Healthcare Innovation Cycle for "Biomarker Diagnostic" Solutions

Biomarker Diagnostics is a broad term for diagnostics that utilize biomarkers. Tracking data has been added that shows an example of an early stage team at risk due to a focus on technology and clinical to the exclusion of Market/Business and Regulatory issues. Select any Maturity Level to see the core Requirements or select the Requirements themselves to see a description of what is involved in completing a requirement and curated resources.

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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 LandscapeReimbursement FamiliarizationComparables IdentifiedIntended Use and Medical Device DeterminationIdea Screening and SelectionBiological Mechanism of Action IdentifiedPreliminary Target Product Profile (TPP)Institutional 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 UseKey In-Sourcing RequirementsUpdated Target Product Profile (TPP)Key Mechanism of Action ValidatedPreliminary Freedom to Operate (FTO) AssessmentUpdated Institutional IP DisclosureFeedback from Clinical Stakeholders 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 ClaimsCyber Security PlanSubmission Pathway DefinedPreliminary Manufacturing-QMS PlanEssential Experiment ResultsWorks-Like and Looks-Like Packaging PrototypesKey In-Sourcing plansProvisional IP filing & formal FTO reviewMedical Advisory BoardFeedback from 5+ KOLsFeedback from 100+ clinical stakeholdersAnimal/First in-with man experimentsClinical Trial EndpointsKey Management Team CommittedFeedback from 20+ 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 Packaging PrototypesFinalized TPP & Essential Technical Experiments ResultsIP Search ReportcGMP Compliant Pilot Manufacturing ProcessPeer Reviewed Publication(s) AcceptedEndpoints Achieved in Feasibility Clinical TrialsDemo Feedback From 20+ Clinical StakeholdersFeedback from 25+ Economic BuyersValidated Quantification1st Institutional investmentPre-Submission FiledData Requirements ConfirmationFull IP ApplicationUpdated TPP & Experimental ValidationAll In-Sourcing Requirements AchievedEndpoints Achieved in Pivotal Clinical TrialsPeer Reviewed Publication(s) Published2nd Round of Institutional InvestmentPurchasing Intent From 10+ BuyersSubmission of Technical File to Regulatory BodyQuality Assured Process Validation (cGMP)Final TPP & Experimental ValidationcGMPs 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) by Others PublishedIncluded in local practice guidelinesProfitable SalesNew Markets LaunchedMonitoring and InspectionsImprovement PlanKey Patents IssuedRecommended Practice by Medical SpecialtyDominant Market ShareHealth Economics StudyProduct Obsolescence PlanComponent Obsolescence PlanningConference/poster session/paper submittedSecure Access to Core IP BioMarker Diagnosticsinnovation 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 21, 2020