Chris Fourment

Decoding FDA Guidance on Decentralized Trials

By MedTech Intelligence Staff

…HCPs to take part in DCTs? Fourment: One potential challenge is compensation. You are taking up the physician’s time, so how do you compensate them effectively? The FDA offers some…

…HCPs to take part in DCTs? Fourment: One potential challenge is compensation. You are taking up the physician’s time, so how do you compensate them effectively? The FDA offers some…

Continue reading

Vik Anantha

Data-driven Surgery: The Next Step in Improving Care and Operational Efficiency

By Vik Anantha

…Surgical Variation The term “digital surgery” is most closely associated with robotics and proprietary technology. To fully incorporate the latest tech and AI into the surgical process, we need to…

…Surgical Variation The term “digital surgery” is most closely associated with robotics and proprietary technology. To fully incorporate the latest tech and AI into the surgical process, we need to…

Continue reading

Sanobar Syed

Market Forecasting: Solving the Problems of Too Little or Too Much Data

By Sanobar Syed

…as many lack reliable data intelligence. Often companies are faced with limited data or, thanks to the explosion of AI and other data collection technologies, vast amounts of data that…

…as many lack reliable data intelligence. Often companies are faced with limited data or, thanks to the explosion of AI and other data collection technologies, vast amounts of data that…

Continue reading

Kaushik Gune

Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance

By MedTech Intelligence Staff

…Class II clearance allows users to add AI algorithms to the disease-agnostic platform, potentially speeding approval of a variety of AI and machine-learning (ML)-powered digital health devices. We spoke with…

…Class II clearance allows users to add AI algorithms to the disease-agnostic platform, potentially speeding approval of a variety of AI and machine-learning (ML)-powered digital health devices. We spoke with…

Continue reading

Bob Bouthillier
Soapbox

Leveraging AI & ML in MedTech: ML vs. Traditional Algorithms

By Bob Bouthillier

…system architecture and knowing which tools are best suited for the application—it is best to understand and investigate alternate approaches before deciding whether the AI/ML approach is best for your…

…system architecture and knowing which tools are best suited for the application—it is best to understand and investigate alternate approaches before deciding whether the AI/ML approach is best for your…

Continue reading

Steve Thompson

Risk-Based CSA Validation: Ensuring the Least Burdensome Approach

By Steve Thompson

…Thompson. https://www.valgenesis.com/blog/how-computer-software-assurance-csa-will-impact-traditional-software-testing [4] Testing and validation: From hardware focus to full virtualization? November 23, 2017 | Article https://www.mckinsey.com/capabilities/operations/our-insights/testing-and-validation-from-hardware-focus-to-full-virtualization [5] How to Calculate the ROI of Digitized Validation | eBook. https://www.valgenesis.com/resource/how-to-calculate-the-roi-of-digitized-validation…

…Thompson. https://www.valgenesis.com/blog/how-computer-software-assurance-csa-will-impact-traditional-software-testing [4] Testing and validation: From hardware focus to full virtualization? November 23, 2017 | Article https://www.mckinsey.com/capabilities/operations/our-insights/testing-and-validation-from-hardware-focus-to-full-virtualization [5] How to Calculate the ROI of Digitized Validation | eBook. https://www.valgenesis.com/resource/how-to-calculate-the-roi-of-digitized-validation…

Continue reading

Juliane Ray

Facilitating Connections with MedTech KOLs

By MedTech Intelligence Staff

…during development or commercialization that you hope to address with Link? Ray: Before coming to Veeva, I was the head of commercial operations at a cardiovascular company, so I had…

…during development or commercialization that you hope to address with Link? Ray: Before coming to Veeva, I was the head of commercial operations at a cardiovascular company, so I had…

Continue reading

Adrian Jennings

Using RTLS To Improve Operational Efficiency

By Adrian Jennings

…an epidemic of disease, but of missing mobile medical equipment (MME). The side effects include operational inefficiencies resulting in increased costs, wasted time, and—perhaps most alarmingly—patient care being compromised. However,…

…an epidemic of disease, but of missing mobile medical equipment (MME). The side effects include operational inefficiencies resulting in increased costs, wasted time, and—perhaps most alarmingly—patient care being compromised. However,…

Continue reading

FDA Logo

FDA Announces Additional Steps to Modernize Clinical Trials

By MedTech Intelligence Staff

…will be open for public comment for 60 days. The ICH Expert Working Group will review and consider comments on this draft guidance, as well as feedback from other ICH…

…will be open for public comment for 60 days. The ICH Expert Working Group will review and consider comments on this draft guidance, as well as feedback from other ICH…

Continue reading

Artificial Intelligence Graphic

AAMI and BSI Partner to Publish Guidance on Artificial Intelligence

By MedTech Intelligence Staff

…Intelligence Committee, in AAMI’s inaugural Medical Device Safety in Focus report, Artificial intelligence: The Trust Issue. “Recognize the fact that AI systems, data, and clouds are going to change and…

…Intelligence Committee, in AAMI’s inaugural Medical Device Safety in Focus report, Artificial intelligence: The Trust Issue. “Recognize the fact that AI systems, data, and clouds are going to change and…

Continue reading