When a medical device malfunctions, it is up to the doctor to alert the hospital, the hospital to alert the device maker, and the device maker to alert the FDA 30 days later. Not exactly a fast process. Well the US House of Representatives just approved a renegotiated agreement between the FDA and device industry that would push this 30 days back to three months. While device makers are happy because this agreement also includes lowering the proposed annual user fees, it has some watchdog groups and critics up in arms and bringing up all the bad memories the device industry wishes they could forget. Who knows, maybe malfunctioning trends will become more apparent with this extension, but it certainly doesn’t scream “patient safety.”
Millions of people depend on inhalation drug delivery devices to aid in relieving the symptoms of chronic respiratory diseases and acute respiratory attacks. Machines can often be bulky or inefficient in delivering the right doses of necessary drugs to the human system. But change is coming. Companies like SmartInhaler and Propeller are working to provide more data and reminders to patients online and through apps about the efficiency of their inhalation. These data can also be transmitted digitally to doctors or caregivers, presumably in support of monitoring medication compliance. It’s about time your inhaler joined the Internet of Things community, right? What’ll we connect next, an egg tray? That’s so 2016. Here are some other goofy things we’ve felt the need to webify.
Between emails, private information and (ahem) elections, what else could we possibly worry about getting hacked? How about medical devices? Yep, our pacemakers and insulin pumps are sitting there pretty much defenseless. To bring in some reinforcements, the US FDA has just released its final guidance on the post-market management of medical device cybersecurity. Devices nowadays are connected to hospital networks and even patients’ Wi-Fi so the FDA is suggesting that manufacturers consider cybersecurity throughout a device’s development and even once on the market (i.e., inside patients). This guidance includes detecting vulnerabilities, assessing the risk and deploying mitigations to address any issues. Thanks, technology. By the way, this is what we think all hackers look like. (Warning, you will not get smarter if you click that link).
In accordance with a new policy released last Wednesday, the FDA has increased patient accessibility to hearing aids. The guidance, which takes effect immediately, removes the requirement of medical evaluation or waiver-signing before buying a hearing device. The agency also said they’ll consider creating a category for OTC hearing aids. So go ahead and prepare yourself now for some campy, elderly-consumer-focused commercials. The move was done in part to encourage industry innovation/competition to create cheaper hearing devices, which would also serve to increase access for the 30 million Americans who live with hearing loss. That’s something we can all get behind, right? Hear, hear!
We’ve all had cuts and scrapes and most of them have healed pretty quickly. Well, the chronic wounds (i.e. diabetic ulcers) that affect 6 million US patients per year require a little more attention than antiseptic and a band aid. So much in fact that the US health care system spends an estimated $20B annually on treating these wounds. Cue the brilliant minds at Drexel University who have created a small, battery-powered, wearable device that uses low-frequency ultrasound to heal wounds. This caught the attention of the NIH who has awarded Drexel $3M to test the therapy over the next five years. Batteries make terrible band aids, but 6M patients a year means they’ll be in a lot of medicine cabinets.
A study published in Nature this week demonstrated a new device that shows a lot of potential in addressing paraplegia. Researchers used a “brain-spine interface” to grant two partially paralyzed monkeys the ability to walk again. A quick physiology review: the connection between the brain and the spinal cord is what allows the brain to signal movement commands to the rest of the body. The device creates an interface for those signals to be interpreted and relayed to the body, bridging the connection problem caused by a spinal cord injury. The scientists say many of the components they use have already been, or are in approval for human use, so we could see a human clinical trial within the next decade. No monkey business, we promise.
Remember when Theranos was making huge waves in the med device market just months ago? They’ve taken a pretty awful bludgeoning since then. In a move to regain footing, the company recently debuted a new technology, “miniLab,” at the American Association of Clinical Chemistry’s annual meeting. However, in addition to the fact that miniLab’s technology already exists, the debut was a surprise to the expert attendees who were expecting a straight-up explanation about the company’s original (and completely unrelated) blood-testing device that got CEO and founder Elizabeth Holmes banned from running a clinical testing company. It is still under fire concerning its highly inaccurate test results. Some daresay the miniLab release was a distraction from Theranos’ looming woes, but “forgive and forget” isn’t big on the scientific scene.