Roth Plastic Technology develops design for medical device
The suction handle with its removable filter made of synthetic bone substitute helps the bone to heal itself. During the surgery, the filter is moistened and activated using the patient's own regenerative tissue components. The surgeon can then use it to treat bone defects.
Objectives of the medical device design
In addition to the appearance, another major factor when developing the design of the BoneFlo was the feel of the device while avoiding uncomfortable shapes. The instrument must be simple to use and provide a secure, stable grip to support doctors as they need during everyday surgical operations. Thanks to an intense exchange of knowledge with TissueFlow, the product designers at Roth Plastic Technology in Dautphetal-Wolfgruben drafted the shape of the medical device up to the 3D printing process to produce the design sample. Sebastian Herrmann, manager at Roth Plastic Technology, emphasised: "The instrument should provide the greatest medical benefits and also be able to stand up to the demands of everyday clinical use and use with patients." Another factor of the development order was consultation about the material selection for manufacture using the efficient injection moulding process. The suction handle consists of five components made of polymethyl methacrylate (PMMA). Each element of the assembly had to be designed in accordance with the plastic and the tools. In addition to the injection behaviour, the deformation of the shape must be taken into account during this process. By carrying out simulations, Roth Plastic Technology was able to determine the flow properties of the PMMA during the injection moulding process in the steel tool. This method of calculation also reveals possible changes in the shape after the material cools, such as shrinkage, which would have an effect on the dimensions and usability of the product. Therefore, the filter used inside the suction handle can be made of either plastic or ceramic (bone substitute material). For this component change interface, it is very important for the housing to be designed and manufactured to fit the threaded part precisely.
"Development work with our partners is one of our strengths. We rely on the expertise of our specialist departments and our partner network in all areas that deal with plastics processing. With the BoneFlo for example, we have demonstrated that we are a competent partner for developing plastic products for many different industries, including the design, engineering, simulation and sample preparation for entire assemblies", explained Sebastian Herrmann.
From innovation to market approval
The development of the BoneFlo suction handle with integrated bone substitute is based on the scientific pre-work of a research team at the University of Duisburg-Essen. For the first time, they succeeded in verifying the great regeneration potential of the body's own cell-tissue mixture (such as small bone fragments, bone marrow components, fatty tissue, blood). This material is captured during operations on the bone and can be returned to the patient. The Essen University Hospital and the University of Duisburg-Essen were involved in the development.
The working group of the Professorship for Orthopaedics and Trauma Surgery in the Medical Department of the University of Duisburg-Essen includes Professor Dr Marcus Jäger, M.D. (mentor), Dr Marcel Haversath, M.D. (founder) and Dr André Busch, M.D. (spokesperson for the founder team).
The BoneFlo is a product created by TissueFlow, which was founded in 2019. The company's founders, headed by Professor Dr Marcus Jäger, M.D., want to shepherd the product to its market approval. Their medical device has received funding from the state of North Rhine-Westphalia and the European Union. The BoneFlo project saw success as one of eleven winners of the North Rhine-Westphalian "START-UP-Hochschul-Ausgründungen" competition, a company spin-off competition among universities of applied sciences. The programme supports potential company founders from universities of applied sciences in North Rhine-Westphalia on their way to entrepreneurial independence.
For more information, please visit websites of manufacturer and University Duisburg-Essen.
The development of the BoneFlo was subsidised by funding from the European Regional Development Fund (ERDF).