How to get FDA approval for mobile medical apps

If your parents house is anything like mine, there are random health machines all over the place, mobile monitors of all sizes and shapes for monitoring blood pressure, ECG electrocardiograms, and god knows what. But smartphone apps are a-coming.

AliveCor mobile ECG monitor

Today I covered the FDA approval of the first smartphone operated, continuous ECG mobile monitor, eMotion ECG Mobile, for inventorSpot. While I was researching the multitude of competitors, I saw a few smartphone operated ECG’s, mainly for use by clinicians in their clinics. It made me wonder how the FDA is dealing with this influx of smartphone medical device apps.

Having trained and worked as a Biomedical Engineer, I can tell you from personal experience that the FDA approval process is no fun – when people’s lives are at stake, things tend to get serious. But as an iPhone app developer, the Apple approval process has at times been too much to take. I can’t imagine having to do both!

So it turns out the FDA released guidelines just a few months ago about how they are going to regulate what they call mobile medical apps.

And they have been dealing with an influx:

The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years.”

They’ve decided to focus their oversight on mobile medical apps that:

  • are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
  • transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices.”

I guess that means it takes a long time to get mobile medical apps through the FDA, and will keep the barriers to entry high for the majority of aspiring mobile medical app inventors. Looks like my parents will be waiting a while before they can download mobile medical apps for everything they need right on their smartphone.

What medical devices are lying around your home? Do you have any cool ideas for medical device apps that you think should be built?

If you want to hear more about the latest in health and fitness technology inventions, you can find me writing over at inventorSpot


Update: Low cost safety device for solo travellers (male or female)

Wow. Guess what I just came across. The device of my dreams – on indiegogo. The BiiSafe buddy. This is like, super awesomely amazing. For 35 bucks (69 will be normal retail price) they’ve created what I wanted, but in a much niftier way – they’ve just used bluetooth in the device and let the phone do the tracking. Super cool.

BiiSafe buddy location tracking


How I find problems and invent solutions

inventions and inventors

It’s been over a month since I started this invention experiment and so far I’ve learned a LOT about myself, about the things I like to invent, and the way I like to invent things.

I learned that the majority of my inventions come from the “Why can’t I?” place – that angry, frustrated voice that questions my discomfort, or blind acceptance.

Why can’t I travel alone without worrying my family? Why can’t I take as many risks as a man when traveling alone?

Why do I have to hop up and down and get my clothes covered in yucky fluids when I need to change my underwear?

Why can’t I use the wifi of coffee shops nearby without buying something?

Why can’t I tell people I live in hostels without feeling uncomfortable?

I learned that I am motivated by Repeated Personal Experience, e.g I am easily motivated to invent under a solo female travel safety device when I am constantly confronted with the anger and frustration of traveling solo as a female, but as soon as I am living somewhere stable, I get demotivated.

I learned that I like designing apps, but I like to design both simple, and multipurpose solutions, which is difficult to achieve in an app context. They often need to target specific niche audiences and be solo purpose.

I learned that I get triggered by my surroundings, and that I can come up with different inventions by simply putting myself in a new situation.

I learned that many of the solutions to my current set of identifiable problems have already been invented, and that the bigger problem is often KNOWING about them, or CARING enough to spend money on them.

I also learned that I want to invent things that solve big problems, but I’m either living too perfect a life, or oblivious to the problems I deal with everyday. I need to dream bigger, look deeper, and challenge how easily I accept the status quo, if I am to cultivate anger and frustration for the more important problems.

How do you invent solutions to problems? How do you identify the problems you would like to solve? 

Tracking food allergies detective iPhone app

I’m pretty sure I’m allergic to wheat. Or at least intolerant of it. I don’t think I can handle dairy either. But I’m not sure. My symptoms are not bad enough to make it overwhelmingly obvious, so it’s only when I get acne breakouts, or crash out from tiredness, or experience bouts of bloating, that I remember I should probably figure it out. That or stop eating so much of it.

So last week I wanted to build an app to help me easily track things like what I’m eating and what I’m feeling. I actually found a really good app on my search, Food Allergy Detective, and even though I tried to redesign the interface to make it prettier and more fun to use, it turns out MY pain wasn’t big enough, and THEIR solution wasn’t bad enough for me to be motivated to continue.

food allergy detective app iphone

It was a lesson in knowing when to keep going with something, and when to just concede gracefully.

But it also made me aware of how many things I do a half assed job of tracking, like when I get my period, and what symptoms I experience, or how much I am spending, and how much I should be spending.

It would be nice to track activities without any explicit action required.

I have no problem tracking what I’m eating when I’ve just had a stomach ache, because I’m highly motivated to find the source. But a day passes, and the pain passes, and I forget. I have no incentive to track what I’m eating when I’m asymptomatic. The same can happen with tracking expenditure, or the dates of my period.

So what if there were a way to track things in the background, or what if it were more fun to track behaviour?

I wrote recently about the fertility tracking app, Glow, and they too are asking people to manually enter data, as are Clue, the app for tracking periods, and Insandouts app for tracking baby activities.

Some more intelligent tracking apps that come with a smart device that does the data entry automatically are the Mimo Baby Monitor for tracking your baby’s temperature, activity, and sleep; Propeller that collects data for asthma sufferers, so they can see how many puffs they’ve taken, as well as where and when; and OMSignal clothes that track your biometrics like heart rate and stress levels.

But what would be an automated way to track what we are eating? A device in our mouths? Or in our stomachs?

Maybe I’m crazy, but there is power in tracking. Feedback loops work:

…humans are self-regulating creatures, with a multitude of systems working to achieve homeostasis… Feedback loops are how we learn, whether we call it trial and error or course correction. In so many areas of life, we succeed when we have some sense of where we stand and some evaluation of our progress. Indeed, we tend to crave this sort of information; it’s something we viscerally want to know, good or bad. As Stanford’s Bandura put it, “People are proactive, aspiring organisms.” Feedback taps into those aspirations.”

If I knew that I was always tired after I ate dairy, then I might have more of an incentive to stop eating it. Or maybe not 😉

Are you good at tracking your behaviour manually? Do you have any cool apps that you recommend that motivate you when you feel demotivated? Would love to hear in the comments!

How to get wifi passwords & free wifi when you are traveling

Inventing is so much fun. When you think you’ve invented something new, it’s an awesome feeling. Then when you realise that your invention would never work, instead of being depressed, you find yourself slap bang in the middle of another potential invention, and so the cycle begins again.

My first solution-vention was this solo travel safety location device, but when I tested out my theory, I discovered that it wouldn’t work because I didn’t actually buy a Sim card when I got to Peru.

As a result, I found myself in the middle of another problem – where can I find wifi passwords to access free wifi when I am traveling? All of a sudden, I became hyper aware of my desire to find wifi passwords everywhere I went.

On one occasion, I was in Ollantaytambo, Peru, with a few hours to kill before grabbing the train to Machu Picchu. I had sent a friend in town a Facebook message before arriving to arrange to grab dinner with her. But when I got there, my only option to get wifi was to pay and sit to get coffee. I didn’t want coffee. I didn’t want to sit. I just wanted to see if she had written back.

In the end we just bumped into each other by chance (Ollantaytambo is a pretty tiny town) so we didn’t need technology’s help, *gasp*; but I can often be found hovering outside coffee places just to send a quick message or check my email. I even snuck into Starbucks in Cusco recently, *only for their wifi*, and hid in a corner until I had done what I needed to do 🙂

I wondered why I couldn’t just have a crowdsourced list of wifi passwords to log into one of the many wifi hotspots in Ollantaytambo. [Having open wifi in cities will happen sooner or later, and perhaps that’s a bigger solution-vention for when I graduate from these smaller thought exercises… I need to build up to it 🙂 ]

I remembered foursquare tips contained passwords, and so my brain got to solution-venting.

Foursquare wifi password for Ollantaytambo

Why couldn’t I scrape all the passwords from foursquare, add in a community element so people could comment when they are or aren’t working, and make it available offline?

I was ready for my third solution-vention exercise! So next I went looking for competitors.


I found the usual iPhone wifi hacking apps  for proper hackers with jailbroken iPhones and a desire to crack passwords, or take advantage of hardware loopholes.

But then, after more searching and a useful Reddit thread, I found it – 4sqwifi.

Released 2 years ago.

Invention is so humbling.

4sqwifi to find wifi passwords when you are traveling

I downloaded it but lucky for me, I was disappointed. Why?

  1. I had to log in with Foursquare. Foursquare? That’s lame.I understand it makes it easier for users to add more tips of wifi passwords directly to foursquare, and you are always aggregating the latest tips… but no one uses Foursquare!
  2. It doesn’t work offline. So it’s basically the equivalent of what I already do whenever I remember to do it – which is go into foursquare, and do a search for wifi. Why not just use Foursquare then?

My design

So not to waste my weeks invention exercise, I set to work improving this already extremely well executed app.

Ideally I wanted a clean dataset, pulled from multiple sources including Foursquare, maintained by a community.

I wanted it to work at least for the situation in Ollantaytambo so it needed the following functionality:

– Be available offline

– Be able to search by name of town, or name of coffee shop

Some extras:

– Background tasks to check up to date-ness of wifi passwords

– Allow users to login to add a comment or help improve app

In a future version, I envisioned it being able to automatically log in to an available wifi network, but I tend to shy away from solutions that are off limits by Apple rules. I like to think of these rules as creative constraints, but perhaps that’s naive of me…  

There are rules and restrictions about scraping data from Foursquare, or caching/storing that data for later use. As this is just a thought experiment, I just ignored them for now to see if I could even get the data I need.

So I tried their explore API, searching for wifi near Ollantaytambo using this query:,-72.264268

Screen Shot 2013-11-20 at 19.59.41

And got what I wanted – a venue list with wifi tips attached:

Using Foursquare explore API to get Wifi Password Dataset for Venue

Using Foursquare explore API to get Wifi Password Dataset for Venue

Next step – put the relevant data in a database somewhere and clean it up… and do this for every city I am planning on attending in the next few weeks/months.

Unfortunately, this is where my time ran out for this week’s solution-vention experiment, but I will keep you updated on my progress! To hear more, subscribe for a weekly newsletter here

Some learnings: 

What’s useful about seeing someone else’s execution is becoming aware of the business opportunity – which in this case is ridiculously small. But luckily, that’s not the point of this experiment of mine. I keep having to remind myself that this is not about building a multimillion dollar company, but about training my invention muscles.

Have you ever used 4sqwifi when you’re travelling or otherwise? Any feedback?

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Update: testing iCloud hack to track location for solo female travel safety

Here’s my update from testing my solution-vention of a low cost female traveler safety hack – using iCloud to send and store my phone’s location so people know where I am… on my solo female trip to Peru.

On my way out of the airport in Santiago, I just did a quick check to see if it was grabbing my location.

Grabbing location using iCloud for female solo traveler safety

All good.

When I got to the airport at my destination, I was approached by one of the many taxi drivers. I asked him where the collectivo was (a small minibus which is really cheap into town), and he told me that on Sunday mornings there are none. I had a feeling he was lying, so I asked at information and she told me where to find it – of course there was a collectivo.

When I got in, I opened my phone, and in that moment, I really wanted to send my location to iCloud. I felt the desire to “check in” somehow – but not in a public, look how awesome I am, foursquare type of way. So I turned on roaming because I didn’t have a local Sim card yet.

The downside with my iCloud hack in this situation was I didn’t know how long it would take for my location to be stored. I wanted an app that would tell me my location was stored, so I could turn off roaming – which isn’t an ideal solution in case something happened en route, but I felt it was better than nothing.

When I arrived at my hostel in Peru, all seemed to be happy and accounted for:

 Screen Shot 2013-11-11 at 10.56.12

But I have a confession to make – I’ve been here for a few days now, and I haven’t bought a Sim card yet… I guess this is why we user test an idea before we build anything.

I meant to, but then I read some forums that made me think that buying a prepaid Sim card in Peru was too difficult – something about needing to register in order for the number to work. Then I heard it was $49 usd for the month- bit pricey. Another slight problem is I don’t know how long I will be in Peru for – I might leave tomorrow for all I know. Sure – when I first arrived, I was convinced from the boredom and ickiness of 24 hour bus/plane travel that I would stay for infinity… but 24 hours later, I found myself researching what other long, boring bus journeys I can take to countries nearby.

To add to the disadvantages of an app solution, I met a fellow solo female traveler yesterday who was stood up by her airport pick up taxi driver. She agreed to let another driver phone her hostel, on his phone, to get the address, and, without actually confirming that he was actually talking to anyone, she took him up on his offer of a lift. Nothing happened, obviously, but she told me that her battery was almost dead on her smartphone anyway, so an app wouldn’t have tracked her in this case, and she didn’t have a local Sim.

Doesn’t look good for my solution so far…

However, there is one more thing I noticed – when I was planning to take a trek off the beaten path, the idea of getting a Sim card really appealed to me, not only in case I disappeared but because I was motivated by the fear that I would twist an ankle along the way, and need to call for help.


To sum up:

Four factors have slowed down my optimism on using iCloud and a Sim-

  1. the effort to buy a Sim card
  2. the high price of Prepaid Sim card when you only need it for this one purpose
  3. not knowing how long you will stay in any one country – desire to keep options open
  4. battery life

And two factors have given me hope that we need a better version of just an iCloud hack for this –

  1. when I know I’m going to be in a random, off the beaten track location, I want to be tracked, properly
  2. I have some inner desire to “check in” when I get somewhere

I will keep watching my behavior and see what else I discover. But for now, the idea of a custom built app for female solo travelers is officially on the shelf.

Want to see what solution I invented this week as part of my experiment? Check out my unrelated, rather ridiculous, but fun to make, underwear solution-vention here

Inventions everywhere

Since I’ve started this, I’ve noticed so many inventions coming up in my facebook feed – first there was the invisible bike helmet, then this electronic tattoo that acts as a microphone, the urine sensor for wet diapers, and now an invention to allow assistance dogs to better communicate with their handlers.

doggie dialogue invention for assistance

It’s interesting how you notice things more when you are in a different frame of mind. People are inventing things every single second. At least it makes my experiment a lot easier.

Now you can find me blogging about health and fitness gadgets, and medical device apps over at InventorSpot