Otivio WARM is a novel non-invasive (requiring no penetration of the skin) pre-hospital (outside the hospital) treatment device using a pulsating vacuum and Far Infrared Heat to actively heat patients to avoid and/or treat hypothermia (a body temperature lower than 35º celsius). The device is placed on the patient’s arm away from any injuries. As the vacuum pulsates (mimicking the heart) blood is pulled from the core out to the limb, warmed and sent back to the body core. The device is designed specifically for the pre-hospital scenario where portability and ease-of-use is paramount for the survival of patients.

A trauma injury is defined as a “physical wound caused by an external force”, typically a bleeding injury. Between 3-5 million people die annually worldwide due to trauma injuries, representing about 10% of all deaths. Providing proper treatment for the injured is essential, but the hospital emergency room might be far away. In this period it is crucial to avoid hypothermia. Failure to do so will lead to the trauma triad of death – a vicious circle that ultimately leads to coagulopathy, a state where the body’s blood cannot form clots to stop the bleeding. In this state patient cannot undergo surgery as it will only expedite the blood loss. In short - if the body temperature cannot be raised, the patient will bleed to death. This means that a warm patient is a treatable patient.

Treating Hypothermia is therefore crucial to ensure the survival of the patient.

As industrial designers we approached the project from a Service Design point-of-view. By approaching the Medical Treatment Scenario as a holistic service we were able to map out all the stakeholders and better understand all the involved actors. This uncovered unmet needs for both a product and a service.

While professional health personnel are well-informed about the dangers of Hypothermia, the general public lacks knowledge on how to avoid and/or treat it. The service offering would therefore inform and educate the general public (and any health personnel with a lack of knowledge), and complement the product.

This thorough understanding of the scenario also guided the product design process. Trauma situations operate under different rules. Users are partially or completely disabled. Stress levels are high. People operate more by instinct than rationale. The design had to account for all these factors and operate in a very simple and intuitive way.

WARM is the result of a comprehensive design process, covering a wide range of topics such as medical theory & treatment, user scenarios, materials & technology. Research into medical treatment scenarios uncovered a large unmet need in trauma injuries. While basic treatment methods (CPR, wound treatment) are well documented, Hypothermia proved to be a hidden danger, and a deadly one as well. Product benchmarking of existing products also uncovered that there were no non-invasive pre-hospital products on the market today.

In addition to the medical/treatment research, a lot of research effort was also placed in materials and technology. The military scenario was chosen both because of the urgent need for such a device, and because it defined very rigid requirements ensuring efficiency in the design. The product has to form a large rigid container large enough to fit all hand sizes within the 95th percentile and withstand a 5% vacuum pressure, but also be lightweight and easily foldable. The enabler of such contradicting requirements is a vacuum-activated material that can go from soft to hard by removing the internal air. The material allows the product to be molded around the patient arm to provide a custom fit - and upon activation - create a stiff construction capable of withstanding the pulsating vacuum pressure. Additionally, the product can be folded flat when not in use. A custom fit also means a highly energy-efficient product, keeping the pump and battery size to an absolute minimum.

Another key area of research was heating technology. The requirements of heating a human body renders most solutions on the market unsuitable. The solution was found in EXO2 – a unique polymer capable of emitting Far Infrared Heat that penetrates deep into human tissue, delivering the heat where it has an effect.

When designing products for medical situation – and military products in specific - understanding the user scenario is crucial. Such scenarios are often highly stressful, so care was taken to make the product as intuitive as possible. Simple four-step instructions are printed directly on the product and the corresponding functional surfaces are clearly decorated to guide the user through the process.

Protoyping was a central tool of the product development, spanning from simple paper mockups to explore and test the potential of various forms to precisely sewn full scale proof-of-concepts prototypes to validate design solutions.

Between 3-5 million people die annually worldwide due to trauma injuries, representing about 10% of all deaths. Trauma is the fifth cause of death regardless of age, and the leading cause of death in the?age 1-44. Over 300 million per year require medical treatment as a result of trauma. In 1998, Hagautvalget stated that with optimal injury treatments, 20 to 25% of injured patients can be saved equal to saving 5-6000 person years in Norway alone (Aalvik & Asbjørnsen, 2009). On a worldwide basis, this number is in the millions. Improving the state of the patient before arriving at the hospital greatly reduces the workload of treating the patient and increases the chance of a full recovery – both benefiting the society as a whole. WARM is the first non-invasive pre-hospital device that actively heats the patient and prevents hypothermia. As patients cool down, the circulation of blood is limited to the core of the body to ensure the function of vital organs. As this happens, your skin turns cold due to lack of blood.

Existing non-invasive products cannot raise the core temperature of the body, but only affects the outer skin. This has no effect on the core temperature due to lack of circulation, and fails to prevent hypothermia. WARM solves this by taking a completely new apprach through the innovative use of vacuum pressure and Far Infrared Heat. It makes sure the heat goes where it’s needed – the core of the body.