Healthcare Innovation Cycle for "Digital Medicine" Solutions

Digital Medicine is a broad term for the subset of the Digital Health field that related to promoting wellness or providing medical care (see Digital Therapeutics Alliance Definition). Tracking data has been added that shows an example of an early stage team at risk due to a focus on technology. Select any Maturity Level to see the core Requirements or select the Requirements themselves to see a description and curated resources.

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.

Download a complete 
checklist.

Note: Download and open the PDF so that it is fiilable

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 SelectionSystem and Module Requirement SpecificationInterface Mock-UpsInstitutional IP Disclosure [Not Applicable]Feedback from Clinical Stakeholders in 5+ settingsUpdated Need Statement and Workflow ScenarioTarget OutcomesPreliminary Path-to-Payment PlanPreliminary Value PropositionStakeholder MapCompeting Solutions CharacterizationBusiness Protection ModelPreliminary Regulatory Classification and PathwayPreliminary Indications for UsePreliminary Risk and Hazard AnalysisKey In-Sourcing RequirementsDemonstration ResultsKey Module PoC PrototypesPreliminary System and Software ArchitectureUpdated Institutional IP Disclosure [Not Applicable]Feedback 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 DefinedSoftware and Hardware ArchitectureRisk Mitigation and Interoperability PlanEssential Experiment ResultsWorks-Like PrototypesKey In-Sourcing plansProduct Requirement Document (PRD)Medical Advisory BoardFeedback from 5+ KOLsFeedback from 100+ Clinical StakeholdersClinical PilotClinical 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 prototypesEssential Technical Experiments ResultsInteroperability ValidationcGMPs Medical Software and Production Environment(s)Peer Reviewed Publication(s) SubmittedEndpoints 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 specification & 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)Updated Specification and Experimental ValidationSpecialty Medical Group(s) Review in PlaceTraining Materials & Support EstablishedInitial Sales/ DeploymentPublic Coverage and Code DeterminationRegulation and ListingRegionalization RequirementsFinalized cGMP Production EnvironmentPeer Reviewed Publication(s)Included in local practice guidelinesProfitable SalesNew Markets LaunchedMonitoring and InspectionsImprovement PlanRegionalization ImplementedRecommended Practice by Medical SpecialtyDominant Market ShareHealth Economics StudyProduct Obsolescence PlanComponent Obsolescence PlanProvisional IP filing & initial FTO reviewIP search reportRegionalization PlanSecure Access to Core IP Digital Medicineinnovation 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 19, 2020