14 Responses

  1. Bernard Farrell
    Bernard Farrell November 12, 2009 at 6:40 am | | Reply

    Amy, excellent summary.

    Why do you think everyone was so dumbstruck? Did they think diabetes management was easy? I hope not.

    I agree that FDA is most concerned with efficacy and accuracy, they could care less about design. And maybe that’s OK. But what about interoperability?

    They could easily require that all devices provide data in a common format, if they make it extensible then vendors would be free to ‘enhance’ it. This is not rocket science. Many device vendors in other industries have learned that common formats are a benefit, think early fax machines or modems. The value of the individual device goes UP when it shares data with other things.

    One day….

  2. Bennet
    Bennet November 12, 2009 at 7:26 am | | Reply

    Adherence. Barf.

    Yeah Barnard!

    Let’s flip this around. Who should be adhering to what?

    Are the manufacturers adhering to standards that facilitate, simplify and standardize care?

    Why no. They do not.

    They each invent proprietary systems that require the patient to adapt to new processes, new data formats and new software to comply with their one size fits all vision (or lack there of) of how to maintain diabetes.

    There is a big medical / tech industry process to create standards for wireless care. 200 plus companies including most of the big diabetes firms are in. Zero patient participation.


  3. Daerick Lanakila
    Daerick Lanakila November 12, 2009 at 8:04 am | | Reply

    Thanks Amy for reminding them there is a patient side. Apple wasn’t the first to invent a portable digital music player. They were the first to make it user friendly. And they made it work with PC’s also. Then they stole the market because of that. These device manufacturers could learn a lot from Apple.

  4. Bob Fenton
    Bob Fenton November 12, 2009 at 8:17 am | | Reply

    Great information Amy!

    Adherence is the name of the game for one thing only – the bottom line. When patents expire, then we may see some improvement in products. Or… when the manufacturers and Pharmas wake up to the fact that PWD may know more than they want us to – maybe some things will change.

    With the technological advances in computers and other electronic equipment, it only makes sense that there should be advances in equipment for control of diabetes… as well as equipment for other medical problems.

    With the increased exposure that diabetes bloggers are getting, I feel that in a few years (too slow) that more changes will happen because of people like Amy. While I am a T2, I still have an interest in speeding up the changes (equipment) needed in all types of diabetes and medical problems in general.

    Proactive intervention by patients will bring about change.


  5. uberVU - social comments
    uberVU - social comments November 12, 2009 at 9:18 am |

    Social comments and analytics for this post…

    This post was mentioned on Twitter by CureT1Diabetes: RT @diabetesinsulin The Diabetes Technology Society: Frm Algorithms 2 Adherence: The Diabetes Technology Society annu ..

  6. Medical Quack
    Medical Quack November 12, 2009 at 10:18 am | | Reply

    That was a very good post and addressing the issues with algorithms that I have been speaking about for the last year too, as it affects all chronic illnesses with devices, and yes there has to be a human side. I post quite a bit about the devices coming out left and right, hopefully as an awareness item so consumers are aware of what pops up next.
    The key to using devices and algorithms is implementation as if not done properly, you will have disruption, huge disruption. We all still have to function as humans and can’t have devices interrupting that course of our lives.

    Who knows one day the FDA might have to approve our cell phones too. The areas that used to be defined in different areas are running together now so there’s a lot of gray. I used to write code and developed an EMR years ago so this gives me some insight here as there were many times when what I thought was a good idea was actually not a good software design and had to go back and change when working with the family practice doctor. We call it “eating our own dogfood” in the software side of things. Actually eating one’s own dogfood though is how it should be, otherwise you do not know how designs, devices, etc. will work in the real world. There’s a huge difference between what is called proof of concept and the real world!

    Also, with devices you need to know where your information is going too and with all the web based software applications that come with devices this gets a bit gray too. I feel it should all go to a personal health record where it keeps the patient in control. All of this is confusing the average patient by all means and this is not what is supposed to be going on.

    Devices and drugs are also changing delivery methods, many to inhalants as there are devices that can track this. I have posted about these items with correspondence from the likes of Cambridge Consultants, one of the companies who designs such devices and sells the license and product to healthcare companies. Some of what I hear sets me on edge as well. Yesterday I posted about Best Buy joining in the device business as well as selling other fitness products.

    UCLA has a study going on about participatory sensing with devices and i hope they have some results soon too!

    In summary, you can’t just through devices out to consumers and expect results if they do not have a model to implement without total disruption of life, I agree 100% on this. Some of what I see out there scare me too! Again, I think perhaps if some of the experts actually got involved themselves and used some devices to get some first hand experience as to what the patient can expect, we might have some different expectations, so I am back again to eating one’s own dogfood.

    We are being driven crazy with compliance I agree and how to go about it with a human model and just simply meeting the parameters of the algorithms they design is not going to work. I stuck the word “algorithms” smack center on my blog so hopefully consumers can learn what this is all about and how to make sense of what is being designed without real world human experiences and rather relying on a “proof of concept” notion. I deal directly with physicians too and they are frustrated on their side of the coin too as they watch all of this evolve as well.

    Bottom line is to not forget we are humans and all healthcare is the people business. We can’t stop technology but we can all certainly voice our opinions and remind everyone at all levels that we are in fact all still humans and need to be cared for as human beings. This entire area of devices that report data is becoming so fragmented and confusing to everyone all the way around and there are no real laws and regulations for so much of it as it is so new.

    The FDA is still catching up with getting their technology act together, literally as of at the end of 2008 there were employees there who were still writing studies out in longhand and not using a computer! That is scary in itself but I believe now that is quickly being corrected throughout.

  7. Chris Stocker
    Chris Stocker November 12, 2009 at 2:36 pm | | Reply

    This “adherence” stuff just goes back to Marketing 101 and Business 101 – you make a product that people need. Here, it seems to be, we create a product that is almost what you need, but not what you want, but we will market the heck out of it to convince you that you can’t live without it. It’s almost a snake oil salesmen approach, and until they get it right, this adherence BS will be around.

  8. David
    David November 12, 2009 at 2:50 pm | | Reply

    Sure seems that the FDA should be lighter and quicker on its feet. What outside forces exist to ensure the FDA is efficient and sensible vs a slow, oblivious, powerful Washington D.C. bureaucracy?

  9. mcityrk
    mcityrk November 12, 2009 at 8:30 pm | | Reply

    I think the deficiencies with devices are not because the manufacturers do not understand what the patients need and want, it’s because that is all the current state-of-the-art technology can do. Certainly they are pushing to get devices to fail-safe status as then sales of the devices would take off and they might actually make some money.

  10. Carl Anderson
    Carl Anderson November 13, 2009 at 7:24 am | | Reply


    I heard your discussion at the Diabetes Technology Conference and I am enjoying your blog. I am a former FDAer and share many concerns that others have. However, I thought the FDA presence at the conference was impressive. I see them at a lot of conferences (different folks, same agency) and they have constraints on what they can and cannot say. This was definitely one of their better efforts.

    I am also a type 1 for 25 years or so (who’s counting?). I was about the same age as you at my onset. I spoke at a session on clinical trials in a pre-conference workshop. I wrote a brief account of the conference, from a different perspective, on my blog: Carl’s Blog on FDA Stuff. Stop by sometime. The words below are very difficult for an old man with bad eyes. I’m on my second attempt.



  11. John Schmalbach
    John Schmalbach November 13, 2009 at 9:51 am | | Reply

    NON-EVASIVE!!! Just because the strips and lancets are a multi billion dollar per year industry is the only possible reason we do not have the technology to have a hand held device to take a reading instead of the “blood letting” that I have been putting my precious daughter through for 14+ years of her 16 1/2 years on this earth! When she was 4 I got on a first name basis with the head of the FDA to try and get a hearing scheduled for a manufacturer of such a device, when she stopped answering my persistent calls I spoke with the Surgeon General who got her to call me! There was a hearing but the FDA said they didn’t have enough time to research the testing company, they only had 2 1/2 years to do so. We can send rocketships that take close up pictures of planets how many miles away? Technology??? No, it’s ALL about the money!!

  12. Fran Eriksen
    Fran Eriksen November 17, 2009 at 11:10 am | | Reply

    I am not diabetic but have lived with it for 35 years with my husband, youngest son(at age 15 1/2) and now oldest grand daughter at age 6. Thank you for all the good comments. It is all about the money!!!!

  13. metin2 yang
    metin2 yang November 17, 2009 at 11:15 pm | | Reply


  14. Scott K. Johnson
    Scott K. Johnson November 29, 2009 at 6:27 pm | | Reply

    Great post (and comments) here Amy. I bet it was really something to get to see things from the inside. I appreciate you sharing it all with us.

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