Out for Blood in Silicon Valley. Theranos Series
The coronavirus pandemic has not only slowed down FDA approval of typical devices but also delayed the trial of ex-Theranos CEO Elizabeth Holmes, which was supposed to be the blockbuster courtroom drama of summer 2020.
#Telenovela
I am sure you all remember the “rise and fall” of Theranos and its founder, Elizabeth. There is even an HBO documentary about it, which I highly recommend:
Inventor: Out for Blood in Silicon Valley
As a quick refresher, Elizabeth Holmes dropped out of Stanford University at 19 to start the blood-testing startup Theranos and grew the company to a valuation of $9 billion. Theranos was known as the startup HOTTY with the promise to revolutionize healthcare.
But it all came crashing down when they were hit with FDA 483s (quality deficiencies) and the shortcomings and inaccuracies of the company’s technology where exposed. Theranos and Holmes were ultimately charged with “massive fraud.”
#NoBueno
There are many lessons that we can learn from Theranos, and my goal is to help you NOT to be the next Theranos.
We don’t really need another one POR FAVOR!
As promised, I am going to share with you 3 Product Design Specification Shielding Actions that you could be doing right now, and I am going to use the Theranos FDA 483s to show you why you should care and prevent those issues.
Product Design Specification Shielding Action - Numero Uno #1
It may sound surprising, but Theranos is actually not the first company to get this type of quality deficiencies. In fact, most of the FDA violations cited in the 483s are quality issues that many medical device companies, especially startups, struggle with.
Theranos just happened to be trending and have the full attention of the press!
Anyway, click HERE to check the gossip or FDA observations from 2015 Therano’s audit in Palo Alto, CA.
Observation 3 states that design input requirements were not adequately documented.
#HelloTracebility
This translates into Theranos failing to properly define and document design input requirements, which derive from user needs.
So it all begins with User Needs!
The development of a robust foundation of product design specifications/requirements is the single most important design control activity. You begin this process by accurately and thoroughly defining and documenting (not in your head) your products’ user needs.
Once defined, these user needs become your Golden Compass that guides your entire product development process. Hence, it is critical to do this correctly from the get-go to ensure that you design the right product for the users.
Product Design Specification Shielding Action - Numero Dos #2
Observations 1 and 2 apply to both Shielding Actions Numero Dos #2 and Tres #3.
When I see these types of issues is because the company has failed to separate their intended use, indications for use, and design specification requirements. So, it is important that you apply this shielding action POR FAVOR.
If you only have 5-10 design specifications, I say PELIGRO!
This is a clear sign of insufficient product design specification due diligence, especially if you have a high-risk device. Take your social distancing time to be comprehensive here and save yourself from the awful recall statistics that could translate into harming patients, as Theranos unfortunately did.
#YesWeCanDoBetter #HealNotHarm
Additionally, you should be collecting your user needs from sources such as competitor’s products analysis, complaint analysis, literature, etc, and
THE MOST important of all is your customer or user’s feedback
You MUST design with your customers and properly identify these stakeholders in order to design a product that actually meets the user’s needs. The users may include the entire ecosystem such as surgeons, nurses, patients, hospital settings, etc.
Product Design Specification Shielding Action - Numero Tres #3:
Basically, Theranos did not define the product fully. They did not translate user needs into proper design specification requirements.
Theranos’ design validation did not ensure that the nanotainer “conforms to defined user needs and intended uses.” The inspection report indicated that the FDA had reservations about the design validation in the 2014 inspection as well.
#SmellFunny?
You should understand how the intended use translates into user needs because ultimately the design validation testing is going to be performed against those user needs.
Another pickle, DO NOT mix up user needs and design inputs POR FAVOR
This is a problem in our industry, especially for those new to this process. User Needs describe how your medical device is going to be used and tend to be subjective and abstract, while Design Inputs must be objective and measurable.
For example, Theranos was developing an IVD “Nanotainer”, a user need could be that “ Nanotainer must contain sufficient volume for diabetes test,” and its corresponding design input would be “Nanotainer shall contain XX microliters of blood.” Developing clear and accurate user needs and design inputs directly impact the quality and success of your verification and validation testing.
The steps above are the engine of your medical device product development process. And if you invest the time to do this correctly, you will most certainly be NASCAR ready! You will reduce risks by having a comprehensive design specification and risk analysis because it is the foundation of creating a robust Verification and Validation plan,
which is pretty much all the FDA will look at to decide to SWIPE RIGHT or LEFT on you!
#RegulatorySexy
And if you’d like access to the entire Theranos series and more Shielding Actions, get it HERE
If you are building a medical device right now and have no idea what I am talking about above, please call me immediately! Kidding… not really.
If this information rings a bell, and you are seeking more help and clarity, Book a Call below to learn more about how Genius Shield can help you bring your invention to market seamlessly + safely as only the Genius Shield team can!
May the innovation force be with you