Getting Your Medical Device to Market Quickly Takes More Than a Good Design
A good design is the right way to begin your medical device, but the end product is only as good as your manufacturing partner. When you want to move your product quickly from the initial idea to the end product, you need to find an ECM partner who has all the services you need to get the project done effectively and efficiently. You also need to find an ECM partner that is certified in crucial compliance requirements such as ISO 13485. A domestic, turnkey ECM can take your design through all the stages the right way.
Design For Manufacturing and Reverse Engineering Capabilities
Design for Manufacturing (DFM) means getting the engineers involved in the process from the beginning. Many designs don’t take manufacturability into account, which means that a device that looks great on paper may end up being expensive, complicated, slow, or even impossible to produce. When your design goes through DFM analysis, the engineers will look at the parts, the specifications, the functionality, the assembly, and the tooling to ensure that your medical device is not only able to be produced well, but will have a long lifetime. Engineers with reverse engineering capabilities can give new life to your legacy designs, negating the need to continuously reinvent the wheel. In the case of a glitch during testing and prototyping, reverse engineering can identify precisely what will need to be adjusted before a full scale production run.
Vetted Supply Chain
A vetted supply chain is important in all PCB manufacturing, but in medical device manufacturing, the need for high quality parts is increased. For a medical device to meet the industry standards, the risk of counterfeit or obsolete parts needs to be mitigated. Choosing an ECM with a vetted supply chain ensures that your design will move through the manufacturing process with the right parts from suppliers who can be relied upon to provide legitimate and quality components that meet the high regulatory standards for medical devices.
Industry Experience, Certifications, and Equipment
Finding the right ECM means finding a facility who has the right people working with the right equipment. A quality ECM will have engineers with experience in medical device manufacturing and the certifications to back that up. A good ECM will have continuous improvement practices in place for both their experts and their equipment, and will be able to assure you that they can handle your design.
A Domestic, Turnkey ECM is the Right Choice
Outsourcing overseas can look like a smart, cost-effective choice, but outsourcing internationally can mean slow communication due to time zones, possible language barriers, no definitive IP protection, and delays in importing. Choosing a domestic, turnkey ECM means the entire process can be handled by one partner, and that partner will be able to communicate easily with you throughout the entire process. A domestic partner understands the high regulation of medical devices, and a turnkey facility significantly reduces the risk of any errors that come with moving your product through different stages in different locations. When you work with a domestic, turnkey facility, you will know that they can handle the entire process from design through delivery.
Your design may be amazing, but if you don’t have the right ECM partner to handle the PCB manufacturing, you could end up with high costs, significant delays, and even a failed product that won’t meet proper standards and regulations. When you partner with the right domestic turnkey ECM, you are setting your medical device up for success. Levison Enterprises is a highly skilled, ISO 13485 certified turnkey ECM with extensive medical device manufacturing experience. Contact us today for a quote on your next medical device assembly.