Is the FDA really going to protect patients from mHealth device failings? I’d rather have a patient champion like Walter Mossberg…

Reading this very positive review of the Telcare M2M mHealth monitor by Walt Mossberg in todays Wall Street Journal – a patient who has been trialing this FDA approved device recently – and I found the various feedback loops going on very interesting:

I did find some bugs, all of which the company pledges will be fixed before next week’s launch. In one case, when a reading produced a clearly erroneous number (something that can happen with every meter I’ve used) the Telcare failed to offer advice on what to do. Two subsequent readings were correct, however, and the company says such errors are rare. In another case, I found I could alter a reading on the iPhone after transmission

With the ability patients now have to so easily provide feedback on their experiences to (interested!) medical service providers and the ability to reprogramme remote devices isn’t it time that we start saying something doesn’t pass the “mother test” unless the company behind it is prepared (as Telcare clearly are) to readily accept and proceed with development based on user experiences?

In the comments section Jonathan Javitt MD, CEO & CoFounder, Telcare, has also taken the opportunity to elaborate (in reply to some unfair criticism from other commentators) on some of the real world patient experiences the device is capable of supporting:

It’s fine to criticize the merits of our product. We can take it. However, it’s brutally unfair to implicitly criticize the 28 million Americans who have diabetes and to suggest that if only they would diet and go to the gym they would not have the disease. Nobody knows exactly what causes insulin-dependent diabetes, but the majority of people who get it are young, fit, and lean. Telcare’s product was invented especially for the mother of the child in school with diabetes who spends her day worrying about whether this will be another normal day or an unexpected trip to the hospital. Telcare was invented for the working son of an elderly, home-bound mother with diabetes who is just trying to help keep his mom out of crisis. Criticize us all you like, but please don’t suggest that if only mom would get out of bed and go to the gym all would be well. As far as the preventive app you are asking for, stay tuned. That will be Telcare’s next product release

We also have some patients doing a great job reminding the technologists that chronic disease management isn’t always the doddle they might assume it to be:

As a 45 year type I diabetic I would really like to see the folks who think it is so easy to just use another App on their phone, actually do it. I will even send them the meter and supplies and see how they do after a couple days/weeks

Our daughter was diagnosed with Type 1 diabetes last February. I remember seeing the “supplies” that came home and the struggle to figure it all out. The glucose meter we started with wasn’t compatible with our Mac. That meant that 6, 7, 8 times a day we’d have to take a reading, write it down, and then remember to fax (FAX?!??!!!) it to our endocrinologist for feedback. As early adopters of technology, my husband and I were amazed, astounded, and saddened that this archaic system was the norm

Clearly there have to be high standards for patient safety but I think the speed of change resulting from this single article highlights how much more capacity there is for us to improve the safety and effectiveness of services through agile development that is based on more open discussions (eg. initiated by patient champions and clinical leaders) rather than the uncertain and all too often unquestionable processes that are still held dear by regulatory authorities.

5 Responses to Is the FDA really going to protect patients from mHealth device failings? I’d rather have a patient champion like Walter Mossberg…

  1. This is an excellent article. I enjoyed the Patirnt experience story. If the government and more companies like Telcare listened to patients, the system would work better. People don’t get tickets for jaywalking or not wearing seatbelts, and would obey these laws more with education than legislation.

  2. […] I mentioned Walt Mossberg’s review of the Telcare device in an earlier post, and over on the 3G Doctor blog, there’s an interesting take on some of the issues that have to be settled with these […]

  3. […] 2012 the expectation we have for access to information and the recognised value of patient contributions are inconsistent with the FDA Approval process. The market should be under no uncertainty about the […]

  4. […] CEO Brian Krzanich being interviewed by Patient Champion Walt Mossberg after giving every member of the ($6,500 a ticket) Re/code audience a Basis Band […]

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