Warren Lesack

EU MDR: Ensuring Labeling Compliance

By Warren Lesack
Warren Lesack

EU MDR requires significant reforms to the device labeling process. Manufacturers must ensure that identifiers are correctly applied to products, and that key data elements and formats are accurate. In addition, manufacturers need to have access to centralized data, audit tracking, robust security controls, eSignature capabilities and strong workflow management to ensure compliance.

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Roger Lam
Soapbox

5 Ways to Maximize the Security of Edge Medical Devices

By Roger Lam
Roger Lam

Timely firmware updates are only one part of the hardware-related security equation. Whether it’s a hematology analyzer, CT scanner or any other networked medical device, the ability to withstand as well as recover from a malicious attack begins with the contract manufacturer that builds the embedded system. Here are five questions to ask your hardware integrator to be sure that your devices are equipped with maximum protection both before and after delivery.

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John Schwope
Soapbox

The Power of AI to Enhance Clinical Trials

By John Schwope
John Schwope

AI not only improves data collection and analysis, it impacts which products are engaged in clinical trials, determines necessary medical criteria, helps design the trials and can even choose the best participating facilities. The result is, organizations that leverage AI will be more successful and will go to market faster than those that don’t.

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David Goldman
Soapbox

Revolutionizing Healthcare: Augmented Reality’s Unprecedented Impact

By David Goldman
David Goldman

Augmented reality (AR), with the help of artificial intelligence (AI), is providing healthcare professionals with the means to offer patients an unprecedented level of care and personalized treatments, and assisting MedTech and life sciences companies in product design and development. Yet, the potential of AR with AI in health care is still far from fully explored.

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Patient on ventilator
MEDdesign

MD PnP Presents Remote Control Care Testing and Verification Method

By MedTech Intelligence Staff
Patient on ventilator

For “Systematic Testing of a Ventilator Remote Control System Towards Safe Use in Tele-Critical Care and Prolonged Care,” researchers developed a prototype system for network-based far remote-control of the NKV-550 critical care ventilator, with the goals of identifying and implementing foundational remote-control capabilities, and exploring essential performance, interoperability, and cybersecurity requirements.

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Amanda Bloom
Soapbox

MedTech Marketing Pearls for FDA Clearance and Beyond

By Amanda Bloom
Amanda Bloom

As VP of Product Marketing for a MedTech startup, my role is to champion pioneering medical technology, strategically spark interest and drive it out of the design lab and into the field where it will ultimately change, or even save lives. Over the last two decades, I’ve seen the industry evolve in interesting ways, and I’ve learned some enduring lessons about market introduction and launch of market-making technologies post-FDA clearance.

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Supply Chain and Adv Mfg 2023
From The Editor's Desk

Join J&J, Pfizer and FDA at the Supply Chain Summit and Advanced Manufacturing Conference

By MedTech Intelligence Staff
Supply Chain and Adv Mfg 2023

Supply chain challenges and the move to advanced manufacturing are two key issues affecting the Medtech industry. On November 7-9, MedTech Intelligence will be hosting the MedTech Advanced Manufacturing Conference and Supply Chain Summit, in partnership with Axendia, Inc. The two events will run back-to-back with registration options available for each program as well as a discounted rate for professionals who would like to attend both programs.

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