C.R. Bard

C.R. Bard Timothy Ring, chairman and CEO, speaking during the Stifel 2016 Healthcare Conference on November 15:

Ring

"I would suggest that changes in the Affordable Care Act or repeal isn't going to have that much of an impact on the volume. It didn't have the impact coming in with the incremental volume. We haven't had the price...

November 16th, 2016
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Stryker

Katherine Owen, vice president of strategy and investor relations at Stryker, speaking during the Stifel 2016 Healthcare Conference on November 16:

"I would say it's very much business as usual. I think there's optimism that corporate tax reform may be much more of a reality, which like many companies, we have a trapped cash problem. We generate about two-thirds of our cash outside the U.S. and continue to build up cash OUS. We would welcome tax reform.

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November 16th, 2016
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Boston Scientific

Boston Scientific CFO Dan Brennan, speaking during the Stifel 2016 Healthcare Conference on November 15:

Brennan

"I don't think we see anything specifically in terms of election results that makes us want to change our strategy. ACA, we've been very consistent in saying that we haven't seen a bump on the way up relative to ACA, so we...

November 16th, 2016
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Johnson & Johnson

On the day after the election, Alex Gorsky, chairman and CEO of Johnson & Johnson, published a message offering the company's support of the incoming administration and Congress.

Gorsky

Writing that Johnson & Johnson's role as "the world's largest and most broadly-based healthcare company" brings with it "a unique responsibility," Gorsky emphasized a focus on providing the best healthcare "at the best possible value."

"We...

November 16th, 2016
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What do medical device executives have to say about expected changes to the healthcare industry under the incoming Trump administration? Here's what five medtech leaders are saying about the potential for impact to their businesses.

More than a week has passed since the elections and medtech executives have had some time to consider what President-elect Trump and the new Congress will mean for their business.

Full or partial repeal of the Affordable Care Act is on the table, as is permanent elimination of the medical device excise tax and the possibility of a corporate tax repatriation holiday. What does this mean for device sales, investment in...

November 16th, 2016
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FDA launched two major initiatives in 2016—cybersecurity requirements and a national system for real-world device monitoring.

Jim Dickinson

The last year of the Obama Administration will likely be remembered by FDA-watchers for two major agency initiatives affecting medical device regulation: cybersecurity requirements and CDRH’s establishment of a National Evaluation System for “real world” device monitoring, one of three strategic priorities for the 2016-2017 timeframe.

Each of these has been under congressional scrutiny, something that both the Trump Administration and the reinvigorated Republican majorities on Capitol Hill seem likely to continue.

Cybersecurity vulnerabilities first came under notice in a 2005 FDA guidance, but did not get serious...

November 16th, 2016
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Harvard researcher Conor Walsh—a 2016 Rolex Award Laureate—discusses his team's development of a soft, wearable exosuit for people with physical impairments.

Marie Thibault

A soft, wearable exosuit for patients who have suffered strokes or have other mobility issues is in development.

Wearable robotic technology in the form of powered exoskeletons is undeniably one of the most futuristic and appealing developments in the medical device field today. The devices help patients impaired by spinal cord injuries or strokes walk. As miraculous as these capabilities are, the next phase of this technology is already on the way—soft exosuits that can be worn under regular clothing.

Conor Walsh, PhD, a core faculty member at...

November 15th, 2016
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Medical device makers should be aware of how FDA decides to regulate wound dressings containing drugs, since that regulation is likely to be broadly applied to all devices containing antimicrobial agents.

Randy Prebula, Jennifer Henderson, Danielle Humphrey, Chan Lee, Shilpa Prem

On September 20–21, 2016, FDA convened an advisory panel to seek recommendations about the regulatory classification for wound dressings containing drugs. These devices are widely used to treat medical conditions ranging from minor cuts and burns, to diabetic foot ulcers and historically have...

November 15th, 2016
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The in vitro diagnostics industry is expected to undergo a transformation. Learn more about the potential disruptors and what IVD companies can do to keep pace.

Karl-Hubertus Gruber, Dr. Michael Marquardt, and Laszlo Horwitz

Disruptions Form New Champions

Business has taught us plenty of examples in various industries of disruptive changes that severely restructured the market order. In the course of these disruptions, many well-known market leading players did not see these changes coming and missed the opportunity to effectively adapt their strategies, business models, and portfolios on time (see picture 1).

Picture 1: Examples of major market disruptions in the last 10 years

...

November 14th, 2016
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A pilot project focused on Parkinson's disease will use patient preference and risk tolerance to set statistical significance levels in clinical trial design. How will this impact the future of medical device trials?

Marie Thibault

A first-of-its-kind research project is aiming to translate patients' risk tolerances and preferences into innovative clinical trial designs. That means that statistical significance levels could differ based on a disease's severity and patients' willingness to accept riskier treatments.

The collaboration between the Medical Device Innovation Consortium (MDIC), The Michael J. Fox Foundation for Parkinson's Research (MJFF), FDA, RTI Health Solutions, and the Massachusetts Institute of Technology (MIT) is starting with a...

November 14th, 2016
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