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September 2026 Issue is Now Live!

 
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September 2026

Features

Current Events in Custom Medical Electronics

Medical electronics sit at the nexus of sophisticated device functionality, demanding clinical requirements, and complex manufacturing considerations.

Features

Mean Machines for Medical Device Machining

Medtech machining is evolving to keep pace with growing design complexity, device miniaturization, faster prototyping, and ever-tighter tolerances.

Features

Advancing Automation in Medical Device Manufacturing

Sophisticated tools such as IoT and AI are taking automated systems to the next level, offering opportunities for manufacturers to address labor shortages and the skills gap.

Editor's Letter

Additive Manufacturing at the Point of Care Is Here

In late July, 3D Systems announced it participated in an effort to make point-of-care additive manufacturing a reality.

Design Viewpoint

Protecting Form in Functional Systems: Design Patents in Medical Robotics

Design patents can play a meaningful role in medical robotics, where appearance influences adoption and competitive positioning.

Supply Chain

Medical Device Shortages Demand Greater Supply Chain Resilience

FDA's focus on supply chain resilience reinforces the importance of moving from reactive shortage management to proactive risk identification.

Cybersecurity

The New Minimum Elements Standard for SBOMs

The safe course of action for a manufacturer is to build SBOM generation into the build pipeline now (it should already be there).

Software Solutions

Automation to Autonomous Process Units: The Next Shift in Medical Device Manufacturing

The competitive advantage is no longer automation alone, but turning every manufacturing cell into an adaptive, validated quality system.

C-Suite Reflections

When the Medtech Carve-Out Becomes a Competitor

Two of medtech outsourcing’s most established names changed owners on the same Monday in August.

Regulatory Perspectives

FDA’s AI Expansion: Opportunities, Risks, and What Companies Should Expect

The FDA has invested significant time and resources into harnessing AI’s power.

From the Bench

Integrated Approaches to Reduce Use of Animals in Biocompatibility Testing

Biocompatibility evaluation is moving away from a prescribed battery of tests and toward an evidence-based assessment of biological risk.

Technology Spotlight

Commodity or Strategic Advantage? Rethinking Sterilization to Reduce Risk, Cost, and Time

The question is no longer whether a process can sterilize to standard, but how to make it more efficient, controlled, and predictable.

Datawatch

An Update on Human Factors Usability Testing for Medical Devices

2026 guidance rewards teams that were already doing human factors well and penalizes those who treated it as a documentation exercise.

Medtech Musings

AI Chatbots: A Conundrum for the FDA

AI chatbots have eased workloads for clinicians but raise concerns about safety and regulation.