From the Editor

In December, we asked Medical Design Briefs readers to cast their ballot to choose from our 12 Products of the Month the technology they felt was the most significant new introduction to the...

FDA says it is continuing to advance its scientific and technical capabilities, but a recent New York Times editorial says the agency is in...

AT&T is building up its FirstNet network, while also rolling out 5G New Radio — both of which are part of the future of connected of healthcare. FirstNet is a...

Under new rules to market medical devices in the European Union (EU), only 27 percent of respondents said they will be fully compliant with the regulations...

From the Editor : FDA/Regulatory
From the Editor — The Modern FDA: A New Pathway Gets Under Way

As a first step toward implementation of its recently established Safety and Performance Based Pathway for medical devices, FDA is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices:

With increasing investments in R&D to develop self-healing, comfortable monitoring systems, a recent report indicates that electronic skin is gaining...

From the Editor : Manufacturing & Prototyping
From The Editor — What Manufacturers Want Most

Manufacturers are focused on improving their design processes far more than on improving their design tools, according to a recent study.

The test phase of FDA’s Software Precertification (Pre-Cert) Program has hit its halfway point. The agency has released an update on its progress and the...

From the Editor : FDA/Regulatory
From the Editor — FDA Moves to Increase Transparency of Medical Device Reporting

In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of important steps to update its Medical Device Reporting (MDR) Program, says Dr. Jeffrey E. Shuren, MD, JD,...

Political uncertainty will be the biggest factor that could upend healthcare transactions according to a recent Merrill InsightTM poll of global mergers and...

A new house bill is set to end the medical device tax once and for all. H.R. 2207 was introduced in April — it’s goal to permanently repeal the...

Spurring Innovation of Brain-Computer Interface Devices FDA is continuing to encourage innovation in novel areas — the latest being novel brain implants, often...

From the Editor : Wearables
From the Editor — Reimagining Digital Health Devices: FDA’s New Precertification Model

When digital devices and technologies became the rule rather than the exception, FDA had to rethink its regulatory framework and evaluation process for getting these devices to market. In January, FDA issued its new Software Precertification (Pre-Cert)...

From the Editor : FDA/Regulatory
From the Editor — Giving the 510(k) Pathway a Much-Needed Makeover

Making changes to a regulatory process is usually difficult, slow, and often painful — after all, it involves lots of bureaucracy and many “cooks in the kitchen.” But I’m encouraged by FDA’s recent announcement that it plans to modernize the 510(k) pathway. In...

From the Editor : Electronics & Computers
From the Editor — Revolutionary New Radio Architecture Brings the Long Battery Life Needed for IoMT

The IoMT has ushered in a new era for connected medical technology. But battery life is often mentioned as one of the impediments to the advancement of IoMT. Batteries in medical devices need a long lifespan so that users aren’t having to...

With a 2020 deadline looming for the European Union’s Medical Device Regulation (MDR), medical device makers “lack understanding of the new rules...

From the Editor : Medical
From the Editor — Apple’s Mobile Apps Break New Ground in Cloud of Controversy

In September, FDA granted de novo classification to two apps offered in the new Apple Watch Series 4, which the tech giant says have been “redesigned and re-engineered to help users stay connected, be more active, and manage their health in powerful new...

From the Editor : FDA/Regulatory
From the Editor — Can Your Medical Device Help Solve the Opioid Crisis? Tell FDA

Earlier this year, FDA sent a challenge to the medical device industry: develop devices and diagnostics to help combat, prevent, and treat the opioid crisis.

From the Editor : Medical
From the Editor – If Reinstated, Excise Tax Should Apply to Broader Base

New research has confirmed what device companies have been saying since the medical device excise tax was imposed on medical devices as part of the Affordable Care Act: the tax forced them to cut funding for research and development.

From the Editor : Medical
From the Editor — Medical Device Sector Remains Attractive to Investors, Neuro Shows Significant New Interest

The medical device industry’s active M&A market and uncrowded investment space make it attractive for investors looking to get into healthcare. A recent report from Silicon Valley Bank (SVB) says that as a result, traditional...

From the Editor : Medical
From the Editor – MedInnovation: A Roadmap for Emerging Technologies

I am truly excited about this month’s inaugural MedInnovation conference. It’s goal is to present a roadmap for getting innovative — and by that, I mean game changing — emerging technologies to market. This intimate forum will be a platform for the exchange of ideas...

From the Editor : Software
From the Editor – Mitigating Device Misuse and Lability via Virtual Reality Training

A virtual reality system for training surgeons is gaining traction with major medical device companies looking to mitigate misuse and liability concerns.

From the Editor : Medical
From the Editor – Learn How to Commercialize Emerging Technologies from the Ones Who’ve Already Done It

A new interactive conference will address key strategies for the commercialization of emerging medical technologies, and its unique format will have you on the edge of your seat.

From the Editor : Photonics/Optics
From the Editor — And the Winners Are ...

In December, we asked Medical Design Briefs readers to cast their ballot to choose from our 12 Products of the Month the technology they felt was the most significant new introduction to the design...

From the Editor : FDA/Regulatory
From the Editor – FDA Ushers in a New Era of 3D Printing and Additive Manufacturing

FDA is monitoring the emerging field of 3D printing and additive manufacturing, an area FDA once considered a “futuristic technology on the distant horizon.”

From the Editor : Robotics, Automation & Control
From the Editor: Are Medical Robotics About to Change the Face of Healthcare?

The integration of robotics into medical devices has seen explosive growth in recent years with new applications in areas such as prosthetics and rehabilitation, surgical, and even drug-delivery devices. A new report predicts that the medical robotics market will...

From the Editor : Medical
From the Editor: The MDDT Program: Streamlining Medical Device Approval

FDA has qualified the first tool under its new Medical Device Development Tool (MDDT) program. According to AAMI, after some 20 years of use, manufacturers of devices designed to address heart failure will no longer have to justify using the Kansas City Cardio­myopathy...

From the Editor : Medical
From the Editor: Making Sure Medical Devices Play Nice Together

In this world of increasingly smart technology, the one place that interconnectivity is critical is in healthcare. Patients and their care givers should be confident that the devices that are “talking” to one another are doing so safely and without error.

From the Editor : IoMT
From the Editor: The Future of Medical Manufacturing

The Future of Medical Manufacturing implementing automation. It is embracing 3D printing, Industry 4.0, the Internet of Things, artificial intelligence (AI), and even augmented reality — the layering of the physical and digital worlds.

From the Editor : Medical
From the Editor: A Cure for the U.S. Medical Innovation Ecosystem

As 2016 came to a close, the U.S. House of Representatives overwhelmingly approved the 21st Century Cures Act by a vote of 392–26, and the Senate passed it by a vote of 94–5. The Act, which was strongly supported by the device industry, is the result of a two-year effort to...

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