Developing a Successful Medical Device with the Right Electronic Contract Manufacturer

Medical device manufacturing can be challenging. There is high demand to manufacture products quickly and affordably, but these devices also must meet the high standards and regulations of the industry. It is crucial that the ECM you partner with is mindful of compliance and certified in compliance standards like ISO 13485. Medical device manufacturing requires an experienced, knowledgeable, and thorough ECM with the capabilities, skilled workforce, and facility to do the job right.

Medical professional holding an ultra sound medical device.

The Right ECM Can Provide DFM Analysis

It is important to plan for manufacturing early in the design process. A high-quality turnkey ECM can provide a Design for Manufacturing analysis, which will take a close look at the manufacturing design, materials, and manufacturing methods to ensure the best possible outcome. Without DFM analysis, potential issues may not be noticed until later in the manufacturing process, which can cause lengthy and expensive corrections. In addition, the parts and components may not be available, and a DFM analysis can focus on creating a prototype with the best parts and components available. When it comes to medical device manufacturing, there is no room for error, and incorporating this analysis into the process early will avoid any potential ones.

8 Key Things Medical Manufacturer

The Right ECM Has a Vetted Supply Chain and Counterfeit Parts Mitigation

Documenting the supply chain is crucial for medical device manufacturing. In the case of a product recall, a detailed record of the parts and components used in the device is essential. To avoid the risk of counterfeit parts, the ECM you choose to partner with should have a vetted supply chain and a plan in place for counterfeit part mitigation as well as what to do in the case of parts obsolescence. Counterfeit parts are especially concerning in medical device manufacturing, and a quality ECM will be able to source the correct components without concern.

Look for a Turnkey, Domestic ECM Partner with the Right Capabilities

A vertically integrated, turnkey, domestic ECM partner is key for medical device manufacturing. The right ECM should have all necessary services, team, and facilities in-house, which can take your product through development, to design, and on to prototyping and testing before beginning the manufacturing process. When the project remains in-house with a dedicated project manager throughout the process, there is less of a chance of errors as the project moves from phase to phase. The team will work together throughout the process, overseen by the engineering team, with continuous improvement and thorough documentation processes already in place. Having a domestic team with the proper registrations and certifications is important, as the medical device industry is highly regulated and every device manufactured must meet strict industry standards.

DFM Analysis

When it comes to medical device manufacturing, the right team will have experienced engineers ready for DFM, reverse engineering, and troubleshooting. The ECM partner that is right for your business will have the plans in place for compliance, supply chain management, and continuous improvement. Partnering with an ECM with compliance certifications like ISO 13485 ensures that your medical device will meet all the requirements needed. The facility will be ready to handle the entire project from start to finish and will work to ensure the final product is high-quality and functional.

Finding the right ECM with the right experience can be a challenge, but if you’re looking for an ECM to partner with for your medical device manufacturing, it is well worth the effort to ensure the manufacturing is done right. Here at Levison Enterprises, we have a wide variety of industry experience and certifications, and we’ve been successful because we’re good at what we do-help businesses like yours design and build great products people can count on. If you’re looking for an ECM partner for your next medical device manufacturing project, contact us to learn more about how we can help.

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