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Tools & Devices
Patient Warming Device

FROM: Concept write-up

TO: Manufacturing prototype and FDA pre-sub

A manufacturer of automotive climate control systems came to in2being with an idea for a patient warming device for military field use. Because the client had no prior experience with medical device development, they also sought in2being’s help setting up a medical device division for their company.

For trauma victims and patients in the operating room, hypothermia (a core body temperature less than 36°C) is a serious concern. Hypothermia decreases the body’s ability to stop bleeding and increases the risk of infection. In military settings—for example, transporting a wounded soldier from the battlefield to a field hospital—maintaining normal body temperature may be critical to saving lives.

The Starting Point: A Concept Write-Up

The manufacturer brought in2being a concept write-up for a ruggedized, military-use patient warming device. Although they had experience developing climate control products for human use in automotive settings, they needed guidance for the unique challenges presented by medical device development.

In conjunction with developing the patient warming device, in2being also advised the client on setting up a medical device division within their company.

The Process: From Design to Manufacturing Prototype

In this long-term engagement, which ran from 2015 to 2021, the client company sought  in2being’s help setting up a medical device division within the business and developing a patient warming device.

During this engagement, in2being provided the following services:

  • Mechanical design: in2being designed an enclosure for the device and assisted with other aspects of mechanical design.
  • Prototyping: in2being created early prototypes and, ultimately, a functional manufacturing prototype.
  • Manufacturing readiness: in2being developed quality systems for the device to satisfy the Food and Drug Administration’s (FDA’s) quality system regulation. This included the development of design controls and carrying out verification testing.
  • FDA pre-submission: in2being also prepared an FDA pre-submission (pre-sub) for the client—a filing preliminary to a 510(k) submission seeking FDA feedback.

In addition to the foregoing services, in2being provided project management services and training for the client throughout the engagement.

The Results: A Medical Device Division, a Working Prototype, and an FDA Pre-Sub

At the outset, this manufacturing client needed to gain medical device experience. By the end of the project, they had an established medical device division within their company. At the outset, the patient warming device existed only on paper; by the end, the client had a manufacturing-ready prototype and was well on the way to preparing a submission for FDA clearance.

No matter what stage you’ve reached in developing your new medical device, in2being has the expertise to move your project forward. We provide full-service med-tech consulting, offering everything from engineering, design, prototyping, and laboratory testing to assistance with protecting your intellectual property and obtaining regulatory clearance.

To find out how we can help you, contact us today.

Let us get you there.

We're ready to lead you from concept, to prototype, to FDA clearance. Let us show you how to push your project forward with a free project analysis. Are you ready to bring your medical device to market?

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