United States
388 articles
FDA Early Feasibility Studies (EFS): The Strategic Playbook for Novel Medical Devices
A comprehensive guide to the FDA Early Feasibility Studies (EFS) Program for medical devices. Dissects EFS IDE protocols, risk mitigation, and OHT routing.
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 Map GMLP, June 2024 transparency, and January 2025 draft guidance to submission and labeling artifacts.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.
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.
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.
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.
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.
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.
How to Get FDA to Tell You Which Center Will Regulate Your Product: The Pre-RFD Playbook
A comprehensive regulatory guide to FDA's Pre-Request for Designation (Pre-RFD) process for borderline and combination products under the revised November 2025 guidance.
How Generative AI Now Picks Medical Devices for Hospital Procurement
Discover how Value Analysis Committees and hospital procurement teams use generative AI to source devices, and why off-site evidence footprints dominate AI recommendations.
US Medical Device Imports Teardown: Why Mexico — Not China — Is America's #1 Source
A data-driven teardown of US medical device imports using the CEPII BACI dataset, analyzing the difference between core devices and the PPE/consumables basket.
NIH SBIR/STTR Medical Device Funding Teardown: Winners and the Phase I to II Funnel
A deep dive into $2.97B in NIH SBIR/STTR medical device R&D grants. Analyze Phase I vs Phase II funding, repeat winners, geographic hubs, and grant strategy.
US Federal Medical Device Procurement Teardown: Who Wins VA, DoD, and HHS Contracts
A data-driven analysis of $37.6B in federal medical device contracts. Learn which agencies buy, which suppliers win, and how to navigate VA, DoD, and HHS procurement channels.
The US Public Medical Device Company Universe by SEC SIC Code and State
A structural analysis of 1,273 SEC-registered medtech companies by SIC sector and state. Explore industry clustering, sector-value asymmetry, and geographic opportunity corridors.
Continuous Glucose Monitor FDA Recalls & MAUDE: Dexcom & Abbott Teardown
An in-depth analysis of continuous glucose monitor (CGM) recalls and MAUDE safety data, comparing Dexcom and Abbott sensor, receiver, and software failures.