NAME Prototipo-laborategia

DESCRIPTION

Osasun-produktuen diseinu integrala, gailu medikoei buruzko araudi espezifikoaren arabera (ISO 13485). Gure lean metodologiaren helburua da garapen-kostuak minimizatzea tresna digitalak erabiliz esperimentazio-faseei ekin aurretik. Produktu-motaren arabera, modu intentsiboan erabiltzen dira simulazio-ingurune espezifikoak, gutxieneko produktu bideragarrien alternatibarik onenak konfiguratzeko. Prototipatze azkarreko sistemen bidez, simulazioaren emaitzak modu esperimentalean kontrasta ditzakegu, eta aukera onenak hauta ditzakegu. Hala, minimizatu egin daitezke azken diseinua lortzeko behar diren baliabideak. Diseinu horrek zenbait baliozkotze-etapa igaroko ditu, ahalik eta aldaketa gutxien eginez. Hori guztia diseinuaren etapa bakoitzeko arriskuen analisian eta dokumentazioaren trazabilitatean lagunduz garapen-ziklo osoan.

FIELDS OF APPLICATION

Additive manufacturing

Biomedical consumables

Electromedical devices

In-Vitro diagnostics

MOST OUTSTANDING EQUIPMENT AND COMPONENTS

  • Design, calculation and simulation applications

    Design, calculation and simulation applications:
    • 3DEXPERIENCE® SOLIDWORKS (2021)
    • CAD SolidWorks.
    • PDM Solidworks.
    • FEM – MSC, Altair Optistruct, Ansys.
    • CFD - Fluent, Flow.
    • Mutibody Dynamics Simulation- Adams, Motion.
    • Multiphysics dynamic modelling - Modelica.
    • Dynamic multi-domain modelling – Simulink.

  • Formlab SLA Form3 3D Printer

    Formlab SLA Form3 3D Printer.
    • Biocompatible medical grade materials
    • XY resolution: 25 microns.
    • Laser power: 250 mW.
    • Build volume: 14.5 x 14.5 x 18.5 cm.
    • Layer thickness: 25 - 300 microns.

  • ISO 13485 certified

    ISO 13485 certified

  • Open source FDM ANET8 3D printer

    For multiple polymeric materials in filament and pellet format.

  • Stratasys FDM 3D printer

    Stratasys Dimension 1200es FDM 3D printer
    • material: ABSplus in 9 colours
    • working area: 254 x 254 x 305 mm
    • layer thickness: 0.33 mm or 0.254 mm

SERVICES OFFERED BY THE ASSET

Analysis of idea / product

Initial analysis of the feasibility/opportunity of the idea compared to the state of the art.

Pre-clinical validation

Realisation of prototypes for validation in relevant environments of use.

Product Assessment on ISO 13485

Integral development and support to homologation for industrialisation.

Proof of concept

Realisation of minimum viable products to validate the functionality of key technologies.

Strategic advice and support in the (co) development of new products or services (evaluation of ideas, specifications, early dialogue and health technology assessment, etc.)

Elaboration of a detailed state of the art on the technologies involved including intellectual property aspects.

ENTITY MANAGING THE ASSET

ENTITY MANAGING THE ASSET
FUNDACIÓN TEKNIKER
Contact person:
Jesus Alonso
jesus.alonso@tekniker.es