I could call today's guest post a "straggler" from my Summer Reading series, but that might downplay its impact. Good things take time, as noted today by Samantha Katz, who along with a fellow graduate student at Northwestern University, won the the $10K Grand Prize in the 2009 DiabetesMine Design Challenge.
She was subsequently hired by Medtronic as a Global Product Manager for their evolving insulin pump systems (! - and she served as a judge in the 2010 Design Challenge). Now that she's an "industry insider," I asked Samantha to comment on the state of new insulin pump technology — and I found out that's she's learned a few things:
A Guest Post by Samantha Katz, of Medtronic Diabetes
I have to admit that I was pretty naÃ¯ve when I won the 2009 DiabetesMine Design Challenge. The concept of an iPhone — which already contained so many great technologies like GPS, Bluetooth, and Monacle Augmented Reality — controlling someone's insulin pump and even continuous glucose monitoring system seemed pretty simple to me. I assumed the reason something like it was not yet on the market was design-related, and I figured the LifeCase & LifeApp System would be on the market in, say, two or three years, right?
Wrong. It has been over a year now, and for various reasons personal to me and Eric LifeCase & LifeApp is no closer to fruition. But even if we had chosen to pursue developing the system and somehow had corralled enough funding and talent to help us, there is no way we could have the product on the market in such a short amount of time.
That's because insulin pumps are complicated machines that safeguard health. They are extraordinarily complex to develop, especially if they have integrated continuous glucose monitoring, and no matter how many colors they come in or how flashy their marketing is they will never be pure consumer devices. When working in Medtronic's booth at ADA this past June, I would often hear impatient chatter about Medtronic's patch delivery system or Dexcom's delayed integration with Animas and OmniPod. All I wanted to do was remind people that this is not your PDA or iPod we are talking about. An insulin pump is a device that keeps you alive.
Because of that, insulin pumps also benefit from the oversight of the FDA and other regulatory authorities around the world. I say "benefit" because without regulation there would be little trust between patients and physicians and pump manufacturers, and that trust is what motivates physicians to prescribe pumps and entrust us with their patients. This trust also keeps people with diabetes on insulin pump therapy, which, according to several studies, is the best therapy for managing diabetes.
However, the FDA has very strict guidelines regarding the clinical data that is required before a device is approved. At Medtronic, safety is our top priority and therefore we have been working closely with the FDA to launch the most technologically advanced, safest pumps possible. I truly wish I could put every last bit of technology in our insulin pumps because I know that someone out there could benefit, but sometimes that is not feasible until the required data is available.
While this takes time, there are several signs that our industry is making strides. When taking a break from booth duty at ADA, I had the chance to check out AgaMatrix's WaveSense Direct Connect Cable and Debiotech's Jewel Pump and Android app. I am thrilled to see these advancements in the vein of my LifeCase & LifeApp System, and I know that small steps with the FDA in the short term will set the precedent for further advancement in the long term. All of the diabetes device manufacturers are working feverishly to automate insulin delivery and ultimately close the loop, and I believe that this sense of urgency sprinkled with a healthy respect for impeccable safety will get us there — perhaps it will just take a little longer than my initial estimate of two or three years.
For more on iPhone integration, see this neat Timeline: the iPhone as a Medical Tool from MobiHealthNews.