AI in Medtech: Innovating in An Era of Uncertainty

Posted by Kate Templeton on July 23, 2019

This post is the second in a multi-part 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.

With the speed and impact of innovation increasing rapidly, our institutions have struggled to keep up. For better or worse, rules and regulations have typically lagged behind the innovation frontier, responding only when a crisis or particular incident highlights a new challenge to be managed or risk to be mitigated. This dynamic isn’t specific to healthcare—just think back on all of the questions raised in the last few years with Tesla’s autopilot car crashes to see the parallels. Regardless of industry, for those innovators on the cutting edge, this creates an environment of regulatory uncertainly that is inherently risky for the companies that blaze forward assuming a specific regulatory approach will be adopted by the relevant authorities. The more disruptive the technology, the more likely it is that such an environment will exist.


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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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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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How COAPT’s ‘All or Nothing’ Trial Design Is Making Sense of a Messy Disease

Posted by Kate Templeton on October 12, 2018

Landmark. Groundbreaking. Blockbuster. All of these words, and then some, have been used to describe Abbott’s recent trial (COAPT) to support MitraClip’s indication expansion to include functional mitral regurgitation.

The trial decisively demonstrated that transcatheter mitral valve repair using MitraClip reduced hospitalizations for heart failure by 47% and all-cause two-year mortality by 38% when compared to medical therapy alone in patients with heart failure and severe functional mitral regurgitation (FMR). When the principal investigator, Dr. Greg Stone, announced the results to a standing-room-only crowd at TCT 2018 last month, the data was met with spontaneous applause.


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Planning Your Launch Amid the US/EU Regulatory Convergence

Posted by Kate Templeton on January 4, 2018

Dan Frey and Barun Maskara co-wrote this blog post with Kate Templeton. 

Five to 10 years ago, many medium- and high-risk medical devices were expected to be commercialized first in Europe, with U.S. approvals lagging years behind. Industry leaders often criticized the FDA for inconsistently enforcing sometimes unclear regulations, and lamented that the lengthy and unpredictable U.S. approval timelines were driving innovation overseas.


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