Bob Bouthillier Director, Electrical Engineering, Veranex We live in a time where we have easy access to biometrics that help both our clinicians and us manage our health. Some of these biometrics include the following: O2 saturation and heart rate via pulse...
Leveraging AI and ML in Medical Products – Part 2
Bob BouthillierDirector, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence (AI) and machine learning (ML) today, its potential across a variety of applications, an analysis of challenges faced by...
Leveraging AI and ML in Medical Products – Part 1
Bob BouthillierDirector, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence (AI) and machine learning (ML) today, its potential across a variety of applications, an analysis of challenges faced by...
Building Blocks of Quality: The Role of Design Control in Medical Device Development
Design Control is a critical quality management system process that allows for a concept be developed and evolve into a reliable and safe product that can be consistently and reproducibly produced for commercial use. The process uses a systematic approach to define...
Achieving Regulatory Clearance for a Novel Device – Provisio Medical
Provisio™ SLT IVUS™ System Creating a novel medical device typically includes innovation around treatment, capabilities, cost reduction, or usability that results in improved patient outcomes. It also requires working with regulatory authorities to determine which...
Playing Defense: Cybersecurity for Diagnostic Devices
No industry or device is immune from the risk of cyber attacks. And it’s especially important that medical devices including diagnostic instruments combine a robust cyber security post-market release plan with software applications to support data safety along with...
Expert Insights: Project Management with Matt Perry
Matt PerryVP of program management at VeranexRecently we sat down with Matt Perry, VP of program management at Veranex, to talk about common project management issues within medtech, and his recommendations for overcoming them based on more than two decades of...
Ensuring Compliance with New FDA Guidance on Software Documentation & Cybersecurity
New guidance from the FDA replaces similar, but now obsolete, guidance. Some of the guidance was issued in response to the PATCH Act, which is a 2022 amendment to the Food, Drug and Cosmetics Act of 1938 that also pertains to medical device cybersecurity. It includes...
Clinical Utility Evidence Planning: Framework, Assessment Techniques, and Case Study for a Diagnostic Test
Clinical utility describes the usefulness of a medical product (device, diagnostic/prognostic, or therapeutic) for physicians and/or patients, and key questions include the following: “Would physicians change their medical recommendations for the better (e.g., align...
Appropriate, early planning for medical device development could help outshine the darkness of Alzheimer’s disease
Exciting developments in the area of medical devices for the diagnosis, prognosis, treatment/management, and monitoring of Alzheimer’s disease (AD) have progressed over the last few years, including a wrist-worn device that measures sleep and daytime activity as well...