Medical Blog

Flex Boston Innovation Center: Taking Products from Sketch to Scale

Staying relevant in the medical device industry requires operating “with real-time information, comprehensive capabilities, and a global physical infrastructure to deliver speed, scope, and scale to keep pace in this rapidly changing market.”

From the Editor — From Wearables to the Surgical Suite: The Future of Electronic Skin

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 — 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.

Fighting the Opioid Crisis: Researchers Present Breakthrough Tool in Upcoming Webinar

“Opioid abuse, misuse, and addiction has become one of the most profound public health crises facing the U.S. today,” says Jeffrey Shuren, FDA, CDRH....

Latest Patent Trends Favor Patentees — What Device Makers Need to Know

Medical device companies have challenged thousands of patents using the Patent Trial and Appeal Board’s (PTAB) administrative adjudication system. Introduced in 2012,...

From the Editor — Digital Health: Lessons Learned So Far from FDA’s Test Phase

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 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...

From the Editor — Outlook Mostly Upbeat for Healthcare Deals Next Year

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

From the Editor — Permanently Repealing the Device Tax to Protect Medical Innovation

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...

From the Editor — Spurring Innovation of Brain-Computer Interface Devices

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 — 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...

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...

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...

From the Editor — EU MDR: Many Device Makers Unprepared as Impending Deadline Draws Near

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 — 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...

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...

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...

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...

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...

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...

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...

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 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...

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...

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...

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...

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...

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...

From the Editor — Muddy Waters May Be in Hot Water over Flawed St. Jude Report

In late August, short-selling investment firm Muddy Waters issued an alarming report claiming that St. Jude Medical’s pacemakers, ICDs, and CRTs “should be...