The Biggest MedTech Flops Of All Time

The Scanadu Scout first hit the headlines in 2013 when it launched a crowdfunding campaign through Indiegogo to raise funds to gain FDA approval in the U.S. market. It was marketed as a sort of Star Trek Tricorder-style device that promised to track health data and pre-empt user illnesses by monitoring a range of bodily functions. To use it, users would simply need to aim the device at their forehead, and a range of readings including heart rate, blood pressure and even emotional stress would be automatically beamed straight to their smartphone. An ambitious idea, perhaps, but one with seemingly strong commercial potential considering other fitness tracking wearables like Fitbit had just started to gain traction with consumers.

After years of hope from backers, the Scanadu Scout was eventually rejected by the FDA in 2016. Despite backers paying between $149 and $199 for each device and voluntarily sharing their medical data with the company, Scanadu offered little explanation for the closure. A spokesperson for the company simply told TechCrunch, "From the beginning of the campaign, this was an investigational device that was part of a study which has now reached its endpoint [...] we will deactivate the [Scout] by May 15, 2017." Understandably, Scout customers felt duped, as they'd been given the impression that support for the devices would be ongoing after their purchase. It's also not clear what happened to all the medical data that had been shared through the device after it was deactivated.

One of the most well-known MedTech failures in living memory, the downfall of Theranos and the trial of its founder Elizabeth Holmes has been covered extensively and even dramatized in the 2022 Hulu series "The Dropout." The supposedly revolutionary company was essentially built on a foundation of lies, deceit, and fraud, with Theranos' blood-sampling device able to perform almost none of the functions it claimed to. What's worse is that patients were given misleading results from these defective tests, with one woman being told she was having a miscarriage when in fact she had a healthy pregnancy, reports CNBC.

Other patients relying on the device were given false positive HIV results, and one was erroneously told to stop using blood thinning medication. In one study that was depicted in "The Dropout," Holmes arranged a study using Theranos devices to monitor late-stage cancer patients, despite the fact she knew the devices didn't work. After a lengthy trial, Holmes was eventually convicted of fraud and sentenced to 11 years in prison, but that will be of little comfort to the scores of victims whose lives were changed forever because of her fraudulent device.

The FDA issued a Class I recall on St Jude Medical Inc.'s Riata defibrillator leads in 2011, after concerns were raised about an unusually high rate of failure. Class I is the most serious classification, meaning the devices carry a high risk of serious injury or death. The recall was issued after two patients died and one suffered a serious injury after surgeons tried to extract the defective leads. The failure of the devices was found to be caused by "externalized conductors," where the wires poke through their insulation and can deliver unintended shocks to patients.

As well as causing unintentional shocks, the wires' failure also left them vulnerable to not delivering a shock at all when one was required. The Riata leads were recalled and a replacement line, the Durata, was developed. But, this replacement also suffered from a high rate of defects, leading to a major lawsuit from investors that accused the company of initially lying about the extent of the problems. St. Jude eventually settled the case for $39.25 million, although as part of the settlement, admitted no liability for any alleged wrongdoing.

The idea of bioprinting seemed revolutionary when it was first developed, and plenty of investors were keen to get in early for the first wave of startups that promised to commercialize the technology. Organovo was one such company, first entering a partnership with Pfizer in 2010 and then launching an initial public offering through a reverse merger two years later. Investors were won over by Organovo's promises to develop and commercialize the growth of human tissue, and the fact it was the first company of its kind to list on the New York Stock Exchange drew even more hype.

However, a decade later, things aren't looking so rosy. The company has failed to generate any significant revenue and continues to burn through considerably more cash than it's making. Organovo's stock price reflects this lack of progress, with shares hitting an all-time high of $268.60 in late 2013, but collapsing to less than $1.50 at the time of writing. The beleaguered company is still struggling on, but it seems investors have almost totally given up hope that it could become commercially viable, especially in the wake of a third-quarter earnings report that recorded just $77,000 in revenue. It seems like the writing is on the wall for one of the last decade's most promising MedTech startups, with the question now being when, not if, it will close for good.

Originally touted as a better alternative to plastic implants, metal-on-metal hip implants have been found to carry some unique risks that arguably make them more dangerous for vulnerable patients. A recall was even issued in 2010 in response to a large number of patients having to undergo surgery to fix defective implants. The scandal led to thousands of lawsuits being filed, some of which are still ongoing. Aside from faulty devices, all-metal hip implants have also been found to have a much shorter lifespan than other forms of hip implants, according to the Arthritis Foundation. They can sometimes need replacing after five years, rather than lasting 10-15 years like most other forms of the implant do.

There's also evidence that additional bone and tissue damage can occur over time, leading to inflammation and decreased mobility. Metal particles from the device also wear out, and in some cases, they can enter the bloodstream. The Arthritis Foundation claims that these metal particles have been linked to heart disease, neurological decline, and even cancer. Even if patients aren't affected by any of these issues, the shorter lifespan of the implant means that there's a higher chance that they'll have to undergo a second surgery to replace it again. This second operation is reportedly less successful, as bone loss from the damage caused by the original implant makes it harder to anchor a new one in place. Overall, a failure from what should have been an innovative MedTech solution.