Back to the Orchard

Back to the Orchard

According to an article posted on the Regulatory Affairs Professional Society web site;

“Last week, tech behemoth Apple signaled its interest in further pursuing the development of new medical devices with a new patent granted for an electronic device that “computes health data.”

The article goes onto to state;

“The patent also shows Apple may use the device to communicate with a database maintained by a doctor and/or other medical or health provider.”

Now from what we can tell this patent does not specifically address glucose monitoring, however it is well known that Apple has been working in this area and they also have been very public about their relationship with Dexcom (NASDAQ: DXCM).

What we find interesting here is the term “computes health data” which obviously could mean many things but we based on what we know it confirms something we’ve written about before; Apple is about to make the deep dive into diabetes. The fact that this patent adds in that the device may communicate with healthcare professionals means that Apple is about to enter the domain of companies like OneDrop, Livongo and MyDario among others.

Not one to gloat but we seem to remember that just yesterday we noted that all these way cool whiz bang cloud enabled conventional point to point systems have a valuation problem, a problem which just got worse. We mentioned that high tech cash rich companies like Apple can easily replicate what they are doing and all they need is the hardware to gather the data. Gee, based on this patent and what we know about their CGM effort it seems like Apple is doing just that.

We still maintain that Apple’s independent non-invasive CGM will never work, that they are running into problems that no amount of money will solve. The company stands a much better chance of incorporating Dexcom’s technology into their platform than going it on their own.

Admittedly we are somewhat surprised that a company known for 6-month product cycles would want to get into any device which requires FDA approval. But then again if they are to make the deep dive this is what they will need to do. We cannot see the FDA allowing Apple to provide any coaching or advice without the device being approved. Nor do we see Apple trying to skirt the approval process as they realize that patients, physicians, CDE’s and payers will demand FDA approval.

What we see developing here is a slow, methodical and deliberate approach, something Apple can do not just because they have tons of money but also because they do not NEED to be in diabetes they WANT to be in diabetes. Just as Google and Amazon see diabetes as a way to increase adoption of their platforms so does Apple. We may make lots of jokes about Alexa and Siri and how they will interact with patients but this day is coming and coming very soon.

The question we have with these cash rich high tech players is well they make the same mistakes as everyone else or will they actually think outside the box. Will they understand that for non-intensively managed patients, the biggest market there is and the sandbox they all want to play in, is vastly different than intensively managed highly engaged patients. Put in simply terms will they listen to the needs of real patients who live in the real world.

We cannot overstate how different the worlds are between an intensively managed engaged patient and one who is non-intensively managed. This is NOT just a matter of whether they use insulin or not, this goes well beyond which therapy option their physician has prescribed. This goes to how they think about their diabetes, what motivates them and what turns them off. It’s about how a patient interacts with their diabetes, what we like to call the patient experience.

There is no question that Apple has the money to make a series run in diabetes as does Google and Amazon. This has never been in dispute. The question comes down to will this money be well spent or wasted.