Pilot Production of Medical Devices

Pilot Production of Medical Devices

What is Pilot Production?

processes close or equal to those to be used in production. Pilot production is a crucial process for devices that will be tested in clinical trials or pilot markets before transitioning to full-scale production. If the customer’s medical device is successful in a pilot market or clinical trial, it will likely transition to full- scale production. But if the medical device has flaws that are revealed during the pilot production phase, the medical device may need to be reworked. Reworking a medical device takes more time and more money. This is why customers need to find a medical device company that takes seriously the integrity of this process.

Our Pilot Production services

At STEMart, we work hard to personalize our approach to your specific device requirements and budget, and create a streamlined process that is customized to your unique needs. Some of the things we address during pilot production are:

• Process development
• Design and construction of assembly tools and fixtures
• Process FMEA
• Device master records
• Design transfer to manufacturing
• Process validation
• Manufacture of clinical and low volume commercial product

During the pilot manufacturing phase, our engineers will work closely with selected contract manufactures to elaborate product design, QA processes and iteratively implement all necessary changes before full- scale production, where design changes may become too costly and significantly delay your project. Our experienced engineers will unearth potential difficulties to save customers significant headaches, and costs, down the road.

With our pilot production process, we research your design and processes to incorporate iterative improvements early in the process. Our on-site talent and resources ensure the best possible process — before you commit to major capital equipment expenditures. By identifying potential issues, we can save you considerable time and costs later on.

STEMart offers pilot production of medical devices to support your testing, promotional, and other needs. Through continuous refinement and validation, we ensure your medical device will seamlessly transition to full-scale production.

If you have additional questions about Medical Device Prototyping or would like to find out more about our services, please feel free to contact us.