Design Thinking in Medical Devices. What is ideation, prototyping and testing?

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The design of a product or device, including those that are medical devices, must take into account the experience of users and patients, as well as usability. In today's market the focus should be on patients, so it’s necessary to improve their experience.

Manufacturers have the obligation to carry out usability studies, where the information from patients and users is valuable to design medical devices that intend to avoid human error, when they are used according to their intended purpose.

What is design thinking?

Design thinking is a methodology that is applied in a simple way. Five steps are followed, divided in two main phases. In the first one the objective is clear: carry out a study to be able to put oneself in the patient's place,empathizing with the users and their relationship with the devices.In the second phase, the problem to be solved is defined, different alternatives are to be presented and selected. The key is that only after fully understanding the user and patient perspective the search for solutions can begin. This search for solutions is divided on 3 iterative steps:

Ideation

In this phase, contribution of innovative and creative ideas is the key. The type of ideas that arise in this process isn’t limited, but rather encouraged as radical or unorthodox approaches can help solve part of the problem or be building blocks for more ideas.

In the ideation phase, the engineer acts as a creative would in any design process, starting  from a brainstorming session that is continuously refined to find the best solution to solve the problem. 

Prototyping

Once the innovative solution to the problem is available, a design must be made with a physical or digital prototype of the device. The idea is to make reduced and inexpensive versions of the designs in order to be able to test them in the next phase.

Test or test

The final phase of design thinking occurs when the efficacy and performance of the new device is tested. Medical prototypes must be tested by patients in order to obtain the necessary feedback, in a safe manner. Depending on the nature of the medical device testing the prototypes could involve a series of bechtests with constant input from the user  to measure the degree of success of the solution. 

The user's opinion is fundamental to establish a favorable result of the solution, demonstrating the importance and protagonism that he/she has in the development of the product. 

Design thinking is an appropriate methodology that can be adapted to provide patients with new medical devices to take care of their health. The great span of medical devices proposes a great opportunity to adapt the methodology in different instances having greater impact on devices where the patient will be in continuous use of the device to monitor or improve their health. 

As with all design methodologies, an open mind to assess all types of ideas, construct and mix them together, will enhance the innovation process. Compounding that with the ability to empathize with the patient and caregiver, addressing their different but valid needs, makes design thinking applied to medical device development a very useful tool.

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