Performing tests with a drop of blood is nothing new.
Diabetics have been doing this on their own for over two decades with a blood glucose meter or glucometer that uses a an electro-chemical strip where the sample drop is placed in a spot that contains glucose oxidase, an enzyme that reacts to glucose by forming gluconic acid, this acid then reacts with another chemical on the strip called ferricyanide forming ferrocyanide.
When this chemically activated strip is inserted in the glucometer it completes a circuit through an electrode where a current is induced. The higher the glucose in the blood the higher the reading provided by the meter due to the variation of the resistance proportional to the ferrocyanide level. The process described in this paragraph is denominated the amperometric method.
There is another method that differs from the one explained above which is called the colorimetric method.
Simple, right? Not so, these blood drop tests have a lot of technology behind them. And the glucose meter is probably one of the most technologically simplest that exists.
There are other devices that use a drop of blood to provide measurements of some sort.
The A1C, or hemoglobin A1c, is a blood test that provides information about a person’s average levels of blood glucose over the past 90 days. Today, a diabetic can also perform this test at home with a small meter and a drop of blood.
Another common home test device that uses a drop of blood is the cholesterol meter. Although the home test is limited to overall cholesterol and it doesn’t distinguish between LDL, HDL and triglycerides.
For this discussion let’s set aside the true clinical efficacy of all of the aforementioned devices. Let’s assume that they are all clinically accurate in the same way as the ones of the general diagnostic laboratories.
What’s important to consider is that drop blood tests are not innovative or new. They’ve been around for several decades.
But let’s not get further into the science and technology (S&T) of this topic. Hopefully, and if I did a good job at explaining, you got the point.
What is going on with Theranos has very little to do with the S&T and more to do with the regulatory and business aspects around startups and especially for those that may become unicorns.
But what do the above mentioned devices have in common? They are all FDA approved medical devices. That means that they have been rigorously tested for quality, reliability and accuracy. Or they should have, we hope.
A FDA approval of a medical device is a seal of legality to be able to market and sell it.
From what I’ve been able to read in the media, Theranos only has the FDA approval for what appears to be a CLIA waiver to perform a test that detects the presence of the sexually transmitted disease known as herpes simplex virus (HSV-1) outside of a controlled laboratory environment.
Theranos is also seeking the FDA approval, in the same fashion according to the media information, for 120 more tests.
In their website they list more than 120 tests even with pricing: Theranos Test Menu. Talk about transparency! This is one of the most transparent organizations I have witnessed in the USA healthcare system! It gives me “I feel good!” goosebumps!
But one important activity that Theranos has not been performing is manufacturing their medical device(s) using a quality control system that is required by the FDA for medical device manufacturers. Elizabeth Holmes, CEO of Theranos, claimed that they had been using a laboratory standard instead of the one typically used by medical device manufactures, the ISO-13485 based quality control system.
For a company valuated at 9 billion dollars I find it rather intriguing that they weren’t doing the things that medical device manufactures typically perform. Did they have the wrong counseling? Was it a strategic approach to preserve secrecy as much as possible?
If it was a strategic approach then somehow they didn’t account for the media debacle that ensued.
Theranos is in a serious situation even if they come out of the regulatory scrutiny unscathed. Healthcare is unforgiving to missteps and negative media.
Partners have distanced themselves from Theranos. Building these partnerships takes years and rebuilding them is almost impossible.
If you are an entrepreneur that is running a startup in the healthcare space, read carefully:
- It’s not easy to know when you are entering the space of a medical device
- When you learn that you have, it’s almost too late to do the right thing if you hadn’t prepared for it
- You only get one shot in healthcare, there’s no double-dipping here
- It’s not hard to do the right thing and don’t let process-adverse employees dissuade you – Implementing an ISO-13485 based control system is like cooking with a recipe – It’s not hard at all
Only time will tell how Theranos and Elizabeth Holmes will overcome the conundrum in which they’ve fallen into. Elizabeth is a very smart person and this is obvious by observing her in the media throughout the ordeal she’s been involved in.
But you, dear entrepreneur, may not be as lucky. Get your act straight from the beginning.
And believe me, many of you in Health IT are indeed manufacturing software as a medical device and you don’t know it. You’re even in denial because many of you have heard it personally from me.