These three technologies, or lack thereof, are standing in the way of automated diagnostics.

Nigel Syrotuck

In August, a stumped group of Japanese doctors treating a 60-year-old woman turned to IBM’s Watson for help, eventually reaching the diagnosis of a rare form of leukemia. Artificial Intelligence is a natural fit for diagnostics: there are millions of medical papers available and more being released daily. Sifting through them and compiling data is a natural fit for a processor. There is just one catch: they are written in scientific English.

Thankfully, language interpretation is one of Watson’s key strengths, and it is...

November 9th, 2016
1

With CMS bundled payments expanding from joint replacement procedures to hip and femur fracture surgeries, Johnson & Johnson Medical Devices Companies offer consulting and data insights to help health systems cope.

Christina Farup, MD, MS

The end of 2018 is approaching, which is the date CMS has set as the goal for when half of healthcare providers will be reimbursed under an alternative payment model. There will be many stepping stones on the path to value-based care, from the Comprehensive Care for Joint Replacement Model (CJR) to the recently proposed Episode Based Model (EBM...

November 8th, 2016
0

It’s more important than ever for medical device developers to embrace a collaborative design process, but a number of hurdles stand in the way of achieving that goal.

Mary Beth Privitera, M.Des., PhD, FIDSA, and Tor Alden, MS, IDSA

It is an interesting and exciting time to be in the field of medical product design. User-centered design has become widely adopted and advancements in technology have provided many opportunities to improve the medical device use experience. But these steps forward have also come with challenges. One challenge for the design and development community is demonstrating the use and usability of medical devices as required for regulatory approval.

In...

November 7th, 2016
0

Improved medical technology and data tools can be helpful in improving value-based care, but they aren't always the key factors in providing accurate, cost-effective care for patients. Here's why.

Marie Thibault

As bundled payments and value-based care have taken over healthcare, many medical device manufacturers have introduced new products promising more accurate care and new services aimed at helping caregivers improve efficiency and cut costs. Yet new products and services aren't the only inputs in the value-based care equation. 

Richard Herzog, MD, executive director of the Quality Research Institute (QRI), discussed his research on the wide variability in MRI reports during the Spreemo QRI Summit...

November 7th, 2016
0

Who is repairing your medical devices? FDA should extend its regulatory oversight to the entities that service medical devices.

Patrick Hope

Who fixes your local CT scanner or MRI machine? This probably isn’t a question that keeps you up at night, but maybe it should. You might be shocked to learn that in many cases there are essentially no regulations on who services medical devices.

Currently, FDA only exercises oversight over service activities performed by manufacturers. However, devices are often serviced by many other entities, including in-hospital engineers and third party repair shops which vary in size and sophistication. These non-manufacturer groups are not currently held to any minimum quality, safety, or regulatory requirements.

...
November 7th, 2016
1

Edwards Lifesciences takes an old-school approach to innovation that will never go out of style.

Edwards Lifesciences's third-generation TAVR valve, Sapien 3, was
granted an expanded label for intermediate-risk patients this year. 

 

We had already decided to name Edwards Lifesciences the 2016 Medtech Company of the Year when I attended the AdvaMed 2016 conference in late October, but some of what I heard at the industry’s annual meeting of the minds made me question our choice.

...
November 4th, 2016
0

An expert details the Critical Feature Confirmation (CFC) process, which enables non-experts to offer input on a new medical device design without determining the final critical features. Learn more about the CFC process and how it can speed your time to market.

Edward Jaeck

The design of a new medical device is exciting, but presents unique challenges to new product development teams. Teams must design products with exciting features that provide new functionality while not delaying the product’s time to market. 

One current practice that can hinder this time to market is the complicated process of critical feature identification which can sometimes entail non-experts weighing in on portions of the new product development process that have no need of...

November 4th, 2016
0

Boston Scientific's chief medical officer discusses Watchman, Lotus Edge, and the company's three-pronged bet on bioresorbable scaffold technology.

Marie Thibault

Positive data on the Watchman left atrial appendage closure device shows how the product is performing in the real world.

Despite the less-than-stellar data on Abbott's bioresorbable vascular scaffold released at the Transcatheter Cardiovascular Therapeutics conference this week, Boston Scientific isn't backing away from the technology's potential. "Clearly, conceptually, a stent that disappears, leaves nothing behind, is very appealing," said Keith Dawkins, MD, global chief medical officer at Boston Scientific.

Rather than turn away...

November 3rd, 2016
0

Designing and testing devices using 3-D physical simulation is a key part of developing a commercial product.

Steve Levine

The Living Heart Project enables realistic simulation.

At a time when the industry is facing some of its toughest challenges, more than 200 regulators, engineers, and healthcare leaders came together in Chicago at the American Medical Device (AMD) Summit in October, to discuss the state of the medical device industry and focus on opportunities to accelerate innovation, with increased predictability and profitability. From a regulatory, patient and payer perspective, medical device business models are changing, creating an environment that has rendered sustainable...

November 3rd, 2016
0

While editors chose Edwards Lifesciences as the 2016 Medtech Company of the Year, readers selected another company as their favorite.

Marie Thibault

Hypertension and heart failure are some of the biggest health problems facing patients today, so it's fitting that MD+DI's readers chose a company focused on solving those problems as the Readers' Choice Medtech Company of the Year. CVRx has developed the Barostim Neo, an implantable system that stimulates baroreceptors to treat high blood pressure and heart failure.

CVRx, which has CE Mark for its device, has had...

November 2nd, 2016
0