Last week, thousands of healthcare companies and investors therein descended upon San Francisco for the 2011 JP Morgan Healthcare Conference. Although I wasn’t able to attend personally, I’ve been keeping an eagle eye on what happened there in terms of diabetes through my friend, seasoned industry observer David Kliff of Diabetic Investor — reporting daily on what he calls “the wacky world of diabetes devices.”
He’s kindly given me permission to summarize some of his thoughts.
First off, Kliff says that two clear themes emerged from the conference this year: the importance of emerging markets (growing middle class in India and China, for example) and the influence Apple is having on the technology front. Woot to the latter!
“It is not an overstatement to say that no other company or product has forever changed the future direction of medical technology. What the iPhone and iPad have proved is that consumers not only want cool technology but easy to use technology that fits into their life and helps make their lives easier.” Ya think? This just warms my design-friendly heart.
More specifically, here are some things I learned:
♦ Insulet previewed its smaller pod, which won’t hit the market until at least 2012. (I have this info and photos directly from the company). It will be approximately 1/3 smaller and 25% lighter than the current pod, but with all the same features. That means a 200-unit reservoir, and 80-hour pod life. The delay to 2012 seems to be entirely an FDA holdup. *sigh*
♦ Dexcom and Insulet are still working together to integrate the Dexcom continuous monitoring system with Insulet’s OmniPod tubeless insulin pump. But the companies seem to be blaming each other as to why this project is delayed. Kliff reports that Dexcom’s CEO Terry Gregg stated in his presentation that “the ball is in Insulet’s court.” Later that afternoon, he says “Insulet returned the serve… when they noted the reason for the delay is Dexcom’s FTC wavier for their transmission frequency, which expires in 2013.” Apparently they’re not sure whether Dexcom will receive an extension beyond 2013. *sigh again*
Kliff observes that once again, money may be at the root of the issue:
“The simple fact is while an integrated system would help Insulet more effectively compete with Medtronic (which already has an integrated system), this does come at a cost. Simply put, any existing OmniPod patient who decides to use this integrated system would need a new PDM, the device that controls the OmniPod. While Insulet has stated that it’s no big deal to swap out the older PDM with the new PDM… it will cost the company money, (which) they appear unwilling to spend at this point.”
Here’s a question to fellow OmniPod users: wouldn’t you be willing to pay a small fee for the new PDM, to get the integrated CGM? I sure would.
♦ Meanwhile, OmniPod still has a gi-normous leg up in the patch pump market. Even though pharma giants Roche and Medtronic have both acquired patch pump technology, nobody else seems to be able to get this “next great innovation” off the ground.
“Medtronic continues to change the timeline for their much-hyped and much-delayed patch pump. The latest (estimate) is the first half of their fiscal year 2013,” Kliff says.
He adds that Roche has “invested almost $200 million for a patch pump, that still is not on the market, may never actually make it to the market and even if it does make it to market will be so difficult to use it will actually help sell the competition’s product.” Ouch!
♦ Sanofi-Aventis publicly acknowledged that the US launch of the exciting new Apple-integrated BGStar and iBGStar products will be “slightly delayed until the second halfof this year.”
♦ MannKind’s founder Al Mann was still bullish on their new inhaled insulin product Afrezza, although “not as bombastic as in the past,” Kliff says. Mann noted that he remains “cautiously optimistic” that the FDA will approve Afrezza — a much subdued tone compared to his previous public presentations.
♦ btw, another new developer of inhaled insulin has emerged by the name of Dance Pharmaceuticals based here San Francisco. The company is run by a former exec from Nektar Therapuetics, and their new product is weirdly based on aerosol technology. I’ll be talking with them more intensely very soon.
♦ It looks like Intuity Medical, a company that’s been developing an all-in-one glucose
monitoring system called Pogo™ for quite some time, has finally “solved the mystery we call the FDA and will soon be submitting … for approval,” Klilff reports.
“Although the Pogo is not a revolutionary device, … the simple fact is patients with diabetes have too many things to carry around and the Pogo not only makes glucose monitoring simple and easy, but is contained in one nice neat device,” he writes. I’d have to agree that it looks attractive — given that patients can get the product and required cartridges reimbursed by insurance (??)
♦ After spending three days seeped in all the latest and greatest in drug development and new med device technology, Kliff writes that he “anticipates that 2011 will be a transitional year in the diabetes world; where the old guard will make way for some desperately needed new blood. Companies once thought to be invincible will face some very serious competition from these newcomers and just might not be able to adapt. Stuck in the past and unable to move to the future, the diabetes world could be turned upside down.”
Really? WOW.
What is the role of the governmental regulatory bodies in all these delays? What does the future hold for these governmental bodies approving devices? If they are delaying which is part of the problem or most of the problem…what can we do about it?
As far as newcomers…well I would not trust to any of them without a proven track record. You might find the company going out of business or with little customer support.
Amy (and David), thanks for a most useful summary. It seems as if the FDA is holding up a good deal of development work. Is there any way we can exert influence on them to speed up the process? Should we be talking with our legislators about this?
It’s sad to see that two things I’ve been looking forward to, smaller OmniPod and iBGstar, are pushed back.
Would I pay a percentage of the upgrade to the OmniPod PDM with CGM integration? I probably would depending on the cost and how “integrated” the system actually is. OmniPod currently offers people with other pumps to switch for $149 (I think, or something like that). That price tag would be reasonable to me.
The next question would be insurance coverage. I know a lot of insurance companies won’t approve CGM’s for younger patients. Our particular insurance won’t typically approve them for patients under 25!!
If OmniPod could work with current users to help get insurance approval fast tracked, then I think a lot more people would be willing or interested in switching to the new OmniPod/CGM system.
What we love about OmniPod right now is that our young child does not have to have the PDM on her body at all times (as opposed to insulin pumps w tubes which require children to wear a fanny pack or have it clipped to their clothing). I’m assuming that CGM integration means that my daughter would have to have the PDM on her at all times.
At home we keep her PDM in her “pump bag” (a small purse) hanging on the door knob in the kitchen. At school she keeps it on the shelf right inside her classroom door. Everyone knows where it is and they get it as needed.
By the time CGM integration is a reality and we got through the insurance approval process, my child would no longer be a tiny six-year-old, so carrying the PDM may not be as much of an issue.
(Long comment from me AS ALWAYS!)
Fantastic review! Thanks so much for the info Amy and David.
And yes – willing to pay for the updated PDM. I don’t see why Insulet should have to bear that cost.
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Love the update. I also wonder what’s going with the FDA. From the outside It sure looks as if they are unnecessarily restrictive and should make large scale changes in policy.
Thanks for the update about the smaller pod. We are excited here and cannot wait for a smaller, more slimlined pump. I think it will attract even more people to the OmniPod and make it even more discrete. And yes, I would certainly pay, out of pocket even, to upgrade to the new PDM when it is integrated with Dexcom. And like Leighanne said, many of us are fighting insurance companies about a CGM for the younger folk – G’s Medicaid will not pay for a CGM – AT ALL. So, integrating them both into her actual pump she is using might prove a bonus for us – it’s already in there. Interesting stuff to pose to the insurance company and personally I cannot wait for the day!
Nothing from Abbott? As a happy Freestyle Navigator user this worries me.
Also – ironic that news on diabetes devices has to come from conference from **investors**. Shows you where the pharma corps focus!
I wonder if Insulet has considered new users? As a Medtronic pump customer, I have been holding out for their patch pump. I’ll take which ever integrated tubeless system arrives first, and pay for the upgrade.
Thanks for the great update. Since my pump warranty expires in a little over a year, I love to read about the new improved options that may be available to me. I’m also really excited about the BGStar meter – hopefully we will see it’s release in 2011. That Pogo system was new to me, although it looks very very similar to my Accu-Check Compact Plus. I was disappointed that I couldn’t find any information on the Pogo web-site about the size of the system. I love my Compact Plus but I’ve always wished it was smaller.
Not many surprises here. The issues getting FDA approval on new pod design have been known for a while (would not surprise me if they start shipping limited quantities before 2012). The true backstory on Dexcom/Insulet are probably a whole lot more messy than meets the eye. Hopefully they can figure it out and do not have a falling out.
Insulet needs some competition in the patch-pump market. Once someone else does it – it is really going to make competition a reality (either Insulet prevails and improves their product ahead of all the others awaiting approval or someone else will).
I’m still amazed that BGStar is going with a plug-in approach to the iPhone. The bluetooth is there – use it! It would also open up their device to other avenues — android, blackberry, and of course actual computers…
One of these days we’ll get current-decade technology to the user.
Any word on whether OmniPod and CGM integration means a choice of two different pods and PDM’s or if ALL the pods shipping after integration will have the CGM in them?
I assume there will be an increase in price to include the CGM and I hope that is not a cost that non-CGM users will have to bear.
That being said, if it is included and the same price, it may be easier to get insurance companies to approve. I don’t know.
I almost hope that there is separate pricing based on whether or not you want the CGM because I would NOT be happy to pay a higher price for pods if we aren’t actually using the CGM technology.
(And like I’ve said before, I don’t think we are even considering CGM until there is integration.)
This was a great update, yet again the FDA delays in approving the new products is disappointing.
It is interesting that the technology companies are talking to investors, but not the end users. I use the omnipod and am disappointed that the PDM looks like a 1980′s garage door opener. Why can’t it look like a smart phone or ipod? I can’t fit it into my jeans pockets like I can my phone. Why is there just ONE style of PDA?
Why does the insulet pump only offered in white? It could come in several skin color shades, so its not so noticeable.
I believe the integration of the omnipod and the dexcom CGM would occur by having a single PDA controlling both devices. You would still have to wear two devices -the pump and the CGM.
Let us know how we can persuade the FDA and the companies to move more quickly on these products.
[...] Mine Insulet’s New Smaller Pod, Dexcom Integration, and More from JP Morgan (Lots of news on the medical device [...]
[...] For an informative post on smaller Pods and DexCom integration, visit DiabetesMine.com. [...]
It’d be nice if Insulet could get more insurance companies to pick up coverage. My daughter is using the Omnipod (and is really looking forward to the smaller version), but it’s pretty spendy without Kaiser footing part of the bill.
FDA is kind of against using Bluetooth, hence why theres been sort of a hold on meters with BT technology, like the Agamatrix Wavesense Jazz Wireless, and thats why they went the route they did with the BGStar…
The FDA doesn’t want to certify IOS or other OS’s (Android)… ideally they want all meters to be propriatary and can only send data to another device.. cant interact with it…
This is also why theres not much Windows 7 updates to pump/cgm/meter software…. i honestly think they are being too protective since most stuff is already at the users risk..
Interesting stuff. Thank you Amy and David.
Wouldn’t it be great to see something really revolutionary in the world of diabetes? Unfortunately, the FDA wants to see something that’s already been proven safe, which usually means a copy of an existing thing, or an expensive study proving the new thing is safe.
What new company would want to fund such a study? It’s too expensive.
do you have any info on whether omnipod has plans to reduce the size of the PDM? I’d love a mini-controller that just had bolus/basal adjustment functions w/o the rest of the bulk/weight.
I’m very interested in this new smaller Pod. Ihave been wearing the original Omni Pod for over 5 years. I have been campaigning to have the Omni Pod coverd by Medicare. Will there be an issue with Medicare coverage for this new Pod?
I think the Omni Pod is the best thing to hit the market for diabetics since Insulin.
I have my fingers crossed.
I have been a diabetic since I was 18 mos old,back then glass syringes with a bblue glass plunger and a metal needle had to be boiled before every use. It was a problem when we went to visit my aunt in New Jersy,because there was something to do with the water ther and whenever my parenst did the boiling that was recquired the syringe jammed and I had to go to the hospital to have an insulin injection. We went back to my Aunts house and my father,mother ,and 2 sisters and 1brother were piled in the car and on the way back to Boston. Next came the plastic syringed they were oook.
What seemed like a great number of years later came the plastic syringes by BD,they’re still on the market. Then started the pumps with all kinds of tubing which would easily catch on to belt buckles when you were in the ladies room.
I’ve been through almost every step of advancing the Omni Pod made by the Insulet Corporation,so now the Congress put Code Numbers on it and made it disposable. I’ve petitoned the Congress with others to change the Code Numbers to a durable Code.
I hope they will put a code number on the newer pump allowing it to be covered by Medicare.
If you’re not approaching 65 you’re pretty safe,and will have plenty of time to “Fight Washington.”
I hope that someother diabetics that use the Omni Pod Insulin Pump will contact here Representative in Congress to have the Code Numbers on the Omni Pod changed from POD A 9274 and PDME 0784 to a durableCode Number.
So far I have support from Congressperson David Cicilline and David Gregory from MSNBC.
Contact anyone and everyone that is on MSNBC and The Representative that are representing your area in Congress. Get in touch with Jill Biden she is an MD.
Contact the President and the Vice President tohelp get the code numbers changed.
We shouldn’t be punished because we have diabetes.
I’ve contacted David Gregory who has given me a thumbs up. I’ve tried to contac Joe Scarborough with no success.
Contact your Representatives,they are the ones who applied the “disposable item” code numbers to the Omni Pod.
Lets stick together and get those Code numbers changed. Remember a lot of these Representatives want to return after the nex election!
Keep on contacting the Congresspersons who represent you. Remind them that we hire and fire them.
We want a durable code number applied to the Omni Pod Insulin Pump. It’s up to theRepresentatives in Congress to do this.
If their not interested in returning after the next election they can ignore us.
This pump is the best thing that has been on the market in all the years that I’ve been a diabetic.
Iwas diagnosed when I was 18 mos old in Feb.1950. I am now 62 years old and I’m not going to give up the battle.
I’m so tired of carrying my Dexcom 7plus and my smart phone. When will somebody do the obvious and integrate a BG sensor with the smartphone. The software app is a weekend’s work for a decent programmer and how hard is it to design a transmitter/antenna that would fit into a SD card slot? Please this is not rocket science somebody make this happen. Screw the FDA cert, just sell it as plug in hardware and an android app, no need to get big brother involved.