Multiple Authors
By: J. B. Silvers, Mark Votruba

The new healthcare venture formed by Amazon, Berkshire Hathaway, and JPMorgan Chase announced June 20, 2018, that Harvard professor and well-known author Atul Gawande would be the company’s CEO. The idea for the new company is to innovate by cutting costs from the healthcare system, starting with the more than one million employees of the three companies behind the venture.

Previous efforts to contain healthcare spending—from managed care to high-deductible health plans to alternative payment models—shared the goal of eliminating unnecessary and overly expensive services. But these practices are very hard to change, since they’re based on physicians’ clinical judgment and patient preferences.

The new joint venture may find it is easier to start with a different question entirely: Can we reduce spending by 15 to 20 percent just by cutting out unnecessary middlemen?

As business school professors, we know that cutting the unnecessary transactions costs generated by unneeded middlemen is the classic first step. We expect it will quickly be seen as the low-hanging fruit for this new organization.

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By: Janet Woodcock

The staff of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) always tries to utilize cutting-edge science and up-to-date process management, befitting our stature as the global “gold standard” in drug regulation. Maintaining that standard requires us to keep up with evolving technology and the latest scientific, medical, and regulatory advances.

Current factors impacting drug development include the genomic revolution, the rise of targeted therapy, the availability of digital health data, the focus on patient involvement, complex drug-device combinations, globalization of drug development, and harmonization of international standards. To be successful drug regulators, we reach well beyond the borders of the FDA. We collaborate with a wide variety of medical and scientific organizations such as those in biomedical research, the pharmaceutical industry, academia, global organizations, and other regulatory agencies. Importantly, these collaborations also extend to patients and their caregivers and advocacy groups. All these interactions are critical to successful drug regulation.

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By: Mohammad Jalali

Like any large company, a modern hospital has hundreds, even thousands, of workers using countless computers, smartphones, and other electronic devices that are vulnerable to security breaches, data thefts, and ransomware attacks. But hospitals are unlike other companies in two important ways. They keep medical records, which are among the most sensitive data about people. And many hospital electronics help keep patients alive, monitoring vital signs, administering medications, and even breathing and pumping blood for those in the most dire conditions.

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By: Marin Hedin

Limiting first-year medical residents to 16-hour work shifts, compared to “flexing” them to allow for some longer shifts, generally makes residents more satisfied with their training and work-life balance. It also makes their training directors more dissatisfied with curtailed educational opportunities, a new study from the New England Journal of Medicine has found.

For the study, investigators from the Johns Hopkins School of Medicine and the Perelman School of Medicine at the University of Pennsylvania surveyed and tracked the activities of thousands of first-year residents in 63 internal medicine training programs nationwide. The study—which is part of a five-year effort funded by the National Heart, Lung, and Blood Institute and the Accreditation Council for Graduate Medical Education (ACGME)—also found that shift-length regulations have no effect on the residents’ activity or test of medical knowledge scores one way or the other.

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By: Knowledge at Wharton

America’s healthcare system has been on the examining table lately: from the tortuous battle over the Affordable Care Act, to Senator Bernie Sanders’ bill to allow low-cost prescription drugs in from Canada, to the intriguing announcement in January that Amazon, Berkshire Hathaway, and JPMorgan Chase would create an independent healthcare company for their employees.

Meanwhile, less noticeably but significantly, the basic notion of “going to the doctor” is changing. During the past several years, pharmacies like CVS, Rite Aid, and Walgreen’s have been making inroads into providing basic medical services you could only get at a physician’s office (provided it was during business hours and you could make an appointment) or a hospital emergency room.

During the recent Wharton Health Care Business Conference, CVS executive VP and chief medical officer Troyen Brennan shared the pharmacy giant’s plans to reshape the health care landscape.

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By: Malvina Eydelman

The U.S. Food and Drug Administration’s (FDA) Breakthrough Devices Program is beginning to show important results for patients since it was established in late 2016 under the 21st Century Cures Act to help patients gain timely access to breakthrough technologies.

Consider Second Sight Medical Products Inc.’s Orion Cortical Visual Prosthesis System, which recently qualified for the FDA’s voluntary Breakthrough program.

Eligible technologies must provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. In addition, there must be no approved or cleared treatment, or the device must offer significant advantages over existing approved or cleared alternatives.

Multiple Authors
By: Ian Setliff, Amyn Murji

The current 2017–2018 flu season is a bad one. Hospitalization rates are now higher than in recent years at the same point, and infection rates are still rising. The best line of defense is the seasonal influenza vaccine. But H3N2 viruses, like the one that’s infecting many people this year, are particularly hard to defend against, and this year’s shot isn’t very protective against H3N2.

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By: Mary Beth O’Leary

Matt Bianchi had a problem. As chief of the division of sleep medicine at Massachusetts General Hospital, he needed a better way to diagnose sleep disorders. Typically, a patient seeking a diagnosis needs to come into a sleep lab and be attached to a number of devices. This setting is hardly representative of the patient’s normal sleep environment. Bianchi needed a way to track and measure sleep at a patient’s home.

Bianchi outlined this problem in a recent presentation to the students of 2.75 (Medical Device Design). The class brings clinicians from Boston-area hospitals and MIT students together to design prototype devices that help solve problems identified in the clinic.

“We use the design of medical devices as a vehicle to teach a deterministic design process,” says course instructor, professor Alexander Slocum.

Medical devices offer students an opportunity to work on something they can personally relate to since at some point in their lives, either they or a loved one has needed to use one. “The more we can do to make medical devices simpler, lower cost, and better performing, the more we help not only the world, but ourselves,” Slocum explains.

Multiple Authors
By: Morten Wendelbo, Christine Crudo Blackburn

Flu season in the United States typically peaks in February, but this year’s outbreak is already one of the worst on record. As of Jan. 6, 2018, 20 children have died from the flu, and overall mortality caused by the virus is already double that of last year’s.

One reason the flu is so severe this season is that the dominant strain is H3N2, which has an impressive ability to mutate and is particularly aggressive against Americans over 50.

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By: AssurX

Recent FDA warning letters indicate that many drug manufacturers do not have their manufacturing in a state of current good manufacturing practices (CGMPs) control. During the first half of 2017, the FDA cited adulterated products and insanitary conditions as the two most common violations in drug manufacturing. Here are four ways an automated quality and compliance management system builds control into the production process with respect to adulteration and potential contamination.

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