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There seems to be a lack of appetite by US medical device companies to find their way through the hoops and hurdles of the regulatory landscape. Nowhere has this been more evident than the almost six year saga of genetic test company 23andMe going toe to toe with the FDA, which spawned precedent-setting warning letters that were widely read and reported. The spat finally ended with FDA approval of the company’s direct-to-consumer genetic tests, together with $115 million in Series E funding, setting its valuation at $1.1 billion.

While CEO Anne Wojcicki reports that the dialogue between 23andMe and the FDA goes as far back as 2008, it wasn’t until 2010 that the FDA notified them that their genetic tests were  considered medical devices that required federal approval. Two years later, the company issued its first submissions for FDA clearance, but it was yet another year before they were issued a stop marketing order. During this entire time, 23andMe continued to sell their direct-to-consumer genetic tests and amass one of the largest genetics databases in the world, enabling lucrative pharmaceutical collaborative opportunities.

This action shouldn’t necessarily be attributed to a ‘move fast and break things’ attitude however, as it was later revealed that internally 23andMe had issues understanding the language that the FDA was using. “It was a small company at the time and complying with the FDA was an overwhelming data challenge” said Kathy Hibbs, a lawyer who would later join the company as their chief legal and regulatory officer. Hibbs would play a pivotal role in helping 23andMe rebuild their relationship with the FDA and reach their billion dollar valuation1.

Now once again another company is in the media spotlight – this time, diagnostics company Theranos is facing redacted audit results by the FDA in light of the company’s highly publicised struggles. Looking at the auditor’s complaints more closely, the company’s failed transition from CLIA laboratory framework to a 21 CFR 820.30 compliant quality system seems to be the chief deficiency.

Theranos, like 23andMe, seeks to reduce/eliminate accessibility barriers to mass-testing, like those associated with availability and cost. However, we’re yet to see a technical champion emerge from the smoke – as Kathy Hibbs did for 23andMe – to help Theranos resume its place as healthcare’s Silicon Valley darling.

We’re at PDA’s Universe of Prefilled Syringes event this week in Vienna, exploring the latest in pharma science and technology around injection devices, and being here, the words from Theranos’ CEO, Elizabeth Holmes, really start to resonate: “First they think you’re crazy, then they fight you, and then all of a sudden you change the world.” As new formulations create new device challenges, companies are using conferences like this to showcase latest developments such as non-conventional primary packaging, pen injectors utilising connectivity to encourage adherence and empower patients, and manufacturers leveraging device technology to improve healthcare economics. In short – a whole host of impressive and exciting new products. But what complex regulatory barriers do they face to successfully get to market?

If you’re going to go changing the game, it’s clear that a competent technical development partner that has experience with the demands and hurdles of regulatory submissions can make the difference between bankruptcy and billion dollar valuations.

If you’d like to talk to us about game-changing drug delivery systems, please contact our medical devices team: or call 01223 264428. If you’re at The Universe of Prefilled Syringes and want to connect, contact Uri Baruch, head of Drug Delivery at (Twitter @CDP_innovation @uri_baruch)


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