Welcome to the Guidance and Impact Tracking System (GAITS) Platform Portal

A secure, web-based project milestone and portfolio management platform to de-risk and accelerate healthcare innovations.

MaturityDisplay

Unmet Need StatementDisease State CharacterizationExisting Solutions CharacterizedNeeds Screening and SelectionRegulation FamiliarizationState of the Art SummaryFeedback from 5+ Clinical StakeholdersUpdated Need StatementWorkflow ScenarioEnvisioned Benefit StatementKey Stakeholders IdentifiedEnvisioned Value PropositionCompetitive LandscapeComparables IdentifiedIntended Use and Medical Device DeterminationIdea Screening and SelectionHypothesis and Experimental DesignPaper PrototypesInstitutional IP DisclosureFeedback from Clinical Stakeholders in 5+ settingsUpdated Need Description and Workflow ScenarioTarget OutcomesPreliminary Path-to-Payment PlanPreliminary Value PropositionStakeholder MapCompeting Solutions CharacterizationBusiness Protection ModelPreliminary Regulatory ClassificationPreliminary Regulatory PathwayPreliminary Indications for UsePreliminary Risk and Hazard AnalysisKey In-Sourcing RequirementsDemonstration ResultsKey Component PoC PrototypesPreliminary Freedom to Operate (FTO) AssessmentUpdated Institutional IP DisclosureFeedback from Users in 20+ SettingsUpdated Need and Workflow DescriptionsUpdated Target OutcomesBusiness Advisory BoardPreliminary Business ModelFeedback from 5+ Economic BuyersKey Relationships IdentifiedDevelopment PlanDraft Essential Requirements ChecklistInstitutional Approval Request(s)Draft Instructions For UseDraft Product ClaimsSubmission Pathway DefinedPreliminary BOM and Manufacturing-QMS PlanEssential Experiment ResultsWorks-Like and Looks-Like PrototypesKey In-Sourcing plansProduct Requirement Document (PRD)Provisional IP filing and formal FTO reviewMedical Advisory BoardFeedback from 5+ KOLsFeedback from 100+ Clinical StakeholdersAnimal/First in-with Man ExperimentsClinical Trial EndpointsKey Management Team CommittedFeedback from 10+ Economic BuyersInvestor Ready Business PlanInitial Seed InvestmentKey Relationships FormalizedIncorporation and Founders AgreementClinical Investigation Approval(s)Essential Requirements ChecklistApplication to Regulatory Authority SubmittedElectronic Protected Health Information (ePHI) PlansKey In-Sourcing Requirements CommittedWorks-Like, Looks-Like, Made-Like prototypesEssential Technical Experiments ResultsIP Search ReportcGMPs Compliant Pilot Manufacturing ProcessEndpoints Achieved in Feasibility Clinical TrialsDemo Feedback From 20+ Clinical StakeholdersFeedback from 20+ Economic BuyersValidated Quantification1st Institutional investmentPre-Submission FiledData Requirements ConfirmationGDPR-HIPAA ComplianceSecurity and Vulnerability CertificationsFull IP ApplicationUpdated PRD & Experimental ValidationAll In-Sourcing Requirements AchievedEndpoints Achieved in Pivotal Clinical TrialsPeer Reviewed Publication(s) Accepted2nd Round of Institutional InvestmentPurchasing Intent From 10+ BuyersSubmission of Technical File to Regulatory BodyQuality Assured Process Validation (cGMP)cGMPs Compliant Manufacturing ProcessSpecialty Medical Group(s) Review in PlaceTraining Materials & Support EstablishedInitial SalesPublic Coverage and Code DeterminationRegulation and ListingIP for Improvements FiledFinalized cGMP Production EnvironmentPeer Reviewed Publication(s)Included in Local Practice GuidelinesProfitable SalesNew Markets LaunchedMonitoring and InspectionsImprovement PlanKey Patents IssuedRecommended by Medical SpecialtyDominant Market ShareHealth Economics StudyProduct Obsolescence PlanComponent Obsolescence PlanningSecure Access to Core IPUpdate Regionalization PlanscGMPs Compliant Manufacturing Plan MedTechinnovation cycle1. Need1. Need2. Idea2. Idea3. Proof of Concept3. Proof of Concept4. Proof of Feasibility4. Proof of Feasibility5. Proof of Value5. Proof of Value6. Initial Clinical Trials6. Initial Clinical Trials7. Validation of Solution7. Validation of Solution8. Approval & Launch8. Approval & Launch9. Clinical Use9. Clinical Use10. Standard of Care10. Standard of CareClinicalMarket/BusRegulatoryTechnology OUTCOME MARKERSMinor PivotMajor PivotStopped ProgramLaunched New Program
September 1, 2023

Note:

To access the Resources that describe each Deliverable, use the Sign-in button above to create an account and then click on the Deliverable or the Innovation Maturity Level to see all Deliverables at that level and click on the one of interest. 

MedTech

Classic electro/mechanical medical devices such as surgical instruments and imaging systems.

See Guidance >

Biomarker Diagnostics

Diagnostics that are based on chemical or biological biomarkers.

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Digital Medicine

Digital solutions such as Apps and AI enabled systems that improve health and/or wellness.

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IVD

Tests done on samples such as blood or tissue that have been taken from the human body.

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Therapeutics

Chemically synthesized pharmaceuticals and biopharmaceuticals that are manufactured from biological sources.

See Guidance >