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Posts Tagged ‘mobile healthcare’

The Time is Ripe for Physicians to Become Mobile Medical App Entrepreneurs

Posted by Plish on December 21, 2013

On September 25th of this year, after approximately 2 years of soliciting comments from Industry, the FDA released a guidance document entitled “Mobile Medical Applications.”  The document defines under what circumstances smartphone apps, and the like, are considered medical devices.   The reason that this is important is because if you or I create an app that performs some medical function, (e.g. it turns a phone into an electrocardiogram that records and sends irregular heartbeats to the doc,) it becomes a medical device and as such, regulations require that you register yourself with the FDA as a medical device manufacturer and become compliant to the regulations.  You may even have to submit a pre-market notification to the FDA for the app you choose to commercialize.  Ignore these regulations and you could be fined and even thrown in jail.

By issuing this document, the FDA acknowledged that it’s in the 21st century and that medicine is becoming more and more mobile.  It’s also acknowledged that the mobile medical industry is only in its infancy, so rather than anticipate what types of apps should be classified as medical devices, it created a framework for determining when an app is a medical device. (The ECG app I mentioned is but one example.) All in all, whereas most new regulations often can stifle innovation, this document isn’t like that.  It actually can further innovation.

This is because one particular group of developers (who also happen to be the app users) are in a privileged place – they are not considered medical device manufacturers and  hence  not required to register with the FDA.  Who are these folks?

Licensed medical practitioners (physicians, dentists, optometrists, etc.).

These professionals are able to innovate in a way that other app developers are not…with one caveat.  These doctors can only use their apps in the context of their own practices (or keep them within their group.) If a doctor chooses to commercialize the app, she then becomes a medical device manufacturer and all the regulations kick in.

Still, even with this caveat, physicians are in a very good place, entrepreneurially speaking.

Think about it.

By exempting physicians who create and use mobile medical apps,  physicians can:

  1. Receive real-time feedback on the suitability of the app for its purpose and modify/optimize it as needed.
  2. As a result of number 1, they  can ascertain what the potential market for the app may be.
  3. Buzz can be created about the app (both amongst patients and doctors) and results can be published if desired.

The above benefits are things that are very hard to come by in the medical device world (for that matter, they’re often difficult to obtain for non-medical products and services!)   In addition, they enable physician entrepreneurs to see if a business case can be built around the app.  If it can, time and money can be spent on registering with the FDA and becoming regulatorily compliant – in short, a medical device company can be started and the product commercialized.  (It’s important to note here that not all mobile medical apps are the same, even if they are regulated.  Some are under more stringent regulations than others and require different types of manufacturing systems.)

Again, this is an enviable position for physicians to be in.  Not too many entrepreneurs in regulated industries are allowed to do what physician entrepreneurs are able to do.  It will be interesting to see how many physicians answer the call to create apps that help others, and then build businesses from those apps.

If you’re a physician entrepreneur, or a non-physician entrepreneur, with a mobile medical app, I’d love to hear your story.  If you’re confused by the regulations, I’m here to help.


Posted in culture of innovation, Design, Entrepreneurship 2.0, Healthcare, innovation, Medical Devices, Quality Systems, Start-Ups | Tagged: , , , , , , , , , , , | 4 Comments »

Insights Into the Future of Healthcare From RSNA 2013

Posted by Plish on December 10, 2013

Last week I spent some time at the Radiological Society of North America (RSNA) meeting, networking, speaking with medical Thought Leaders, scouting new technologies. In particular I enjoyed the posters – it’s an opportunity to see what’s cutting edge in the world of radiology and interventional radiology.  (You can check out abstracts for papers, posters, etc. here.  I will be blogging in the future on their Radiology Cares pledge drive)

Radiology is an unsung hero in the world of healthcare.  Not only are these the people that make diagnoses based upon X-Ray, Ultrasound, MRI, CT and other visualization technologies, they also help heal people – doing certain types of ‘surgeries’ – through minimally invasive techniques that use access holes often much smaller than pencil.

Because these procedures are being done in a minimally invasive manner while viewing the inside of a person’s body on a LED/LCD screen, radiologists of all types find themselves on the cusp of some of the newest imaging and interaction technologies.  It’s no surprise then to see iPads, tablets, display screens and controllers of various types being mentioned in presentations, posters, and being exhibited.

If someone were to ask me what technologies I think will impact future healthcare, based upon what I saw at the conference, I’d mention two: Mobile and Interaction Technologies.

Mobile Tech

Mobile technologies go beyond iPads.  They represent a whole new network of interconnectedness – they enable collaboration and eliminate barriers of time and space.  What is key in this realm is fidelity: the x-ray/ultrasound/MRI/etc. needs to look the same on a handheld screen in Africa as it does on a 26″ or larger screen in Chicago.  While the newer iPads are being used for their high-resolution screens, the general rule is that the smaller the screen/image, the greater the chance of misinterpretation.  For the future, any company that creates a lighter, larger, higher resolution screen (folding perhaps?) will be the mobile device of choice.

Interaction Tech

While Apple may have paved the way for the acceptance of touch sensitive screens (though it is still being used as an interactive e-book platform for educational purposes), the world of medicine is moving beyond the limitations of touch on a 2D surface and diving into the 3D world.  In procedural suites a small screen is not only limiting, but a doctor or nurse that needs to maintain sterility can not easily interact with 2D touch surfaces.  Even when dealing with 3D data sets (CT/MRI/etc. scans), manipulating the data and being able to look in-depth at areas of interest is much easier and intuitive when using game controllers like Microsoft Kinect, Leap Motion and the like. I recorded a video of one such control system: the teistler imager DIAG system.  I played with it and found it extremely simple to use – even in its ‘rough’, prototypical state.

Are these the only technologies that will be impacting the future?  Hardly.  Technologies enabling us to look more accurately into the body without breaking the skin are growing in leaps and bounds.  (In fact, one problem is that certain imaging modalities like MRI can now detect miniscule, suspicious looking lesions. So, what’s the problem?   The lesion is so small, it can’t be found by any other imaging method, so it also can’t really be tested in order to make a definitive diagnosis.)  In addition, newer techniques are extracting more information from diagnostic images so that, in some cases, a diagnosis can be made without even having to take a biopsy. (There are even newer technologies being developed that enable diagnoses with only a small sample of blood.)

With technologies getting better, the world is getting smaller and the world of ‘ the small and unseen’ is becoming more accessible every day.  These are exciting times in the world of healthcare, and coupled with a patient centered approach, Radiology, both on its own and as support for other medical disciplines, will only help people live longer and healthier lives.



Posted in Conveying Information, Design, Healthcare, innovation, Medical Devices, The Future, Trends | Tagged: , , , , , , , , , , , , , , , , , , , , , | 1 Comment »

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