When it comes to verification and validation, medical device companies need to ensure that what they're doing actually makes sense. 

Jon Speer

 

 

How confident is your medical device company when you reach the design verification and design validation stages?

Known colloquially as “V&V,” for many it feels like you’re on the homeward stretch to market, yet there are often issues causing companies to get stuck.

For example, do you want to ensure that you have the “right” answers? Or are you more interested in asking the right questions? The distinction can be very important and is a big part of what should inform your V&V processes.

I had a...

August 21st, 2017
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It’s easy to lose track of the “big picture” when you are deep into the design and engineering of a next-generation product. Having a focus on a systems approach is important throughout the process. 

Erik Reynolds

In product development, the big picture matters. The “big picture” isn’t just theory. It’s a mindset that needs to be a part of every decision.

It’s important that both engineers and designers tasked with bringing that next great idea to life have a broad systems-level understanding of what’s being created. It’s also crucial for these professionals to possess an understanding of the market for the device so they can optimize development against clear and decisive goals.

Having a focus on a...

August 18th, 2017
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Which categories of digital health products will be subject to which actions within the CDRH's Digital Health Innovation Action Plan? Experts dissect the latest developments.

Nancy Stade, Allison Fulton, and Zimu Yang 

FDA Commissioner Scott Gottlieb’s recent blog posts in the FDAVoice about FDA’s Digital Health Innovation Plan have sketched out multiple different actions that cover a diverse group of digital health products. This group ranges from fitness trackers that...

August 11th, 2017
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These are some of the biggest game changers in the medical device industry right now—and some lesser-known financing strategies that manufacturers can consider to prepare for continued growth.

Austin Wilson

The medical device industry, and the healthcare industry as a whole, is poised for exponential growth in the coming years. Deloitte’s 2017 Global Health Care Sector Outlook points to a projected $8.7 trillion in global healthcare spending by the year 2020.

This rapid growth, along with ever-advancing technologies and debated changes to healthcare policy, presents both...

August 10th, 2017
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Laser marking is an effective and safe solution for marking unique device identifiers directly onto medical devices.

Tom Glass

Laser marking can be used to mark medical devices with a unique device identifier.

In 2013, FDA enacted a measure that requires most medical devices manufactured in the United States to carry a unique device identifier (UDI). This rule is intended to improve patient safety and increase accountability for manufacturers of medical devices in case of an adverse event. Laser marking is an effective and biocompatible method to keep manufacturers fully compliant with these new...

August 8th, 2017
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Here are the 11 medical technology products in the running for the 2017 Prix Galien USA Best Medical Technology Award.

Every year, the Galien Foundation chooses top products in the medical technology, biotechnology, and pharmaceutical fields to honor with its Prix Galien USA Awards. This year, there are 11 products vying for the title of 2017 Best Medical Technology Award.

To be considered for the prize, these medical technology products all received regulatory go-ahead from FDA in the past five years and have shown the capability to have an outsized effect on...

August 4th, 2017
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ATTUNE® Knee System

The ATTUNE® Knee System from DePuy Synthes, part of the Johnson & Johnson family of companies, is designed for knee reconstruction. Various knee technologies are available through the system, including the ATTUNE Fixed Bearing Knee, ATTUNE Rotating Platform Knee, and ATTUNE Anatomic Patella. Earlier this year, data from the National Joint Registry for...

August 4th, 2017
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BrainScope® One

The BrainScope® One from BrainScope Company received FDA 510(k) clearance in September 2016. The device consists of a disposable headset outfitted with electrodes and a smartphone component that uses machine learning and algorithms. The system takes electroencephalograph (EEG) readings to evaluate the extent of brain damage in patients exhibiting signs of mild traumatic brain injury, and is intended to...

August 4th, 2017
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CardioMEMS™ HF System

The CardioMEMS™ HF System from Abbott is an implant that remotely monitors for signs of worsening congestive heart failure by measuring a patient’s pulmonary artery pressure. FDA approved the system in May 2014. Data from the “CardioMEMS Heart Sensor Allows Monitoring of...

August 4th, 2017
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EVARREST® Fibrin Sealant Patch

The EVARREST® Fibrin Sealant Patch from Ethicon, part of the Johnson & Johnson family of companies, uses human biologics—thrombin and fibrinogen—to create a structure for clot formation to stop bleeding. In December 2012, FDA granted approval for the product’s adjunctive use in specific surgical cases, including open retroperitoneal, intra-abdominal, pelvic, and non-cardiac thoracic...

August 4th, 2017
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