Medical Device & IVD Blog
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.
Why Medical Device Clinical Trials Stop Early: 6,155 Terminated Studies Analysis
Analysis of 6,155 terminated medical device trials on ClinicalTrials.gov: leading failure causes, enrollment bottlenecks, and trial survival playbooks.
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.
EU MDR Article 22: Systems and Procedure Packs — Producer Obligations Guide
Complete guide to EU MDR Article 22 system and procedure pack producer obligations, the no-additional-CE-mark rule, Article 22(4) triggers, UDI, and the FDA convenience-kit comparison.
Master Protocols and Platform Trials for Medical Devices: The Adoption Gap
Analysis of master protocol, platform, basket, and umbrella trial adoption in medical devices — with ClinicalTrials.gov data showing near-zero device uptake and when the design pays off.
FDA Medical Device Development Tools (MDDT): Program & Qualified Tools Guide
Complete guide to the FDA Medical Device Development Tools (MDDT) program: 4 tool categories, 2-phase no-fee qualification process, and full matrix of all 21 qualified tools.
Medicare CLFS Under PAMA: What IVD & Diagnostic Developers Must Know in 2026
Comprehensive 2026 guide to Medicare CLFS lab payment under PAMA: applicable lab rules, 3-year CDLT cycle, ADLT status, gapfilling, and CAA 2026 Section 6226 updates.
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.
FDA Medical Device Master Files (MAF): Types, LOA & Sourcing Strategy (2026)
2026 guide to FDA Medical Device Master Files (MAF under 21 CFR 814.20): functional categories, LOA workflow, MAF vs DMF vs DMR, and eSTAR integration.
FDA Regenerative Medicine: 351/361 HCT/P Determination and RMAT Designation
A regulatory and decision framework for cell and gene therapy sponsors: determining 351 BLA vs 361 HCT/P status, qualifying for RMAT designation, and comparing expedited pathways.
MDSAP in 2026: Revised Audit Approach, TGA Migration, and Post-QMSR Value
A strategic evaluation of MDSAP in 2026: analyzing the February 2026 revised audit approach, the TGA mdsap.global migration, and a post-QMSR ROI decision framework.
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.
FDA Medical Device Advisory Committees: Panel Referral & Prep (2026)
Guide to FDA Medical Devices Advisory Committee (MDAC) panel referrals under Section 515(c), voting mechanics, sponsor preparation, and TAP vs FDORA 3302.
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.
FDA Pediatric Medical Device Regulation: Pathways, Section 515A, and Waivers
A guide to US FDA pediatric device regulation: Section 515A submissions, premarket pathways, MDUFA user-fee waivers, extrapolation, and PDC grants.
Medicare OPPS Device Pass-Through: CY2026 Categories and Criteria
A guide to Medicare OPPS transitional pass-through device payments, covering CY2026 categories, 42 CFR 419.66 criteria, and the FDA Breakthrough pathway.
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.