Innovative screening test for allergy diagnostics

The prick test is the most popular allergy test method. Although efficient, it is anything but pleasant. An innovative life science company wanted to change this and, together with RoweMed, developed a novel screening test for allergy diagnostics.

Case study allergy test

The prick test is the most popular allergy test method. Its name already announces what happens: "Prick" means "sting." The doctor drips solutions containing allergens onto the skin and pricks or scars them slightly. The liquid gets into the skin and triggers a skin reaction in the case of an allergy. If you are not allergic to a substance, nothing happens at the corresponding part of the skin. Patients thus receive definite proof of their allergies.

Although efficient, this procedure is anything but pleasant. An innovative life science company wanted to change this and developed a novel screening test for allergy diagnostics to replace the unpleasant prick test.

In this case, no mature product was available. With the support of RoweMed, the customer wanted to develop housing for the allergy test.

 

The application

The new allergy test should make it possible to make an initial statement about the presence of an allergy and even its severity in a simple way using a single drop of blood. And this with maximum protection for the patient.

  • First, a drop of blood is taken from the fingertip.
  • This is inserted into the housing with a syringe and strongly diluted in several rinsing processes.
  • With the help of special test strips, the blood reacts and translates into an optical signal: allergy yes or no?

 

Scope of the project

As an expert for the development and production of medical plastic products, RoweMed focused primarily on the development of the housing and not on the core of the medical product (in this case the reaction of the blood with the test strip and the translation into an optical signal).

RoweMed supported its customers in the process flow and in understanding the required parameters (pressure, temperature, flow, etc.) to advance the optimization of the product efficiently. In the present case, there were some special requirements to be considered for housing.

 

The requirements for the housing:

  • Biocompatible plastic housing
  • Complex and precise internal fluidics; a controlled and precise distribution of the liquids in the housing was required
  • High demands on tightness and pressure resistance
  • Safe disposal of residual liquids
  • Reliable reading of the test result
  • Good usability, self-explanatory handling, later automation should already be taken into account
  • High-quality optics / design

 

Finding a solution - from the hand-drawn sketch to the series product

In concrete terms, the following steps were taken from the hand-drawn sketch to the finished series product:

  • Development of molded parts /optimization of molded parts
  • Choice of materials
  • Development of the production technology for the joining of the housing parts
  • Development of a packaging concept
  • Accompanying documentation (For every series production, extensive accompanying documentation is required, such as drawings, manufacturing and testing instructions, documents for incoming goods inspection and in-process controls, etc.)

 

The individual steps:

1.

 

Concept development

The starting point is the product idea (hand sketch, hand model, etc.)

Understanding the customer's wishes and drawing up a specification sheet

2. Product design

Development and optimization of individual part geometries

Developing partial solutions, drafting drawings and creating images

Testing the function and interplay for the joining of the housing parts

Consideration of aspects such as design, handling/usability but also production-oriented design

CAD design

3. Prototyping

First, a simple prototype is created

In the further course of the project, additional prototype phases take place, which becomes more and more similar to the desired end product.

In this way, functional prototypes consisting of individual parts are assembled to form a complete solution.

4. Material selection

Consideration of aspects such as biocompatibility, chemical resistance, and processability

5. Development of production technology

Examine alternative technologies (in this case, bonding vs. welding vs. mechanical joining).

Validation of manufacturing processes

6. Product qualification

aging tests

Clinical Evaluation

Preparatory work for product approval

documentation

7. Investment

Design, manufacture and qualify tools and equipment

e.g., injection molding tools, welding equipment, assembly devices

8. Development of a packaging concept

Individual packaging (primary packaging)

Secondary packaging (cardboard boxes, pallets, etc.)

Packaging validation, transport validation

product labeling

9. Introduction to series production

For each series production, a comprehensive system of processes is developed with the corresponding documentation (drawings, manufacturing and testing instructions, documents for incoming goods inspection and in-process controls, etc.).

Including the associated process validation

Create production documents, define test processes, etc.

 

The individual project steps are closely interlinked.

Within the entire development process, there were numerous redesign loops, which made it necessary to jump back to project phases that had already been completed.

All project steps include the creation and maintenance of the detailed accompanying project and product documentation.

 

Series production: Evolution vs. development

Even if the product has been transferred to series production, the development process is not complete. With increasing experience in manufacturing and, above all, application, there are usually numerous starting points for product changes. In many projects, this is a continuous process of adapting the product to the requirements of the market, which can be described as evolution.

The potential need for continuous further development of the product should be considered in every project from the beginning. What is the probability that the product will be significantly changed after a short time? Or is there a need for continuous no optimization? Such possible changes should already be taken into account when making investment decisions in the required production technology.

For example, molded part changes have a severe impact on the topic of injection molding production. Depending on the change, costly tool changes or new investments may become necessary.

Another example is product packaging. Among other things, packaging changes have an impact on the topic of sterilization. Under certain circumstances, a change in packaging may require a new validation of the sterilization process. Material changes also frequently occur. Material changes, in turn, affect technical product characteristics, chemical resistance, and biocompatibility.

The evolution of a product is therefore not only about developing a product, but also about continually optimizing, adapting, and further developing it. This working method requires a high degree of efficiency and is carried out in close cooperation with the customer and coordination with the application. This is precisely what RoweMed AG - Medical 4 Life specializes in constant optimization, creation of variants, further systematic development, EVOLUTION.

Do you also have a project that you would like to implement from the idea to series production? Then rely on a strong partner who supports you in the continuous optimization process of a medical product. With RoweMed you have a partner at your side who offers practical problem solutions worldwide for the MedTech, Pharma and Biotech sectors.

 

 

 

 

 

Further info
Service groups:
Engineering, data generation
    Product development

Your contact person for this showcase
Image of  Dr. Dirk Forberger

Dr. Dirk Forberger

RoweMed AG - Medical 4 Life

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