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Volume 13 Issue No. 06 |
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Soapbox
By Beth Doladee and Neelima Paranjpey, Ph.D., The Vaya Group In an industry fraught with constant challenges, medtech leaders need to close the growing skills gap of their employee base and develop leadership from within. The pandemic’s impact on an increasingly remote workforce has caused companies to adopt a new approach to cultivating emerging leaders. |
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Strategic National Stockpile Ventilators Can Support ‘Most’ Patients, but That Is Not Enough By Sam Alnajjar, M.D., Abrazo Central Campus ICU, Phoenix Critical care hasn’t had many breakthroughs in recent years and in order to change that, I believe we need to put more of an emphasis on integrating technology–specifically artificial intelligence (AI)–into the field. |
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More Cyberattacks in Healthcare, Yet Most MedTech Leaders Unprepared, Says Survey By MedTech Intelligence Staff A mere 13% of IoMT leaders believe their organization is in a good place to mitigate future risks related to cybersecurity. |
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COMPLIMENTARY |
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COMPLIMENTARY Virtual Events The European In Vitro Diagnostic Regulation (EU IVDR) will profoundly affect the global diagnostics market, requiring new procedures, evidence development, documentation, organizational structures, data management, reporting, and a reassessment of legacy portfolios. Preparation will involve strategic thinking and buy-in at the highest levels. Implementation of IVDR is scheduled for May 2022, with no indication that it will be deferred. For those who have not already begun planning for the change, it is urgent to begin now or face exclusion from the European market. March 30, 2021: EU IVDR Introduction April 6, 2021: Quality Processes and Documentation April 13, 2021: Clinical Evidence & Surveillance April 20, 2021: Supply Chain Management: Economic Operators, UDI, and Labeling April 27, 2021: Strategy and Planning |
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MEDdesign Quantum Computing Makes Inroads in Life Sciences By Eric M. Luyer, Axendia, Inc. Quantum computing has spurred the development of new breakthroughs in life sciences from using machine learning methods to diagnose illnesses sooner to identifying materials to make more efficient devices. |
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Part 1: The wireless network serves as the backbone supporting patient care in every department of a healthcare facility. It is crucial to optimize and future-proof WiFi networks. |
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Part 2: How AI and automation can help avoid expensive and time-consuming upgrades. |
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Featured Quote — David Gwyn, AMPLEXOR Life Sciences |
| MedTech Library |
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Sponsored By bsi. To comply with the Regulation on in vitro diagnostic medical devices (2017/746) (IVDR) manufacturers must classify their in vitro diagnostic (IVD) devices in accordance with the rules set out in Annex VIII of the Regulation. There are some significant differences between the classification systems for medical devices and IVD medical devices under the new regulations.This white paper provides a historical perspective on the development of medical device and IVD device classification, explains the new rules and analyses the implications of the new system. |
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MDR Documentation Submissions: Best Practices Guidelines Sponsored By bsi. |
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Telemedicine Cybersecurity Report: Android Patient-Facing Mobile Apps Sponsored By Irdeto |
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Unlocking Medtech’s Future Potential with Connected Devices and Services Sponsored By S3 Connected Health |
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How to optimize coatings and substrates for compatible medical devices Sponsored By KRÜSS |
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Securing devices so that clinicians and patients connect without fear. Sponsored By Irdeto |
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Telemedicine Cybersecurity Report: iOS Patient-Facing Mobile Apps Sponsored By Irdeto |
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The engineer’s guide to wearables Sponsored By 3M |
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The Growing Need for Real-World Evidence in Medical Devices Sponsored By Evidera |
Explaining IVD Classification Issues
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