The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials

Aaron V. Kaplan; Ariel Dora Stern

Article | JAMA Cardiology | January 2018

The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials

Abstract

The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of patients worldwide. Medical device innovation requires a robust ecosystem that involves medical technology innovators, often at start-ups, large medical device manufacturers, and clinical investigators. Central to this process is strong regulatory oversight, which in the United States is provided by the U.S. Food and Drug Administration’s Center for Devices and Radiologic Health (FDA/CDRH). This viewpoint discusses the effect of the regulatory approval process and the role that FDA/CDRH plays in the design and execution of the pivotal trials (clinical studies) that are used to support the regulatory approval of high-risk devices. We also review norms in the publication of pivotal trials in peer-reviewed medical journals; these publications often fail to acknowledge the role of the FDA/CRH or discuss results within the context of the device approval process.

Keywords: Health Testing and Trials; Business and Government Relations; Governing Rules, Regulations, and Reforms; Information Publishing; Medical Devices and Supplies Industry; United States;

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Kaplan, Aaron V., and Ariel Dora Stern. "The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials." JAMA Cardiology 3, no. 1 (January 2018): 5–6.

Working Paper | HBS Working Paper Series | 2018

Digital Innovation with High Costs of Entry: Evidence from Software-Driven Medical Devices

Cirrus Foroughi and Ariel Dora Stern

Does technological opportunity enable the rise of new entrants or reinforce the position of incumbents? Research on this classic topic often ignores the high costs of entry seen in some industries. We offer a novel approach to this question in the context of regulated medical technology, where the introduction of software is of growing importance and has created fresh opportunities for new product development. Pioneering a new application of supervised document classification, we consider over 35,000 new medical devices that came to market in the United States from 2002 to 2016 in order to identify predictors of digital innovation in this industry. We consider the relative importance of key factors such as geographic and within-firm capabilities and the role of financial resources. We find that location in a region of concentrated expertise and prior firm commercialization experience reinforce one another in predicting digital innovation. While venture capital funding appears to play a role in supporting innovative entrants, closer analysis suggests that this funding selects on other variables that predict digital innovation; in this regulated industry, financial resources do not substitute for existing capabilities. We conclude that incumbent firms have an advantage in innovating in this setting.

Keywords: Technological Innovation; Software; Market Entry and Exit; Product Development; Experience and Expertise; Medical Devices and Supplies Industry;

Citation:

Foroughi, Cirrus, and Ariel Dora Stern. "Digital Innovation with High Costs of Entry: Evidence from Software-Driven Medical Devices." Harvard Business School Working Paper, No. 18-094, March 2018. View Details

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This teaching note provides guidance and recommendations for teaching HBS Case No. 618-025, entitled “Adaptive Platform Trials: The Clinical Trial of the Future?”

In late 2014, Dr. John Moore (CEO), Frank Moss (chairman), and Scott Gilroy (CTO) of Twine Health (Twine) had to resolve several challenges that threatened to restrict the widespread dissemination of its sole product, Twine. Twine was a cloud-based platform that enabled patients to create and manage chronic disease treatment plans in conjunction with their primary care providers and specialized coaches. Twine had already enjoyed impressive successes in early clinical trials and among early adopters. The issues Twine's leadership team had to address included identifying clinical care providers willing to pay for Twine, ensuring adoption and effective use by both patients and health care providers, adding capabilities to support the management of additional chronic diseases, and seamlessly integrating Twine with a client organization's electronic medical record (EMR) system and information technology (IT) infrastructure. The need to solve these problems had become more pressing since Twine was named a finalist in the Health Acceleration Challenge (HAC) sponsored by Harvard Business School and Harvard Medical School. Teaching Note for HBS No. 615-068.

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The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials

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