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...
Document Review: A Nuanced Process in Medical Writing
Veranex is determined to provide complete support to our healthcare partners to reach our shared goal of advancing medical care and improving patients’ quality of life. Our integrated, comprehensive solutions support every stage, from concept to commercialization. In...
Case Study: Determining Daily Fertility Through an App that Tracks Basal Body Temperatures and Period Data
Key Insights on the Challenges of Whitespace Innovation
We recently sat down with three big-picture thinkers at Veranex to talk about whitespace innovation — its challenges, how we’ve seen it done successfully, and our unique approach. Read on to find out what Lisa Carmel, Greg Johnson, and Mike Susi have to say on the...
Risk Management in Pharmacovigilance
It’s important to know that whenever a new medicinal product is authorized based on specified indications at the time of authorization, the benefits of the product for the target population must be shown to outweigh the risks of using the product. Generally, ...
Avoid These Four Medical Device Supply Chain Woes
Anyone who works in medtech product development knows that surprises are a guarantee. That’s why it’s important to create stability and predictability whenever possible — especially when it comes to supply chain. Below, experts from our manufacturing team lay out four...