A very interesting read about Theranos and what can happen on the front line of innovation without due diligence and

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1

A very interesting read about Theranos and what can happen on the front line of innovation without due diligence and active governance …
https://www.penguinrandomhouse.com/books/549478/bad-blood-by-john-carreyrou/9781524731656/

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Yes interesting read but I cannot believe that so much cover up, greed and negligence has occurred here.
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Unfortunately its probably more common than you think. The Stamina cases in Italy are a scary case - where lobbyists are able to influence regulation of mesenchymal stem cell therapies through politicians. In this case Italian scientists were able to fight back and have the regulations overturned.

https://www.nature.com/news/disgraced-stem-cell-entrepreneur-under-fresh-investigation-1.20985
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A new documentary has been released on Netflix this week, The Bleeding Edge - looking at the fast-growing medical device industry in the USA, and how the rush to innovate can lead to serious consequences for patients.

"Their main concern is a loophole which allows many devices to reach the market without much clinical testing. New devices are supposed to go through a pre-market approval process similar to a new drug, which requires that the device be tested in humans to show it’s both effective and safe. Yet because so many new devices are brought to market, including new iterations of already approved devices, some medical companies argue that it’s too expensive to send each device through massive amounts of clinical testing.

To address that, a provision called the 510(k) pathway was created, whereby a manufacturer can also obtain approval if they can prove that their device is “substantially equivalent” to another device already on the market. The problem, the film argues, is that while that pathway was supposed to be an exception, it’s become a common way devices are approved for sale, and sometimes, it creates an approval chain of devices that are on the market without recent testing."

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Thanks I will look out for this doco. We have a 510(k) clearance for our ableX handlebar device and software (I hasten to add as a Class I device it has a very different risk profile to those profiled by Netflix!). As a kiwi-financed startup 510(k) was the only realistic way to go, and they cleared based on the published efficacy we had from early studies at UoO. At the time the FDA responded with unexpected encouragement, we think because our approach was non-invasive and simple rather than complex. It will be interesting to see how they respond when we eventually apply to clear our armskate device.
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