Show HN: A side project in medical devices

By chrisseaton - 3 days ago

Showing first level comment(s)

Great write up !

I am working in medical devices but I am more familiar with the FDA regulations.

What I wonder regarding risk management is how you justify the safety of QT /iOS / Android. In its risk management, the FDA asks you to list of your SW dependencies you are using "off the shelf", and you have to analyze how any failure of any of your dependencies could lead to a failure of your device/application (which is good sense really).

So usually for a simple library it is easy to justify and identify the failure mode, but you look at the OS or big frameworks, it is always harder to find a clear mitigation. Especially at the OS level where potentially any part of memory could be corrupted, your thread not being scheduled, etc.

For example, in your case imagine you have a driver or QT rendering bug that makes the red overlay layer becoming transparent on some HW. That would lead to the user not identifying the correct area and in the end lead to a wrong computation. (I can see on some screenshots you have the percentage displayed so that could be a mitigation in itself)

I am working in the embedded space so generally we have less dependencies and a simpler code base, but we are always reluctant to use off the shelf SW because of the added risk management required. This is counter intuitive for safety but from a regulatory stand point it is sometimes easier to reimplement some features, than using a proven library, because this is less a hassle to justify or maintain.

So was it something raised by the regulator ? Can you give us some example of how you addressed it?

seren - 2 days ago

There is absolutely no way you'll remember this but years and years ago--when I was maybe 13--I found Katahdin somewhere online and was absolutely enamored by the idea (I can say with a lot of confidence that it's what sparked my interest in programming languages/compiler research). I think I contacted you for help installing and using the project. You were one of the nicest people I've ever met for having the patience to assist me with something you had probably put down for a couple of years at that point when I probably understood 0% of what you were saying. Anyways, I remember at the time you had just listed Mersey Burns on your website. It's super cool to see that it's still something that you're doing and that it's been a success. Just wanted to thank you again and congratulate you on this :)

nv-vn - 3 days ago

Also see, which the authors created explicitly to build medical devices out of low-end mobile devices for third-world-countries. It is cross-platform.

They have several such apps on the website.

Warning: it uses the Scheme programming language.

i_feel_great - 2 days ago

We found that there were a lot of awards and prizes that we could enter.

I would love to see a list of these.

Edit: I guess this is a partial list within the article itself, UK based stuff, though I would be more interested in a US based list:

Winner, Excellence in Mobile Healthcare and overall winner, eHealth Insider Awards, 2013

Highly Commended, Improving Care with Technology, Health Service Journal Awards, 2013

Highly Commended, Innovative Mobile App of the Year, BCS UK IT Industry Awards, 2013

Highly Commended, Best Use of Mobile Technology in Healthcare, eHealth Insider Awards, 2012

Winner, Excellence in Innovation, NHS North West Health Innovation Awards, 2011

DoreenMichele - 3 days ago

I find this a really impressive project: 1. it actually helps society and 2. the author did it as a side project, not being a software developer, writing an iOS, Android and web app that's polished and being used. Wow! Great write up!

rollulus - 2 days ago

Really interesting read! Do you mind sharing the basics of the process you went through to get regulated by the NHS?

osrec - 3 days ago

Really cool stuff.

I have few friends who are pharmacists maybe I could develop something with them. :)

avgDev - 3 days ago

Any plans to get this through FDA approval in the US? I don't know which process you'd have to go through(510k, De Novo or PMA) but I'd imagine the NHS approval would help a lot.

jschwartzi - 3 days ago

This is really awesome. Can this be made available in India?

kulu2002 - 2 days ago

Why it is not available in Turkey?

nurgasemetey - 3 days ago