Publications

Article

Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries

By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer

Objectives:
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details

Keywords: Digital; Medicine; FDA; Health Care and Treatment; Applications and Software; Safety; Cybersecurity; Medical Devices and Supplies Industry

Article

Advancing Digital Health Applications: Priorities for Innovation in Real-World Evidence Generation

By: Ariel Dora Stern, Jan Brönneke, Jörg F Debatin, Julia Hagen, Henrik Matthies, Smit Patel, Ieuan Clay, Bjoern Eskofier, Annika Herr, Kurt Hoeller, Ashley Jaksa, Daniel B Kramer, Mattias Kyhlstedt, Katherine T Lofgren, Nirosha Mahendraratnam, Holger Muehlan, Simon Reif, Lars Riedemann and Jennifer C Goldsack

In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a “Fast-Track” regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can... View Details

Keywords: Digital Health; Health Care and Treatment; Technological Innovation

10 Mar 2015
News

Innovation and Implementation in Cardiovascular Medicine

21 Apr 2014
Research & Ideas

Bio-Piracy: When Western Firms Usurp Eastern Medicine

discover how immigration law affects the number of such patents, and explain how, under certain conditions, patenting traditional medicine can mutually benefit both corporate firms and indigenous communities. Where's The Proof? The... View Details

Keywords: by Carmen Nobel; Legal Services; Biotechnology

December 2020 (Revised January 2022)
Supplement

Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (B)

By: Linda A. Hill and Emily Tedards

In 2011, Michael Ku became Pfizer’s Vice President of Global Clinical Supply (GCS) after the company had undergone three large-scale mergers and acquisitions. As Ku and his new leadership team set out to build a proactive, end-to-end, digital and physical clinical... View Details

Keywords: Digital Technology; Customer-centricity; Innovation; Customer Focus; Talent; Talent Management; Leadership; Innovation and Invention; Transformation; Organizational Culture; Customer Focus and Relationships; Change Management; Talent and Talent Management; Supply Chain; Mission and Purpose

May 2020 (Revised January 2022)
Case

Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (A)

By: Linda A. Hill, Allison J. Wigen and Emily Tedards

Michael Ku joined Pfizer in 2011, after the company had undergone three large-scale mergers and acquisitions. His mission was to drive the digital transformation of the company’s clinical supply chain, but he knew he had to start with the culture. Over the next eight... View Details

November 2017 (Revised October 2018)
Case

Brandless: Disrupting Consumer Packaged Goods

By: Jill Avery

Brandless, an online direct-to-consumer seller of upscale private-label consumer packaged goods, offered consumers a limited assortment of values-conscious products delivered directly to their homes with the simplicity of one fixed $3 price point that promised an... View Details

October 2016 (Revised November 2016)
Case

Innovating Beyond Ochsner

By: Richard G. Hamermesh and Olivia Hull

The Ochsner Health System has developed a proprietary software tool designed to treat hypertension. Built into the system’s electronic medical records, the Hypertension Digital Medicine program allows patients to record their blood pressure at home and share readings... View Details

April 2021
Article

Today's Surgeon Compensation Models Fall Short: Aligning Incentives to Create More Equitable and Value-based Compensation Models

By: Susanna Gallani, Mary Witkowski, Lauren Haskins, Haley Jeffcoat, Vinita Mujumdar and Frank Opelka

Modern medicine is undergoing a transformation that involves innovative surgical approaches, increased medical treatment options, clinical care pathways that require collaboration beyond hospital walls, and health data captured by electronic health records and other... View Details

Keywords: Physician Compensation; Surgeons; Health Care and Treatment; Business Model; Compensation and Benefits

October 2021 (Revised January 2022)
Supplement

Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (C)

By: Linda A. Hill and Emily Tedards

This case is the third installment in a series about the 10-year cultural and digital transformation of Pfizer’s Global Clinical Supply organization. In 2011, Michael Ku became Pfizer’s Vice President of Global Clinical Supply (GCS) after the company had undergone... View Details

Keywords: Clinical Supply Chain; COVID-19; Vaccine; Agile; Innovation and Invention; Change Management; Organizational Culture; Transformation; Leadership; Corporate Strategy; Health Pandemics; Crisis Management; Mission and Purpose; Health Care and Treatment; Supply Chain Management; Digital Transformation

01 Sep 2009
First Look

First Look: September 1

industries and poor selection of investments within industries. Venture capital organizations with more experience tend to outperform those with less experience. Practicing Medicine in the Age of Facebook Author:Sachin H. Jain... View Details

Keywords: Martha Lagace

February 2019 (Revised August 2019)
Case

Maccabitech: The Promise of Israel's Healthcare Data

By: Scott Duke Kominers and Carin-Isabel Knoop

Dr. Varda Shalev bridges technology and medicine through Maccabitech, a "research and innovation wing" of Israel's Maccabi Healthcare Services (MHS) that partners with research institutions, pharmaceutical companies, and startups. Shalev hopes to scale Maccabitech's... View Details

Keywords: Big Data; Healthcare; Analytics and Data Science; Digital Platforms; Health Care and Treatment; Innovation and Invention; Research; Entrepreneurship; Risk Management; Israel

11 Apr 2017
First Look

First Look at New Research, April 11

different innovation policies can help to explain who finances radical innovations and when and where radical innovation occurs. Publisher's link: https://www.hbs.edu/faculty/Pages/item.aspx?num=52506 March 17, 2017 Science How Economics Can Shape Precision View Details

07 Mar 2018
Research & Ideas

Electronic Health Records Were Supposed to Cut Medical Costs. They Haven't.

twice the administrative overhead found in Canada and is significantly higher than most other high-resource countries. Adoption of certified EHR systems was seen as a potential antidote. By digitizing patient records and adding billing... View Details

Keywords: by Roberta Holland; Health

November 2022
Teaching Note

Proximie: Using XR Technology to Create Borderless Operating Rooms

By: Ariel D. Stern, Alpana Thapar and Menna Hassan

Founded by Nadine Hachach-Haram in 2016, Proximie was a digital medicine platform that used mixed reality and a host of digital audio and visual tools to enable clinicians, proctors, and medical device company personnel to be virtually present in operating rooms (ORs),... View Details

Keywords: Technological Innovation; Business Growth and Maturation; Growth and Development Strategy; Corporate Social Responsibility and Impact; Decision Making; Health Industry; Medical Devices and Supplies Industry