Clinical Evidence
73 articles
Non-Inferiority Clinical Trials for Medical Devices: Margin & Design Guide
Master non-inferiority clinical trials for medical devices: set M1 and M2 margins, protect against learning curves and biocreep, compare FDA and EU MDR, and analyze pivotal trial cases.
Bayesian Statistics for Medical Device Clinical Trials: FDA Guidance & Approvals
Master FDA CDRH guidance for Bayesian device trials. Explore prior borrowing, adaptive designs, 47 PMA approval statistics, and the 2026 drug draft contrast.
Data Monitoring Committees (DMC/DSMB) in Medical Device Clinical Trials
Comprehensive guide to DMC and DSMB oversight in medical device clinical trials: FDA 2006 vs 2024 guidance, chartering, stopping rules, and operator learning curve management.
FDA Bioresearch Monitoring (BIMO) and 21 CFR Part 58 GLP Device Guide
Guide to FDA Bioresearch Monitoring (BIMO) and 21 CFR Part 58 GLP for device sponsors, covering compliance manuals, NAI/VAI/OAI, and PMA pre-approval audits.
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.
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.
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.
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.
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 Coverage with Evidence Development (CED) for Medical Devices
A comprehensive guide to Medicare Coverage with Evidence Development (CED) in 2026, mapping active device NCDs, study and registry requirements, and the graduation timeline.
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.
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.
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.
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.
Disposable Circumcision Devices: FDA 510(k) Pathways & Clinical Evidence
An in-depth regulatory and clinical analysis of disposable circumcision devices (staplers, clamps, and rings), detailing FDA product codes, clinical trials, and market entry due diligence.
Medical Device Clinical Trials on ClinicalTrials.gov by the Numbers (2026)
A deep quantitative teardown of the ClinicalTrials.gov database for medical devices. Analysis of phase NA dominance, results-reporting compliance, sponsor classes, and decadal growth trends.