Sing Rihana B** Better Have My Money: $9B! Theranos Series

I cannot talk about Theranos without talking about DINERO and the $9 billion dollar investors lost.

#HayDiosMio!

It still blows my mind how a company valued at $9 billion did not have and or did not invest in a robust Quality Management System that included Complaint Handling and Post Market Surveillance controls. 

All the SIGNS were there! I could not help myself but share a few:

Sign - Numero Uno #1

The reports released by the FDA saying that Theranos had used an unapproved medical device, did not adequately follow up on customer complaints and had various deficiencies in quality control procedures. See report HERE.

The "nanotainer" was a medical device that had not been cleared by the FDA BUT was being shipped in interstate commerce!

#QUE #LOCO #RISKforpatients!

Sign - Numero Dos #2

Theranos initiated clinical investigations for two Zika related clinical trial protocols and collected samples from subjects without Institutional Review Board (IRB) approval.

#WHOdoesthat?!  #Theranos #Unethical

Sign - Numero Tres #3

For a medical technology as revolutionizing as this blood testing was supposed to be, there were ZERO individuals with science and engineering backgrounds in the Theranos’ advisory board. Instead, Holmes' board included an unusual roster of names for a healthcare startup, with leaders who 

had more experience in politics and government than healthcare such as former US secretary of state Henry Kissinger, and James Mattis retired US Marine and ex-Trump’s secretary of defense. 

#FISHY

Theranos was not short of high-profile investors like Tim Draper of venture capital firm Draper Fisher Jurvetson, secretary of education Betsy Devos and family, the Walton family founders of Walmart, media mogul Rupert Murdoch, Atlanta’s billionaire Cox family. Even investors outside of the U.S. were duped by Holmes, including Mexican tycoon Carlos Slim, and members of a South African diamond dynasty.

#DameDINERO!

Bottom line, if any of these investors had done a little bit of digging and conduct 

Quality and Regulatory Due Diligence on Theranos prior to their investment in 2013-14, the verdict would have been super clear 

#PELIGRO!   #DONOTInvest!

If only they had asked some of these important questions around their Regulatory Strategy and Plan, and how their Quality System was working, OR NOT in this case, they would have been spared from the scene in October 2015 when 

#POOPOOHitTheFan

While the Theranos debacle is juicy from a bystander standpoint, it is clearly been financially devastating for those who bought into the hype.

#9Billion$

LESSON? Your Investment Shielding Action – Numero Uno #1:

If you are an investor or even a company looking to get investment, hire an expert to do Quality and Regulatory due diligence.

REPITO, hire an expert to do Quality and Regulatory Due Diligence!

This is a no brainer and a win-win scenario for both the innovator and investor, as both will gain valuable knowledge on crucial regulatory and quality issues early in the game, de-risking and increasing your chances for a successful product development and product launch. 

#DoNOTBeTheranos

Ok, we are done recounting the horror story of Theranos! 

And if you’d like access to the entire Theranos series and more Shielding Actions, get it HERE

If you are an investor or inventor seeking help with your quality and regulatory due diligence, click BOOK A CALL below to learn more about how Genius Shield can help you bring your invention to market seamlessly + safely like only the Genius Shield team can

May the innovation force be with you