Histamine Quick Test
Biohymed NMI

Industrial Design for Research and Development

Defortec is partner in a development project that puts histamine quick tests on a new analytical and user-friendly basis. The core of the project is a small device that enables people with histamine intolerance to test food for its current histamine content independently and safely.

The tool which is intended to be a single-use product is based on a new test procedure developed by the NMI (Natural and Medical Sciences Institute at the University of Tübingen). The procedure is capable of analyzing liquid as well as solid food in just a few minutes and outputs a semi-quantitative result by color code. This means that histamine tests could theoretically also be used outside the laboratory in everyday life.

Histamine intolerance - a very common diagnosis

Histamine is found in numerous foods such as fish, cheese or wine. The histamine content fluctuates depending on the freshness or degree of ripeness of the food. Histamine is regarded as a mediator substance for allergic reactions and also plays an important role in immune defence. The substance is broken down by enzymes in the intestines but this process can be disrupted so that too much histamine accumulates in the body. The consequences are digestive problems, itching, headaches, cardiac arrhythmia and other, sometimes chronic reactions. Around three percent of people worldwide are said to suffer from histamine intolerance, i.e. around a quarter of a billion people. In Germany alone, about two million people have to do without numerous foods.

From process design to product design

Defortec first analyzed the test process and divided it into logical individual steps starting with sampling and ending with the visualization of the result. This was the only way to reduce complexity and transfer the process into a miniaturized product. The actual development took place in extensive series of tests in which the CAD designs were converted into real, verifiable models using 3D printing. In particular the sampling and the mixing process with the digestion solution had to be repeatedly tested and refined on the real model. At the end of the day the process design and the functional sequences and usability were initially the main focus of defortec's activities. The actual product design was then derived from these findings.

Design Thinking defines the Use Case

At the very beginning, before the definitive development work started defortec invited all project partners to a Design Thinking Workshop which first defined the target group, their expectations and the use case. Thus, the test is aimed primarily at private individuals who expect the easiest possible handling and low costs. defortec wanted to defuse the waste problem of the disposable product by using biodegradable plastics. However, during the research it was discovered that the idea was only available in a limited range of materials. In short, this aspect has not been conclusively resolved by the end of the project, and the dimensions of the prototypes currently undergoing testing can also be further optimized.

Miniaturized product concept

Defortec's product concept is based on a slim cylinder. Extensive shape and ergonomic studies led to this configuration: at the tip the sample is taken, sucked or punched, then rotated to grind and mixed with the digestion solution. A few minutes later a line image appears on the integrated Lateral Flow Test (LFA) strip, providing information on the histamine concentration. The design concept thus visualizes the linear test sequence starting at the tip and ending with the result display at the other end. Gripping surfaces accentuated with nubs contribute to the intuitive handling.

The prototype designed by defortec is very detailed and already optimized for mass production using injection molding. The start of production however has not yet been determined; this would be the task in the next project phase. At the moment the NMI is working on testing - but with simpler devices made of stainless steel that can be reused several times in the laboratory as part of extensive process test series.

Research project with a concrete goal

The research project, completed in 2019, was funded by the German Federal Ministry of Economics and Technology under its Central Investment Program for Medium-Sized Enterprises (ZIM). Partners were the NMI, Contexo GmbH and defortec. While Contexo was to take care of the series production aspects, defortec focused on industrial design, reviewing ergonomics, materials, production aspects and of course the product design.

The defortec services at a glance

  • design-thinking workshop
  • process and functional analysis
  • process optimization
  • design concept with functionality testing
  • cooperation with an interdisciplinary project team
  • material research
  • testing ergonomics and functionality
  • prototyping