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FEATURE ARTICLE

The Human Side of AI Medical Devices: Why Safety Depends on Design, Not Just Algorithms

By Shreya Sridhar

Human factors engineering plays a critical role in the design of AI-enabled medical devices and whether they might improve care or introduce new risks.  



FEATURED CONTENT

The Healthcare Burnout Backlash (pt 3): How Workflow Redesign Is Helping Healthcare Organizations Offset Staffing Shortages

By Melissa Corneal

As organizations introduce additional technologies, including AI-enabled tools and CRM platforms, these gaps become more pronounced. Those that are seeing meaningful improvements are taking an end-to-end view, evaluating how systems interact within a unified workflow and ensuring that data flows seamlessly and actions are triggered in a coordinated manner, thereby reducing the need for manual intervention and follow-up.

The Healthcare Burnout Backlash (pt 2): Positioning AI pilots for success within EHR-integrated environments

By Melissa Corneal

In this part 2 of a 4-part series, Melissa highlight how the moment AI begins to influence decisions or workflows, it is operating within a regulated environment. Aligning with documentation standards, keeping data within established pathways, and ensuring actions are consistently recorded are all ways to support that reality early, rather than adapting to it later. Seen this way, integration is not just a technical milestone.

How Rural Health Systems Are Advancing Cardiac Imaging

By Dr. Joseph Cardenas, Dr. Khidir Osman MD, FACC

Geography is effectively determining whether patients receive timely cardiac diagnosis, or even any diagnosis at all. In an effort to address the problem, cardiologists and health systems are increasingly looking to cardiac CT to redefine how advanced imaging can be delivered closer to where patients live.

The Human Side of AI Medical Devices: Why Safety Depends on Design, Not Just Algorithms

By Shreya Sridhar

Human factors engineering plays a critical role in the design of AI-enabled medical devices and whether they might improve care or introduce new risks.

Healthcare Burnout

The Healthcare Burnout Backlash (pt 1): Burnout Reaches Well Beyond Clinicians

By Melissa Corneal

In this part 1 of a 4-part series, we look at how the burden of digital transformation is impacting the entire healthcare ecosystem, and that while burnout in healthcare is most often framed around clinicians, it does not reflect where the full transformation work is actually being carried...or its impact across healthcare.

healthcare data

Clinical Trials Have Too Much Data…That’s the Problem.

By Melissa Mooney

Data has become overwhelming in healthcare. While it has provided tremendous solutions and outcomes, however, it can sometimes be a problem, too! How can data utilization in Clinical Studies and a ground up data strategy help make your technologies, your team, and your trials more efficient?

The 510(k) Pathway in 2026: Navigating a Shifting Regulatory and Political Landscape for Medical Devices

By Partha Anbil

A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. It is a foundation for the U.S. Food and Drug Administration's (FDA) 510(k) premarket notification process, the primary pathway for new devices to enter the market.

MedTech Commercialization

Decision Criteria for Technology Commercialization of Medical Devices in 2026

By Partha Anbil

Commercialization strategy in 2026 and beyond is more than a checklist. It requires a new mindset where cybersecurity is seen as a patient safety imperative, data is treated as a critical strategic asset, and product lifecycle is an intelligent process.






MEDTECH VIEWPOINT

north star

Beyond Reimbursement: Why Market Access is MedTech’s Strategic North Star

By Joan Hinrichs

Companies that embed Market Access early in innovation are the ones best positioned to navigate the changing global landscape.

QMS Interoperability

Chicken or the Egg: Should Device Interoperability or QMS Interoperability Come First?

By Carl Washburn

To achieve medical Device Interoperability, system boundaries need to be defined, system architecture needs to be aligned, and interfaces and communication protocols need to be established across individual components of the medical device. In some cases, it is as important to design and implement QMS Interoperability as it is to design Device Interoperability.

Why Digital Tool are Needed to Cope with Increasing Pressures in MedTech Innovation

What is driving the need for increased transparency across the MedTech organization relative to product innovation, development and commercialization?

Mental Health Reimbursement

Demand for Non-Pharmacological Mental Health Needs a Delivery System

By Allan Gobbs

The next phase of digital mental health adoption depends less on innovation and more on how the industry uses real-world evidence, builds reimbursement frameworks, and applies regulatory precedent to accelerate scale.

ASK THE EXPERT

medtech development

Product Development Outsourcing Needs Speed, Safety & Certainty

Seek partners who can see your vision — the full picture, anticipate challenges, and help you navigate complexity with confidence.

medtech design standards

4 FAQs to Notified Bodies

Notified bodies receive numerous questions from legal manufacturers during technical assessments. We cannot always answer them for individual legal manufacturers because this would constitute consultation.

Product Lifecycle Management

Managing MedTech Cost Pressures With Data-Driven Lifecycle Intelligence

To navigate increasingly complex global regulations and rising market expectations, organizations are embracing the Intelligent MedTech Lifecycle: a unified, data-driven approach that breaks down silos and drives agility across the entire product journey.

NEWS

  • BD Announced Application of CE Mark for the Liverty TIPS Stent Graft

  • Blackstone and TPG Complete Acquisition of Hologic; Names New CEO

  • Endospan Receives FDA Approval for the NEXUS Aortic Arch Stent Graft System

  • InVera Medical Receives FDA Clearance for Non-Thermal Chronic Venous Disease Device

  • Allevion Medical Receives 510K Clearance for Vantage Spinal Decompression System

  • Boston Scientific receives FDA clearance for the Asurys Fluid Management System

  • Serenity Medical Receives FDA Humanitarian Device Exemption for IIH Venous Stent

  • Merit Medical Acquires View Point Medical, Inc., expanding the Merit Therapeutic Oncology Portfolio

  • FDA Publishes New Set of Real-World Evidence Examples

  • CDRH Guidance: Patient Preference Information (PPI) in Medical Device Decision Making

  • BSCI’s LAAC CHAMPION-AF study for WATCHMAN FLX meets primary and secondary safety and efficacy endpoints

  • Apple Store to ID Regulated Medical Device Apps

  • Where are you with EUDAMED?

  • HL7 Launches Real‑Time Medical Device Interoperability Accelerator

  • Two GA Tech ATDC Startups — Nephrodite and OrthoPreserve — Secure FDA Breakthrough Device Designation


Upcoming Events & Webinars

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On Demand Events & Webinars

December 1, 2025
From Silos to Synergy: Building the Intelligent MedTech Lifecycle
September 17, 2025
Japan Medical Device Reimbursement Strategy
February 26, 2025
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery
September 26, 2024
Adopting a RIM Platform in MedTech: Myths vs. Reality
August 27, 2024
Decoding global regulatory pathways: How to classify your Medical Device
July 31, 2024
Managing global regulatory strategy and compliance: assessing status, gaps, and needs.
July 18, 2024
Now that the EU MDR deadline is passed, how do you sell your device abroad?









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Upcoming Events & Webinars

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Boost Product Quality with Integrated ALM and PLM
Whether you’re managing complex product portfolios, navigating regulatory pressures, or striving to deliver higher customer satisfaction, this guide will help you understand the tangible benefits of integrating ALM and PLM.

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