No surprises here

No surprises here

Yesterday Companion Medical announced they have received FDA approval for their InPen® system. According to a company issued press release;

“Companion Medical, a leader in the development of advanced technology to improve diabetes care, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the InPen® system, its wireless-enabled insulin pen and proprietary mobile application.  The InPen is the first and only FDA-cleared SmartPen™ that includes technology to:

  • Calculate and recommend optimal dosing;
  • Track history and timing of doses;
  • Monitor insulin temperature;
  • Display last dose and insulin-on-board; and
  • Track and report to the health care provider.”

Some may recall that we created a bit of controversy when we reported that Lilly (NYSE: LLY) who invested in Companion had decided to abandon the InPen in favor of an internally developed system. Information we received from inside Lilly, denied by Lilly and then clarified by Lilly.

Regardless of whether Lilly actually adopts the InPen or not is almost immaterial as the InPen is just one more piece of hardware that will fit within the coming diabetes management systems. It should also be noted that the InPen is not the only smart pen under development.

What is significant here is a couple of points. First and foremost, this approval is just another reason why patch pens will have a hard time gaining traction in the marketplace. As we have been stating there really isn’t a place for these dumb pumps. The simple fact is patients and physicians are very comfortable with insulin pens and with these new smart pens which help calculate dosing will only make them more comfortable.

A hidden benefit of smart pen technology is that it provides an avenue for Lilly or any insulin company for that matter to delivery insulin directly to the patient. Since the pen delivers information to the cloud the possibility exists that the patient would no longer have to visit their local pharmacy for prescription refills, refills which can be automatically sent via the mail or delivery service.

Of course we cannot ignore the potential for better patient outcomes as like all the other way cool cloud enabled devices the data collected can be analyzed, with optimal dosing calculations sent back to the patient via the app. Dosing calculations which would be confirmed by the patient’s physician as they also would be seeing this data.

The fact is all the pieces are falling into place to make comprehensive diabetes management systems a reality. Systems which combine hardware, drugs and data analytics in one nice neat package. The question isn’t when these systems will get here but how they will adopted. How will they paid for, who will be in control of all the data, analytics and fulfillment?

Is it possible say that Lilly would partner with Google who in turn would partner with Amazon and create such a system. Is it possible that included in this system would be the disposable continuous glucose sensor being developed by Google and Dexcom (NASDAQ: DXCM)? Would that not make sense not just because the sensor provides better data but also because it lowers the burden placed on the patient, as they would no longer need to monitor their glucose levels with a conventional monitor. Under such a scenario would all the players/partners benefit financially? Does not such a system also benefit the patient and the physicians who treat them?

This ultimately is the goal of any diabetes management system, creating multiple winners. All the stakeholders win with increased revenues. The physician wins as they can more effectively advise their patients and most importantly of all the patient wins.

It’s about time everyone wakes up and realizes that diabetes management isn’t about which hardware is used to deliver insulin or which insulin that system delivers. Diabetes management is about data collection combined with data analytics. This isn’t the future my friends this is ready to go today, let’s see who has the vision and fortitude to make it happen.