Uncertainties regarding the appropriate choice of materials, e.g., for the alloy
Unforeseen delays in the development and manufacturing process
Lengthy prototype testing
Vague predictions regarding how long resorbable implants will maintain stability in the body
A strenuous validation process until the implant is finally approved
Clarity and certainty that you have chosen the best materials
Continuous development and manufacturing in one go
Fast and valid results from prototype testing
Clear predictability
Implant approval without documentation chaos
Dr. Frank Feyerabend has been a lecturer at the Technical University of Hamburg for over 13 years. He has published his research on resorbable magnesium implants in over 100 different publications. His design, material selection, and development of a magnesium stent have also already received two patents. Thanks to his many years of medical research work, he is your ideal expert on resorbable magnesium implants as a Consultant Medical Devices at invenio Healthcare Solutions.
No trial and error, but rather solid knowledge will lead you to safe, reliable, and approved products that will actually be used.
We look at the big picture and, in addition to our expert in resorbable magnesium implants, we also offer further expertise as well as in-house testing facilities and workshops at invenio AG.
We involve medical professionals right from the start, ensuring that your implant can ultimately be used by doctors without the need for extensive training.
The use of resorbable implants shortens hospitalization time – a factor that contributes to relief on many levels in times of nursing shortages and bed shortages.
The choice of material depends primarily on the forces that need to be absorbed in the body. This determines how strong the magnesium needs to be and how long the implant's supportive function is required. Another very important factor is how the magnesium behaves when it is broken down in the body. Depending on the properties derived from this analysis, the magnesium is combined with other alloying elements.
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The design process for resorbable magnesium implants is relatively complex: among other things, the location where the implant will be used must be carefully considered. It is also possible to transfer designs from existing implants, but the material plays a key role here. This is because a resorbable implant made of magnesium may look different from one made of titanium, even though they are used in the same location. Key questions in this development step also include whether a design is feasible at all and whether it can be implanted by the doctor without having to rethink the procedure.
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When testing prototypes, we distinguish between testing mechanical properties and biological compatibility. In order to thoroughly test the mechanics, we perform tensile tests on a specified mixture of magnesium and alloying elements. These are then exposed to various forces and environments, and their behavior is analyzed in detail.
When testing biological compatibility, an environment that is as close as possible to the corresponding location in the body is required. These environments are developed in the test laboratory. The exact details of these tests remain the property of the manufacturer upon request.
After testing, you will receive a complete plan for the production process of your resorbable magnesium implant.
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Proof that the implant functions perfectly and is safe in the intended location must be provided in order to bring your resorbable implant to market and support patients in the healing process. We support you in this step with both planning the validation and conducting the necessary tests. For this purpose, invenio has its own test laboratory, including a workshop, so that test devices can be quickly and individually adapted. Smaller companies in particular often find it difficult to be familiar with and comply with all regulations on a global level. But this should not prevent you from developing your product, because we provide this expertise. Another challenge is that some countries have different requirements for how validation should be carried out. In some cases, animal testing is mandatory. We ourselves are very interested in enabling safe alternatives to animal testing and are continuously conducting research in this area.
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Upscaling from small-scale prototype production to larger quantities is no small feat. We analyze the process and advise you on the implementation of the manufacture of your resorbable magnesium implant. Here in particular, clean work steps are extremely important in two senses. Furthermore, there are adjustment screws that can be used to optimize production, for example, the temperature or speed in the casting process.
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invenio Healthcare Solutions GmbH applies its core expertise as an interface between engineering and the life sciences in the life sciences industry. Our aim is to help shape the future with targeted, intelligent solutions in the field of healthcare, thereby significantly improving the quality of life for everyone. The invenio company bridges the gap between process expertise, compliance, and innovations from technologies such as artificial intelligence. Many customers appreciate our pragmatic approaches, which nevertheless meet all requirements. We look forward to cooperative collaboration, enjoying the project, and achieving good and fast results.
Dr. Frank Feyerabend and Stephan Drozniak
Resorbable implants – unlike those made of titanium, for example – only replace bone parts until the gap is closed and the bone is completely healed, as they slowly dissolve in the body. This eliminates the need for stressful implant removal and the associated complications for patients. They are used, for example, as screws or pins for fixing bones or tissue. In order to benefit from the advantages of resorbable implants in all areas of medicine, invenio Healthcare Solutions is strongly committed to the research and development of innovative implants.
Thanks to its inherent properties and strength, magnesium is best suited for resorbable implants. Many resorbable materials are not suitable for bone replacement, for example, because they do not provide the necessary stability. Magnesium does provide this stability – studies now show a complete, very high healing rate. It is important to use high-quality magnesium and the right alloy in the manufacturing process. invenio therefore carefully checks the requirements for the implant in order to find the most suitable material and involves a medical professional from the outset.
How quickly a magnesium implant dissolves depends on where it is used in the body, the necessary healing time, and the alloy selected. It is essential to define, depending on the type of application, what forces act on the implant and how stable it must be as a result. invenio therefore tests not only mechanical properties in the laboratory, but also the degradation rate of the implant in an environment that is as close as possible to the corresponding location in the body.
Alloy systems that mainly contain substances found naturally in the body are particularly suitable. Microalloys are also used, which contain only very small amounts of foreign matter in order to avoid side effects. At invenio, we work with established and comprehensively tested systems such as WE43 and E11.
Appropriate tests during development can be used to predict what is happening in the body and how the material is being broken down. Imaging methods are also used during resorption.
In vitro tests that simulate accelerated degradation and correlate with actual degradation in the body are particularly suitable for this purpose.