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INDUSTRY FOCUS MEDICAL & PHARMACEUTICAL


DON’T ‘FAKE IT UNTIL YOU MAKE IT’ IN THE MEDICAL INDUSTRY


In 2003 a company was founded to develop a new solution capable of analysing blood through non-invasive techniques. But, the company


struggled to translate the buzz over its technology into reality. Nigel Whittle FRSB, head of Medical & Healthcare at Plextek, explains why the ‘fake it until you make it’ approach is a lesson for the Medical Device Industry


bathes every tissue of the body, and is the transport mechanism for nutrients, regulatory agents, signals, metabolites, by-products, and waste products. From a patient’s perspective, it would be ideal to analyse that blood through non-invasive techniques. However, while a few such technologies are under development, current blood chemistry analysis generally requires drawing a sample. It is no wonder then, that a company with a


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technology that promised to be able to conduct hundreds of analyses from a pinprick of blood would rapidly become the centre of investors’ attention. The fact that the company’s philosophy was for patients to be more in control of their own health data, ordering blood tests for themselves and seeing their own results, was a further draw for investors. That company was Theranos. On 3rd January


this year, its founder, Elizabeth Holmes, was found guilty on four charges of fraud, and is now awaiting sentencing. So where did it all go wrong? Why were so many investors fooled? And was the technology ever possible in the first place?


DEVELOPMENT Holmes founded Theranos in 2003 with a plan to develop a new blood-testing technique. This technique involved a device called a nanotainer, which was used to collect blood through a finger prick. A further device called the Edison was claimed to be able to conduct numerous tests, from measuring levels of glucose or cholesterol, to detecting marijuana, opiates and even cancer. There was, however, never any clarity about how the Edison was supposed to work. Although it is possible to detect, for


example, tiny amounts of nucleic acids from blood using PCR techniques, for the most part blood analyses require significant sample volumes. There were several patents associated with the Edison – for example, around how the device might communicate with the internet – but these patents were all unclear on how much blood the device would actually require to conduct these blood tests. Despite this lack of transparency, investors


poured hundreds of millions of dollars into the company, which was once valued at nearly


44 DESIGN SOLUTIONS MARCH 2022


ne of the most obvious ways to diagnose almost any medical condition is through analysis of a patient’s blood. Blood


US$10 billion, and boasted a stellar Board line-up including Henry Kissinger, Jim Mattis and George Shultz (notably individuals with no professional experience of the medical industry). Although with hindsight this seems crazy, the pervading ethos within Silicon Valley has always been ‘fake it until you make it’, encouraging founders to take an aggressive, optimistic view of the product or service, making big promises, often with little proof of efficacy, to attract investors. The company made its first tests available to patients in 2013, including through a partnership with Walgreens, but there were increasing concerns about the accuracy and validity of the tests. By 2014, Theranos was clearly struggling behind the scenes to translate the buzz over its technology into reality. Several former employees later claimed that the Edison device was handling just a small fraction of the tests then sold to consumers, with other tests being performed on standard blood analysers. In fact, there had been continuous concern about the capability of the Theranos tests from whistle-blowers within the company. In 2015, Prof John Ioannidis (Stanford


University) pointed out that no peer-reviewed research from Theranos had ever been published in the medical research literature. In the same year, Prof Eleftherios Diamandis (Mount Sinai hospital) analysed Theranos technology and concluded that ‘most of the company's claims are exaggerated’. Later that year The Wall Street Journal reported that Theranos was using traditional blood testing machines instead of the company's Edison devices to run its tests. The game was almost up for the company.


A WAKE-UP CALL FOR INDUSTRY Since 1976 the US FDA has regulated products that match the legal definition of a medical device, using a classification system to define risk and regulatory oversight. Such devices are generally amongst the most highly regulated products in the modern economy. However, during its technology development, Theranos played fast and loose with these FDA guidelines. For example, the FDA assessed the nanocontainer as a Class II device, which therefore required certain performance standards and post- market surveillance. But, Theranos claimed that it was only a Class I device and supplied it for two years without proper clearance. A more significant regulatory loophole was


that the Theranos tests were classed as laboratory-developed tests, or LDTs: designed, manufactured, and used within a single laboratory. Such diagnostic tests do not require companies to submit tests to the FDA before using them on patients, meaning Theranos did not require regulatory evaluation of its tests before providing them to patients. Unsurprisingly, dozens of other start-ups


have taken advantage of the loophole in recent years, according to the FDA. Amazingly, nearly 900,000 test results were generated each year by Theranos at its peak. In the absence of pre-market regulation, such a large number of faulty tests are likely to have provided much misleading information to patients and doctors, potentially causing serious patient harm. Many professionals have called the Theranos


story a wake-up call to the medical device industry. In an environment where business success and profit are put above patient welfare, there seems a need for increased regulatory oversight. Indeed, the FDA has proposed increased regulation of laboratory tests, and has sought a public discussion on the issue. However, these proposals have predictably faced push-back from the medical device industry. The efforts stalled under the previous administration and currently appears to be ‘in limbo’ under the Biden administration. In the absence of a firm commitment to regulation of laboratory- developed tests, patients are likely to face further significant risks to their health.


TREAD CAUTIOUSLY So, not only should start-ups and their founders tread more cautiously in the future, but workers in technology need to speak out whenever they see corporate wrong-doing.


Plextec www.plextek.com


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