Advanced Medical Technology


Technology is rapidly creating new ways by which the medical industry can enhance our lives and save billions of dollars in health care costs.

Researchers use 3D printers to cheaply create medical devices that can be directly implanted into the human body. Already, doctors have fashioned 3D-printed splints to help children with rare breathing disorders and have successfully implanted a 3D-printed titanium sternum and ribs into a cancer patient.

Wearable technologies can likewise aid in improving proactive health care.  Sophisticated wearable health devices can remind users to take medications or contact medical professionals as necessary and eventually help users track and even diagnose various conditions before advising a course of action. Other experiments with implantable “hearable” devices, “smart” contact lenses and glasses, and even tactile networked patches and fabrics seek to cheaply and seamlessly monitor other health vitals like blood glucose levels, blood pressure, brain activity, and stress.

Regulators must take care that their new policies allow patients to enjoy the full benefits of these advances in medical technology. In the case of health care, the choice between permissionless innovation and precautionary regulation can literally be the difference between life and death for those waiting for life-saving medical care.

You can find more Mercatus research and commentary on advanced medical technology below.

Research

The Right to Try and the Future of the FDA in the Age of Personalized Medicine
Adam Thierer
July 2016

In a new study for the Mercatus Center at George Mason University, Mercatus Senior Research Fellow Adam Thierer offers a fresh perspective on the right to try. Rather than wading into the ethical debate, the study questions the practicality of government control over patient decision-making in an era of increasingly personalized medicine and decentralized technology. Owing to the nature of technological innovation, a de facto right to try may already exist for some medical devices, such as 3-D–printed prosthetics. The practicality of government regulation matters, and the FDA’s old command-and-control approach is increasingly ill-equipped to handle future medical developments. The FDA should reorient itself to focus on risk education, streamline its review processes, and improve consent mechanisms to keep pace with innovation.

Guns, Limbs, and Toys: What Future for 3D Printing?
Adam Thierer and Adam Marcus
June 2016

This Article will focus on how 3D printing could offer the public significant benefits, but not without some serious economic, social, and legal disruptions along the way. Part I explains what 3D printing is, how it works, and discusses specific applications of this technology and its potential benefits. Part II turns to the policy frameworks that could govern 3D printing technologies and itemizes a few of the major public policy issues that are either already being discussed, or which could become pertinent in the future. Part III offers some general guidance for policymakers who might be pondering the governance of 3D printing technologies going forward. Finally, the authors suggest making the default policy position for 3D printing permissionless innovation. This is the notion that innovation should generally be allowed without prior restraint, and that problems, if they develop at all, are better dealt with in an ex post fashion. Contrary to the many other articles and position papers previously penned about 3D printing policy, which only selectively defend permissionless innovation in narrow circumstances, this paper endorses it as the default rule across all categories of 3D printing applications.

The Proper Role of the FDA for the 21st Century
Joseph Gulfo, Jason Briggeman, and Ethan Roberts
February 2016

This study evaluates current FDA policy toward new medical products and concludes that the FDA must return to its role as gatekeeper of safe and effective drugs and devices. The FDA has made significant incursions into private health decisions by exercising its public health mandate in a manner that was not intended by Congress. Rather than allowing doctors and their patients to determine how best to use a drug and ensuring that drugs placed in the market are safe and effective, the FDA has increasingly become concerned with controlling the outcomes of future judgments by physicians and patients regarding benefits and risks. The new medical marketplace should refocus the FDA on safety and effectiveness, leaving patients and doctors to evaluate and determine benefits and risks based on their experiences with the drugs.

U.S. Medical Devices: Choices and Consequences
Robert Graboyes, Adam Thierer, and Richard Williams
October 2015

This paper shows why the current system of medical device approval discourages technological innovation and ultimately affects patient choice. The approval process could be improved by introducing competition for approval—a process that already exists in the European Union. Private evaluation organizations, which already evaluate products and make approval recommendations, and the FDA can compete to inform patients and doctors about the safety and effectiveness of medical devices. Because each relationship between a doctor and a patient has different risk preferences, all would likely be better served by a system in which the FDA must compete not just on safety and efficacy information, but also on timeliness and cost. Instead of trying to elicit and aggregate patient preferences for a one-size-fits-all decision, product evaluation can serve individual preferences of patients and physicians. This shift in approval structure is appropriate in an era when, unlike in the past, negative information that emerges through analysis and use will quickly spread throughout the medical marketplace to both patients and doctors.

The Internet of Things and Wearable Technology: Addressing Privacy and Security Concerns without Derailing Innovation
Adam Thierer
February 2015

This paper highlights some of the opportunities presented by the rise of the so-called “Internet of Things” and wearable technology in particular, and encourages policymakers to allow these technologies to develop in a relatively unabated fashion. The better alternative to top-down regulation is to deal with these concerns creatively as they develop using a combination of educational efforts, technological empowerment tools, social norms, public and watchdog pressure, industry best practices and self-regulation, transparency, and targeted enforcement of existing legal standards (especially torts) as needed. Finally, and perhaps most importantly, we should not overlook the role societal and individual adaptation will play here, just as it has with so many other turbulent technological transformations.

Fortress and Frontier in American Health Care
Robert Graboyes
October 2014

For decades America’s health care debate has pitted Left against Right, federal against state, public against private. All sides, however, have shared a similar, inhibiting mindset—an excessive aversion to risk and deference to medical insiders—instead of stressing the ideal goal of better health care for more people at lower cost on a continuous basis.

This study shows how this “Fortress” mentality has limited innovation in health care, constraining medical advances and raising costs. Shifting to a “Frontier” approach—one that tolerates risk and opens the field to other participants and disciplines—would bring to health care the kinds of creativity seen in many other fields, such as information technology.

The American Health Care System: Principles for Successful Reform
Robert Graboyes
October 2013

The health-care system cannot adequately serve consumers and patients without cost-cutting (“disruptive”) innovation that sends costs plummeting and quality of service. Disruptive innovation requires three conditions: 1) innovators must be allowed to innovate; 2) consumers must have choices; and 3) price and quality information must flow freely among consumers and producers.

Projecting the Growth and Impact of the Internet of Things
Adam Thierer and Andrea Castillo
June 2015

This summary provides a brief explanation of IoT technologies before describing the current projections of the economic and technological impacts that IoT could have on society. In addition to creating massive gains for consumers, IoT is projected to provide dramatic improvements in manufacturing, health care, energy, transportation, retail services, government, and general economic growth. Poorly considered policies should not prevent us from reaping these enormous benefits.

Public Comment and Testimony

Statement for the Record for Hearing Titled “Disrupter Series: Wearable Devices”
For the House Energy and Commerce Committee, Subcommittee on Commerce, Manufacturing, and Trade
Adam Thierer
March 2016

This statement will address how wearable technologies will impact economic growth, how policymakers should approach wearable technologies, and how cybersecurity and privacy concerns should be addressed. Wearable technologies, or “wearables,” are a significant subset of Thierer’s broader research on the “-Internet of Things”

Videos

Commentary

Might We Avoid a CRISPR Technopanic Altogether?”
Jordan Reimschisel and Adam Thierer at Plain Text
August 31, 2017

A Full Toolbox Will Speed Regenerative Medicine
Adam Thierer and Jordan Reimschisel at Plain Text
August 30, 2017

Ignoring the Future Won’t Forestall It
Christopher Koopman and Jordan Reimschisel at U.S. News & World Report
August 21, 2017

What A Supreme Court Decision on Cheerleading Uniforms Means for the Future of 3D Printing
Jennifer Huddleston Skees at Plain Text
August 2, 2017

Will Genetic Editing Advance Faster Than Our Ability to Regulate It?”
Jordan Reimschisel and Adam Thierer at Medium 
July 31, 2017

The Growing AI Technopanic
Adam Thierer at Medium 
April 27, 2017

The FDA Must Return to Its Public Health Mission
Joseph Gulfo at The Hill
March 4, 2016

FDA Must Focus on Drug Safety and Effectiveness
Joseph Gulfo at The Hill
February 19, 2016

The FDA is Showing Its Age
Richard Williams at U.S. News and World Report
February 1, 2016

Congress and the FDA Are Blocking Medical Innovation
Richard Williams at U.S. News and World Report
November 30, 2015

The Martian vs. the FDA on How to Science S#!t
Richard Williams at InsideSources
November 11, 2015

Replacing the FDA
Robert Graboyes at Real Clear Policy
October 23, 2015

Uncle Sam Wants Your FitBit: The Fight for Internet Freedom Gets Physical
Adam Thierer at Reason
May 2015

Healthcare Cures and Innovation for the 21st Century
Richard Williams at The Hill
May 29, 2015

Why We Need a Medical Innovation Impact Index
Joseph Gulfo at The Hill
May 28, 2015

Steampunk Regulation, Medical Technology, and the IT Revolution
Robert Graboyes at Real Clear Technology
March 12, 2015

Medical Devices Are No Sin
Richard Williams and Matthew Mitchell at The Hill
February 13, 2015

Health Care Innovation through Less Regulation
Richard Williams at U.S. News and World Report
January 26, 2015

Why We Need to Liberate America’s Health Care
Robert Graboyes for PBS Newshour
January 9, 2015

How to Print Yourself a New Hand
Robert Graboyes for CNN
October 24, 2014

Innovation Is the Key to Health Care Reform
Robert Graboyes at Reason
July 1, 2014

Paging Dr. Jobs
Robert Graboyes at the McClatchy Tribune
October 2, 2013