Virtual reality can be used to help develop medical products people will want to use.

Andrew Sweeney

The basics of virtual reality (VR) are no secret: originally adopted by gamers, it’s a computer technology that reproduces a physical environment, allowing the user to simulate a presence in and interact with that environment. What may be a surprise, however, is its application to areas beyond gaming—including medical device development.  

Simulation in VR provides a medical device development professional with a first-person glimpse into a world experienced only from the product users’ perspective. This is important, because an empathetic understanding of end users must be maintained throughout the product development process. That impacts human...

July 26th, 2017

In the third installment in a series on women in medtech, Maria Sainz talks about the challenges and missions of her prior roles as a division president at Guidant/Boston Scientific and president/CEO of Cardiokinetix.

Maria Shepherd

Maria Sainz, former division president of Guidant/Boston Scientific and former president and CEO of Cardiokinetix, is no stranger to taking risks in her career. She started in medtech in sales and quickly became the France country manager for IVAC & Physio-Control when they were divisions of Eli Lilly. After a move to Guidant in 1995 as manager of Emerging Markets EMEAC, she rose to president of the Cardiac Surgery Unit of Guidant in 2003 and then successfully led Guidant’s Cardiac Surgery through its ...

July 25th, 2017

In an increasingly connected world, how do we ensure that the software that controls medical devices functions as planned with little to no risk of harming the patient?

Jeffrey Fortin

Medical devices, including patient monitors, ventilators, and defibrillators are created to provide lifesaving capabilities. Today’s medical device manufacturers are also at the forefront of developing innovative new ways to deliver patient care, from wearable electrocardiograms for use at home to more complex devices such as robotic nurse assistants to help caretakers lift patients within a healthcare facility. However, to ensure that patients are not at risk, it is critical that any of these medical devices behave correctly in all circumstances.  ...

July 24th, 2017

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

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

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

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

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

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

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