It seems many medtech companies are still struggling with the concept of a shift toward value-based care, so we asked an expert for insight on tackling the challenge.

Marie Thibault

There's little doubt that a shift in business models from fee-for-service to value-based care is coming to the medical device industry—or rather, is already here. We need only look to recent headlines—Medtronic and Boston Scientific are two major companies that have begun to align themselves more closely with hospitals and patient outcomes—to see evidence of this.

Yet for all the discussion about the topic, it seems many medtech companies are still...

May 6th, 2015
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A look at what’s new in two recent legislative efforts to define FDA oversight of software.

Bradley Merrill Thompson

MEDTECH Act

The Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act took a big step forward on April 27. In reintroducing the bill, Senators Michael Bennet (D–CO) and Orrin Hatch (R–UT) significantly improved the language.

The MEDTECH Act is intended to implement the recommendations of the Food and Drug Administration Safety Innovation Act Workgroup, which Senators Hatch and Bennet requested in the 2012 FDASIA legislation. That working group, which took the form of a federal advisory committee comprised of patients, consumers, health care providers, startup companies, health plans or other...

May 6th, 2015
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Not every company can imitate Google’s practice of giving employees 20% of their work time to pursue passion projects, but there are other ways to foster a culture of innovation. 

Steve McPhilliamy

Today, the medtech industry is more dynamic than ever, with companies facing a growing number of competitive forces, including emerging technologies that impact core products, new user experiences that draw customers away from current offerings, and new startups that will change the competitive landscape. All of these threats have one thing in common: They are driven by innovation.

To be in sync with emerging and evolving market needs and stay ahead of...

May 5th, 2015
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Boston Scientific is the latest cardiovascular company to pair up with healthcare providers and software makers to extend its reach.

Marie Thibault

Like its competitor, Medtronic, Boston Scientific has found itself working more closely with hospitals to help centers increase efficiency and save money. Unlike Medtronic, however, the Marlborough, MA-based company will not directly manage hospital catheterization (cath) labs to do this.

On April 30, Boston Scientific announced two new partnerships outside of its usual device relationships. Under an agreement with MedAxiom, which is a cardiovascular consulting company and network for healthcare providers, Boston Scientific will design and offer programs to improve cardiovascular care and to help centers put in place methods of becoming more...

May 4th, 2015
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For technology to have big impact on healthcare, care programs need to be reinvented as technology alone cannot improve outcomes and reduce costs.

Arundhati Parmar

It's an exciting time in healthcare, believes Sean Hughes, vice president at Philips design who leads the firm's its strategic design consulting effort.

Data and connected devices are helping to move healthcare beyond the walls of the hospital into other care settings including the home. But while technology can enable the transition, ultimately success will be tied to how processes, design and care delivery programs evolve to meet the new demands caring for patients at home. Moving care of patients to their homes and monitoring them remotely leveraging technology is a...

May 1st, 2015
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What are the best uses for 3-D printing in medical devices today?

Andy Pfahnl, ScD

The medical device industry is embracing 3-D printing for a range of applications that include true medical devices and clinical use, and not just for medical or health-related products. We look at the three top reasons to consider 3D printing for medical devices by examining specific applications best suited for the state of the additive manufacturing technology.

Background

Medical devices are regulated and categorized according to risk level, which in general reflects the rigor required in their development. The adoption of 3-D printing for medical devices is in part gated by the rigor in verification and validation of designs and processes that are required with particular consideration of mechanical and thermal properties, and biocompatibility. There are several different 3-D printing methods for both metal and plastics. They...

May 1st, 2015
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Long FDA timelines and voracious cash requirements from portfolio companies have hobbled medtech angels in recent years.

Wende Hutton

The obstacle course of medtech innovation has proven so tough that another casualty is now on the horizon.

Instead of emerging as the winner of the race, angels and incubators are stumbling over one too many reroutes at FDA and treacherous paths to future financings. These early stag financiers are no longer lining up at the starting line with resources to take the place of dried-up venture dollars, leaving the ecosystem even more stretched to keep medtech leadership alive in the US.

While 2014 saw an enormous influx of $9 billion venture dollars into healthcare with an average round of $16.5 million dollars into Seed and Series A, medical device deals lagged the...

May 1st, 2015
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A relatively new technology has proven hackable by a group of academic researchers.

Marie Thibault

It seems nothing is safe anymore. The potential perils of hackers attacking lifesaving devices like insulin pumps and ICDs may already be well-known in the medtech community. However, the idea that patients could be harmed or even killed by remote tech-savvy villains is still shocking to most.

But those devices seem relatively banal compared to the latest medical technology to undergo testing by researchers who want to uncover its hackable shortcomings: telerobotic surgery. Killer robots, anyone?

Telerobotic surgery is still a novel concept to many. It essentially allows an...

May 1st, 2015
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Jamie Hartford

One of the best parts of my job is getting to attend the Medical Design Excellence Awards (MDEA) jurors’ weekend each February.

We round up a team of 12 esteemed engineers, designers, and clinicians—luring many of them to our office in Southern California from colder parts of the country just as winter is at its harshest—and then hold them hostage for two days while they comb through entry forms and product submissions. Their mission: to choose the most innovative products in 10 categories ranging from over-the-counter and self-care products to surgical equipment, instruments, and supplies.

I don’t participate in the judging, but I do get to hang around and be a fly on the wall. It’s...

April 30th, 2015
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A Zimmer executive explains to analysts why his company has so far steered clear of two major trends in orthopedics: robotics and value implants. 

Marie Thibault

While many of their peers have turned toward technologies like robotics or to cost-saving offerings like value implants, it seems Zimmer plans to stay away from those hot trends, at least for now.

This is notable because some of Zimmer's biggest competitors—Stryker, Smith & Nephew, and Johnson & Johnson—have either entered or announced plans to enter the robotic space. In...

April 30th, 2015
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