes in an existing manufacturing process, when utilizing new technology and equipment, or when relocating to a new facility, The PFMEA method gives electronic contract manufacturers the ability to plan for potential failures and put preventative measures into action, saving you time and money by avoiding errors due to unforeseen circumstances.
Certifications and FDA Registration
Certifications are required, not optional. They also provide proof that your ECM partner has the equipment, skills, and capabilities needed to handle your manufacturing needs. Special certifications provide further proof that your ECM partner is equipped to manage your needs and ensure your design, and the manufactured product itself, meets all industry standards and regulations. Without certification, there is zero accountability for the quality and reliability of the product. Registration with the FDA is required for manufacturing medical devices.
Experience and knowledge in your industry are crucial factors in selecting an ECM partner. The company you choose needs to have a history that’s greater than a couple of years. You need a reputable and established company with solid experience in the medical industry who carries the certifications and registrations necessary to manufacture medical devices safely.
In-house engineering is extremely important and beneficial for your medical device project. Troubleshooting and testing can occur at any point during the production, and on-site engineers can identify errors and solve them quickly on the fly. Identifying problems early in the process allows for a more streamlined corrective process. On-site engineers are essential for quality assurance. They provide the knowledge and expertise necessary to improve designs, prevent problems, troubleshoot, and ensure a successful product at completion.
Reverse Engineering Capabilities
Reverse engineering is another benefit to choosing a turnkey ECM, especially when manufacturing medical devices. In the medical device industry, legacy products are common. These are devices that still work great, and the healthcare community relies on them, but because technology evolves so quickly, a medical device can become obsolete soon after production. Reverse engineering allows you to update or retrofit your design so your reliable product can stay on the market longer. Your manufacturing partner’s team of engineers can strip it down to find better component placement, compatible parts for obsolete components, and redesign it for manufacturing efficiency. This is especially helpful in times of supply chain shortages.
Why Partner with Levison Enterprises?
As you can see, there are several reasons why partnering with a turnkey ECM like Levison Enterprises makes sense. We’re your one stop shop for medical device manufacturing and that’s not easy to find. The most important criteria when considering a partner for your electronic medical device manufacturing is industry certifications and experience. Not only do we have the experience and certifications you’re looking for, but with our turnkey service, we can assist you with the design through to shipment of your end product, and everything in between. Contact us today for a quote.
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