Work Packages

The objective is to ensure compliance with the ethics requirements set out in this work package.

Ethics requirements and potential ethical issues that may arise during this project are related to personal data, non-EU countries, and artificial intelligence.

Personal Data Protection:
Throughout the project, collection of any and all personal data through interviews for commercial purposes, workshops, and conferences will be in full adherence with Article 15 of the Grant Agreement (Personal Data Protection).

Implementation of EU standards:
Since this project involves partners from non-EU countries, we will ensure that modified biomaterial/devices manufactured in EU countries will not be exported to non-EU countries and/or imported back to the EU. Partnering institutions that handle biological material and will manufacture our biohybrid catheter are located in Spain and Italy, whose regulatory agencies recognize Quality-by-Design as a guiding evaluation principle; therefore, we do not foresee any ethical issues to be raised in this domain.

Artificial Intelligence:
Artificial Intelligence we will use in the project should not raise any ethical concerns related to human rights and values because it will be used to train neural networks based on physico-chemical data and cannot be extended to other domains.

We do not foresee any harmful impact of BioMeld’s activities on the environment, stigmatization of particular social groups, misuse, or political or financial consequences.

The external independent Ethics Advisor for the project is Antonia Bierwith, who will be consulted on any potential issues regarding data protection and implementation of EU standards in non-EU countries.


1. Define the overall structure of the computational framework;
2. Implement an evolvable 3D simulator of BHM structures;
3. Define Bill of materials;
4. Implement computational modules for precise simulation of BHM behavior;
5. Implement machine-learning procedures for optimization of simulated behavior.

The completion of these objectives will set the foundation for the development of BHMs.

In WP2 we will set specifications for the computational framework (T2.1) and develop the initial Bill of Materials (T2.2) that will be updated throughout the project. We will estimate observable parameters in order to determine a set of optimal modelling parameters (T2.3) and use them in further modelling tasks. To automate the generation of optimized biohybrid catheter structures we will rely on evolutionary AI algorithms that will create a set of candidates that will be first evaluated in simplified 3D space (T2.4) and then further refined by the inclusion of physically realistic analytical modules (T2.5). Further optimization (after experimental testing) will be performed by the use of DNNs (T2.6).

To streamline the manufacturing of muscle-actuated biohybrid machines, including:
– its artificial skeleton consisting of smart materials;
– integration of 3D bioprinted skeletal muscle and feedback system for respective stimulation and force monitoring;
– culturing chamber to provide optimum growth and performance conditions.

In WP3 we will manufacture modular, adaptable, and reconfigurable biohybrid catheters. This will be carried out in several phases: initial catheter design (T3.1) will be created in collaboration with WP2 tasks T2.2 and T2.4-5. Catheter actuators will be muscle cells that will be integrated with the overall design (T3.2) while stimulating electrodes and force sensors will be designed, fabricated, and calibrated in Task T3.3 and further developed into the Electronic module for catheter control in Task T3.4. Remote control of catheter navigation and monitoring will be done through a dedicated software app developed in T3.5. To ensure cell viability within the lifespan of the device, we will design a chamber for living cells (T3.6). Finally, all catheter modules will be integrated and produced by 3D printing (T3.7). All parameterization results will be communicated with the modelling groups (T3.8).

1. Ensure that the biohybrid catheter is properly implemented;
2. Collect experimental validation data and use them to calibrate the simulation platform;
3. Check accuracy of simulation results and use them to improve the catheter;
4. Estimate simulations uncertainties;
5. Establish BIMC

In WP4 we have two main goals: to establish, analyse, and refine the manufacturing-simulation feedback loop and to integrate all previous steps into a bio-intelligent manufacturing cell (BIMC). We will first define a testing plan and establish all internal testing procedures including data management of testing data (T4.1). Experimental performance testing will be done in T4.2 while in parallel we will run corresponding simulations (T4.3). Results of both will be analysed (T4.3, T4.4) and communicated to WP2 for improving simulated catheter design (T4.5), and together with all main aspects of the design, simulation, control, and manufacturing process will be integrated into a BIMC (T4.6).

1. Guarantee the global quality of the project, timely finalization of deliverables and reports, tight budget following, good communication, collaboration and transparency between the partners and with the EU Commission.
2. Define a market deployment goal and a tech-to-market strategy fitting to that goal.
3. Widely disseminate project results and progress.

WP5 covers several different tasks, including consortium management and project monitoring (T5.1), dissemination and communication activities (T5.2 and T5.6), preliminary market analysis as well as Business Development Plan and commercialization assessment (T5.3 and T5.4), all of which are intended to increase the impact of the project. All IP aspects of developed technology will be assessed in T5.5.