Level General description Technology readiness level - BioPharma

1 to 3 Non applicable Non applicable

4 Validation of the technology in the laboratory

• Preclinical R&D. Optimization of candidates and in vivodemonstration of activity and efficacy. Identification and integrationof critical technologies (animal models, biomarkers, assays, etc.)in continued characterization of and development of potentialcandidates.

• Initiation of GMP process development and manufacturing of non-GMP material and drug formulations.

• Evaluation of safety, pharmacodynamics and pharmacokineticproperties.

• Formulation of a Target Product Profile initiated.

5 Validation of technology in a relevant environment

• Further characterization of candidate, i.e. absorption, distribution,metabolism and elimination.

• Manufacturing process established amenable to large scale GMPmanufacturing and consistent with the intended use of the drug.Development of in process controls and relevant analytical assays.

• Continued development of animal models for efficacy and dose-ranging studies. Selection of candidate drug. GLP safety studies forIND submission and Phase 1.

6 Demonstration of technology in relevantenvironment

• Clinical development. GMP production, IND submission and PhaseI clinical evaluation performed proceeding to Phase II.

• Additional safety evaluations conducted necessary to supportfurther development.

7 Technology prototype demonstrated in anoperational environment

• Phase II clinical study is completed. Manufacturing process scale-up and process validation initiated and stability testing ongoing.

• Continued safety studies to support further clinical testing.

• TPP refined when necessary. Phase III clinical plans definedand approved by regulatory authorities. approved by regulatoryauthorities.

8 Technology system completed and qualified through test and demonstration

• Manufacturing processes validated.

• Pivotal clinical Phase III testing and safety studies completed.

• NDA or BLA prepared and submitted. Approved by appropriateregulatory authorities.

9 Technology system in its final form ready for full (commercial) deployment in relevant operating environment

• Product launched.

• Post-marketing studies (Phase IV) and surveillance.

Readiness level guideTechnology readiness level - TRL

Intellectual Property readiness level - IPRL Customer readiness level - CRL

Funding readiness level - FRL

Level General description Technology readiness level - Med tech & Diagnostics

1 to 3 Non applicable Non applicable

4 Validation of the technology in the laboratory

• Preclinical R&D. Laboratory testing of critical components andprocesses.

• Proof of concept of device demonstrated in relevant laboratory andanimal models.

5 Validation of technology in a relevant environment

• Further development of device candidates and system solutions.Validation of system components and processes in relevantlaboratory environment.

• Classification of device by appropriate regulatory body and whenappropriate an Investigational Device Exemption (IDE) prepared andsubmitted for review.

6 Demonstration of technology in relevantenvironment

• System/device prototype demonstrated in an operationalenvironment. Clinical testing to demonstrate safety may be required.

• Depending on the classification of the device Premarket approvalor Premarket notification (510(K)) apply.

7 Technology prototype demonstrated in anoperational environment

• Clinical safety and effectiveness trials conducted using a fullyintegrated prototype version of the medical device in an operationalenvironment.

• Data evaluated to support further development

• The final product design validated and final prototype and/or deviceintended for commercial use produced and tested.

8 Technology system completed and qualified through test and demonstration

• Premarket application or premarket notification submitted andapproved.

9 Technology system in its final form ready for full (commercial) deployment in relevant operating environment

• Product launched.

• Post-marketing studies and surveillance.

Readiness level guideTechnology readiness level - TRL

Intellectual Property readiness level - IPRL Customer readiness level - CRL

Funding readiness level - FRL

Level General description Technology readiness level - Digital Health

1 to 3 Non applicable Non applicable

4 Validation of the technology in the laboratory

• System components integrated and tested regarding preliminaryefficiency and reliability.

• Software architecture and other system components developmentto address reliability, scalability, operability, security, etc.

5 Validation of technology in a relevant environment

• System component architecture established.

• System tested in relevant testing environment as expected in theoperational environment.

• Verification, validation and accreditation when appropriate initiated.

6 Demonstration of technology in relevantenvironment

• Representative model or prototype system demonstrated inrelevant live or simulated environment. System component releasesare “beta” versions and configuration controlled.

• Support structure in development and verification and validationand when needed accreditation for safety reasons in progress.

7 Technology prototype demonstrated in anoperational environment

• System tested in an operational environment. Support structure inplace and System component releases in distinct versions.

• Verification, validation and when appropriate accreditationcompleted.

8 Technology system completed and qualified through test and demonstration

• Development completed. System demonstrated to work under reallife conditions.

• Testing of design specifications. System component releases areproduction versions.

• Support structure in place to resolve technical issues.

9 Technology system in its final form ready for full (commercial) deployment in relevant operating environment

• Product launched.

Readiness level guideTechnology readiness level - TRL

Intellectual Property readiness level - IPRL Customer readiness level - CRL

Funding readiness level - FRL

Level Intellectual Property readiness level - IPRL

1 to 3 Non applicable

4 • Novelty / patentability confirmed by IP professional

• Other forms of protection confirmed possible if patent is notrelevant (e.g. software).

5 • First patent application filed.

• Initial IP Strategy supporting value creation in place.

6 • FTO assessment made.

• First initial feedback on patent application obtained from patentauthority.

7 • Patent entered national phase.

• Other relevant forms of IPR initiated (Trademark, design etc.)

8 • First patent granted.

• IP strategy in place and actively implemented.

9 • Patent maintained and in force in relevant countries / markets.

Readiness level guideTechnology readiness level - TRL

Intellectual Property readiness level - IPRL Customer readiness level - CRL

Funding readiness level - FRL

Level Customer readiness level - CRL

1 to 3 Non applicable

4 • Problem / need confirmed from multiple sources and producthypothesis refined if required

• Key Opinion Leaders (KOLs) identified.

5 • Product (core features) / solution fit confirmed by customers.

• Customers (focus group, advisory board etc) engaged in providinginput on market requirements.

6 • Testing of product/prototypes by users/customers where the valueand benefits of the product is evaluated and confirmed

• Partnerships are formed with key stakeholders across the valuechain (e.g. suppliers, partners, customers).

7 • Customer / supply agreements in place; all relevant stakeholdersengaged in product/process qualifications.

• Product design is complete.

8 • Customer qualifications complete; initial products manufacturedand sold to a few customers. Payment willingness confirmed.

• Business development and sales mature and adapt to supportlarger scale sales efforts (e.g. clear sales process/organization, CRMsystems etc)

9 • Widespread product deployment with sales to multiple customers.

Readiness level guideTechnology readiness level - TRL

Intellectual Property readiness level - IPRL Customer readiness level - CRL

Funding readiness level - FRL

Level Funding readiness Level - FRL

1 to 3 Non applicable

4 • Budget and activity plan for 12-18 months drafted

• Succinct oral pitch prepared; written business concept in place.

5 • Soft funding (0,1 - 0,5 Meuro) obtained.

• Pitch deck tested and fine-tuned; supporting documentation inplace.

6 • Investment prospectus prepared.

• Pitch deck including financials and business prospect ready.

7 • Complete business plan incuding financials and milestone plan.

• Series A round initiated.

8 • Follow-up investments with series A investors ongoing.

9 • Extended investor network with series B.

Readiness level guideTechnology readiness level - TRL

Intellectual Property readiness level - IPRL Customer readiness level - CRLFunding readiness Level - FRL