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Cimon Medical NeoDoppler

Innovative cerebral blood flow measurement for premature infants.

This is how optimal user interface design and pragmatic usability engineering for a complex medical device works.
With Data Driven UX Design (3DUX).

This is how optimal user interface design and pragmatic usability engineering for a complex medical device works.
With Data Driven UX Design (3DUX).

ZTNeoDoppler von Cimon Medical.
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ZTNeoDoppler von Cimon Medical.
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INITIAL SITUATION & THE PROJECT

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Premature births are common: one in ten children is born prematurely. Despite the incidence, there are major risks associated with this. Many of these infants are highly susceptible to respiratory and hemodynamic instability. The youngest of them have up to 50% increased risk of severe brain damage.

There are countermeasures against such instabilities, but for this to happen, these instabilities must be detected by altered blood flows in the brain. Currently, there is no solution for constant monitoring of these values.

Cimon Medical’s NeoDoppler is intended to change this in the future by constantly monitoring cerebral blood flow. Changes in cerebral blood flow should be detected immediately and signaled to healthcare professionals – and this is exactly where the challenges of the project lay:

  • How can NeoDoppler be operated quickly and without errors in hectic situations?

  • How can measured values and alarms be communicated as simply and directly as possible to medical personnel, but also to parents who are present?

  • How do you implement the duty of usability engineering in a way that is as beneficial as possible for a even better product?

NOTICE: NeoDoppler is currently in development and is not yet available for clinical use.

Premature births are common: one in ten children is born prematurely. Despite the incidence, there are major risks associated with this. Many of these infants are highly susceptible to respiratory and hemodynamic instability. The youngest of them have up to 50% increased risk of severe brain damage.

There are countermeasures against such instabilities, but for this to happen, these instabilities must be detected by altered blood flows in the brain. Currently, there is no solution for constant monitoring of these values.

Cimon Medical’s NeoDoppler is intended to change this in the future by constantly monitoring cerebral blood flow. Changes in cerebral blood flow should be detected immediately and signaled to healthcare professionals – and this is exactly where the challenges of the project lay:

  • How can NeoDoppler be operated quickly and without errors in hectic situations?

  • How can measured values and alarms be communicated as simply and directly as possible to medical personnel, but also to parents who are present?

  • How do you implement the duty of usability engineering in a way that is as beneficial as possible for a even better product?

NOTICE: NeoDoppler is currently in development and is not yet available for clinical use.

OUR METHOD

We guided this exciting project with our Data Driven UX Design (3DUX) approach from the very first minute.

3DUX is our method for guaranteed user-centered and safe products. Traditional UX design creates user interfaces based on assumptions of usage. 3DUX focuses on the actual user and their workflows with continuous testing and actively involves them in the design process.

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PROJECT PLANNING AND KICKOFF

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We place great value on good project management and respect our clients time.

This is our basis for a successful project at eye level.

Therefore, this project was also completely planned from the beginning with definite dates and deadlines for agreements and customer releases.

Particularly in view of the professional test users of the studies and their time availability, the forward-looking project management proved to be an advantage and contributed to the desired compact project duration.

In addition to project planning, the joint kickoff also served to get to know each other as a project team and to discuss open questions and planning in person.

We place great value on good project management and respect our clients time. This is our basis for a successful project at eye level.
Therefore, this project was also completely planned from the beginning with definite dates and deadlines for agreements and customer releases.
Particularly in view of the professional test users of the studies and their time availability, the forward-looking project management proved to be an advantage and contributed to the desired compact project duration.

In addition to project planning, the joint kickoff also served to get to know each other as a project team and to discuss open questions and planning in person.

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First Wireframes

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First iterations of wireframes are the basic framework for the 3DUX approach and provide a quickly created, but as real as possible MVP for first usability tests. The goal of the wireframes was to validate or falsify different design approaches of the workflows and functions of NeoDoppler with the later users already in an early project phase. This allowed us to collect real opinions from real healthcare professionals already in the subsequent user tests – and thus to adapt the workflow within NeoDoppler exactly to the user needs.

The actual visual design (e.g. colors and text) was initially neglected for this purpose.

First iterations of wireframes are the basic framework for the 3DUX approach and provide a quickly created, but as real as possible MVP for first usability tests. The goal of the wireframes was to validate or falsify different design approaches of the workflows and functions of NeoDoppler with the later users already in an early project phase. This allowed us to collect real opinions from real healthcare professionals already in the subsequent user tests – and thus to adapt the workflow within NeoDoppler exactly to the user needs.

The actual visual design (e.g. colors and text) was initially neglected for this purpose.

First User Tests

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After the release of the wireframes by Cimon Medical, the users were presented with typical tasks of such a device, which they were to perform on the basis of the wireframes.
In addition, the handling of current solutions was considered and feedback on the wireframes was obtained in a well-structured manner.

The tests with NeoDoppler were conducted by our team of usability testers and psychologists, evaluated and processed for our design team.

For this purpose, we recruited a total of 5 nurses and 9 physicians from the pediatric environment and confronted them in their daily work environment.
These tests with the smallest possible prototypes are the base for the safe and smooth function and also approval of a critical product. Therefore, they are the elementary part of our 3DUX approach.

In addition, they reveal – as in this project – user experience and usability problems at the earliest possible stage of the project.

After the release of the wireframes by Cimon Medical, the users were presented with typical tasks of such a device, which they were to perform on the basis of the wireframes.
In addition, the handling of current solutions was considered and feedback on the wireframes was obtained in a well-structured manner.

The tests with NeoDoppler were conducted by our team of usability testers and psychologists, evaluated and processed for our design team.

For this purpose, we recruited a total of 5 nurses and 9 physicians from the pediatric environment and confronted them in their daily work environment.
These tests with the smallest possible prototypes are the base for the safe and smooth function and also approval of a critical product. Therefore, they are the elementary part of our 3DUX approach.

In addition, they reveal – as in this project – user experience and usability problems at the earliest possible stage of the project.

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First Visual Design

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Based on the user tests we elaborated a first and complete interface design for Cimon Medical’s NeoDoppler. The workflows within NeoDoppler were revised and a visual design of the interface based on the Cimon Medical style guide was created by our design team.

In addition to user & client requirements, requirements of other stakeholders were also considered. For example, the interface was designed with a calming effect on parents and avoiding bright light sources in neonatal intensive care units in mind.

Based on the user tests we elaborated a first and complete interface design for Cimon Medical’s NeoDoppler. The workflows within NeoDoppler were revised and a visual design of the interface based on the Cimon Medical style guide was created by our design team.

In addition to user & client requirements, requirements of other stakeholders were also considered. For example, the interface was designed with a calming effect on parents and avoiding bright light sources in neonatal intensive care units in mind.

Final Design and Approval Studies

Data Driven UX Design now again focuses on user contact of the device.

Design changes are validated again on the basis of the user tests. This ensures high usability and the best possible fulfillment of the requirements for the summative approval studies in the design process.

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FORMATIVE STUDIES & DESIGN SPRINT

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In addition to validating the initial visual design, the second formative evaluation of NeoDoppler was a pre-summative evaluation.
Experiences and observations from the user tests can be translated directly into the interface design as new input.
In addition to new design input, we thereby acquire additional insights for the implementation of the later summative evaluation. In this way, we can ensure a risk-minimized and regulatory-compliant medical device – already during the development phase.

The test setup, the study procedure and the functions to be tested in the last formative evaluation followed the planning of the summative study, in particular to safeguard the hazard-related use scenarios and identify weak points.  Acceptance criteria and Instructions for Use (IFU) were already included in the tests at this stage of the project.

These tests were carried out under real conditions in our own medical usability labs at our Darmstadt site. Again, pediatric healthcare professionals were recruited and confronted with usage scenarios by usability testers and psychologists.

These second formative tests with NeoDoppler were also evaluated by our user research team and processed and written down in final changes for our design team.

From the results, a final interface design was developed and delivered to our client. 

In addition to validating the initial visual design, the second formative evaluation of NeoDoppler was a pre-summative evaluation.
Experiences and observations from the user tests can be translated directly into the interface design as new input.
In addition to new design input, we thereby acquire additional insights for the implementation of the later summative evaluation. In this way, we can ensure a risk-minimized and regulatory-compliant medical device – already during the development phase.

The test setup, the study procedure and the functions to be tested in the last formative evaluation followed the planning of the summative study, in particular to safeguard the hazard-related use scenarios and identify weak points.  Acceptance criteria and Instructions for Use (IFU) were already included in the tests at this stage of the project.

These tests were carried out under real conditions in our own medical usability labs at our Darmstadt site. Again, pediatric healthcare professionals were recruited and confronted with usage scenarios by usability testers and psychologists.

These second formative tests with NeoDoppler were also evaluated by our user research team and processed and written down in final changes for our design team.

From the results, a final interface design was developed and delivered to our client. 

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Summative Studies

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After the final design sprint, we are currently (August 2021) conducting the summative evaluation according to IEC 62366-1 with our TÜV Rheinland certified Medical Devices Usability Experts. IEC 62366-1 also mandates “suitable persons” with appropriate competencies, education, training and/or experience for such summative evaluations.
The summative studies also take place in our Medical Usability labs at the Darmstadt site. There, we have been specialized in conducting such studies since 2013.

The work base of the usability test is as detailed as possible to the later work environment: an incubator with lifelike dummy of a premature baby and NeoDoppler itself.

Again, the study participants are recruited by us on the basis of Cimon Medical’s requirements.
In 30 usability tests of 1.5 hours each, the participants are provided with a Quickstart Guide and guided through the scenarios by our experienced team.

The use cases consist of (among other things)

  • the setup of the device

  • the setup of the measuring unit of the device

  • the handling of different tasks in the interface

  • realization and handling of alarms.

After the summative evaluation, the study results are subsequently evaluated and written up in the Usability Engineering File (UEF) for technical documentation.

After the final design sprint, we are currently (August 2021) conducting the summative evaluation according to IEC 62366-1 with our TÜV Rheinland certified Medical Devices Usability Experts. IEC 62366-1 also mandates “suitable persons” with appropriate competencies, education, training and/or experience for such summative evaluations.
The summative studies also take place in our Medical Usability labs at the Darmstadt site. There, we have been specialized in conducting such studies since 2013.

The work base of the usability test is as detailed as possible to the later work environment: an incubator with lifelike dummy of a premature baby and NeoDoppler itself.

Again, the study participants are recruited by us on the basis of Cimon Medical’s requirements.
In 30 usability tests of 1.5 hours each, the participants are provided with a Quickstart Guide and guided through the scenarios by our experienced team.

The use cases consist of (among other things)

  • the setup of the device

  • the setup of the measuring unit of the device

  • the handling of different tasks in the interface

  • realization and handling of alarms.

After the summative evaluation, the study results are subsequently evaluated and written up in the Usability Engineering File (UEF) for technical documentation.

The Result

The result is a user interface that was designed on the basis of real users, their needs, their behavior and their desired workflows.

The visual design is very clean and allows a fast information transfer. Parameters and alarm modes can be set with a few intuitive finger movements.

We are very pleased that not only the users, Cimon Medical and we are enthusiastic about the result, but also the juries of well-known awards. The interface design of the NeoDoppler was awarded as RedDot Winner Interface Design for the year 2021.

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About The Project

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Tormod Thomsen, Phd – CEO Cimon Medical

“The biggest challenge was to balance the request from our advance clinical research users to include “everything” in the GUI against the need for an intuitive and easy to understand GUI for users in a busy clinical everyday routine. We spent a lot of time interacting with the different user groups and in thinking through what we really wanted to achieve. Also, the possibility to switch between standard and advance mode makes it possible to optimize NeoDoppler for any given clinical setting.
The most important thing in case of the GUI was that everything displayed on the screen should be easily understandable for the user. In the NICU, the parents are often present in the room with the patient worrying about the situation and all curves, numbers and changes that occurs.
In a situation like this it’s important for the user to be able to communicate accurately with the patients.

We think we have found a great solution to this.
Comparing the prototype Matlab version with the finished NeoDoppler product there is a world of difference in usability and how we display information that is intuitive and easy to understand.

Our biggest fear was that we were not going to be able to balance between the need for providing enough clinical relevant information versus simplicity and ease-of-use.
We believe that we have resolved those issues, and that NeoDoppler will become a highly relevant clinical tool that is easy to work with and understand.

I would suggest Custom Medical to anyone who needs to develop a medical user interface and wants to be sure, that this will be most effective as possible.”

LET’S GET STARTED

Do you want to work together quickly, purposefully and respectfully at eye level?

Let’s talk openly about your challenges and find out together how we can support you.

Do you want to work together quickly, purposefully and respectfully at eye level?

Let’s talk openly about your challenges and find out together how we can support you.

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