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Popper and Company Advisor Michael Little Offers Insights on FDA’s 2014 Regulations for LDTs


August 15th, 2014
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On July 31, 2014, the U.S. Food and Drug Administration announced its plans for regulation aimed at ensuring that certain tests used by healthcare professionals provide accurate, consistent and reliable results. First, the FDA issued a final guidance on the development, review and approval or clearance of companion diagnostics. Second, consistent with the requirements of the FDA Safety and Innovation Act of 2012 (FDASIA), the agency notified Congress of its intention to publish a proposed risk-based oversight framework for laboratory-developed tests (LDTs).

I recently spoke to new Popper and Company senior advisor, Michael Little, Ph.D., who recently retired from industry after a long career as a senior executive in the in vitro diagnostic (IVD) and companion diagnostic (CDx) industries. Following are excerpts from that interview.

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FDA Mobile Apps Loophole Hazardous For Healthcare


July 23rd, 2014
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This post is originally published on InformationWeek Healthcare, July 23, 2014

THE FDA’S RELUCTANCE TO OVER-REGULATE MEDICAL APPS OPENS A PITFALL FOR HEALTHCARE ORGANIZATIONS THAT INNOVATE TOO FAR AHEAD OF THE CURVE.

The FDA’s recent guidance on mobile medical apps creates a gray area in which the agency will not automatically require approval for all new mobile medical apps, but may exercise “enforcement discretion,” depending on how the app functions, the risks it introduces to patients/consumers, and its intended use.

Read full post on InformationWeek Healthcare.


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What Does the Future Hold for Medtech? (Physicians Will Be More Like Engineers)


July 14th, 2014
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This post is originally published on MD+DI “Medical Device Business,” July 10, 2014
 

When I was asked to think about how physicians will be affected by the changes in the medtech industry over the next 5–10 years, I initially thought “not much.”

 

The field of medicine is a slow-moving beast with substantial inertia. Physicians tend to be quite conservative when treating patients for a number of reasons. Many physicians practice the way they were trained, which may have been a number of years ago, despite the continuing medical education requirements to maintain state licenses. Moreover, physicians may be liable if a bad outcome results from treatment that deviates too far from the current standard of care, so they may be reluctant jump on the latest trends in treatment, no matter how promising they seem. And the very first oath a future physician takes when entering medical school is Hippocrates’s, promising to “do no harm,” which often means “watchful waiting.”

 
Read full post on MD+DI.


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Q&A Part Two: Technology & Healthcare Efficiency—Not Always the Perfect Match


June 20th, 2014
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David Lee Scher, M.D., is a cardiac electrophysiologist and a pioneer in remote patient monitoring, adopting such devices to his medical practice more than 13 years ago. He also is the author of the well-respected blog, The Digital Health Corner, which addresses emerging issues regarding the adoption of digital health technologies. In Part One of my talk with David, who is the newest Popper and Co. team member, we discussed how technology can impact today’s healthcare environment, especially healthcare efficiency. In Part Two, we discuss challenges in development and adoption of these technologies.

 

WHY HAVE PHYSICIANS RESISTED A LOT OF HEALTHCARE TECHNOLOGIES?

Physicians are scientists. The first thing they want is evidence that something works. Few digital technologies have demonstrated benefit with regards to improving patient outcomes. But physicians still have a huge bad taste in their mouths from the original introduction of electronic health records, which represents the face of digital technology to them. Technology has to appeal to them in the way they practice medicine, addressing problems they face daily. It needs to solve whether they deal with communications, scheduling, medical adherence, or other issues in clinical management. Finally, many physicians are ideologically distant from participatory medicine. They don’t yet give the patient extreme importance when it comes to participating in their care. Part of this lies in the fact that they are not taking advantage of some digital tools available now which can improve patient self-management and involve caregivers to a larger extent.

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Enhancing the “Coolness Factor” in our Later Years


June 17th, 2014
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Biomedical advances over the last century have advanced our life spans to degrees that would seem miraculous to a late 19th century observer. But as a 100-year lifespan begins to approach “normal,” do we have a plan on how these extra 30 to 50 years should be lived?

Recently, I spoke at the spring meeting of the Buck Institute for Research on Aging, where topics ranged from better ways to prevent diabetes, to drug development for an aging population, to the importance of social networks among the aging, and other clinical and scientific approaches.

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Conversation about Veterans Administration’s Woes Has Not Yet Hit the Right Note


June 11th, 2014
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The Veterans Administration’s (VA) recent efforts to handle a huge influx of medical cases of former soldiers has quickly reached “scandal” proportions in Washington, D.C. and received widespread national media attention. But as revelations surface about the ways many of the agency’s offices tried to hide long wait times for veterans seeking care, the conversation about how to resolve the VA’s problems has not yet hit the right notes.

Current proposals to correct the VA’s course include firing Secretary Eric Shinseki (who resigned on May 30), ordering a criminal investigation by the FBI, and providing more funding to the VA. Meanwhile, the VA has seen an influx of 1.5 million veterans in the past three years, and 200,000 of them suffer from post-traumatic stress disorder (PTSD) or traumatic brain injury, according to Senator Bernie Sanders, Chairman of the U.S. Senate Veterans Affairs Committee.

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Q&A Part One: Technology & Healthcare Efficiency—Not Always the Perfect Match


May 28th, 2014
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David Lee Scher, M.D., is a cardiac electrophysiologist and a pioneer in remote patient monitoring, adopting such devices to his medical practice more than 13 years ago. He also is the author of the well-respected blog, The Digital Health Corner, which addresses emerging issues regarding the adoption of digital health technologies. I recently had a chance to talk to David, who is the newest Popper and Co. team member, about today’s healthcare environment, and the impacts technology can have on healthcare efficiency.

How did you get involved with digital health?

I became involved with remote patient monitoring in 2000 as the first cardiologist in private practice to utilize this for my patients with implantable defibrillators. But even before that, I used electronic medical records in my group practice. The system was even mobile (on the Palm Pilot in the late 1990s). From 2003 to 2005, I was instrumental in managing a project that took remote monitoring data from implantable cardiac rhythm devices to electronic records; this was cutting edge at the time. When mobile health/digital technologies started getting into the realm of smart phones, and sensors really fanned out, I wanted to get more involved in the field of mobile health, applying my clinical and technological experiences as a consultant. In 2011, when I started blogging on the subject, a clinical perspective was lacking. There still exists a gap between developers and clinicians. This gap is no better demonstrated than in the area of electronic health records and mobile health technologies.

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How Health Innovators Can Foster Patient Empowerment


May 6th, 2014
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Now that questions about implementation of the Affordable Care Act shift from “how many people have enrolled” to “will patient outcomes be improved,” healthcare innovators similarly would be wise to turn to finding ways to help shape, define and encourage the right outcomes.

Recently, the U.S. Department of Health and Human Services (DHHS) issued a draft set of recommendations for setting up a healthcare IT structure that helps ensure the physical safety of the patient (as well as his or her information), while preventing medical errors, reducing unnecessary tests, increasing patient engagement, and quickly identifying and responding to public health threats and emergencies.

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It Takes More than Technology to Change Health Behaviors


April 9th, 2014
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There’s no question that medical apps and software aimed at improving healthcare outcomes are hot items. In a previous post for Popper and Company, I discussed the growth in popularity of medical apps and the FDA’s new approach toward them, showing how new technology can simultaneously empower the patient/consumer and make important health-related information easier to access.

But during one discussion at last month’s SXSW Interactive Conference in Austin, experts and innovators alike underscored a more important consideration: How well do any of these inventions interact with patients and consumers?

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Five Tips for Folding FDA’s New Medical App Oversight into Your Business Strategy


March 27th, 2014
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In my post for InformationWeek Healthcare (available here), I discussed the implications of the U.S. Food and Drug Administration’s (FDA) final guidance for medical apps. While the September 2013 guidance specified that it would require clearance of any app intended to diagnose, treat, mitigate or prevent a disease, it left an open door to exercise “enforcement discretion” if an app meets the technical definition of a medical device but poses a low risk to the patient.

In this post, I will discuss the practical challenges resulting from this guidance, and how the evolving environment of app regulations should be folded into your business strategy.

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