Sales
Sign your first five hospital customers
Coordinate targeting, demonstrations, negotiation and contracting.
Workflows
Turn your MedTech goals into action.
Launch an expert-reviewed workflow, adapt it to your device and let SAGI coordinate the steps, documents, owners and deadlines.
Integrate leading AI models
In progressCompleted
Objective
Launch in Germany
Cardiology device · new market
In progressCompleted
Clinical agent
Assess the clinical evidence
Intended purpose, available evidence and gaps
In progressCompleted
Market access agent
Define the market access pathway
Reimbursement, hospital procurement and funding
In reviewApproved
Clinical team
Approve the evidence plan
Team review · deliverables and owners
In reviewApproved
Market access team
Approve the access strategy
Team review · assumptions and priorities
In progressCompleted
Sales agent
Prioritize target hospitals
Rank hospitals by clinical fit and access criteria
In progressCompleted
Orchestration
Prepare the rollout
Evidence package, value proposition and CRM tasks
In reviewApproved
Team decision
Approve the pilot launch
Or request additional evidence
Back to clinical assessment
WorkflowsSeptember 2026 edition
One MedTech objective. One workflow to reach it.
60+ expert-reviewed workflows that turn strategic objectives into execution plans: milestones, documents, owners and controls.
Sales
Turn hospital pilots into recurring contracts
Measure results and organize the move to paid deployment.
Sales
Deploy a device across a hospital group
Manage procurement, integration and adoption across sites.
Sales
Scale from a few pilot hospitals to nationwide deployment
Build sales, support and deployment capacity.
Sales
Build a distribution network in a new country
Select partners and manage their ramp-up.
Sales
Launch a new indication within existing accounts
Prepare teams and support adoption of the new use.
Sales
Deploy a home-use device with care partners
Coordinate prescribing, logistics, training and user follow-up.
Sales
Integrate medical software into hospital care pathways
Connect interfaces, care organization and change management.
Sales
Build a commercial partnership with a healthcare company
Qualify the partner, agree the model and launch joint activities.
Sales
Recover adoption after an underperforming device launch
Diagnose barriers and execute an adoption recovery plan.
Market access
Secure French LPPR coverage for a targeted indication
Manage evidence, the assessment dossier and reimbursement milestones.
Market access
Take an eligible digital device through the PECAN pathway
Check eligibility and coordinate the application.
Market access
Transition from early coverage to routine reimbursement
Plan evidence and submissions before early coverage ends.
Market access
Deploy a remote monitoring service with a funded model
Connect reimbursement, care organization and deployment.
Market access
Build a Forfait Innovation project to address evidence gaps
Develop the study, funding plan and application.
Market access
Build a device funding pathway in Germany
Choose the right route and develop the evidence required.
Market access
Build an adoption and funding pathway in the United Kingdom
Connect assessment, buyer needs and local implementation.
Market access
Define and deliver a US reimbursement strategy
Align coverage, coding, payment and evidence.
Market access
Secure hospital adoption through an institutional budget
Demonstrate value and support procurement and deployment decisions.
Market access
Deploy a viable direct-pay model for a suitable device
Validate demand, commercial terms and user support.
Medical affairs
Turn clinical results into a publication program
Coordinate authors, analysis, writing and scientific communication.
Medical affairs
Demonstrate a device’s organizational impact on a care pathway
Measure adoption, resources and effects on care teams.
Medical affairs
Build a network of clinical centers of excellence
Structure collaboration, training and shared learning.
Clinical
Build the evidence needed for initial market access
Connect evidence goals to studies and target submissions.
Clinical
Run a feasibility study through the go/no-go decision
Manage sites, recruitment, data and the scale-up decision.
Clinical
Run a multicenter clinical investigation through the final report
Coordinate site activation, enrollment, monitoring, analysis and closeout.
Clinical
Demonstrate clinical benefit against standard practice
Design the comparison, conduct the study and analyze results.
Clinical
Build the evidence needed for a new indication
Identify evidence gaps and deliver the clinical program.
Clinical
Deploy a post-market clinical follow-up program
Organize data collection, analysis and evidence updates.
Clinical
Generate real-world evidence on device use
Develop the protocol, partnerships and data follow-up.
R&D / Design
Turn a clinical need into a device ready for initial evaluation
Connect user needs, requirements, prototyping and the evidence plan.
R&D / Design
Develop medical software through its first market-ready release
Coordinate design, testing, quality and launch preparation.
R&D / Design
Take a connected device through clinical deployment
Align hardware, software, integration and user readiness.
R&D / Design
Turn a laboratory prototype into a manufacturable product
Strengthen design, testing and transfer to manufacturing.
R&D / Design
Develop the next generation of an existing device
Manage changes, evidence and the transition from the previous version.
R&D / Design
Expand a device to a new indication
Align development, clinical evidence and market access strategy.
R&D / Design
Adapt a device for a new patient population
Review intended use, risks and population-specific evidence.
R&D / Design
Add an AI feature to an existing medical device
Coordinate data, validation, change management and monitoring.
Quality
Build a quality system through ISO 13485 certification
Deploy processes, evidence, audits and corrective actions.
Quality
Transfer a prototype into volume production
Coordinate suppliers, processes, controls and product release.
Quality
Increase production volumes while controlling quality and cost
Secure capacity, processes and performance indicators.
Quality
Secure the supply chain for critical components
Qualify alternatives and plan supply continuity.
Quality
Transfer production to a new manufacturer or site
Manage qualification, validation and continuity of supply.
Quality
Restore quality system control after an adverse audit
Prioritize findings and demonstrate corrective action effectiveness.
Quality
Manage a field safety corrective action through closure
Coordinate assessment, communication, execution and effectiveness checks.
Quality
Manage connected device cybersecurity throughout its lifecycle
Manage risks, vulnerability monitoring and remediation.
Quality
Integrate an acquired company or product range into the quality system
Harmonize processes, responsibilities and product documentation.
Quality
Manage device end-of-life and user continuity
Plan communication, maintenance, migration and phase-out.
Regulatory
Achieve CE marking for a Class IIa device
Manage technical documentation, evidence and conformity assessment.
Regulatory
Achieve CE marking for a Class IIb device
Coordinate quality, clinical evidence and notified body engagement.
Regulatory
Take a Class III device through CE marking
Plan evidence development and conformity assessment.
Regulatory
Prepare a 510(k) submission for an oncology device
Confirm the pathway, compare the predicate and prepare the submission.
Regulatory
Prepare a De Novo request for a device without a suitable predicate
Confirm eligibility and organize safety and performance evidence.
Regulatory
Take a device through a PMA application
Coordinate studies, documentation and submission preparation.
Regulatory
Launch a European-market device in the United States
Define the US pathway and coordinate authorization and launch.
Regulatory
Launch a US-market device in Europe
Assess gaps and prepare the European pathway.
Regulatory
Bring a device to the United Kingdom market
Plan local requirements and distribution arrangements.
Regulatory
Bring a device to the Canadian market
Coordinate local requirements, documentation and launch readiness.
Regulatory
Launch a device in three new countries
Prioritize markets and synchronize access pathways.
Regulatory
Maintain market access through a major device change
Assess impacts and manage evidence, notifications and transition.
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