Commercialization
203 articles
Pure Global AI: A Practical Workflow Guide for Medical Device Regulatory Teams
A vendor-neutral guide to Pure Global AI's regulatory databases, device and predicate agents, and evidence-first workpapers for risk, eSTAR, CAPA, QMSR, labeling, and post-market review.
NPWT Supplier Qualification: Pump–Dressing Compatibility, Alarms, QMS and Total Cost
A technical due-diligence guide for qualifying NPWT systems: pump-dressing compatibility, alarm performance, regulatory scope, and total cost of therapy.
Australia Prescribed List: Device Reimbursement Tiers, Fees and Benefit Reform
Complete guide to the Australia Prescribed List (formerly Prostheses List), covering application tiers, HPA pathways, 2026-27 cost recovery fees, benefit reductions, and post-listing review.
Medicare IPPS and MS-DRGs for Medical Devices: Inpatient Payment Guide
Guide to Medicare IPPS and MS-DRGs for medical devices, covering inpatient payment calculation, NTAP add-on payments, and the FY2027 Breakthrough overhaul.
China Volume-Based Procurement (VBP) for Medical Devices: Price Cuts & Strategy
Guide to China's NHSA volume-based procurement (VBP) for medical devices: round history, price cuts, provincial alliances, and multinational strategy.
FDA TAP Pilot Program Guide: Total Product Life Cycle Advisory Strategy
Guide to FDA CDRH Total Product Life Cycle Advisory (TAP) Pilot Program, Breakthrough Device eligibility, 14-day advisor meetings, and CMS payor alignment.
Commercial Insurance Coverage for Medical Devices: Payer Policy and Prior Auth
Guide to US commercial and private-payer coverage for medical devices — medical policy, prior authorization, ERISA self-funded plans, appeals, and the Medicare NCD/LCD benchmark.
Teleflex Global Regulatory Dossier: Arrow, UroLift, FDA Data & 2025 Sale
Data-driven regulatory dossier of Teleflex (NYSE: TFX): ~440 FDA 510(k)s, multi-country registration counts, Arrow Class I recalls, and the 2025 $2.03B divestiture.
Defense Production Act & Buy American for Medical Devices (2026)
A decision guide for medical device makers on U.S. domestic incentives: DPA Title III grants, Buy American Act thresholds, TAA exemptions, and tax rules.
How to Choose a Medical Device CRO: Selection & Due Diligence (2026)
Vendor-neutral guide to selecting a medical device CRO: ISO 14155:2026 and ICH E6(R3) compliance, RFP execution, FDA 483 due diligence, and cost models.
FCPA Compliance for Medical Device Manufacturers: 2025 Shifts and Case Record
A guide to US FCPA compliance for medical device manufacturers, covering the 2025 DOJ guidelines, historical cases, distributor red flags, and QMS controls.
DMEPOS Prior Authorization for Devices: Master, Required & the 2026 Exemption
A comprehensive guide to traditional Medicare DMEPOS prior authorization. Understand the Master and Required lists, the 2026 updates, and the 90% supplier exemption.
Medicare Advantage Prior Authorization for Medical Devices: Navigating the 2026 Rules
A comprehensive guide to Medicare Advantage prior authorization for medical devices. Learn about CMS-0057-F timelines, CY2026 rules, denial rates, and appeal strategies.
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.
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.
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.
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.