Global
186 articles
Embecta-Owen Mumford $201M Deal: Auto-Injectors and Drug Delivery
Analysis of Embecta's Owen Mumford acquisition, including deal terms, Aidaptus auto-injector technology, diabetes business diversification, and GLP-1 drug-device strategy.
Endologix Acquires Surmodics Pounce Thrombectomy System
Analysis of Endologix's May 2026 Pounce thrombectomy acquisition from Surmodics, covering the device, PAD market fit, FTC context, and vascular M&A impact.
Oura IPO at $11B: MedTech Impact of the Smart Ring Listing
Oura's confidential 2026 IPO filing, $11B valuation, wearable health platform strategy, and what its public-market move signals for medtech.
Iran War Impact on Medical Device Supply Chains and Strait of Hormuz Risk
Analysis of how Iran conflict and Strait of Hormuz disruption could affect medical device supply chains, including helium, plastics, freight, insurance, and sourcing strategy.
Single-Use Device Reprocessing and Medtech Sustainability Guide
Assess single-use device reprocessing, circular economy benefits, hospital savings, carbon reduction, AMDR data, lifecycle evidence, EU MDR controls, and business case.
Medical Device Clinical Trial Diversity: FDA Action Plan Guide
How device sponsors can prepare FDA Diversity Action Plans under FDORA, set enrollment goals, address waiver criteria, and support representative clinical studies.
Medical Device AI Bias Testing: Fairness Validation and Documentation
How to test AI-enabled medical devices for demographic bias, validate fairness statistically, document FDA and EU submissions, and monitor post-market performance.
Medical Device Cybersecurity Incident Response and Breach Reporting
Build a device cybersecurity response plan covering FDA 21 CFR 806, EU MDR vigilance, CISA timelines, containment, patient safety review, and coordinated disclosure.
Medical Device Design Verification Test Protocol Guide
Write and execute verification test protocols with clear scope, acceptance criteria, sample size rationale, results, and FDA, EU MDR, and ISO 13485 alignment.
Medical Device Clinical Trial Cost: 2026 Budget Breakdown
2026 medical device clinical trial cost guide covering per-patient costs, site fees, CRO budgets, IDE preparation, monitoring, pivotal studies, and cost-saving strategies.
Medical Device Cybersecurity Patch Management Guide (2026)
Plan regulated cybersecurity patch deployment for fielded devices under EU MDR, FDA Section 524B, and the Cyber Resilience Act, from triage to verified rollout.
Human Factors Content for FDA Medical Device Marketing Submissions
Guide to what human factors evidence to include in FDA 510(k), De Novo, or PMA submissions, including HF categories, critical tasks, use-risk analysis, validation testing, and documentation.
FDA Patient Preference Information for Medical Devices: 2026 Final Guidance
Guide to FDA Patient Preference Information for medical devices under the 2026 final guidance, including collection methods, validation, regulatory submissions, benefit-risk use, and EU alignment.
SaMD Clinical Evaluation: Clinical Evidence for FDA and EU MDR Submissions
Guide to SaMD clinical evaluation, covering valid clinical association, analytical validation, clinical performance, FDA expectations, EU MDR evidence, and real-world data.
Adhesive Bonding Process Validation for Medical Devices: From Variables to IQ/OQ/PQ
How to validate adhesive bonding for medical devices, including ISO 13485 and FDA QMSR requirements, UV and epoxy variables, IQ/OQ/PQ protocols, surface controls, and revalidation triggers.
Antibody Clone Lock and Lot-to-Lot Bridging for Immunoassay IVD Kits
How to lock antibody clones, manage lot-to-lot bridging studies, and maintain immunoassay IVD performance across manufacturing campaigns under FDA QMSR, ISO 13485, and EU IVDR.
Battery Cell Sourcing for Portable Medical Devices: Supplier Qualification
How to qualify battery suppliers and design medical device battery packs, covering chemistry selection, IEC 62133-2, UN 38.3, BMS controls, traceability, quality agreements, and dual sourcing.
Biological Specimen Sourcing for IVD Development: Serum, Plasma, Matrix
How to source serum, plasma, urine, CSF, and matrix materials for IVD calibrators and controls, covering donor qualification, viral testing, traceability, lot consistency, and regulatory expectations.
Calibrators and Controls Traceability for IVD Kits
How to establish traceability for IVD calibrators and controls, covering ISO 17511 hierarchy models, reference materials, commutability, uncertainty, value assignment, and regulatory expectations.
CDMO Quality Agreement RACI for Sub-Tier Supplier Control
How to structure RACI matrices in CDMO quality agreements for sub-tier supplier control, defining OEM, CDMO, and supplier accountability under ISO 13485, FDA QMSR, and EU MDR.