The Rise of Patient Stakeholders: What CMS’s Shared Decision-Making Policies Mean for Medtech

Posted by Kate Templeton on June 13, 2019

This post is the first in a multipart series on how the rules of the road are changing in medtech, and the implications on commercial strategy. Sundeep Karnik contributed to this blog post.

A few months ago, I attended the 2019 American College of Cardiology conference and was surprised by the number and diversity of sessions on shared decision-making. The concept has taken on a more prominent role in conversations lately thanks to CMS, whose changing policies have opened the door for patients to play an expanding role in therapy selection. In fact, for the second time in six months, the rising role of the patient in the treatment decision-making process was a talking point at a major conference: It was also on display rather poignantly during TCT 2018, when patients joined key opinion leaders on several panels to share their experiences and perspectives on topics ranging from clinical trial design to the impact of particular technologies.


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ACC 2019: What the Latest Procedural Advancements Might Mean for Medtech

Posted by Eric Sin on April 16, 2019

Just a couple of weekends ago, I sat in the crowd at the American College of Cardiology (ACC) conference in New Orleans as Dr. Leon and Dr. Reardon presented on transcatheter aortic valve replacement (TAVR) trials in low-surgical-risk aortic stenosis (AS) patients. These findings will not only raise paradigm-shifting questions for the AS market but also prompt discussion around some common industry dilemmas, especially for markets where effective but expensive procedure options become more widely accepted for broader patient populations.


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What Medtech Companies Can Learn From Apple's Virtual Clinical Study

Posted by Kate Templeton on March 21, 2019

The American College of Cardiology’s (ACC) Scientific Session and Expo, held March 16-18 in New Orleans, kicked off Saturday morning with the initial results of the much-anticipated Apple Heart Study. For those who keep pace with the fast-moving tech world, I’m sure it felt like an eternity since the study had been announced. But by healthcare standards, the study went quickly and accomplished something unthinkable: It enrolled a breathtaking 419,297 individuals in eight months using a novel, entirely virtual study design.


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