Emerging Products & Technology

“Smart luggage” is truly smart. Companies have created sleek, stylish bags that also contain practical, convenient accessories. Although smart luggage solves all sorts of problems, it has grabbed the attention of airlines and authorities due to the use of lithium batteries.

When companies develop new products, they can often turn to existing regulations to inform the plan and design, ensuring that it complies with the regulations when it is released. But sometimes innovation can make things a bit more complicated. Incorporating new features like an internal scale, GPS tracking, TSA-approved locks, and USB ports to charge electronics, smart luggage perfectly illustrates this tricky situation. Continue Reading Speed and Flexibility: A Smart Approach to Developing Policies

Under the recently enacted FDA Reauthorization Act of 2017, drug and device manufacturers will have more time to report device malfunctions to the U.S. Food and Drug Administration (FDA).

Current standards require medical device malfunction reports to the FDA within 30 days. The 2017 Act maintains the 30-day deadline for reporting events that have already resulted in serious medical consequences to users—“adverse events.” But the Act expands the quarterly reporting function, allowing 90 days to report issues that may cause harm in the future but have not yet resulted in patient complications, injuries, or deaths—“malfunctions.” The Act also allows companies to submit summary malfunction reports when the incident reported is already known and understood by the FDA, rather than reporting incidents individually. Continue Reading New Legislation Gives More Time for Medical Device Reporting

Children of all ages—and many adults—can’t keep their hands off fidget spinners, the best-selling toys of the spring and one of hottest new fad toys on the market. Schools in some states have banned them, while others find them helpful for children with attention-related difficulties. Predictably, fidget spinner manufacturers and distributors are feeling the heat of the spotlight, as reports emerge that children are hurting themselves with these toys. Regulators, distributors, and consumers now must sort out how the toys should be marketed and used. Continue Reading Spinning Out of Control? Fidget Spinner Regulation and Safety

Consider the world today: Smartphone manufacturers have already introduced vehicle infotainment systems in automobiles. Vehicle safety technology may be next.

A recent safety proposal by the National Highway Traffic Safety Agency (NHTSA) raises intriguing questions about how our smartphones and automobiles may interface. The proposal may encourage smartphone manufacturers to add vehicle safety technology to their infotainment system applications. That may start to blur the lines between your vehicle and your smartphone.

Continue Reading Where Does Your Smartphone End and Your Car Begin?

When the fatal car crash involving a Tesla Model S sedan made headlines last fall, we posted about the accident and predicted that government authorities would classify the crash as being caused by driver error rather than an issue with the “Autopilot” system.

Our prediction turned out to be correct.  The National Highway Traffic Safety Administration (NHTSA) was still investigating the incident when we first posted about it, but on January 19, NHTSA closed its preliminary evaluation, which found that driver error was responsible.

Still, the performance of Automated Driver Assistance Systems, or ADAS, is an area of intense regulatory interest, and it was therefore not surprising to see NHTSA’s Office of Defect Investigation deploy a special crash investigations team to reconstruct the accident.

Several news reports have characterized NHTSA as having “exonerated” or “cleared” Tesla of any wrongdoing in connection with the crash. Officially, NHTSA merely closed the investigation, noting that it reached no conclusion about whether a defect existed and retained its right to reopen the investigation later.

That said, NHTSA was clearly satisfied with the performance of Tesla’s ADAS system during the crash, which allowed the agency to close its investigation. Continue Reading Truly Exonerated? NHTSA’s Tesla Autopilot Investigation

Medical device manufacturers are now facing a new challenge: managing the cybersecurity of their products.

On January 9, the FDA issued a Safety Communication setting out potential risks that could be caused by a cybersecurity vulnerability in certain St. Jude Medical cardiac devices. A growing number of devices – including St. Jude Medical’s implantable cardiac devices and corresponding Merlin@home Transmitter – transmit data directly to physicians to allow direct patient and device monitoring. Continue Reading Medical Device Manufacturers Face A Cybersecurity “Heartache”

Medical device manufacturers are now facing a new challenge: managing the cybersecurity of their products.

On January 9, the FDA issued a Safety Communication setting out potential risks that could be caused by a cybersecurity vulnerability in certain St. Jude Medical cardiac devices. A growing number of devices – including St. Jude Medical’s implantable cardiac devices and corresponding Merlin@home Transmitter – transmit data directly to physicians to allow direct patient and device monitoring. Continue Reading Medical Device Manufacturers Face A Cybersecurity “Heartache”

After 130 million miles driven without a fatality, Tesla Autopilot’s perfect track record ended tragically on May 7 with the first fatal crash of a car using Autopilot. Given the infrequency of fatal crashes involving autonomous vehicles, why are commentators suggesting that the auto industry “put the brakes” on this technology?

That’s unclear, especially with the facts here. Autopilot has a better safety record than human drivers. Overall, drivers in the United States cause one fatality roughly every 93 million miles. This was Autopilot’s first fatal accident in over 130 million miles driven. Continue Reading Tesla Crash: Don’t Slam the Brakes on Autopilot

Imagine you are driving down a two-lane mountain road.  As you round a bend, you see five pedestrians in your lane.  You do not have enough space to stop before hitting them, but in the other lane there is only one pedestrian.  Do you stay in your lane, killing five? Do you swerve into the other lane, killing one?  Or do you steer off the road and down the mountain, avoiding the pedestrian fatality but likely killing yourself?  Can you make that decision better than an autonomous car? Continue Reading Why Autonomous Cars Aren’t Hit by the Trolley Problem

On December 8, 2015, researchers at Harvard University announced that they had examined a small sample of flavored e-cigarette products and found that some contained diacetyl, a chemical suspected of causing respiratory illness. In the wake of this announcement, some news organizations reported that the Harvard paper established a “link” between e-cigarettes and bronchiolitis obliterans, a disease associated with diacetyl exposure.

But the Harvard study did not discuss any connection between diacetyl in e-cigarettes and respiratory illness. The researchers merely noted the presence of diacetyl in e-cigarettes and that diacetyl has been associated with respiratory disease in the industrial context. The study drew no conclusions about the possible health risks that vaping poses to consumers. Instead, the study’s authors recommended that this new potential source of exposure to diacetyl be further evaluated. Continue Reading Researchers Turn Their Attention to Diacetyl in E-Cigarettes