Product Recall Decisions Need Balance to Prevent Overreacting

Targeted News Service

January 31, 2018

As healthcare and technology become ever more intertwined, the importance of data-driven, evidence-based product recall decisions is only going to accelerate. According to published research co-written by a University of Illinois expert who studies technology adoption in healthcare, the timely detection of potential medical device recalls could both reduce the cost of and improve the effectiveness of healthcare delivery.


The research is motivated by several recent cases of medical device failures in which the manufacturers recalled the faulty devices only after several patients were harmed, leading to deaths in some cases, said Ujjal Kumar Mukherjee, a professor of business administration at the Gies College of Business at Illinois.


Managing the downside risks of technology in a healthcare setting poses a serious challenge to firms, doctors and patients, Mukherjee said.


Healthcare delivery is becoming more technology-driven, and its only going to become more tech-focused over time, he said. Theres no going back at this point, which is why its so important to get this right because even the best technology may eventually fail.


In a paper published in the journal Production and Operations Management, Mukherjee and co-author Kingshuk K. Sinha, of the Carlson School of Management at the University of Minnesota, find that the situated context of the decision-makersuch as firm size or the depth and breadth of their product portfoliois significantly associated with judgment bias in favor of either overreacting or underreacting.


The danger is twofold, he said. We find that a high signal-to-noise ratio in user feedback is associated with a greater likelihood of underreaction, meaning that firms will take a more hands-off approach to a product recall. But we also find that user feedback related to high-severity adverse events is associated with a greater likelihood of high overreaction, meaning that firms will take an ultra-cautious and conservative approach to recalling the product and repairing, redesigning or remanufacturing the product.


Firms that underreact often fail to heed the signals and often delay their recall decision.


We call this an underreaction to signal, and the outcome or consequences of delaying such a decision for a product that has a design flaw or a manufacturing flaw is very severe in the medical device industry because you are dealing with life-or-death situations, Mukherjee said. Its also led to many millions of dollars in claims and lawsuits in the past.


According to the paper, firms that tend to underreact to failure signals are larger firms with a diverse product portfolio.


Larger firms tend to react much more slowly and delay their recall decision than specific or specialized firms that have clear divisional boundaries, Mukherjee said.


The solution would be for bigger firms to divisionalize their organizational structure around a product or a type of product or service to create greater focus on emerging new products and technologies.


A firm that has an organizational structure in which specific divisions take care of specific products will have a much more proactive approach to managing the problem, he said. In some sense, there is a lack of attention to designing the overall product portfolio when you keep on creating versions and different features in the product, which makes the product portfolio very complex. That leads to inattention toward failure signals in the marketplace, which eventually causes a lot of loss of efficiency and effectiveness in the overall delivery of healthcare.


Failures of medical devices account for a significant chunk of losses in the healthcare systemapproximately 15% of the total cost of healthcare delivery. So its incumbent upon firms to try to look ahead of the curve, Mukherjee said.


If you walk into a hospital now versus even 10 years ago, youll see a lot more technology, he said. And even the best technology may fail, with serious economic and social consequences.


Take the DaVinci Surgical Robot, for example.


Those robots are very high-tech and very expensive, Mukherjee said. The surgeons involvement is mostly in controlling the robot, but it gives doctors much more accuracy, meaning clinical outcomes are that much better. So its an innovation that has helped surgical delivery. All these innovations are coming in the healthcare domain, and theyre improving healthcare delivery.


But its vitally important to proactively manage the downside risks of the technology while it is already in use, Mukherjee said.


Notwithstanding all the benefits, these are such complex pieces of technology that failure is all but inevitable, he said. If the robot fails, and there have been some cases in which surgical robots have frozen mid-surgery, thats obviously a big problem.


But its not just surgical robots. Its also implantable devices, which have proved very effective and efficient in delivering consistent, high-quality healthcare, he said.


It depends on how you manage the risks, which entails predicting the failures, Mukherjee said. So being able to predict and proactively act upon signals of failures of medical devices is very important.


The research was supported by the University of Minnesota and the American Hospital Association.


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Apple Will Delay iOS Features to Focus on Performance, Quality

BGR India

January 31, 2018

The delayed features will reportedly include the refresh to iPhone home screen, improvements to Mail, and Photos app among others.


After the iPhone slow down issue came under the radar, Apple has reportedly changed its iOS software plans. Apparently, Apple will now delay some new features until next year to focus on addressing performance and quality issues.


According to Axios, Apples software engineering chief Craig Federighi announced the revised plans to employees at a meeting earlier this month. As states the report, a number of features have been delayed until 2019, including a planned refresh of the iPhone home screen and CarPlay interface, improvements to core apps like Mail, and updates to capturing, editing, and sharing photos.


While a few features might be on hold until iOS 12, we will still be seeing changes to Health app, improvement to ARKit platform, and parental controls, in the coming updates.


In addition, Apple is said to be prioritizing work to make iPhones more responsive, and less prone to cause customer support issues.


Just last week, Apple previewed iOS 11.3, which teased new Animoji, enhanced AR experience, and battery health and power management features. Apple says that the update will be released later this spring.


Apple is also bringing a new feature called Business Chat, which will be integrated within iMessage app. It will essentially be a way for users to communicate directly with businesses right within iMessage.


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German Automakers Face Heat For Testing Diesel Fumes on Monkeys, Humans

Chattanooga Times Free Press (Tennessee)

January 30, 2018

David Mchugh and Geir Moulson


Public criticism of the German auto industry has escalated after a report that an industry-sponsored entity commissioned a study of the effects of diesel exhaust using monkeys, while another study exposed humans to low levels of one type of air pollutant.


The German government on Monday condemned the experiments and Volkswagen sought to distance itself from them, with its chairman saying that in the name of the whole board I emphatically disavow such practices.


The tests were reportedly commissioned by a research group funded by major German auto companies.


Revelations of the tests add a twist to the German auto industrys attempt to move past Volkswagens scandal over cheating on diesel tests and the resulting questioning of diesel technology across the industry.


Volkswagen Chairman Hans Dieter Poetsch said the tests must be investigated completely and without reservation, the dpa news agency reported.


A report by the New York Times found that the research group financed by top German car manufacturers commissioned experiments in which one group of monkeys was exposed to diesel exhaust from a late-model Volkswagen, while another group was exposed to fumes from an older Ford pickup.


The experiments were carried out in 2014 before Volkswagen was caught using software that let vehicles cheat on emissions tests. They were intended to show modern diesel technology had solved the problem of excess emissions, but according to the Times report the Volkswagen car in the tests was equipped with illegal software that turned emissions controls on while the car was on test stands and off during regular driving.


Volkswagen admitted using the software in 2015. The Volkswagen scandal led to public scrutiny of diesel emissions as regulators discovered that other companies vehicles also had higher emissions on the road than during testing, though not necessarily through illegal rigging. The industry has had to fend off calls for diesel bans in German cities with high pollution levels.


Daimler AG said it was appalled by the nature and extent of the studies and said that, though it didnt have any influence on the studies design, we have launched a comprehensive investigation into the matter.


BMW said that it did not participate in the mentioned study on animals and distances itself from this study. It said it was investigating the work and background of the research group.


The Times report said the group that commissioned the studies, known by German initial EUGT, got all of its funding from the three automakers.


The Times report was followed by one in Mondays edition of the Stuttgarter Zeitung daily that the now-closed research group also commissioned tests in which humans were exposed to nitrogen dioxide, which belongs to a class of pollutants known as nitrogen oxides. The group reportedly said the tests showed no effect on the subjects.


The human study, carried out by Aachen University, involved studying the effects of exposing 25 subjects, mostly students, to low levels of nitrogen dioxide like those that could be found in the environmentfrom a 40-liter bottle, not a diesel engine. The individuals gave informed written consent for the study, which was approved by the ethics committee of the universitys medical faculty, according to the study. The university said the study had no relation to the diesel scandal.


The German government condemned the reported tests on animals and humans. Transport Minister Christian Schmidt has no understanding for such tests … that do not serve science but merely PR aims, spokesman Ingo Strater told reporters in Berlin.


He called for the companies concerned to provide immediate and detailed responses, and said a ministry commission of inquiry that was set up after the emissions scandal broke will hold a special meeting to examine whether there are any other cases.


Chancellor Angela Merkels spokesman, Steffen Seibert, said that the disgust many people are feeling is absolutely understandable.


These tests on monkeys or even humans can in no way be ethically justified, Seibert said. They raise many critical questions for those behind these tests, and these questions must urgently be answered.


He questioned the aims of the tests. The automakers have to reduce emissions of harmful substances further and further, he said. They should not be trying to prove the supposed harmlessness of exhaust with the help of monkeys or even humans.


Seibert said that the supervisory boards of the companies concerned have a particular responsibility.


The governor of the German state of Lower Saxony, a major shareholder in Volkswagen, added his voice to calls for quick answers.


Stephan Weil, who sits on VWs supervisory board, stressed that the behavior of the company must in every respect fulfill ethical demands. He said he hadnt known about the tests.


Original headline: German automakers face heat over tests


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Panera Bread Recalls Cream Cheese Over Listeria Fears

CNN.com

January 30, 2018

By Susannah Cullinane


Panera Bread is recalling cream cheese products from its U.S. bakery cafes over fears of listeria contamination.


The chain said it was issuing the voluntary recall out of an abundance of caution after samples of one of its cream cheese products from a single day of production showed a positive result for Listeria monocytogenes bacteria.


Listeria contamination can cause fever and diarrhea and is particularly dangerous for pregnant women and their unborn children.


In a statement, Panera Bread said it was recalling all 2-oz. and 8-oz. cream cheese products with an expiration date on or before the second of April 2018 (4/2/18).


Tests on cream cheese samples manufactured both before and after the production run in question have all come back negative, the company said.


We have likewise ceased all manufacturing in the associated cream cheese facility, said Blaine Hurst, Paneras President and CEO.


About 1,600 people become infected with listeria each year, and about 260 die, according to the U.S. Centers for Disease Control and Prevention. While the bacteria may cause fever and diarrhea, just like other foodborne bugs, certain people are at greatly increased risk: the elderly, people with a weak immune system, pregnant women and their newborns.


Pregnant women are 10 times more likely than other people to become infected, and the bacteria can be passed on to the developing fetus, the CDC says. The infection can cause miscarriages, stillbirths and premature labor.


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