3D Printing Unit

Justification

3D printing is a type of additive manufacturing that makes it possible to transform a digital model into a real three-dimensional object. Objects are built layer by layer, using different technologies, such as stereolithography (stereolitography, SLA) or fused thermoplastic material deposition (fused deposition modelling, FDM), the latter being the most widespread desktop technology in in-house 3D printing environments. Limited for a long time to the industrial sphere, 3D printing has evolved to reach professional users.

In Medicine 4.0, the manufacture of customised biomodels and devices through 3D printing makes it possible to:

• Personalised healthcare: precision medicine focused on the patient, improving perceived quality through enhanced medical communication, and objective quality by enabling the optimisation of therapeutic times.
• Clinical education and training: medical training and procedure simulation.
• Pre-clinical testing: improving device design by carrying out tests on simulation models.
• Innovation in personalised medical devices: advanced rapid prototyping, reducing verification and validation times.

Hospital General Universitario Gregario Marañón has been a pioneer in introducing 3D printing as a working tool in clinical practice and research. In 2014, the first surgery using patient-specific surgical guides manufactured in-situ was carried out for an Orthopaedic and Traumatology procedure. Since then, interaction with different specialities has made it possible to bring together the knowledge and experience required to offer a cost-effective medical 3D printing service.

It is a fact that technologies such as 3D printing have burst into the medical market with exponential growth in recent years, partly due to the reduced cost of components and the development of new biocompatible printing materials. This is a set of additive manufacturing tools that inherently involves stages of radiological image acquisition, digital segmentation and 3D design, as well as manufacturing using multiple technical materials. This industrial process allows complete freedom of design and geometries, while reducing manufacturing times and the amount of waste, but its main advantage in the medical sector is the personalisation of each product without significantly increasing production costs. Integrating 3D design and manufacturing technology into hospitals as a paradigm of personalised medicine facilitates scalability and cost optimisation, evolving towards new production models in which manufacturing hospitals are identified as hubs within a networked operation, reconciling in-hospital or in-house manufacturing with external outsourcing services, based on collaborative work and the creation of partnerships.

The point-of-care or point-of-care (POC) manufacturing model takes this into account, encouraging the incorporation of engineers into clinical teams and adapting investment in new infrastructure. It is an organisational challenge that breaks with traditional configurations of roles and the distribution of vertical tasks to make way for process-based work Registered in the Register of Foundations of the Community of Madrid, Personal Sheet 285, Entry 1^st, Volume XXXIIII, Folios 302 and following- C.I.F. G-83195305 December 2024. The methodology known as design thinking precisely seeks to co-create through five stages: empathise, define, ideate, prototype and test; and is fully applicable in healthcare when personalised clinical solutions based on this type of technology are implemented.

Integration into the care pathway requires the different stakeholders to be familiar with the scope of application and the regulatory frameworks that define it. In 2017, European Regulation 745/2017 on medical devices was published, which was transposed into Royal Decree 192/2023, highlighting that responsibility for the specific design characteristics of PSM lies with the prescribing surgeon. In Spain, the Spanish Agency for Medicines and Medical Devices (AEMPS) establishes two possible scenarios for hospital manufacturing: in-house and under licence. For the former, the requirement is that the product be manufactured and used in the same hospital, and this is limited to the manufacture of class I products (for example, biomodels) or class IIa products (instruments or surgical guides), whereas for the manufacture of implants (class IIb and III), it is essential to have a manufacturer’s licence and operate under a robust quality management system that prioritises traceability and biovigilance. In this regard, some centres already hold a PSM manufacturer’s licence and certification under the international ISO 13485 standard, which applies to the validation and verification of a medical device’s life cycle.

ECRI (an independent agency recognised worldwide as the leading evaluating organisation in healthcare technology, and a WHO collaborator), in its 2021 Top 10 Health Technology Hazards report, identifies 3D printing technology as a tool that may pose a risk to the patient if the prescribing doctor is not involved in the design of the medical device itself. This is why clinical advice in this change of production model is a critical element, making it essential to develop the methodology and implement these new services with the support of doctors who are experts in the multidisciplinary care process, personalised medicine and the training of the different actors involved in the process.

Description

It is a Research Support Service {SAi) that helps healthcare professionals and researchers who identify a need where 3D printing can contribute to the development of a specific and individualised application in the field of healthcare.

The aim of these activities is for innovative projects in these areas to have greater potential to be transferred to society in general and to patients in particular.

Services offered

• 3D modelling
• Customised CAD/CAM solutions
• Rapid prototyping: functional analysis, technical assessment, design and manufacturing
• 3D printing of biomodels from a 3D model (STL,OBJ)
• 3D printing of patient-specific bioreplicas from medical image segmentation (CT, CBCT, MR, PET)
• Final product development: medical training, surgical simulation, positioning guides, bespoke instruments
• Advice on integrating 3D printing technology into the clinical process

1. Provides advice on launching an in-hospital unit for custom-made medical devices (CMD), including integration and support throughout the academic manufacturing process for CMDs under the point-of-care model.
2. Offers a specialised consultancy service based on innovation, experience and know-how, developing scientific and technical research, training and teaching with the aim of improving the quality of care provided by the centre. All of this serves as a driving force for change and continuous improvement for units dedicated to custom-made medical devices through disruptive technologies such as Additive Manufacturing.
3. Supports adaptation to new technological trends and innovative methodologies. It focuses on knowledge transfer and training for the personnel involved to ensure the safe implementation of a reliable, efficient service with a strong focus on quality management and traceability throughout the process. Through online consultancy, priority is given to supporting the implementation and management of in-hospital 3D services based on the experience and skills acquired to identify potential areas for improvement, optimisation and risk mitigation, and to advocate compliance with the highest standards of safety, efficacy and conformity.

Resources

Location

The SAI 30 Printing Unit is located in the medical 3D printing laboratory situated on the ground floor of the Central Building {IPMQ) of Gregario Marañón University General Hospital.

SAI-3D Printing Rates

Contact

Advanced Planning and 3D Manufacturing Unit (UPAM3D)
SAI 3D - Gregorio Marañón Biomedical Research Foundation
C/ Doctor Esquerdo, 46
28007 Madrid
E-mail: 3dlab.hgugm@salud.madrid. org

www.upam3d.com