Turnkey ECM for Successful Medical Device Development
Whether you are just breaking into medical device development or you are a long-standing company with an impeccable track record, sometimes you just need some extra hands to get a project off the ground. In these instances, working with a turnkey ECM could be the perfect solution.
Turnkey electronic contract manufacturers can handle not only the manufacturing, but also the design, engineering, and manufacturing for your cutting-edge medical device. A turnkey ECM can step in from initial concept or anywhere in the medical device development process and get it market-ready within compliance standards like ISO 13485. Better yet, it is all done under one roof. Most electronic medical device companies that turn to turnkey solutions enjoy many advantages of the service, including saving valuable time and money.
Safety first is always a good policy, but especially when it comes to medical device development. Your turnkey ECM will make sure your device is safe when exposed to environmental extremes it will encounter while functioning in or on the human body, including:
- Extreme temperatures
Your ECM will help address any safety concerns. This will include how the device will be cared for in terms of cleaning and sanitizing. Your medical device will need to withstand dust, moisture, corrosion, and potential contamination.
The reliability of a medical device can literally affect the life or death of a patient. You need an ECM that will guarantee your device is reliable.
Reliability of a manufactured product is defined as the probability that it will perform satisfactorily for a specified period of time under stated use conditions. To determine this, your turnkey ECM will repeatedly test your device under various scenarios to ensure it will properly function when your end user needs it the most.
Proactive Obsolescence Risk Management
Parts obsolescence is a big problem in the electronic medical device industry. Your turnkey ECM should work to mitigate parts obsolescence, so components don’t become scarce before your medical device even rolls off the assembly line. Your ECM will track and manage the availability of parts. They will forecast the risk of components becoming obsolete and stock up or redesign to accommodate a replacement part.
Engineers on Staff
Your turnkey ECM may come with the added bonus of on-site engineers. These troubleshooting experts are always ready, willing, and able to spot errors in the medical device development process before they get the chance to cause major setbacks in your project timeline. They will continuously monitor your project in order to uncover issues that could delay the process, break your budget, or cause other issues that could torpedo your medical device’s success.
Packaging and Shipping
Packaging and shipping is as important to medical device development as design. You shouldn’t trust it to just anyone. Your turnkey ECM will handle that, too. Packaging will work for the exact dimensions and requirements of your device and will be built to withstand harsh shipping conditions where safe handling is never guaranteed.
All medical device development projects can benefit from turnkey solutions. Is this something your manufacturing partner can provide?
Levison Enterprises is ready to take your groundbreaking idea from concept to customer. We have the staff, ISO 13485 certification, and equipment already in place under one roof in order to eliminate problems that can crop up when moving from shop to shop. Levison has the experience and facilities to be your single source turnkey electronic medical device development and assembly solution. Contact Levison Enterprises today to see how turnkey solutions can work for your next project.Get Started