Real-Life Case Studies Linked to the Biomedical Domain

Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 1 Internal BIOMEDIX Erasmus+ strategic partnership for Higher Education Biomedical Innovations through Digital Transformation Chapter 8: Real-Life Case Studies Linked to the Biomedical Domain Project Title Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange KA220-HED-AA8A896B Output Development and Publication of an e-Book on Biomedical Innovations through Digital Transformation Module Chapter 8 Real-Life Case Studies Linked to the Biomedical Domain Date of Delivery 30.06.2025 Authors Giulia ROSELLINI, Raphael LICHTNECKER, Razvan PACURAR, Nikola VITKOVIC, Johanna BRUCKHUBER, Radu POPA, Filip GÓRSKI Case study authors Andrea Lorenz, Laszlo Jaksa, Othniel James Aryeetey, Gernot Kronreif, Dieter Pahr, Marion Koegler, Ivana Llobet, Julien Barthès, Célia Halimi, Céline Paoli, Spela Breceljnik Version V1 This chapter is accompanied with Augmented Reality applications, for Android devices (cellphones and tablets). Use the attached QR codes to download them. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 2 Internal Contents 1 Introduction ............................................................................................................................. 3 2 Case Studies by Materialise ..................................................................................................... 4 2.1 The Power of Engineering on Anatomy ................................................................... 4 Image Processing Software .................................................................................... 5 2.2 Case Study 1 – Double Outlet Right Ventricle (DORV) ........................................... 9 Introduction to Congenital Heart Defects (CHDs) and Double Outlet Right Ventricle (DORV) ................................................................................................................. 9 The Role of 3D Modeling in DORV Management ................................................. 10 Workflow .............................................................................................................. 10 2.3 Case Study 2 – Mandible Reconstruction with Fibula ........................................... 16 Introduction to Mandible Reconstruction ............................................................ 16 The Role of 3D Modeling in Mandibular Reconstruction ..................................... 16 Workflow .............................................................................................................. 16 3 Case Studies by ViscoTec ....................................................................................................... 24 3.1 Upand Downtuning of silicone-based materials for the 3D-printing of realistic anatomical models using a custom multi-material extrusion 3D-printer ............................................. 24 Background information ....................................................................................... 24 Methodology (step-by-step process) ................................................................... 25 Outcomes/Results ................................................................................................ 28 Lessons Learned / Resume ................................................................................... 30 3.2 Innovating for Comfort: The Potential of 3D-Printed Silicone in Ostomy Care .... 32 Background information ....................................................................................... 32 Methodology (step-by-step process) ................................................................... 33 Outcomes/Results ................................................................................................ 35 Lessons learned / Resume .................................................................................... 36 3.3 3D Printed Models of Aortic Aneurysms for Endoprosthesis Evaluation in Endovascular Surgery ............................................................................................................................ 39 Background information ....................................................................................... 39 Methodology ........................................................................................................ 41 Case Study Outcomes ........................................................................................... 43 Conclusion ............................................................................................................ 46 4 Conclusions ............................................................................................................................ 49 4.1 Lessons Learned and Best Practices ...................................................................... 49 4.2 Future Outlook ...................................................................................................... 50 4.3 Summary................................................................................................................ 50 5 References ............................................................................................................................. 52 5.1 Materialise ............................................................................................................. 52 5.2 ViscoTec ................................................................................................................. 52 Appendix 1 – AR application markers ............................................................................................. 55 Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 3 Internal 1 Introduction This chapter brings the concepts, methods, and technologies explored throughout the ebook into a practical context by presenting real-life case studies from the biomedical field. Drawing on the industrial expertise of BIOMEDIX project partners — Materialise and ViscoTec Pumpen in collaboration with the educational institutions — it showcases how additive manufacturing (AM), artificial intelligence (AI), smart biomaterials and immersive technologies are being successfully implemented to address clinical challenges and improve patient care. These examples illustrate how advanced engineering, digital tools and innovative materials converge to produce tangible results, bridging the gap between academic research and industrial practice. Through detailed accounts of collaborative projects with healthcare professionals and universities, the chapter demonstrates how theoretical knowledge is transformed into concrete medical solutions, by reinforcing the core ideas developed in previous chapters, showing their relevance and adaptability in varied medical scenarios. The case studies presented in this e-book chapter covers a spectrum of biomedical applications — from personalized surgical planning and patient-specific implant design to the development of realistic anatomical models and innovative medical devices. Each example is the result of close interaction between engineers, clinicians, and researchers, where the ability to combine domain knowledge with cutting-edge digital tools proved essential to achieving optimal results. By presenting these implementations step by step, the chapter of the e-book emphasizes the importance of a multidisciplinary approach in turning complex healthcare needs into feasible, manufacturable and regulatory-compliant solutions. The challenges encountered along the way — whether related to material selection, design optimization or clinical integration — are discussed not as obstacles, but as opportunities to innovate and refine processes. Ultimately, the aim of this w-book chapter is to illustrate how multidisciplinary expertise, coupled with state-of-the-art manufacturing and design technologies can drive innovation from concept to clinical impact. These real-world stories serve as both inspiration and guidance, offering readers a deeper understanding of how digital transformation in biomedical engineering translates into improved healthcare outcomes. In doing so, they reaffirm the central message of this e-book: that collaboration between academia, industry and the medical community is essential for creating meaningful and sustainable advances in patient care. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 4 Internal 2 Case Studies by Materialise 2.1 The Power of Engineering on Anatomy In the rapidly evolving field of biomedical engineering, digital transformation has revolutionized how medical devices are thought, designed and produced. Personalized medicine, which tailors treatment to the individual patient, is increasingly recognized as a superior approach to standard one-size-fits-all solutions. The key enablers of this transformation are essentially two technologies: the first one is the ability to dispose of an image processing software that allows to use as an input the patient’s anatomy, the second one is to be able to produce unique personalized devices in a safe and viable way via additive manufacturing. Given the present slate of medical devices on today’s market, the overwhelming majority of children born in the 21st century will likely benefit from a personalized treatment. Based on current trends and data, it is foreseen that 75% of these children will receive a personalized medical device at some point during their lifetime (Materialise 2020). Some device treatments, such as surgical guides or orthodontic aligners, have been widely adopted since their introduction less than 20 years ago. Others, such as 3D-printed hearing aids, took just under three years to transform an entire industry. Other devices are experiencing consistently higher rates of adoption, such as cranio-maxillofacial implants. Many others, like sleep apnea devices, are still in the early stages of personalization. Figure 1: This graph represents the cumulative chance of receiving treatment with a personalized medical device over the course of a lifetime as it is expected to be in 2050 (this means a 20-year-old in 2050 will have a >30% chance, while an 80year-old will have a >75% chance). Personalized medical devices that have been taken into account for this projection are taken in the field of orthopedics (orthotics, implants, guides), dentistry (aligners, implants, guides), craniomaxillofacial surgery (implants, guides), otorhinolaryngology (hearing aids, sleep apnea), oncology (guides, implants), and cardiology (valves, stent grafts). Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 5 Internal Image Processing Software By leveraging software tools such as Materialise Mimics, engineers and clinicians can translate medical imaging data into actionable 3D models, fostering innovation in medical device development and personalized treatments. The software enables the segmentation of medical imaging data, allowing for the precise reconstruction of patient anatomy. Just to provide some examples, the virtual 3D model of the patient can be used in multiple ways as: • Preoperative surgical planning: to help surgeons analyze complex anatomical structures and plan procedures in advance. • Anatomical model design: to represent a portion of the body, that serves for multiple purposes as used by medical professionals, students, and researchers to study anatomy, understand medical conditions, simulate procedures, plan surgeries, or explain complex concepts to patients. Figure 2: Design of an anatomical model of the heart, which contours can be checked on the 2D images of the patient. • Patient specific implant design: the software can be used to create personalized devices that perfectly fit the patient’s anatomy. • Patient specific surgical guide design: in the same way, personalized instrumentation can be created to transfer the surgical plan into precise bone cutting and drilling. Figure 1: A personalized hip implant on the left and patient specific knee guide for total knee replacement on the right. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 6 Internal • Medical device testing and development: a virtual patient can be used as a reference for testing new medical devices and tools in a realistic environment. After virtually implanting a device, the model can be optimized for finite element analysis (FEA), computational fluid dynamics (CFD) or musculoskeletal modeling (MSM). Another option is printing an anatomical region to use it as a physical model for benchtop testing. Figure 2: Benchtop test model of an abdominal aortic aneurysm. • Statistical Shape Models (SSM) creation: as patients come in all shapes and sizes, it is important to have a deep understanding of how a target anatomy varies inside the patient’s population, in order to make sure that the size of a device we are developing covers the entire population, or that the test we are performing is representative for all the patients. Please note that the functionality for creating Statistical Shape Models (SSMs) is only available in the Research version of Materialise 3-matic. This version is not a medical device and is intended solely for research and development purposes. It must not be used for diagnosis, treatment, or any other medical purposes. Figure 3: SSM of the aortic arch: the images show how much this shape can differ in the patient population. • Surgical simulation and training: it provides a realistic model of the pathology for surgeons and students to practice procedures. • Patient education and communication: to improve the doctor-patient communication by visually explaining the condition and planned treatment. • 3D visualization: 3D printing the file to obtain physical objects is a valuable tool but not the only possible option. Advancements in technology now offer alternatives such as Virtual Reality (VR) and Augmented Reality (AR). VR provides an immersive experience, allowing surgeons and students to explore and train on the anatomy in a Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 7 Internal fully virtual environment. Meanwhile, AR holds great potential for use in the operating room, enabling surgeons to overlay the surgical plan onto the patient in real time. The workflow begins with the acquisition of Digital Imaging and Communications in Medicine (DICOM) data, typically obtained from computed tomography (CT) or magnetic resonance imaging (MRI) scans. This process involves importing the image data, segmenting the region of interest in the images, and converting the segmentation into a part. The result of image segmentation is a collection of pixels/voxels that represent a region of interest (i.e. mask) within the image dataset. Converting the segmentation into a part creates a digital 3D model that accurately approximates the size and shape of the region of interest that was segmented. This 3D model can then be visualized on the image dataset via a set of contour lines. Now the part is represented in the STL (Standard Tessellation Language) file format, that means that the part is identified by its surface broken down into small triangles, characterized by their nodes and normals. A key feature of an STL file is that the size and position of the triangles can be varied to approximate the object’s shape creating an extremely accurate approximation. Additionally, STL files are equally good at approximating basic geometric shapes as well as organic shapes making the STL file a great choice for modeling complex structures like human anatomy. Materialise 3-matic enables users to optimize the surface of the STL and to edit, create, and combine parts using a broad set of design tools. This open toolbox ensures that a wide range of shapes can be designed, often with more than one method available. Once the design is completed the part can be exported to be printed or visualized in AR/VR environment. In the next chapters some case studies will be presented to show how the theory till here explained can change the life of real patients. Any references made in this chapter to the design of medical devices or surgical planning specifically relate to the use of Materialise Mimics Core Medical and Materialise 3-matic Medical, both of which are medical devices intended for clinical use. Use of the Research version for any medical application falls outside its intended use and may not comply with applicable medical device regulations. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 8 Internal Figure 4: Workflow from importing medical images in the software to exporting a file to be 3D printed. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 9 Internal 2.2 Case Study 1 – Double Outlet Right Ventricle (DORV) Introduction to Congenital Heart Defects (CHDs) and Double Outlet Right Ventricle (DORV) Congenital heart defects (CHDs) are structural abnormalities of the heart present at birth, affecting nearly 1% of all live births (Hoffman 2002, Vos 2015). These conditions vary widely in complexity, from simple defects that may require no intervention to intricate malformations that necessitate advanced surgical planning and lifelong care. CHDs impact normal blood flow through the heart, and their effects depend on the type and severity of the defect. Among the more complex forms of CHDs is the Double Outlet Right Ventricle (DORV). This defect is characterized by both great arteries - the aorta and the pulmonary artery - originating predominantly from the right ventricle, instead of the left and right ventricles respectively. In most cases, DORV is accompanied by a Ventricular Septal Defect (VSD), which is a hole in the septum separating the left and right ventricles. The combination of these anomalies allows oxygen-poor and oxygen-rich blood to mix, placing significant strain on the heart as it struggles to supply oxygenated blood to the body. Without intervention, this condition can lead to severe complications, including heart failure. Figure 5: A normal heart against one with double outlet right ventricle. Reprinted from Double Outlet Right Ventricle (DORV), In Boston Children’s Hospital, March 2025, from https://www.childrenshospital.org/conditions/dorv#:~:text=What%20is%20double%20outlet%20right,connect%20to%20th e%20right%20ventricle DORV is a highly variable defect, with the exact configuration of the great arteries, ventricles, and VSD differing significantly between patients. This variability presents a unique challenge for treatment, as no two DORV cases are identical. Surgical intervention is typically required early in life to correct the defect and restore normal circulation. Two of the most common surgical strategies for DORV are: • Intraventricular Repair: A baffle or patch is created to redirect blood flow from the left ventricle through the VSD to the aorta, effectively separating the oxygenated and deoxygenated blood. • Arterial Switch Operation: The positions of the aorta and pulmonary artery are surgically reversed to restore their correct connections to the left and right ventricles, respectively. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 16 Internal 2.3 Case Study 2 – Mandible Reconstruction with Fibula Introduction to Mandible Reconstruction Mandibular reconstruction is a complex surgical procedure performed to restore the form and function of the mandible (lower jaw) following defects caused by trauma, tumors, infections, congenital abnormalities, or surgical resections. Clinically, these defects can lead to significant functional impairments, including difficulty in speaking, chewing, and swallowing, as well as aesthetic concerns that may affect the patient's quality of life. The primary goal of mandibular reconstruction is to restore both the structural integrity and the functional capabilities of the jaw, often involving a combination of surgical techniques, bone grafts, and implants. Due to the complex nature of such cases, a multi-disciplinary clinical team approach is critical for reconstructive success and optimal patient outcomes (Vincent 2025). Virtual pre-operative planning can assist surgeons to visualize the anatomy and pathology in 3D, simulate different resections and reconstructive options and then, decide on the ideal approach to optimize functional and aesthetic outcomes. One of the most commonly used techniques to reconstruct the mandible is the fibula free flap (FFF). This procedure involves harvesting a segment of the fibula bone along with its associated blood vessels and soft tissue, and then transplanting it to the mandibular site (Taqi 2024). The fibula is often the preferred autograft due to its length, vascular supply, and cortical structure, making it ideal for osseointegration and dental rehabilitation. In some cases, the surgeon may opt to harvest the autograft from alternative donor sites, such as the scapula or the iliac crest. Regardless of the graft's origin, a plate is required to stabilize the bony segments. While standard plates are available in the market, a patient-specific plate can be pre-planned to minimize surgical time and maximize the accuracy of bony positioning intra-operatively (Vincent 2025). The Role of 3D Modeling in Mandibular Reconstruction Advancements in 3D modeling and digital planning have revolutionized mandibular reconstruction by improving precision, reducing surgical time, and enhancing patient outcomes. By utilizing medical imaging and segmentation tools, surgeons can create a virtual representation of the patient’s anatomy, plan osteotomies, and design patient-specific surgical guides and implants. The integration of 3D printing further allows for the fabrication of customized titanium reconstruction plates and cutting guides, optimizing the fit and stability of the reconstructed mandible. Workflow Below is a real case example of mandibular reconstruction using a fibula free flap, kindly shared by Rigshospitalet in Copenhagen, where the patient was treated. The preoperative model shows the presence of a mandibular tumor. The proposed reconstruction approach involves using fibula segments in combination with a 3D-printed porous titanium implant. The following workflow guides through the necessary steps to perform the surgical planning, including the osteotomies and the positioning of the fibula segments to replace the Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 17 Internal missing part of the mandible, and the design of cutting guides for both the mandible and the tibia, as well as the implant and the anatomical model. As previously mentioned, the choice of surgical techniques and devices depends on the specific case and the surgeon’s preference. This example represents one of many possible reconstruction strategies, each tailored to achieve the best possible outcome for the patient. Figure 12: Pre-op and post-op models of the patient treated with mandible reconstruction 1. Import and Segmentation of Imaging Data: The first step is to import the patient's DICOM files into medical imaging segmentation software, as Materialise Mimics Core Medical. Segmentation can be performed manually, using thresholding and editing to isolate specific anatomical structures based on their grayscale values, or through AI-assisted automatic segmentation for greater efficiency. After segmentation, 3D models of key anatomical structures – including the skull and the mandible, next to the fibula, the tibia and surrounding vasculature – are generated and refined. These models provide a comprehensive visualization of the patient's anatomy, allowing engineers and surgeons to assess the reconstruction approach and plan the next steps. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 18 Internal Figure 13: Above: isometric view of the skull and the mandible. Below: lateral view of the tibia and the fibula with surrounding vasculature. 2. Planning the osteotomies Focusing on the mandible isolated, osteotomy planes are defined to determine the area to be resected. A virtual resection is performed to simulate the surgical removal of the affected bone, ensuring precise planning of the reconstruction. Figure 14: In red the surgical plan of the resection. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 19 Internal 3. Defining a reference for reconstruction To achieve an accurate anatomical restoration, it is recommended to define a reference anatomy that will serve as a guide while positioning the fibula segments. There are two common approaches: • Mirroring the contralateral healthy side of the mandible to generate a symmetric template. • Using the pre-resection shape as a reference to replicate the patient’s original mandibular anatomy. Figure 15: In yellow the mirrored mandible, overlapped to the pre-resection mandible. 4. Positioning the fibula segments The next step is planning the placement of fibula segments to reconstruct the mandible. During this step, it is decided whether to use: • One, two or multiple segments of the fibula in series, depending on the defect’s complexity. • Single-bar or double-bar configurations (parallel fibula segments for additional support). As these decisions are clinical, engineers must work closely with surgeons to determine the optimal approach. The fibula model is duplicated as many times as the segments, and each of them is accurately positioned to achieve the best anatomical and functional fit. Once finalized, the osteotomy planes for the fibula are defined. Figure 16: Left: frontal view of the reconstruction with the fibula segments. Right: bottom view of the reconstruction with the pre-resection model overlapped as reference. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 20 Internal Dental implant positions can also be planned in advance to ensure seamless integration of prosthetic rehabilitation into the reconstruction. This involves aligning the implants with the opposing teeth to achieve proper occlusion and facilitate effective chewing. Figure 17: In blue the position of the dental implants. 5. Design of the implant To stabilize the fibula segments and improve mandibular contour, a custom implant is designed based on the newly reconstructed anatomy of the patient. The design process includes: • Defining the implant volume, again with the help of a reference as the mirrored healthy side or the pre-resection anatomy. • Incorporating a lattice structure within the implant volume by the repetition of a unit cell. It is possible to conform the distribution of the unit cells to the surface of the implant to result on a smooth homogeneous surface and avoid cutting unit cells in portions. The lattice structure offers several advantages over a solid design such as to reduce weight, promote bone ingrowth, and improve biomechanical properties. • Determining screw fixation points and directions, ensuring secure attachment of the implant to both the fibula and remaining mandible. Figure 18: Design of the plant and fixation screws. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 21 Internal 6. Design of the mandible cutting guides To ensure precise osteotomies, patient-specific cutting guides are designed for the mandible. These guides incorporate: • A baseplate that fits stably the guide on the bone. • Functional elements as the flanges, to guide the saw blade during cutting, and the drill holes, to predefine the locations of fixation screws. The cutting guides can also be lightened using a lattice structure, maintaining strength while reducing material usage. Figure 19: Frontal and later views of the mandible with the cutting guides. 7. Design of the fibula cutting guide Similarly, a fibula cutting guide is designed based on the planned osteotomy planes. The guide ensures an accurate segmentation of the fibula for precise reconstruction and a stable positioning on the fibula to improve surgical execution. The same design principles used for the mandibular cutting guide apply here, ensuring structural stability and precise cutting. Figure 20: Lateral and anterior view of the fibula cutting guide. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 22 Internal 8. Design of the anatomical model Optionally, a physical anatomical model of the planned reconstruction can be 3D printed. Surgeons may use this model as a visual and tactile reference during surgery, aiding intraoperative guidance. Figure 21: Anatomical model: its transparency allows you to view the roots of the teeth and the nerve canals. 9. Manufacturing and post-processing Each surgical component is manufactured using additive manufacturing (AM), with different materials and processes defined according to their requirements: • Mandibular implant and cutting guides o Material: Titanium o 3D Printing Process: Selective Laser Melting (SLM). This AM process builds the object melting the metal power layer by layer with a high-energy laser. This technology allows printing the porous design directly integrated into the implant design. o Post-Processing: after the production of the parts, these must undergo several postprocessing steps before they are usable in the operating room. Some of these steps include: ▪ Reaming of the features as screw holes and fixation interfaces to ensure precise tolerances. ▪ Anodizing: this surface treatment enhances the oxide layer of titanium, improving durability and corrosion resistance. ▪ Marking: each device must be marked with the essential information to ensure traceability and compliance with regulatory requirements. In most cases, a laser marking technique is used for this purpose. • Fibula cutting guide o Material: Polyamide o 3D Printing Process: Selective Laser Sintering (SLS). Similarly to SLM, SLS uses the energy of a laser to sinter together layers of powder but without ever reaching the melting point of the material. Unfused powder remains in place to support the structure as it is being built, eliminating the need for additional support structures. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 23 Internal o Post-processing: mainly cleaning to remove all the unfused powder and quality control to ensure it meets dimensional tolerances and design specifications. • Anatomical model o Material: Acrylic resin o 3D Printing Process: Stereolithography (SLA). SLA uses a UV laser to selectively cure layers of liquid resin. The advantage of SLA technology lies in its ability to produce rigid models with varying degrees of transparency offering the possibility to incorporate marked or colored indications of internal anatomical structures. o Post-processing: Since SLA is a resin-based technology, support structures must be created during printing and later removed, followed by surface finishing. The model can also undergo additional curing to enhance its mechanical properties or colouring. Before use in surgery, all manufactured parts undergo cleaning and sterilization, following the manufacturer’s Instructions for Use (IFU). Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 24 Internal 3 Case Studies by ViscoTec 3.1 Upand Downtuning of silicone-based materials for the 3D-printing of realistic anatomical models using a custom multi-material extrusion 3D-printer Authors: Andrea Lorenz1, Laszlo Jaksa1, 3, Othniel James Aryeetey2, 3, Gernot Kronreif1, Dieter Pahr2, 3 Company/Organization: 1ACMIT Gmbh, Austrian Center for Medical Innovation and Technology, Wiener Neustadt, Austria 2Karl Landsteiner Private University of Health Sciences, Department of Anatomy and Biomechanics, Division Biomechanics, Krems, Austria 3TU Wien, Institute of Lightweight Design and Structural Biomechanics, Vienna, Austria Background information Anatomic models play an important role in medical technology and health care. In medical device development, they facilitate and accelerate the process by enabling repeatable testing, while at the same time reducing the costs as well as animal or human cadaver use (Wang, et al., 2017) (Rocchi, et al., 2023). In medical education, they have been demonstrated to improve anatomy learning compared to textbooks or virtual models and they facilitate handson training in a safe environment (Khot, et al., 2013) (Preece, et al., 2013). They are also increasingly used in surgical planning, enabling patient-specific preparation and intraoperative orientation, reducing operation time and error rate, increasing patient safety (Betancourt, et al., 2023) (Pugliese, et al., 2018). Traditionally, most simple anatomical models are mass-produced from hard plastics using injection molding and a generic, standardized anatomy [ (Kurt, et al., 2013) (Cooper & Taqueti, 2008). More advanced models are only using the hard plastics for mimicking hard tissue like bones and combine those with soft materials, mostly from rubbers which are processed via casting for mimicking soft tissues. These commercial models are widely used in medical device development and training, but they come with some distinct limitations. First, they are mostly replicating simplified, standardized anatomy, not taking into account patient-specific variations. This can be a particular problem with regard to surgical planning models, where such models are not suitable for. However, with 3D-printing becoming available for the mainstream within the last decade (Ngo, et al., 2018), this new technology offers a solution for the reproduction of patient-specific anatomy, which can be segmented from medical images (Nikitichev, et al., 2018) (Waran, et al., 2014). In addition to the geometric restrictions, in most commercial models the major limiting factor is the representation of their mechanical properties, in particular with regard to soft Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 25 Internal tissue (Wang, et al., 2016; Qiu, et al., 2018). Besides the fact that many simple commercial models are completely made from hard materials, even most of the models including soft parts cannot mimic realistic viscoelastic behavior of human tissue (Ratinam, et al., 2019). While this might not be an issue for demonstration or education models, it makes a huge difference in training and surgery planning models, as the haptic feedback and tool-tissue interaction are mainly determined by viscoelastic behavior. Traditional molding materials like silicones can reach appropriate stiffness levels, but standard silicones still lack the viscosity and therefore damping behavior of human tissues (Estermann, et al., 2020). Other traditional materials as hydrogels are better compliant, but they lack long-term stability (Liu, et al., 2018). Therefore, they can only be used once directly after production or after storage under specific, moist conditions. With regard to 3D-printing, most of the available materials are much stiffer and cannot reach the toughness needed for anatomical models (Bechtel, et al., 2025). In addition, none of the 3D-printing technologies can generate the anisotropic behaviour of most human tissues, that consist of fibres, yielding material behavior with increased stiffness and strength for one preferred direction (Ratinam, et al., 2019) (Bechtel, et al., 2025). In this chapter, a new printing technology will be presented that can close the gap between the available options in 3D-printing, using traditional molding materials like silicones and providing tuning methods for upgrading the mechanical properties to be more tissue-like. In particular, a new multi-material 3D-printing method, combining extrusion 3D-printing with soft and hard materials at the same time. This enables more advanced printing methods and the option to tune the mechanical properties in two different directions: - Uptuning: Using filament fibres to increase stiffness and strength in preferred directions of the silicone base material, mimicking tissue fibres, as seen in muscle, tendons, ligaments etc. - Downtuning: Using fluid filling to lower the viscosity compared to full silicone or airfilled compounds, as it is seen in biological tissue. The development process of the printer and the two proposed tuning methods are described and pre-studies are performed to confirm the basic concepts of the material tuning, comparing the viscoelastic properties of the designed materials to those of biological tissue, i.e., samples of porcine liver and muscle. Finally, a first use-case for the Downtuning methods, i.e., the development of a realistic liver-model with improved viscoelastic and at the same time also radiologic imaging properties is presented (Jaksa, et al., 2021) (Jaksa, et al., 2023) (Aryeetey, et al., 2024). Methodology (step-by-step process) 3D-printing technology A custom multi-material extrusion 3D-printer was developed for the combined printing of hard, thermoplastic filaments and soft, fluidic materials as silicones (Jaksa, et al., 2021) (Jaksa, et al., 2022). While extrusion 3D-printing of filaments is well established and known as fused filament fabrication (FFF) or also fused deposition modelling (FDM, ®Stratasys), extrusion 3Dprinting of viscous fluids, also called direct ink writing (DIW), is less known and still in its infancy. Most DIW printers consist of a pressurized material container with controllable valves Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 32 Internal 3.2 Innovating for Comfort: The Potential of 3D-Printed Silicone in Ostomy Care Figure 29: Case with Odapt: 3D-printed wafers in Ostomy Care Authors: Marion Koegler (Lynxter) [email protected], Ivana Llobet (Odapt) [email protected] Companies/Organizations: Lynxter is a French company based in Bayonne, specializing in the development and manufacturing of modular industrial 3D printers. Their focus is on providing flexible machines for additive manufacturing, supported by a network of expert developers. (https://lynxter.fr/en/) Odapt is a company developing a 3D-printed, reusable silicone wafer designed to prevent ostomy bag leaks. This customized wafer adapts to each user's anatomy and is compatible with existing pouches, aiming to improve the quality of life for ostomy patients. (Home | Odapt) ViscoTec is a German company for pump and dosing technology. Their products offer precise control over viscous and abrasive liquid materials. The additive manufacturing equipment is especially suited for liquid manufacturing (like with silicones). Web: 3D Print Heads - ViscoTec Global; Contact: Johanna.bruckhub[email protected] Background information Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 33 Internal More and more individuals are facing intestinal diseases such as inflammatory bowel disease or colon cancer often requiring ostomy surgery—an abdominal opening for waste disposal— and consequently the use of an ostomy bag. Post-surgery complications often arise, especially leakage with ostomy bags. Conditions such as colorectal cancer (10 % of all cancer cases, 1.9 million new cases in 2020) Crohn’s disease (approx. 2,3 million people in 2021) and ulcerative colitis (approx. 3 million people in 2021) often necessitate ostomy surgery, which can be temporary or permanent. Unfortunately, traditional ostomy bags have not undergone significant design updates since their invention in the 1950s. Consequently, many “ostomates” face challenges such as leaks, lack of attractiveness, skin irritation, and ballooning of the bag. Leakage is the primary concern associated with ostomy bags, affecting a staggering 99 % of ostomates at least once and 50 % frequently. The main cause of leaks lies in the lack of adaptability of the wafer—the part of the bag that attaches to the skin—to different types of stomas. Recognizing this critical issue, the Odapt project team embarked on a mission to develop a 3D printed solution that would change that issue. Addressing this problem head-on, three students from the Master’s in industrial design engineering program at Elisava Barcelona School of Design and Engineering have developed a groundbreaking solution called Odapt—a customized silicone 3D printed disc that prevents leakage in ostomy bags. Several stakeholders are involved in this project. First and foremost, the patients who are directly affected and seek better healthcare solutions. Lynxter and ViscoTec are also key stakeholders as technology suppliers. Methodology (step-by-step process) The scanning is performed through a smartphone. We prefer to keep the specific CAD steps we follow as confidential. However, we can add that we customize the pouch to fit the stoma and belly shape. By leveraging 3D printing technology, Odapt introduces a game-changing design. The key component of Odapt is a customized 3D printed disc/wafer made of biocompatible silicone (Fig. 30). Lynxter printed a variety of custom silicone wafers for Odapt using the S300X – LIQ21 | LIQ11, the Lynxter 3D silicone printer (Fig. 32, 33). This allowed them to test and enhance their solution. The disc is tailored to fit each patient’s specific stoma, ensuring a perfect and comfortable seal, thereby eliminating leaks. The technology used for Silicone 3d printing in the S300X – LIQ21 | LIQ11 is the endless piston principle (eccentric screw pump) provided by ViscoTec Pumpenu. Dosiertechnik GmbH (Fig. 321). A combination of rotor (screw-like rod) and a stator (counter-shaped rubber barrel) enables printing of low to high viscosity liquid materials. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 34 Internal Figure 30: 3D CAD of an Odapt customized wafer Figure 31: ViscoTec dosing pump This technology is specifically ideal for silicones, since the material properties of silicone can be kept. These include biocompatibility, being able to be sterilized, durability for repeated use and water resistance, which are crucial in this case. To enhance adhesion to the skin, a layer of silicone adhesive is applied. Odapt’s disc is compatible with a wide range of pouches available in the market, providing patients with flexibility and convenience. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 35 Internal Figure 32: Lynxter S300X - LIQ21 | LIQ11 printer Material selection We are using biocompatible medical-grade silicone. This is a type of silicone material that is specifically formulated and manufactured to meet the requirements used in medical and healthcare applications. It is designed to ensure safety, biocompatibility, and reliability when being in contact with the human body. The team (Mario Garcia Causapie and Ivana Llobet Leca) is currently undergoing bench testing at Stanford University in California. Outcomes/Results Using 3D printing technology to create wafers for stomas can bring several benefits for both healthcare providers and patients. Some benefits are the following: – Customization and patient-specific designs – Rapid prototyping and iteration – Cost-effectiveness for customization – Minimized waste – Complex geometries – Accessibility and remote production Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 36 Internal Figure 33: Printing a wafer on the Lynxter S300X -LIQ21 | LIQ11 printer Lessons learned / Resume Technical challenges Customization: Stoma wafers need to fit the unique contours of an individual’s body to provide a proper seal around the stoma. Silicone 3D printing allows for highly personalized and precise designs, ensuring a better fit and improved comfort for the user (Fig. 34). Biocompatibility: Silicone is a biocompatible material, is well tolerated by the human body and does not cause adverse reactions. This is especially important for a medical device that comes into direct contact with the skin, as with a stoma. Flexibility and softness: Silicone is known for its flexibility and softness. It can adapt to the body’s shape and move with the wearer, reducing the risk of skin irritation and improving overall comfort. Durability: Silicone is a durable material that can withstand repeated use without significant degradation. Water Resistance: Silicone is water-resistant, which is essential for stoma wafers, as they are exposed to bodily fluids. Sterilization: Silicone can be sterilized effectively, ensuring the safety of the wafer. Regulatory or ethical hurdles Medical Device Regulations: Since Odapt is a medical device, it must comply with strict regulatory requirements (e.g., FDA in the U.S., MDR in the EU). Approval processes can be time-consuming and costly, requiring clinical validation to prove safety and effectiveness. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 37 Internal Biocompatibility and Safety: Ensuring that the 3D-printed silicone material meets medicalgrade standards is crucial. Any risk of skin irritation, allergic reactions, or long-term effects must be thoroughly tested and certified. Data Privacy and Patient Scanning: The use of a smartphone app to scan a patient’s stoma raises concerns about data security and patient privacy. Compliance with regulations such as GDPR (EU) and HIPAA (U.S.) is necessary to protect sensitive health information. Customization vs. Standardization: Personalized medical devices challenge traditional mass-production regulatory frameworks. Defining clear guidelines for quality control and safety in customized healthcare solutions remains a hurdle. Affordability and Accessibility: While customization improves patient outcomes, it may increase costs. Ensuring that these innovations are covered by insurance or remain affordable for patients is an ethical consideration. Liability and Risk Management: In case of product failure (e.g., poor adhesion leading to leaks), determining liability—whether it's the manufacturer, healthcare provider, or patient—can be complex. Clear accountability and risk mitigation strategies are needed. Addressing these hurdles requires collaboration between regulatory bodies, healthcare professionals, and innovators to ensure safety, accessibility, and ethical use of the technology. Figure 34: Different models of Odapt wafers Silicone 3D printing allows us to customize and personalize stoma wafers. Each wafer can be designed to match perfectly in the unique contours and size of the stoma. A properly fitting stoma wafer is crucial for preventing leaks and skin irritation. The customized design made Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 38 Internal possible by 3D printing can provide an improved seal around the stoma, reducing the risk of leaks. “With these changes we are improving the quality of life of the user, giving them more confidence improving both their comfort and mental well-being.” (Fig. 34) Odapt leverages 3D-printed medical-grade silicone, a technology with broad applications beyond ostomy care. Its customization, adaptability, and precision make it well-suited for other applications such as wound dressings, prosthetics and medical wearables amongst many others. With smartphone scanning, patients could order a custom-fit wafer from home, eliminating clinic visits. Local 3D printing would enable production on demand, reducing waiting times and improving accessibility. This approach brings personalized medical care directly to patients, wherever they are. Regarding scalability, we can also specify that with more Lynxter printers and larger emptying systems from ViscoTec, the process can easily be scaled up. This case exemplifies how innovative design and advanced manufacturing technologies can address longstanding medical challenges, offering personalized solutions that significantly enhance patient care. Further research could focus on enhancing the durability and adhesion of 3D-printed silicone wafers, ensuring they provide long-lasting comfort and reliability for patients. AIdriven modeling has the potential to refine the accuracy of stoma scanning and customization, allowing for even more precise and personalized fits. Additionally, integrating this technology with telemedicine could facilitate remote patient consultations, making product adjustments more accessible and efficient. Finally, exploring alternative biocompatible materials could open new possibilities for medical applications, expanding the benefits of 3D printing to a wider range of healthcare needs. The Odapt project is continuously evolving, with ongoing efforts to refine its design and improve production efficiency. At the same time, research into 3D-printed medical wearables is expanding, particularly in the fields of prosthetics, orthotics, and other medical devices. Companies and universities are actively exploring how 3D printing technology can be leveraged to develop more adaptable and patient-specific medical solutions, further advancing personalized healthcare. 1. Traditional ostomy care products have remained largely unchanged for decades, leading to discomfort for patients. 2. The Odapt solution aims to demonstrate how 3D printing and personalized medical devices can significantly improve patient experience. 3. Silicone 3D printing offers unique advantages in flexibility, durability, and biocompatibility. 4. The integration of mobile technology allows for patient-driven customization. 5. Recognition and support from innovation awards highlight the potential impact of this approach. Odapt wafer was created to be flexible and adaptable with biocompatible silicone, combined with 3D printing precision, that could lead to better seals around the stoma, reducing the risk Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 39 Internal of leaks and providing a more secure attachment. With these changes we are improving the quality of life of the user, giving them more confidence. This issue affects many people. Thanks to this technology, many patients see their daily lives improved. With this solution Odapt provides better comfort, fit, and durability of the wafer, users may experience fewer leaks and irritation, potentially reducing hospital stays and healthcare costs. The Odapt team aims to inspire other designers and healthcare professionals to see the benefits of 3D printing and the use of biocompatible silicone in the medical field. 3.3 3D Printed Models of Aortic Aneurysms for Endoprosthesis Evaluation in Endovascular Surgery Authors: Julien Barthès – PhD (CEO and co-founder), Célia Halimi – PhD (COO), Céline Paoli (Healthcare Market Manager), Spela Breceljnik (Marketing Assistant) Companies/Organizations: 3Deus Dynamics 3Deus Dynamics, founded in 2020 and based in Rillieux-la-Pape, France, specializes in silicone additive manufacturing using its patented "Dynamic Molding" process. This innovative technique combines 3D printing and injection molding, enabling the creation of complex silicone parts without the need for support structures. The company serves industries such as healthcare, aerospace and defense, offering solutions like patient-specific anatomical models and functionalized soft composite materials. (https://3deusdynamics.com/) Background information Aortic Abdominal Aneurysms (AAA) are a high-risk condition requiring precise intervention to prevent rupture. They caused 172,427 deaths globally in 2019 (Wang, et al., 2022) Especially for complex AAAs, surgeons need precise simulation tools and advanced training to accurately visualize the vascular anatomy, assess the pathology, and plan procedures. These tools enhance pre-surgical planning by allowing precise measurements and simulations of surgical approaches, improving security and predictability. Innovative advanced 3D-printed models used in (hybrid) operating rooms allow surgeons to rehearse procedures in a controlled and realistic environment. This leads to a steeper learning curve for surgeons, more personalized treatments for patients, and optimized development of medical devices. Surgeon Training Challenges Traditional physical models, especially those made of resin, have room for improvement in terms of realism and durability. The challenge lies in developing more advanced training tools that can better withstand repeated use, while offering lifelike features and realistic haptic feedback that accurately simulates human tissue behavior. These are the features that could provide optimal surgeon preparation, reduce errors and accelerate the surgeons’ learning curve. Patient-Specific Surgical Planning While digital patient-specific simulation tools are commonly used in surgical planning, decisions about medical device placement often rely on manual haptic and proprioceptive memory. The challenge is to develop advanced patient-specific physical models with improved biomechanical realism, to validate the surgical approach, improve accuracy, and minimize patient risks. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 40 Internal Medical Device Development The development of endovascular medical devices is limited by traditional animal models, which cannot fully replicate human anatomical complexity. The challenge is to improve preclinical simulation tools to allow for more precise, patient-specific simulators, reducing risks and improving patient outcomes with better-targeted interventions. Ethical frameworks such as the 3Rs (Replacement, Reduction, and Refinement) advocate for replacing animal models with alternatives that do not cause harm to living beings, but animal models continue to be used due to regulatory requirements. While they offer some degree of procedural realism, they fall short in replicating the anatomical complexity of conditions such as AAAs. Stakeholders Patients Accurate pre-operative planning ensures optimal device fit, reducing the risk of complications and shortening recovery times. Well-fitting devices minimize the need for additional procedures, improving surgical outcomes and reducing healthcare costs. Vascular surgeons Vascular surgeons benefit from advanced tools that reduce surgery time. Patient-specific anatomical visualization enables precise planning and device placement. Realistic, immersive models accelerate trainee skill development, improving learning curves and surgical confidence. Medical Device Manufacturers Accurate models support realistic performance testing, evaluation and validation, expediting the time-to-market for new devices. This reduces reliance on in-vivo testing and streamlines the regulatory approval process with reliable pre-clinical data. These improvements lower costs and minimize risks throughout the device development lifecycle. Hospitals Hospitals can reduce costs by using precise pre-operative planning and well-fitting devices, leading to shorter surgical times and fewer post-operative complications. Realistic training tools enhance staff skill development, improving operational efficiency and resource management. Researchers Researchers are empowered by accurate, patient-specific models, accelerating innovation in surgical techniques and medical device development. The ability to test devices in realistic conditions fosters the advancement of new technologies and treatments, driving progress in healthcare solutions. Companies A diverse array of companies, including experts in 3D printing and material science such as 3Deus Dynamics, as well as manufacturers of dosing and fluid-dispensing systems like ViscoTec, are actively responding to the demand for more realistic anatomical models. These entities, among other suppliers, contribute directly or indirectly to the advancement of medical modeling technologies. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 41 Internal Methodology Solution conceptualization The design phase of advanced 3Deus Dynamics’s 3D printed anatomical models begins with 3D medical imaging, such as a CT scan, which provides the data needed to replicate the patient's anatomy and pathology. Using this data in DICOM format, an STL or STEP file is created of the anatomical region segmented, forming the foundation for 3D printing patientspecific anatomical models that precisely represent the unique details of the patient's condition and pathology (e.g. Aneurysm). “Dynamic Molding” – a new and patented additive manufacturing technique The models are manufactured using the 3Deus Dynamics patented Dynamic Molding process, seen in Fig. 35, a hybrid of 3D printing and injection molding. This innovative uses a granular medium as a dynamic, reusable mold to support the material during the printing process, ensuring that the liquid or viscous injectable material (e.g. Silicone) maintains its structural integrity while gradually hardening. The granular medium creates a "zero-gravity" effect, enabling the creation of complex geometries without the need for external support. This unique approach prevents material deformation and allows for the production of intricate shapes, making it especially well-suited for advanced anatomical model applications. To achieve this precision and control, we rely on ViscoTec Pumpenu. Dosiertechnik GmbH's cutting-edge technology, seen in Fig. 36. The core system is based on the endless piston principle, also known as the eccentric screw pump, which combines a rotor (screw-like rod) and a stator (counter-shaped rubber barrel) to continuously and precisely deliver liquid silicone into the printing process. This ensures smooth, uninterrupted material flow, enabling consistent, high-quality prints and perfect integration with the Dynamic Molding technology. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 48 Internal Collaboration with Leading Medical Institutions The partnership with Marie Lannelongue Hospital (HML) lays the scientific foundation for a clinical and technical analysis of the models, aiming to define the precise specifications for a gold-standard model. Known for handling some of the most complex and challenging cases in vascular surgery, HML’s expertise will be instrumental in advancing the realism and functionality of these models through rigorous clinical testing. Scalability and Versatility The 3Deus Dynamics patient-specific, 3D-printed silicone anatomical models are applicable across a wide range of medical specialties. This scalability is supported by ViscoTec's continuous advancements, which have evolved to meet the specific demands of 3D printing. Ongoing Development A deeper understanding of clinical needs is driving ongoing research and development. Efforts are underway to explore new materials for additional applications and functionalities. Moreover, the potential of Dynamic Molding technology is opening doors to other applications, such as the production of soft, customizable, and ISO 13485 compliant medical devices. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 49 Internal 4 Conclusions 4.1 Lessons Learned and Best Practices The case studies presented in this e-book chapter reveal valuable lessons gained from applying advanced manufacturing technologies in real-life biomedical projects. One of the most significant insights was the ability to address and overcome technical and logistical challenges that inevitably arise when transitioning from concept to clinical implementation. Whether related to material performance, device design constraints or the need for regulatory compliance, each obstacle required flexible problem-solving strategies and close coordination between partners. Collaborating directly with doctors in hospital settings proved both rewarding and demanding. Communication needed to be precise, timely, and adapted to the workflow and priorities of medical professionals, ensuring that engineering proposals aligned with clinical needs. This required a shared language between clinicians and engineers, where medical objectives and technical solutions were clearly understood by all parties. Working with patients brought its own set of lessons, especially in cases involving digitization, device design and rapid prototyping. Ensuring patient comfort, meeting individualized requirements and maintaining ethical standards in data handling were essential for creating devices that truly met user needs. The use of 3D scanning, CAD modeling and additive manufacturing enabled fast iterations, but success depended on continuous feedback from both patients and clinicians. A recurring challenge was tackling scalability and cost-efficiency in personalized medicine. While customization offers clear clinical benefits, it also demands careful resource planning, efficient manufacturing processes, and optimized design workflows to make such solutions viable beyond one-off cases. These experiences have led to the formulation of best practices for industry–academia collaboration, where joint teams can share expertise, leverage complementary resources, and align research objectives with market and healthcare realities. Finally, adapting to technological trends proved to be critical. Integrating AI-driven design assistance and immersive technologies, such as VR/AR visualization into standard CAD workflows not only improved design precision but also enhanced communication with stakeholders. These innovations are gradually becoming part of everyday biomedical engineering practice, reinforcing the importance of staying responsive to emerging tools and methods. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 50 Internal 4.2 Future Outlook Looking ahead, the pathways opened by the case studies described in this e-book chapter point toward a future where advanced biomedical engineering becomes even more deeply integrated into clinical practice. One of the most promising areas is tissue engineering and regenerative medicine, where additive manufacturing and biofabrication converge to create functional, patient-specific tissue constructs. The continued refinement of smart biomaterials, cell-friendly scaffold architectures, and controlled release systems for growth factors will make it increasingly feasible to develop implants that actively promote healing and regeneration rather than simply replacing lost function. Another important direction involves scaling personalized medicine solutions for broader access. While today’s bespoke devices often address unique and complex cases, the challenge lies in making such solutions practical for larger patient populations. Achieving this will require advances in automated design pipelines, AI-driven customization tools and streamlined manufacturing processes that maintain precision while reducing production time and cost. Broader accessibility will ensure that the benefits of personalization extend beyond specialized centers to everyday clinical environments. Strengthening networks between industry, academia, and healthcare providers will be critical to realizing these ambitions. Sustained collaboration enables faster identification of clinical needs, rapid prototyping of solutions and smoother pathways to regulatory approval and commercialization. Initiatives like the BIOMEDIX consortium can serve as anchors for such cooperation, fostering multidisciplinary teams capable of addressing both technical and medical challenges with agility. Finally, fostering innovation through shared knowledge and resources will remain a cornerstone of progress. Open exchange of expertise, data and best practices through conferences, training programs and collaborative platforms will not only accelerate technology transfer but also inspire new generations of engineers, scientists and clinicians to push the boundaries of what is possible. The future of biomedical engineering will be defined by this interplay of technology, collaboration, and vision — driving the transition from specialized case studies to scalable, transformative healthcare solutions that improve outcomes for patients worldwide. 4.3 Summary The case studies presented in this e-book chapter have illustrated how the BIOMEDIX project transforms theoretical knowledge into practical, impactful biomedical solutions. Drawing on the industrial expertise of partners such as Materialise and ViscoTec Pumpen in collaboration with educational institutions, the projects demonstrate how advanced Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 51 Internal technologies — including additive manufacturing, AI-assisted design, smart biomaterials and immersive visualization tools can be applied to address real-world healthcare challenges. These implementations show that the combination of technical innovation, clinical insight and collaborative problem-solving is essential for creating solutions that truly meet patient and practitioner needs. Each example reinforces the central role of industry–academia collaboration in bridging the gap between research and application. The workflows, tools, and methods developed through these partnerships provide not only effective patient-specific solutions but also replicable approaches that can be adapted to new contexts. By integrating engineering expertise with clinical priorities, the BIOMEDIX project demonstrates how cutting-edge technologies can move from the lab to the hospital in a manner that is both efficient and clinically relevant. The outcomes discussed in this e-book chapter also serve as an invitation to look beyond the individual case studies and consider the broader potential of such collaborations. Opportunities abound for expanding these approaches into new areas of the biomedical domain from tissue engineering and regenerative medicine to scalable personalized healthcare systems. Continued exploration, knowledge sharing and cross-sector cooperation will be key to unlocking this potential, ensuring that innovation in biomedical engineering continues to deliver tangible benefits for patients and healthcare providers alike. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. 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Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 54 Internal Waran, V. et al., 2014. Injecting realism in surgical training-initial simulation experience with custom 3D models.. J Surg Educ, Volume 71, p. 193–197. Biomedical Innovations through Digital Transformation of Additive Technologies and Knowledge Exchange ERASMUS KA220 BIOMEDIX This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. Page | 55 Internal Appendix 1 – AR application markers This e-book chapter is accompanied by an AR application (QR code for download on the first page of the chapter). The images below are used as markers for interactive content. Install the application, run it on your Android device and point device camera to the marker to see interactive content. You can print this page out for better results. Silicon wafer for ostomy bag: Aorta visualization: