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Selecting a Resilient Medical Device Contract Manufacturer for Long-term Success

Leave a Comment / cash flow, contract manufacturing, Focus Article, Manufacturing Execution, Market Access, Medical Device, MedTech, MedTech Economics, OEM, Product Design & Development, regulatory compliance, supply chain resiliency / By

Selecting a Resilient Medical Device Contract Manufacturer for Long-term Success     Finding a resilient medical device contract manufacturer (CM) ensures a consistent supply chain, regulatory compliance, and long-term business success. Whether you are a Fortune 500 company or an early-stage startup, you will benefit from taking the time to find a CM partner who can …

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Three Steps to Gain the Full Advantage of Pharmaceutical Business Forecasting

Leave a Comment / business strategy, complex disease, demand forecasting, forecasting, Market Access, Medical Device, MedTech, MedTech Economics, pharmaceuticals, pipeline, Product Design & Development, R&D / By

Three Steps to Gain the Full Advantage of Pharmaceutical Business Forecasting     Business strategy and forecasting influence several functional areas within an organization. These relationships may be in one direction (where forecasts feed into decisions made by the other functional areas) or in many directions (where the forecast is used to generate changes proposed by …

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FDA Releases New CM&S Tool for Metallic Orthopedic Implants Exposed to MRI

Leave a Comment / CMS, device development, Medical Device, MedTech, MMT, nonclinical assessment model, orthopedic implants, Product Design & Development, Quality/Regulatory, simulation / By

FDA Releases New CM&S Tool for Metallic Orthopedic Implants Exposed to MRI     The FDA has released a new computational modeling and simulation tool (CM&S) that can predict the temperature rise in tissue around certain metallic orthopedic implants during a magnetic resonance imaging (MRI) scan. The nonclinical assessment model (NAM) can predict the rise and …

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Intelligent Software Connectivity: An Opportunity to Transform Device Development and Health Care

Leave a Comment / connected device, cybersecurity, data-centricity, Digital Health, Focus Article, intelligent software connectivity, interoperability, MEDdesign, Medical Device, MedTech, message-centric software, Product Design & Development / By

Intelligent Software Connectivity: An Opportunity to Transform Device Development and Health Care     The technologies driving minimally invasive and precision healthcare require the integration of robotics, imaging, sensors, and data-driven technologies. MedTech is evolving from siloed products and devices to increasingly multi-functional and integrated digital systems. One study estimated that the global market for connected …

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Expand Your Regulatory Intelligence

Leave a Comment / certification, FDA CDRH, From The Editor's Desk, ISO:13485, Medical Device, MedTech, Product Design & Development, Quality/Regulatory, regulatory advocacy, regulatory intelligence, remote inspections / By

Expand Your Regulatory Intelligence     In an increasingly digital world, medical device regulators and regulatory professionals have more information than ever to help them identify adverse events and new indications. Combined with shifting U.S. and global regulatory requirements, the task of staying abreast of new requirements and data sources is becoming a Herculean task. On …

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How a Comprehensive UX Approach Brings Value to the Design Process

Leave a Comment / augmented reality, contextual inquiry, device design, Digital Health, grpahic user interface, HFE, Medical Device, MedTech, Product Design & Development, user experience, UX, VR / By

How a Comprehensive UX Approach Brings Value to the Design Process     UX design processes are constantly evolving as the industry continues to embrace IoT (Internet of Things) technologies. With this evolution comes a need to focus on improving UX (User Experience) protocols in the design of medical devices. UX, driven by human factors engineering …

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Increasing Momentum in Medical Device Security

Leave a Comment / cybersecurity, Digital Health, EU MDR, IMDRF, legacy devices, MDMs, Medical Device, MedTech, Product Design & Development, Quality/Regulatory, ransomware, SBOM, Soapbox / By

Increasing Momentum in Medical Device Security     In 2021, an employee at Ireland’s public health and social services system—the Irish Health Services Executive (HSE)—opened a spreadsheet that was sent by email. The file contained malware. After two months of free access to the network, the attackers released ransomware into the system. As the BBC reports, …

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BlackHägen Design Announces Death of Founder and Human Factors Engineer Sean Hägen

Leave a Comment / human factors, IDSA, Medical Device, MedTech, patient safety, product design, Product Design & Development, Quality/Regulatory / By

BlackHägen Design Announces Death of Founder and Human Factors Engineer Sean Hägen     With deep sadness we share that Robert Sean Hägen, co-principal, founder and director of research and synthesis at BlackHägen Design passed away on February 25 after a brief illness. Hägen, who was a contributor to Medtech Intelligence, spent 28 years building BlackHägen …

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Managing Legacy Technology Security

Leave a Comment / cybersecurity, Digital Health, future proofing, HSCC, legacy devices, Medical Device, MedTech, Product Design & Development, risk management, White House / By

Managing Legacy Technology Security     To help address the cybersecurity risks of legacy devices used in healthcare environments, the Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG) has published “Health Industry Cybersecurity – Managing Legacy Technology Security (HIC-MaLTS).” The guide recommends cybersecurity strategies that manufacturers and health providers can implement for …

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Regulating Point of Care Printed Devices

Leave a Comment / 3D printing, compliance, liability, malpractice, Medical Device, MedTech, Product Design & Development, prosthetics, Quality/Regulatory, RC - Quality & Regulatory Market Access Solutions / By

Regulating Point of Care Printed Devices     The use of 3D printing for medical devices opens tremendous opportunities in health care. It allows users to test and adjust components more quickly than traditional manufacturing and enables the creation of personalized products, such as custom prosthetics. However, questions remain about what oversight the FDA will have …

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