Two years ago, Roche was the first to take the plunge, inviting a bunch of diabetes bloggers to visit their headquarters for a day of frank conversations and an “inside look” at how they make the products that keep us ticking. And they hosted us again last year at the CWD Conference.
On Friday, about 25 of us online advocates from the diabetes community were invited
to Los Angeles for a day of similar interaction with Medtronic. Admittedly, we always jump at the chance to gather in person for a DOC pow-wow — yet we were once again somewhat leery of what the day would entail, especially since the agenda was kept secret until the last second (when we arrived by multiple cars from our downtown LA hotel to Medtronic’s HQ in Northridge, CA).
The day turned out to be surprisingly relaxed and informal-feeling, aided by the convivial demeanor of the featured (famous and well-revered!) speakers Dr. Fran Kaufman and Dr. Richard Rubin, both former presidents of ADA.
Kudos to Roche for paving the way. I think none of us were as tense as in those first two years, when we were really wary of what a pharma company might want from us…
Our "goofy" group shot
… so instead of grappling over the impact of social media itself, we were able to focus on much bigger issues in patients’ lives: like where is the technology going at what pace, and how can we help patients everywhere deal better with the psychological and social struggles brought on by diabetes?
Not that we solved all the world’s D-problems in one day, but it definitely felt like Medtronic, the biggest pump company and a leader in the Artificial Pancreas effort, “got” what we were saying about what’s hardest for patients. (And the fact that we all hate that floppy-shell-shaped sensor that’s part of their Guardian CGM – uncomfortable!!)
A lot was discussed. Here are some highlights:
The News
We were privy to a preview of some exciting news: Medtronic D-management software program CareLink is finally available for the Mac beginning this very day! Check out the announcement here.
We also got a “sneak peek” look at their brand new iPhone app for pump customers called MyMedtronic Connect, in the usability testing phase now. It allows users to record their pump settings and order supply refills online, and also contains video tutorials and info on alerts and alarms, etc. It’s initially available for iPhone, iPad, and iTouch and they say they’re “looking at Android too.”
Our group was less than enthusiastic, given that this app is a just a place for Medtronic customers to store settings and get product-specific info — yet it’s not an actual logging program and does not connect with CareLink (?)
Behind the Scenes
At one point in the day, we were divided up into small subgroups for about 20 minutes of “one-on-one” time with Medtronic executives. This was an excellent chance to speak our minds on what we think is wrong with industry now, and where they ought to be going. And also to ask a lot of probing questions — although the FDA was always looming in the background, so lots of answers included the obligatory “that’s all I can say at this point.”
We also got to don hazmat suits for a tour of the “cleanroom” facility where Medtronic currently manufactures ALL of its CGM sensors for the entire world.
(not their actual plant)
It seemed rather small to me for that… but when you view the amount of expensive, intricate machinery, the precious metals being meticulously processed, the scores of diligent workers threading tiny filaments into plastic molds by hand — it certainly gives you another perspective on the supplies that we generally take for granted! And on the costs thereof. This stuff ain’t trivial. Each and every sensor goes through a 33-step manufacturing process, including being driven down to San Diego for a specialized sterilization process and then returned to the Northridge plant for further processing. Wow!
Tidbits
Finally, I wanted to share some interesting “trivia” I picked up throughout the day:
* Medtronic has rights to conduct “data mining” in its CareLink database — meaning they can access “anonymized” customer data to conduct studies. Seems creepy, but probably a very useful thing
* The company’s launching a new eLearning system to train people before they start on the pump, etc.
* In their sensor-augmented pump therapy research (toward the closed loop), they learned:
- patients who are most successful use more smaller boluses more often, taking more corrections
- so best practices for pump use = more boluses/day
- four or more basal rates are sensible. About 4-5 is a reasonable number
* The reason the Paradigm Veo system with automatic shut-off is held up at FDA is because FDA considers it having “crossed the line into the artificial pancreas area — it’s the first time a sensor is telling the pump what to do”
* One idea is for companies to push for a first step: closed loop at night only?
* The new Dexcom and Insulet combo product will be called the “Vibe” (unrelated to Medtronic, but I happened to hear it Friday)
Thank you, Medtronic. This was a useful gathering. We have our issues with all of the vendors of course, but I do believe that exchanges like this one help patients everywhere.
Did you get any clues when the new sensors from Medtronic are expected to be released? I assume that entered the “all I can say” venue…. After goose-egg bruising and swelling from several of my latest sensors (and 2-1/2 years of unreliable results), I’m not sure that I can ever force myself to use one of the old sensors again. I keep using the system because insurance won’t approve me for a new system. I hope to hang on long enough for the new sensors from Medtronic, but I’m losing hope.
In regard to your information on the FDA hold up of the Veo system—my husband has presented to the FDA several times. He is consistently disappointed/astounded to find the review panels are either uninformed or uneducated as to the technology they are considering for approval.
Casabby, the new sensors will probably not be available for at least 2 years.
The new sensors only work with the new pumps because the current pump only supports 3-day sensors (and the new ones are 6-day). Based on their feedback from the FDA, it is unlikely that the new pump will be released for at least two years. They need to complete a current study and conduct another 6-month study (which actually takes 12-months). Then the FDA needs to give approval which can take a year.
As I learn more about FDA reviews for our technology, it’s clear to me that there may be a role for the DOC in those reviews. We are experts in diabetes care for ourselves as individuals and many of us has used a large number of devices so we’re familiar with their benefits and shortcomings.
Maybe it’s time to start brainstorming about a way to establish some type of relationship with the FDA and ultimately reduce some of the roadblocks we’re encountering.
I think I heard them say that data mining is conducted on data after consent but that maybe a good point to check.
Amy – thank you for this rundown! Very awesome and informative. On the whole MyMedtronicConnect – are they at least considering or working toward having it include those management aspects? Is this a “first step” type of thing, or is this what the end-vision was? To me, that seems like MM just wanted to jump on the App Bandwagon and not actually provide anything truly useful to the consumers being served. This is a great idea, but I too only think it really serves a need if offering something practically useful on the day to day, what you might actually want and really need from a smart phone app in the first place? Hope they are moving in that direction…
Bernard—EXACTLY what I was thinking. At the very least, when reviewing diabetic technology, there should be an endocrinologist and/or a PWD involved in the process. Isn’t this just common sense???
I’ll admit that I’m one of those people who will need a lot of convincing before I let an insulin pump decide on dosing. Did they really say that they consider night time as a good first step for closed loop approval? That terrifies me. I definitely want to be awake/aware when that machine is in control!
@Badshoe – it’s in the fine print when you sign up and “accept terms” for using CareLink.
@Kassie – mainly they’re talking about adding automatic “low glucose suspend” at night, meaning the system would stop delivering insulin for a time if you’re clocking in too low.
how about a semi-closed loop where actions by the pump that are derived by CGM have to be confirmed by the user?
Anonymized “data mining” seems completely reasonable to me. This is common in medical research and will presumably lead to improvements in care. If someone thinks my data can be helpful, they can have it (if it is anonymized). I am sure there is a disclosure of some sort in the software license agreement when you install it. This is more commonly called “chart review” and does not always even require the consent of the patient; these studies are carefully regulated by institutional review boards (a panel of lay people and professionals who examine research involving human subjects). Thank all those patients before you for the good medical care you get now.
I appreciate that Medtronic has enlisted the help of the DOC. It’s great to get a glimpse into the future of our technology and also to know that Medtronic is not just focused on technology, but also on the emotional and social aspects of living with diabetes.
“Low glucose suspend” sounds much better to me than “closed loop at night only.”
David–Thanks for the update, although it is disappointing information. I had wondered whether the new sensors would work with the old transmitters and it’s not surprising that they won’t. I just want smaller sensors and shorter insertion needles. Oh yes, and more accurate sensors.
Not to contradict David, but all the information I’ve received (some from Medtronic employees) is that the new sensors WILL work with the old pumps. The old pumps will still require a restart on days 3 and 6, and will not have the upgraded algorithm that the next gen pump will have, but the new sensors will come out before the new pump.
@Megan: I was in the same tour team with David, and I can only confirm what we were told by Jonathan Riley of Medtronic, and that is that the new Enlite sensors will not work with the old pumps. The reason is the FDA will not approve anything that requires circumventing pre-existing FDA approved products. If the old pumps “require” sensors to be changed every 3 days, and the new sensors are being marketed to last 6 days, then the FDA will not allow Medtronic to market something that would require ignoring an already existing FDA approval. Does that make sense? They are not allowed to tell people to just “restart the insulin pump” on the 4th day, even if reps may say that you can do that. Technically they are not allowed to.
The Enlite sensors will be approved in Europe, but they will not be approved for the US.
Well, it would not be the first time Medtonic has lied to me. We are happy with their product, but just so OVER the way they make promises that they can’t/don’t deliver. When my son was diagnosed 3 years ago, the new sensor was going to be out “next year.” And MySentry? That was just around the corner.
I’ve also heard from a fairly reliable source that the patch pump may be scrapped altogether because market studies are showing that it’s not a big revenue-earner.
A year from now when his pump goes out of warranty, I think we’ll be seeing what else is out there.
@Megan: I think it was mentioned in the post, but a huge factor is the FDA. The FDA has become even more strict in recent years, requiring more and more clinical trials and studies to answer even the most mundane (to us) concerns. That causes quite a bit of unpredictability in the market. However, I agree that we should not sacrifice our health while we wait for the “next big thing” and I fully support people utilizing multiple companies to get what they need.
Oh, I know some of it is the FDA, no doubt. I also think some of it is Medtronic promising more than it can reasonably deliver in an attempt to keep customers waiting around hoping that the next big thing is indeed right around the corner. I mean, it’s pretty obvious to me that last year when they promised the new sensor late FY 2011 and the new pump early 2012 they must have known that neither of those things was likely to happen. (And the year before, they promised both of those things earlier than that.)
It is just very disheartening to me that JDRF is focusing less on a cure, but hey! Let’s all get excited about the AP! Well, okay. The AP would be pretty great. Except device companies can’t get the most basic changes through the FDA, so hmmmmm, that AP isn’t looking like it’s coming so soon either. I’ve never had a lot of hope for a cure, but I was really hoping that technology would make my son’s life substantially easier before he left for college. And now…I don’t know that we’ll have much that’s all that different before that happens.
Yeah, this all leaves me feeling bitter and sad. JDRF is turning away from its focus on a cure, and looking at AP technology that will make PWDs lives better. Well, okay. I’ve never held out that much hope for a cure anyway. But when companies struggle for years to get the most basic upgrades to products through the FDA (it took 19 months for approval for the Revel, and it had minor, minor upgrades!), how long will it take for anything actually revolutionary to get through?
So less money going toward a search for the cure, and technology moving at a snail’s pace. Guess I should just get used to our high-maintenance sensors that leave my son’s skin looking terrible, and a pump that looks like a 1980s beeper. Because if MM is saying now that it will take two years for the new sensor and pump, it will be at least four.
@Megan: I actually learned this afternoon that we were both partially correct. The new sensors do work just fine with the old pump, however, the FDA won’t allow Medtronic to market a system that requires a restart of the sensor. FDA requires that Medtronic also have a pump that will run a sensor for 6 days straight, which is why the sensor isn’t being delayed in the U.S.
Apologies for any confusion!
@Allison: Did you mean to say in your last sentence “which is why the sensor IS being delayed in the U.S.?”
Thanks for the clarification. Much appreciated.
@Megan: Yes! I did. The whole sentence should read:
FDA requires that Medtronic also have a pump that will run a sensor for 6 days straight, which is why the sensor is being delayed in the U.S.
thankyou, good post. this has changed my perspective on medtronic, where their pump was probably being inched out of the running for my young son, im now re-considering with the work going into cgms. we are waaaay behind with technology in australia, both availability and affordability. if the you are talking 2 years in the US, then its prob 5 or more here
Where are all the blog posts about the 2 year delay of the Medtronic Enlite sensors? 25 bloggers and no one is blogging about it. Hmmm….
Tracy, I can’t speak for other bloggers, but we did address it in the comments here (apologies for leaving it out of the text!). But there’s really nothing left to blog about. The 2 year delay is primarily the responsibility of the FDA, because the sensors are done. It’s not that Medtronic has delayed the technology of the sensors, but the FDA is basically requiring them to create a new system – a new insulin pump – which takes time to develop and run through clinical trials (which David described earlier). If anything, we may explore the issues with the FDA in upcoming posts.
Telling me the Enlite sensor is compatible with current Minimed pumps is like rubbing salt in my wounds. Seriously. Why even go there when the FDA has blocked it from ever being used in the current pumps? Please don’t send mixed messages that give people false hope. Some of us are at the end of our rope with MM promising products they cannot deliver.
When did the FDA tell Medtronic there would be a 2 year delay on the sensor and when are they planning to announce that? Something smells kinda funny.
Oh Allison, I think there is plenty to blog about. You were the only 25 people in the country to find out about this bombshell and yet you
don’t find that blog worthy? I find that really hard to swallow.
I guess we can blog about Carelink and the Veo (safe topics), but we choose not to bring up the disturbing news that the long awaited MM sensor will not get FDA approval for at least two years. Thank you Dave for at least having the courage to state this in the comments section.
99% of the Diabetic community is blissfully unaware of Medtronic’s 2 year delay. Many of us have been following the Enlite for a long time, hoping for anything that makes our lives easier. I think you should ask yourself why you chose NOT to blog about this.
My opinion only.
I wanted to add that my understanding from contacts at MM is that it is not a surprise that the FDA will not allow them to release the new sensors for use with the existing pumps. MM has known this for quite a while. They originally intended to do a software upgrade of the Revel pumps, allowing for 6-day sensor wear. That would have made it through FDA review much more quickly than an entirely new pump. Instead, they’ve decided to wait to release the Enlite with the next generation pump.
I suspect that if Animas and/or Insulet had brand-spanking new integrated pumps on the near horizon, MM would have done the software upgrade so that they would also have something new out. But when you’re the market leader, holding market share, and your competition can’t find its collective rear ends with both hands and a flashlight, what incentive do you have to get anything new out quickly?
@Tracy – no need to shoot the messenger here! Up until recently, we too were “blissfully unaware” that the Enlite sensor was such a heated issue. (We rely a lot on plucky readers like you to tip us off!) Your request for more coverage of Enlite is well-noted, thank you.
Thanks for the update! I would be curious about two more points:
- Why do you think that Medtronic invited members of the DoC? I think there are plenty of good reasons, but I wonder what your impression was of their purpose in organizing such an event.
- How many of the people that attends USE Medtronic products? Although Medtronic has the market share, I notice on TuDiabetes that many experienced pumpers run away from Medtronic when they can, especially for the CGMS! Do they seem aware how poor the reviews are of the MM CGMS compared to Dexcom? I guess they are (and the new sensor should be the complete answer), but I would be curious if they brought this up directly.
I use the MM722 (without CGMS) and also use Carelink. I figured that they were data mining (and I’m actually fine with it). Whenever I want to get a report for even one day of pump data, I need to upload all the data on the pump. I wonder how useful the data is given that so much information is still missing (in my case, my blood sugars readings).
Hi Guys,
This is Karrie Hawbaker, PR Manager at Medtronic. I’m glad you’re all so anxious for a new sensor here in the U.S. Those who were with us on Friday can attest – so are we! We invest heavily in research and development, are excited by our product pipeline and want to get new products to market as quickly as possible.
I know there are a lot of rumors floating around about Enlite. The thing is, Enlite is approved in Europe and we are working with our regulatory partners to bring it to the U.S. However, this is taking longer than we anticipated which, as you may have already heard from others in the industry, is not uncommon for medical devices in this regulatory environment. So, we really cannot predict the timeline. And because you are consumers, FDA doesn’t allow us to talk to you about products that are not yet approved in the U.S.
I can tell you that we are committed to designing sensors that work with our existing integrated system. And I can tell you that getting a medical device approved in the U.S. involves an ongoing dialogue between the FDA and the manufacturer to ensure that the clinical evidence meets safety and efficacy standards.
So, please, I encourage you all not to jump to conclusions about what the timing is before even we know what that will be or about the product offering before it is approved by the FDA.
And please know that we’re really not holding out on you. We’re working as hard as we possibly can to get a new sensor (and other future products) to you as soon as possible.
I agree with Megan, my gut feeling is that MM has known they couldn’t get approval on Enlite for a LONG time, and kept it under wraps (still is). There are standard, preset conferences set up throughout the FDA filing process, even though MM wants us to think they just sit back helplessly and wait. I’m sure this came up early on.
Remember when MM announced they were extending the current sensor to 6 days (same sensor, longer wear) then that plan was abandoned and the new Enlite was announced? Same deal, same issue. The original plan was probably scrapped because the FDA told them they wouldn’t allow it until the pump was upgraded. MM knew that would be the case for Enlite too. Why wouldn’t it be?
My Opinion Only.
with all due respect Karrie (and in fairness of disclosure my son is a Revel/Cgm users) it sounds an awful lot like the phantom CGM parent monitor that was “being held up by the FDA” back in 2006 and which still has not made it to market. Not everything is the FDA’s fault. MM has a track record of enticing customers with promises of things with no way to deliver them, and then they blame the FDA. If there was competition RIGHT NOW for another integrated pump with better sensors I have no doubt MM would find some way to get their to market first. As it stands though, it makes little business sense for you when you already own the market, to introduce a new product just to appease a few small CGM users.
I’m tired of the FDA being blamed for every holdup. I’d think by now you all know how the FDA works, so instead of pulling the old “Oh, surprise, FDA wants something ELSE..who knew??” you could maybe be honest and say you have no intention of getting that “something else” to market until it’s absolutely necessary.
And while we’re talking – could you PLEASE for all that’s good, get a version of Carkelink PRO with the EXACT same data (minus the dosing ‘suggestions’) to consumers? The dumbed down carelink version you have for us is insulting.
I couldn’t agree more with both Tracy and Megan.
And Karrie … perhaps you can’t fully appreciate how condescending it feels to be told, on the one hand, that you can’t talk to us because the FDA has muzzled you, and yet, we must not, “jump to conclusions”. No, we must sit quietly on our hands and wait …and wait and wait and wait.
Karrie, thank you for posting.
I do have a couple of bones to pick with what you posted. First off, it’s obvious to me that it’s not quite as simple as MM not being able to talk about products that are not yet approved in the U.S. I remember seeing a video a year or two ago that was posted several places on the net where one of the Medtronic mucky-mucks was holding a prototype patch pump and talking at length about it. I’ve also seen multiple timelines given for the product pipeline in quarterly and annual investor presentations and stockholder reports. There was a focus group for (the mythical) MySentry at Friends for Life 2009. I’m sure there are some restrictions on what you can say about non-FDA approved products, but I don’t think they’re as draconian as you represent.
The fact of the matter is, in the past four years, Medtronic has not hit one projected release date. It is downright infuriating to be told time and time again, “Oh, next year. Next year. Next year.” You’re pissing us off. I mean, the year the Revel came out, you were projecting release of the next gen pump approximately a year later. Come on. No one believes you would release two pump updates so close to each other. It was laughable. Why do you DO this?
We are Revel/CGM users, but my patience is wearing thin. There have not been any significant changes to Medtronic’s pump or CGM in years and years. You can blame the FDA, but I sincerely doubt the FDA is responsible for MySentry being promised and not delivered for FIVE years now. Even Abbott was able to beat that sort of timeline with their ill-fated Navigator.
So my advice to you is to give yourself plenty of “wiggle room” in your product pipeline predictions and surprise us when they’re released early. You’re going to make people a lot happier than this “Next year, oh NEXT year” crap that we see time and time again.
[...] is my newest shotglass! I bought it last week when I was in Los Angeles for the Medtronic Diabetes Advocacy Forum. On Saturday, Lee Ann, Leighann and I toured around Hollywood and Venice Beach, and we stopped by [...]