Pilot Production Services for Medical Devices - Labinsights

Pilot Production Services for Medical Devices

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26 April 2024
Pilot Production Services for Medical Devices
Pilot Production Services for Medical Devices | Photo: STEMart

STEMart, a US-based provider of comprehensive services for all phases of medical device development, is proud to announce the launch of its new Pilot Production Services for the medical device industry.

These services allow manufacturers to test and refine their products before full-scale production, streamlining the development process of new medical devices and minimizing risk to save time and costs.

What is Pilot Production

Pilot production is the process of manufacturing a device using a process that is close to or equivalent to the production process. It is a critical process for devices that are being tested in clinical trials or pilot markets prior to full-scale production.

If a manufacturer’s medical device is successful in a pilot market or clinical trial, it may be possible to move to full- scale production. However, if a medical device is found to be defective during the pilot production phase, rework may be required. Rework costs more time and money. Therefore, manufacturers need to find a medical device company that takes the integrity of the process seriously.

As a full-service provider specializing in medical device development, STEMart offers clients pilot production services. These services address critical aspects such as:

  • process development
  • design
  • construction of assembly tools and fixtures
  • process FMEA
  • device master records
  • design transfer to manufacturing
  • process validation

It also provides manufacturing of clinical and low-volume commercial products. STEMart meticulously customizes its solutions to meet clients’ specific device requirements and budget during pilot production.

Pilot Manufacturing Phase

During the pilot manufacturing phase, STEMart’s engineers will work closely with the contract manufacturer to develop the product design and quality assurance process. They will iteratively implement any necessary changes prior to full production, as design changes can be costly and significantly delay the project. STEMart’s experienced engineers can identify potential problems and difficulties, saving the customer significant time and money.

In addition, STEMart studies the customer’s design and process for early iterative improvements, and the company’s onsite talent and resources ensure that the client has the best possible process before committing to major capital expenditures.

STEMart’s team of experienced professionals has a proven track record of successfully helping its clients bring innovative medical devices to market. By partnering with STEMart for the pilot production needs, medical device manufacturers can benefit from STEMart’s expertise, experience, and commitment to quality.

With a dedication to innovation and excellence, STEMart enables clients to achieve a seamless transition from pilot production to full-scale manufacturing, saving clients’ time and costs. If you have additional questions or would like to find out more about Medical Device Pilot Production Services, please visit STEMart’s website.

About STEMart

STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols to access better health worldwide.

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STEMart

STEMart is an industry-leading eCommerce platform, with an expanded global footprint, we now have a broad portfolio of more than 10,000 products. In the fields of science, technology, and engineering,... Read more