It's critical to understand the market landscape and the factors that drive healthcare providers to adopt POC devices. 

Juan Roman

The Alere i system can provide molecular test 

results for the influenza virus within 15 minutes. 

 

The point-of-care (POC) market continues to grow, with devices such as Alere i and cobas Liat now commercially available and intended to disrupt the care pathway for influenza A & B and syndromic diagnosis. More devices and technologies for POC are in development, and...

July 21st, 2017
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Virtual and augmented reality will lead to new medical technologies and change the way medical device designers work. But first, these technologies have some significant challenges to overcome.

Jamie Hartford

It’s 2017, and we finally have true virtual reality (VR) and augmented reality (AR) experiences at our fingertips—or do we? Although AR and VR have advanced by leaps and bounds in recent years, we’re still a ways away from seeing headsets in every home.

VR and AR expert Brandon Bogdalek, a consultant for advanced development with Minneapolis-based design firm Worrell, recently expounded on...

July 18th, 2017
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Virtual and augmented reality technologies are set to disrupt not just medical devices themselves but also the way they’re developed.

Jamie Hartford

 

From Oculus Rift to Pokémon Go, once-futuristic virtual reality (VR) and augmented reality (AR) technologies are fast becoming mainstream. And like many technologies that take root in the consumer world, VR and AR are also making their way into medtech.

MD+DI caught up with VR and AR expert Brandon Bogdalek, consultant for advanced development with Minneapolis-...

July 17th, 2017
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Here are the human factors issues to consider when designing devices for home use versus designing for medical facilities.

Russell J. Branaghan

According to FDA, home use medical devices are intended for any environment, apart from a professional healthcare facility. Devices include capital equipment like hospital beds, therapeutics like infusion therapy, instruments like pulse oximeters, implantable devices like pacemakers, mobile apps, and a host of other products. There are several important considerations when it comes to the human factors of designing devices for home use versus designing for medical facilities.

Human factors engineering focuses on...

July 13th, 2017
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Have notoriously long review times for device regulatory approval in Japan improved in recent years? An expert on the Japanese device market analyzes the evidence in this two-part series.

Keisuke Suzuki

The intent of my research was to examine device lag, which consists of two components: review lag and apply lag. Review lag will determine whether PMDA is slower than FDA to approve new unique medical devices or not. Apply lag is the difference in the speed of availability of new medical devices between Japan and the United States.

Read the first part of this analysis here. 

In the first part of my analysis, we found that PMDA review times have...

July 12th, 2017
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Think FDA's cybersecurity guidance isn't enforceable? Think again.

Dave Saunders

FDA late last year published new guidance documenting postmarket management of cybersecurity in medical devices. It seems prudent to recognize this guidance for exactly what it is: a wake-up call for the medical industry that we are in the 21st century and the potential for hacking any medical device, whether it is connected to a network or not, is a problem that must be taken seriously. In the guidance, FDA provides the means of demonstrating a risk-based management...

July 11th, 2017
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Have notoriously long review times for device regulatory approval in Japan improved in recent years? An expert on the Japanese device market analyzes the evidence in this two-part series.

Keisuke Suzuki

Japan has jokingly been referred to as the last country to gain regulatory approval for medical devices, excluding North Korea. The Japanese government has been working diligently for more than a decade to reverse this last country mentality and to restore their reputation as the second largest medical device market in the world. The government has already revised the regulations a couple times, established the Pharmaceutical and Medical Device Agency (PMDA) as a separate body from the Ministry of Health, Labour and Welfare (MHLW), and hired more reviewers....

July 10th, 2017
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Learn about the crowdsourcing resources available to patients, health care practitioners, and medical device designers seeking to gather data and contribute to solving medical challenges.

Nigel Syrotuck

Online crowdsourcing communities are a game changer. These platforms allow anyone to appeal to the entire connected world for support or participation. They get many of us to participate—Kickstarter processed just shy of $500 million dollars in 2014. Most interesting, at least to me, are platforms for crowdsourcing information. These make up the next generation of online forums, ranging from chat forums to open source hardware development.

When it comes to medical information, open settings are probably not a wise...

July 7th, 2017
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The PocketECG aims to reinvent arrhythmia diagnostics through enhanced physical activity monitoring data.

Kristopher Sturgis

The PocketECG mobile cardiac telemetry system from MEDICALgorithmics includes extensive data on physical activity.

When it comes to diagnosing heart arrhythmia, running a simple electrocardiogram (ECG) often only tells part of the story of a patient’s heart. ECGs are often used to diagnose arrhythmias, but they can also help diagnose other serious conditions like coronary heart disease and cardiomyopathy. While the results are quick and painless, the data can still be limited when it comes to long-term monitoring of the heart.

A new cardiac company based out of Poland, known as ...

June 28th, 2017
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Medtech manufacturers can achieve a host of benefits—from speeding development to forming new partnerships—by looking outside their existing networks for technology solutions.

Bronwyn Monroe

Open innovation has become a mainstream practice for most technology-driven companies looking to accelerate time to market and stay ahead of the competition. The open innovation concept is based on the premise that a technology solution may exist in a more mature form outside of your own network and that connecting to an external solution provider will speed up development of new or existing products.

These external solution providers could be inventors, entrepreneurs, research labs, academics, or even Fortune 500 companies working on their own innovation for a particular application....

June 26th, 2017
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