Open access Procedures for accessing pilot production in the Atlantic Area

To build the interregional capacity for KET-enabled biomedical production, Atlantic KET MED partners developed 27 new procedures for the application of KETs to multistep manufacturing processes. Procedures were developed to common international standards (e.g. ISO 9001) allowing implementation independent of origin. The procedures are based on multistep processes enabled by KETs. The technical capacities of the partners were central to the development of the procedures. The selection was based on criteria such as the innovation potential, relevance to digital manufacturing, complementarity with other partners, strategy alignment, potential market impact, novelty, among others. Interregional collaboration was encouraged by developing procedures addressing issues from one region with technical strengths from other regions. The procedures were developed by the project partners, with technical expertise in the following areas:

  • Science & Technology Facilities Council (STFC) – UK: providing key expertise and facilities in 3D metals and polymer additive manufacturing
  • NUI Galway – Ireland: providing access to extensive facilities and experience in industry focused, photonics research and application facility – the National Centre for Laser Applications (NCLA), part of the School of Physics of NUI Galway
  • The Health Research Institute of Santiago de Compostela Foundation (FIDIS) – Spain: offering their services as the biggest health research institution in the northwest of Spain, supporting research groups in all phases of the value chain of biomedical research, as well as providing access to technological platforms
  • International Iberian Nanotechnology Laboratory (INL) – Portugal: providing a high-tech research environment addressing major challenges in four strategic fields of application of nanoscience and nanotechnology, including health
  • ALPhANOV – Optics & Lasers Technology Center – France: acting as a “technological amplifier” in the field of photonics, with expertise in laser micro-machining, laser sources, fibre components, laser and optical systems, imaging and vision and light/living tissues interaction

A total of 11 companies from Ireland, Spain, the UK, France and Portugal benefited from these procedures. These were:

The procedures carried out in the framework of Atlantic KET MED ensured interregional collaboration between the project partners and the companies involved in the project. Interregional collaboration took place between the UK – Ireland, Ireland – Spain, Portugal – France, UK – France and the UK – Portugal. This interregional collaboration was a key achievement of the project and demonstrates the need for establishing a transnational advanced pilot manufacturing ecosystem for future biomedical products in the Atlantic Area and beyond.

A list of the procedures and a short explanation of each can be found below.

Atlantic KET Med procedures

  1. DMLS Production – Direct Metal Laser Sintering preparation and production
  2. Product Prototyping using Additive Manufacturing – product assessment and print method selection
  3. 3D Printing Using the Selected Process – printing protocol generic
  4. Data acquisition/ medical grade handling in a clinical environment – clinical protocol for diabetic foot ulcer imaging
  5. Image Analysis – extracting thermal readings from a FLIR camera image for wound analysis
  6. Rheometric analysis of a hydrogel-determining viscosity to enable printing of a hydrogel
  7. Peptigel printing trial – printing a peptide crosslinking hydrogel using a polypico microdrop dispenser
  8. Peptigel laser etching trial – determine parameters for aser material interaction for a peptide-based hydrogel
  9. Bioburden in a high TRL pilot manufacturing environment – determine bacterial and fungal contaminant load of a high TRL pilot production system capable of housing a 3D Biolux printer
  10. Identification of bioburden elements for pilot scale bio tissue fabrication – determine the precise nature of bacteria and fungi to identify and eliminate the source
  11. Multichambered biochip fabrication procedure – establishing methodologies for generating microfluidics chips to recreate tumour models. This procedure shall apply to the fabrication, assembling and management of microfluidics chips, as well as to the conformity, efficacy of the fabrication process.
  12. Bioprinting skin tissue models – using multichamber for skin tissue analogue on a chip
  13. Bioprinting bone tumour models – using multichamber for a bone tissue analogue on a chip
  14. Control of non-conformities, corrective and preventive actions – establish a generalised system to control products that do not conform to the specified requirement
  15. Manufacture Traceability – describe the steps to be followed to ensure product identification and traceability from manufacture to delivery to the customer
  16. Nanodevices – Organoid on-a-Chip Device Fabrication procedure – methodologies for the production and management processes of organoid based microfluidic devices. This procedure applies to the fabrication, assembling and management of organoid-based microfluidic devices, as well as in the conformity, efficacy of those devices. 
  17. Risk Management on Medical Devices – this procedure establishes and describes the methodologies and responsibilities for the conduction of risk management processes associated with the production process of medical devices according to ISO 14971:2019.
  18. Procedure for the control of Documented Information – define the methods and responsibilities concerning the creation of documents and the control of existing documented information, in order to ensure the availability of updated and accurate information with full respect for all the established approval flows and responsibilities. It also aims to define the process of controlling the records required to demonstrate the conformity and operation in accordance with the applicable requirements.
  19. Medical Devices –  Risk Management – methodologies and responsibilities for conducting risk management processes associated to the production process of medical devices
  20. Composite Materials Laser Processing – writing carbonised tracks in a composite material
  21. Composite Materials Laser Processing – Energy optimization – optimising laser energy for a given application
  22. Composite Materials Laser Processing – Frequency optimization – optimising laser pulse frequency for a given application
  23. Composite Materials Laser Processing – Wavelength optimization – optimising laser wavelength for a specific application
  24. Composite Materials Laser Processing: laser implementation in a production line – integration of a processing laser into an existing production line
  25. Qualifying a Supercontinuum in a photonic system – this procedure describes in detail the steps to follow to qualify a supercontinuum laser in a photonic system
  26. Graphene functionalisation – functionalising graphene as a sensitive detector of DNA amplification
  27. Testing EGFETs – testing functionalised graphene as a sensitive detector of DNA amplification

Procedures will be publicly available following final review over the coming weeks