Research, Development, Innovation and Industrialization

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The innovation cycle: from research to market

Seven stages, from the first concept (TRL 1) to the industrialised product (TRL 9 and beyond).

INTELLECTUAL PROPERTY AND PATENTINGacross the entire cycle · freedom-to-operate · patent filing · valorisation and licensing

Ideation

The idea takes shape: analysis of the need and of the underlying principles.

Design

The concept and the architecture of the solution are defined.

Research and Development

Feasibility study and laboratory testing.

Prototyping

Building and testing of the first working prototypes.

Validation

Performance testing in a real operational environment.

Technology transfer

Industrialisation of the process and transition to manufacturing.

Industrialisation

Product on the market, patenting and scale-up.

TRL 9 and beyond · patenting and industrialisation

The European Commission TRL scale: what each level means

TRL 1Basic principles observed
TRL 2Technology concept formulated
TRL 3Experimental proof of concept
TRL 4Technology validated in the laboratory
TRL 5Technology validated in a relevant (industrial) environment
TRL 6Technology demonstrated in a relevant (industrial) environment
TRL 7System prototype demonstrated in an operational environment
TRL 8System complete and qualified
TRL 9Actual system proven in an operational environment (competitive manufacturing, commercial deployment)

ACCREDITED RESEARCH ORGANISATION · MUR 001157_ETER

From vision to industrial reality

We work as a hub that turns technological challenges into industrial development opportunities, with an approach combining scientific, technological and managerial expertise. We support companies and institutions along the entire cycle: from basic research to experimental development, from prototyping to industrial validation, through to technology transfer and the valorisation of results.

What we do, stage by stage

The diagram above shows the path. Here is the concrete work we carry out at each of the seven stages: open the one you are interested in.

1Ideation+

Analysis of the need and of the underlying principles. Review of the scientific and patent state of the art, first mapping of the technological landscape, preliminary freedom-to-operate check to establish straight away whether the route is viable.

2Design+

Definition of the concept and of the architecture of the solution: technical specifications, requirements, experimental plan based on Design of Experiments, assessment of the starting technology readiness level and of the objectives that can be reached.

3Research and Development+

Feasibility study and laboratory testing: formulation and fine-tuning, characterisation, parameter optimisation, first experimental evidence documented following a Quality by Design approach.

4Prototyping+

Building and testing of the first working prototypes, iteration cycles on the results, identification of the Critical Process Parameters and Critical Quality Attributes that will have to be controlled in manufacturing.

5Validation+

Performance testing in a real operational environment: method and process validation, stability and release testing, preparation of the technical documentation that will accompany the product.

6Technology transfer+

Transition from laboratory scale to pilot and industrial scale: similarity criteria, definition of the Design Space, IQ/OQ/PQ qualification protocols, batch records, staff training and transfer agreements.

7Industrialisation+

Manufacturing scalability and market entry: completion of the regulatory pathway, placing on the market, post-market surveillance, valorisation of the intellectual property through licensing and transfer.

Intellectual property, from day one

Dealing with patents at the end of the journey is the most effective way to find out too late that someone got there first. That is why intellectual property enters at stage one and never leaves.

BEFORE INVESTINGFreedom to operatePatent mapping by technological domain, freedom-to-operate analysis, identification of the space still available, monitoring of competitors.

WHEN THE RESULT EMERGESProtectionChoice of the protection instrument, timing and territories of the filing, drafting of the text together with the technical team and the patent attorney.

OVER TIMEPortfolio managementDeadline monitoring, cost-benefit analysis, documented decisions on maintaining or abandoning rights.

WHEN IT PAYS OFFValorisationEconomic assessment, licensing strategies, support for the creation of spin-offs, negotiation of transfer agreements.

The three routes to market

The same laboratory result can become a medical device, a cosmetic or a food supplement. These are three different regulatory pathways, with different costs, timelines and obligations: choosing well at the outset changes the project.

Class I medical device

Regulation (EU) 2017/745
1. Device classification and identification of the risk class
2. Technical documentation and clinical evaluation
3. Conformity assessment and declaration
4. Unique Device Identification and registration
5. Post-market surveillance
Notified cosmetic product

Regulation (EC) 1223/2009
1. Formulation and verification of permitted ingredients
2. Product Information File
3. Cosmetic Product Safety Report
4. Notification through the European CPNP portal
5. Labelling and placing on the market
Food supplement and nutraceutical

Regulation (EC) 1924/2006 and Novel Food rules
1. Composition and verification of the substances used
2. Permitted nutrition and health claims
3. Assessment of the need for novel food authorisation
4. Notification to the competent authority
5. Compliant labelling and placing on the market

Scaling up

This is where most projects stall: what works in a laboratory flask does not automatically work in an industrial reactor. It takes engineering, not optimism.

Scale-up engineering and process design

We transfer processes from laboratory to industrial scale using a Quality by Design approach and process analytical technologies, defining what has to be kept under control and within which limits.

Critical Process Parameters Critical Quality Attributes Design Space Similarity criteria CFD simulation Kinetic modelling Design of Experiments IQ/OQ/PQ protocols Process and method validation Batch record

The technologies that speed up the journey

Digital tools we use inside projects, not as a showcase: they serve to reduce the number of trials, to see problems earlier and to protect data.

Predictive models and data analysis
Machine learning to predict performance and reduce the number of experimental trials, pattern recognition in laboratory data, quality prediction.
Computer vision for quality control
Automated in-line inspection, defect detection, waste reduction and traceability of the control process.
Sensors and digital twin
Monitoring of process parameters, predictive maintenance, digital replica of processes and plants to simulate scenarios before building them.
Traceability and data security
Distributed ledgers for supply-chain traceability and origin certification, secure data architectures, access control, audit trail and GDPR compliance.