Innovation Lab
Prototype the next clinical workflow before the purchase order exists.
Medtronic Innovation Lab gives hospital teams a structured bench to test connected monitoring, sterile supply traceability, diagnostic data exchange, and cybersecurity documentation under realistic operating constraints—before a live unit depends on the result.
Innovation roadmap
Five decision gates from constraint mapping to supervised launch.
Each gate produces committee-ready artifacts: intended use, interface assumptions, evidence pack, service ownership, and unresolved gaps with named owners.
Constraints
Define care setting, product family, EMR/LIS versions, evidence needs, and stakeholder sequence.
Simulation
Run workflow tests with representative FHIR/HL7 payloads, UDI lot records, and service assumptions.
Evidence
Package IFU references, 510(k)/CE MDR notes, cybersecurity SBOM/MDS2, and training records.
Service model
Confirm MTTR targets, remote diagnostics path, parts depot assumptions, and escalation matrix.
Decision
Deliver launch recommendation with CAPA-ready residual risks and next evaluation milestones.
Lab modules
Technology benches that produce measurable evaluation outputs.
UDI traceability sprint
UDI-DI lot lookup, expiry, and recall workflow under conversion loadCybersecurity document room
SBOM + MDS2 CVE triage, patch cadence, and coordinated disclosure contactsClinical workflow theatre
IEC 62366 ICU, remote care, laboratory, or procedure-supply handoff simulation
Evaluation partners
Hospital functions that co-own a successful Innovation Lab pilot.
Named institutional partners are not claimed here. The lab instead routes work to the roles that must sign before go-live.
Value Analysis
Aligns clinical need, consumable economics, and committee decision criteria.
Biomedical Engineering
Owns device identity, preventive maintenance, and field-service escalation paths.
IT Security & Informatics
Reviews FHIR/HL7 interfaces, SBOM packages, and SIEM-ready logging assumptions.
Infection Prevention / SPD
Validates sterile packaging, reprocessing references, and lot-level recall drills.
Trade-offs & limits
Innovation Lab does not hide the constraints that stop a pilot from becoming a purchase order.
Hospital teams can use the bench to compare opposing paths with measurable outputs, then document residual risk before value analysis votes.
Single-use vs reusable supply paths
Single-use device (SUD) packets emphasize sterility assurance level (SAL), predictable per-case costing, and reduced reprocessing liability. Reusable paths emphasize lower long-term waste and cost when AAMI ST91 / ISO 17664 reprocessing validation, Spaulding classification ownership, and SPD capacity are proven. The lab records both arguments instead of forcing one narrative.
Central lab vs POCT decentralization
Central laboratory paths protect controlled CV/LOD performance and batch QC; POCT paths shorten bedside turnaround when operator competency, comparator methods, and decentralized QC ownership are funded. Medtronic evaluation packets keep the dispute explicit so committees choose by acuity and staffing, not brochure preference.
Known lab limits
Workshops start without protected health information; live EMR cutover, RF survey results, GPO contract pricing, and country-specific 510(k) or CE marked under MDR 2017/745 filings remain outside the first session. SpO2 accuracy, assay CV, MTTR, and patch cadence claims are accepted only with product-family evidence and named market scope.
Verification path
Teams can request a supervised simulation with sample FHIR/HL7 payloads, UDI lot records, SDS/IFU references, and cybersecurity SBOM/MDS2 packets. Outputs include residual-risk owners, CAPA-ready gaps, and a go / no-go recommendation dated to the committee calendar.
Bring your hardest integration question to the Medtronic Innovation Lab.
The strongest pilot request includes one clinical workflow, one product family, one system constraint, and one committee deadline. No protected health information is needed for the first workshop.
Book a Lab Session