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The Basic Steps Of New Medical Device Design

Developing a new medical device that will improve the quality of care, survival rates, and treatment options for patients is the next step after the idea or the conceptualization process is complete.

There are several steps that have to occur for OEM’s in the process of a new medical device design, and working with a company who can assist in the design and development of implantable medical devices, diagnostic tools, imaging systems, monitoring options and even handheld devices is critical. With their experience and understanding of the various steps and testing components for the device, costs can be reduced, troubleshooting completed effectively, and the designing process can stay on the necessary schedule.

The Design Process

Once your company is working with the technicians and experts from the medical device contract manufacturing company, it becomes more of a partnership. The OEM charged with the medical device design and development will do the necessary work, but there will also be aspects of the device development that will need to occur before a prototype is developed.

These include:

  • A complete understanding of the products on the market currently used for the same medical application.
  • Understand the regulations and requirements for any components based on their use and standards and design control requirements set forth by the industry.
  • Assess and evaluate the design based on current technology, what is offered by the competition and the potential weaknesses or gaps those products have with regards to the new device.
  • Develop a process for design and development that meets all current industry standards and regulations for the specific device type.
  • Evaluate and assess the most effective and cost-efficient option for production of the device based on the specific medical device design.
  • Develop a set testing standard throughout the process that will ensure the medical device meets all standards and passes all safety and efficiency testing.

Throughout the entire process for the medical device development and design, and then into production, there should be a continual record maintained of all changes to the design. Each change should also be verified, tested, and reviewed to ensure it will not change the intended functions and features or the design or in any way impact the standards or the regulations in regard to the device.

Once the work is completed on the design component by the OEM, the medical device will be ready to go into production. When the medical device contract manufacturer has the ability to to work on production, packaging, and even end-of-life management of the instrument or device, your company has a definite advantage.

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