- Client:Loop Diagnostics
- Sector: Medical, Health
- Services: Design, Industrialization
- Year: 2023
- Team:
Design Lead, Ramon Martínez
CTO, Miquel Pons
Dissenyador Industrial, Joel Vallverdú
The first rapid test that identifies bacterial infections in the blood through immunological activity.
Sepsis is a disease that affects 30 million patients and kills 6 million of them, which is about one death every two minutes, more than from prostate cancer, breast cancer and AIDS combined. This disease is a life-threatening condition caused by the body’s inflammatory response to infection. While these are infections that can be treated with antibiotics, they are complex to diagnose and too often identified late.
Loop Diagnostics is a company born in 2018 in Barcelona, which has designed a rapid blood sepsis test with high sensitivity and specificity. The company emerged after the participation of its two founders, Enrique Hernández and Eduard Guerrero, head of operations, in the postgraduate programme Design Health Barcelona, promoted by Biocat.
Can industrial design help detect sepsis with a simple drop of 💉 blood?
PROCESS
Design and development to obtain a prototype that prioritises functionality, runtime and cost-efficiency.
Through iterative work, the characteristics that the device had to have in terms of functionality, interaction with the user, materials and aesthetics were narrowed down until a clear briefing was defined for the prototype that was finally developed.
In this first phase, in collaboration with the rest of the project partners, the specific components that the device has to incorporate are defined, both in terms of software and equipment (screen, PCB, camera, LEDs, motors, power supply, connectors, peltier, limit switches, connectivity, algorithm…). In addition, other elements that are required for all these components to work correctly and interact with each other have also been foreseen.
Conceptualisation of the design according to technical and usability requirements
During this phase, the different iterations of the design were conceptualised in sketch format, in order to be able to discuss each of the most relevant aspects of the design with the rest of those involved. The incubation module, the system for pressing the plunger and the integration of all the functionalities in housings that allow a good interaction with the user have been specially addressed.
NEEDS
Prototype a functional and cost-efficient table-top device for automatic reading at the point of care.
The aim of the SEPTIBELL project is the design and development of a new quantitative and automatic colorimetric reading system for Septibell lateral flow strips, an innovative in vitro cellular immunoassay, the first of its kind, which identifies bloodstream infection (progressing to sepsis) through immunological activity.
Specifically, Stimulo has focused on developing the state-of-the-art “point of care” desktop reader device to quantify the level and severity of an infection using Deeptech technologies, such as artificial intelligence and machine vision (image processing) algorithms for feature extraction and dimensionality reduction to condition subsequent data analysis.
A carriage with a plunger will move vertically through a threaded shaft, driven by a motor, and press down on the consumables. Consideration has been given to the speed and force of this carriage and plunger so that they do not generate jerky movements that could splash the contents of the consumables or hinder the overall operation of the device.
The trolley will also have a horizontal movement to be able to access and act on all consumables. This also includes the reader unit, i.e. the camera with the integrated software to read the results of the inserted samples. In this case, the range of vision of the camera and the light it receives must be taken into account.
When developing the mechanism, heat dissipation and ventilation of the device must also be taken into account.
Prototype design for clinical validation
In this phase, the design is matured through CAD, with parametric 3D modelling in SolidWorks. This software allows the concepts to be more detailed, all the chosen components to be drawn and located, and simulations of the mechanism’s operation to be made.
As mentioned above, the aim of the design is to create a cost-efficient prototype that allows testing, so for now it is a design intended to create few units and is conditioned by that. In future iterations, when scalability of the device is addressed, superior materials and manufacturing processes will be available, resulting in a more compact and evolved design in all respects. For this reason, standard, off-the-shelf components, processes such as laser cutting and 3D printing, and materials such as methacrylate and aluminium have been used. All this is especially optimal for rapid prototyping.
On the other hand, through studies on the most suitable materials for medical devices and possible manufacturing methods, this phase concludes with the choice of selective laser sintering (SLS) 3D printing technology with PA12 material for the housings, due to its advantages in terms of strength, durability, rigidity, and the ease and freedom it provides in terms of geometric design.
Finally, a black methacrylate sheet is used for the flat surface that will integrate and join the SLS printing parts and the screen that the user will interact with.
In summary, all of these materials and manufacturing processes allow the production of a prototype that offers significant advantages in terms of speed, efficiency, cost and design flexibility.
Once all these parts have been designed and located, a list of components and materials (BOM) is generated and procurement is carried out through various suppliers and manufacturers.
VALUE
The human factor in medical devices.
The flow of user actions has to be as natural as possible.
From the outset, the collaboration with Draco Systems to integrate the mechanical and electronic parts of the device was aimed at minimising the dangers and risks associated with its use, so that users can use the device safely and effectively.
However, since the probability of usability errors is very difficult to determine and, in fact, many usability errors cannot be anticipated until the use of the device is simulated and observed, work is done on a prototype on which to apply appropriate human factors or usability engineering processes to evolve the design deficiencies associated with the use (risk analysis).
The result is an optimal integration into the Point-of-Care (POCO) configuration taking into account technical optimisations tailored to the reference device, as well as a simple and ergonomic system that will allow the future design of the self-explanatory user interface for ease of use.
Our holistic approach and design expertise in the consumer goods sector allowed us to develop a highly professional minimum viable product (MVP) prototype with a user-friendly interface.
Prepared for the results of clinical trials.
LEARNINGS
With the right partners, everything is easier
LoopDx, ColorSensing, Draco Systems, the Institute for Research and Innovation Parco Taulí (I3PT) and Stimulo Design have collaborated with ambSsecpho, the Deep Tech cluster to develop this new automatic colourimetric reading system called SEPTIBELL that identifies sepsis in blood 10 times earlier through immunological activity.
The project has been funded by the Ministry of Industry, Trade and Tourism and the European Union-Next Generation EU, within the support programme for Innovative Business Clusters, which aims to digitise industry.
“We are extremely satisfied with the efficiency and attention we received. From the outset, they proved to be prompt and attentive, understanding our needs perfectly. What really impressed us was their ability to anticipate our desired improvements; not only did they adapt well, but they were also proactive in anticipating aspects we had not even considered. This ability to anticipate and exceed our expectations demonstrates their commitment and professionalism.”“We are extremely satisfied with the efficiency and attention we received. From the outset, they proved to be prompt and attentive, understanding our needs perfectly. What really impressed us was their ability to anticipate our desired improvements; not only did they adapt well, but they were also proactive in anticipating aspects we had not even considered. This ability to anticipate and exceed our expectations demonstrates their commitment and professionalism.”
Queralt Caus (R&D manager, Loopdx) and Enrique Hernández (CEO, Loopdx)
AWARDS OR RECOGNITIONS
The company has received 2.25 million euros from European Next Generation funds and 100,000 euros from Capital Cell.
The first Western European start-up to participate in the HWildCatters programme, Dallas (USA).