Medical Device & IVD Blog
Outcomes-Based & Value-Based Contracts for Medical Devices: Commercial Playbook
A comprehensive guide to structuring outcomes-based and value-based contracts for medical devices. Analyzes OIG safe harbors, Stark Law, metrics, and case studies.
Certificate of Need (CON) for Medical Devices: State-by-State Guide
State-by-state guide to Certificate of Need (CON) rules for capital medical devices. Map reviewable equipment, thresholds, and sales strategy.
FDA AI-Enabled Medical Device Guidance: Transparency, Labeling & GMLP
Guide to FDA AI medical device rules. Map GMLP, June 2024 transparency, and January 2025 draft guidance to submission and labeling artifacts.
FDA Import Alerts & DWPE for Medical Devices: The Border Gate
Guide to FDA Import Alerts and Detention Without Physical Examination (DWPE) for medical devices. Learn the Red List removal and petition workflow.
Hospital Value Analysis Committees and GPOs: How US Medical Devices Get Bought
Playbook on US hospital Value Analysis Committees (VAC) and Group Purchasing Organizations (GPOs). Explains evaluation rubrics and contracting pathways.
HEOR and the Global Value Dossier: Building Device Evidence That Wins Reimbursement
A guide to HEOR and Global Value Dossier strategy for medical devices. Dissects device-specific economic modeling and payer evidence requirements.
Panama Medical Device Registration: The DNDM Law 90 Compliance Guide
A comprehensive regulatory guide to medical device registration and licensing in Panama under DNDM, Law 90, Executive Decree 490, and Law 419.
Aesthetic Device Market Structure: FDA 510(k) and PMA Approvals Analysis
A data-driven map of the US aesthetic medical device market, analyzing 510(k) energy devices, the laser oligopoly, PMA implants (dermal fillers and breast implants), and recalls.
EU PFAS Restriction for Medical Devices: REACH Timelines and Derogations
How the EU REACH PFAS restriction affects medical device components, key transition timelines (5- and 12-year derogations), concentration limits, and substitution roadmaps.
SPC for Medical Devices: Cpk/Ppk Targets, Gauge R&R, and Process Validation
A quality engineering guide to statistical process control (SPC) and process capability (Cpk/Ppk) for medical device process validation, including Gauge R&R and FDA QMSR compliance.
Burundi Essential Medical Devices List Teardown: ABREMA 2025
A data-driven teardown of Burundi's National Essential Medical Devices List (2025). Analyze the risk-class split, clinical-service mix, WHO-style tomes, and ABREMA legal framework.
Malawi PMRA Medical Device Register Teardown: Supplier Landscape
A data-driven teardown of Malawi's PMRA Medical Device Register. Analyze the supplier landscape, geographic concentration, registration timeline, and PMRA legal framework.
Mongolia Diagnostic & IVD Device Register Teardown: 2024 LMMD Reset
A data-driven teardown of Mongolia's diagnostic and IVD register. Analyze the risk-class split, country-of-origin mix, top manufacturers, and 2024 LMMD regulatory reset.
Botulinum Toxin Adverse Events: Refreshed FAERS Safety Analysis
A comprehensive teardown of botulinum toxin adverse events in the FDA FAERS database, comparing safety profiles of Botox, Dysport, Xeomin, Jeuveau, and Daxxify.
DR Congo ACOREP Register: China's 51% Share and Local Agent Lock-in
A quantitative teardown of the DR Congo medical device register under ACOREP, analyzing import dependency, local agent concentration, and product categories.
Lebanon MoPH Authorized Implantable Medical Devices Teardown
A detailed analysis of Lebanon's Ministry of Public Health implantable medical device register under Decree 455/1, examining risk classes, manufacturers, and supplier dynamics.
Adaptive AI Medical Devices: Why an FDA PCCP Won't Update Your Model in the EU or Japan
A cross-market analysis of AI medical device change control, comparing the US FDA PCCP, Japan's IDATEN framework, and the EU's MDR and AI Act modification rules.
Why FDA or CE Clearances Fail to Register Aesthetic Devices in China, Korea, and Brazil
A deep regulatory analysis of aesthetic device classification and registration pathway divergence across the US, EU, China, South Korea, and Brazil, mapping sequencing strategies and all-in costs.
Bangladesh DGDA Registered Medical Devices Teardown: Chinese IVDs & Class C Majority
A data-driven teardown of Bangladesh's Directorate General of Drug Administration (DGDA) registered medical device list, analyzing risk classes, manufacturers, and importers.
Why One FDA/CE Clearance Opens Far Fewer CGM Markets: The Global Class-Divergence Map
A comprehensive cross-market analysis of continuous glucose monitor (CGM) classification, clinical trial requirements, and reimbursement gates across the US, EU, China, Japan, and Canada.