level general description technology readiness level ...• the final product design validated and...
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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