Software in Medical Devices, by MD101 Consulting

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Friday, 14 February 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 6 Conclusion

To conclude this series about clearance of mobile medical apps, here are a few tips to newcomers in the world in medical devices.

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Friday, 31 January 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 5 Deployment

Back to my blog after a while (you missed me :-)). After the previous article about usability, we're going to see the deployment of mobile medical apps. This article is the last of this series on clearance of mobile medical applications, before conclusion.

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Saturday, 28 December 2013

Happy new year 2014

2013 was the year of the confirmation of your interest in my blog. You were 100+ unique visitors per day. A success for a so specific subject!

I thank all of you, who supported my blog by reading the posts and downloading the templates.

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Friday, 8 November 2013

14th november 2013 - World Usability Day

If usability is something theoretical for you, I encourage you to have a look at the World Usability Day.

The official theme of this year is: Healthcare: Collaborating for Better Systems

Dozens of events will be hosted by enthusiastic volunteers! Browse events on World Usability Day website. There's probably an event happening close to you.

Friday, 27 September 2013

Want to post a medical App on Apple Store? Things get harder!

Apple now asking app developers to provide sources of medical information says imedicalapps.com web site.

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Wednesday, 18 September 2013

'Tipping point' for mobile health apps, on BBC News

Here is a record of an interview on BBC News radio.

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Tuesday, 10 September 2013

What is Digital Health?

Last week in stumbled upon a video made by Paul Sonnier, head of the Digital Health Group on Linkedin.

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Friday, 16 August 2013

2013 Summer break

Summer break. See you at the end of the month with new templates and new articles about hot subjects like mobile apps or software risks management.

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Friday, 10 May 2013

When computers prescribe better than doctors

Two computer science researchers of Indiana University have found that predictive algorithms can make better decisions that doctors, reported Indiana University News website.

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Friday, 3 May 2013

Interoperability matters, Wireless devices ditto

Today, two publications of the AAMI about interoperability and wireless devices.

The first one is the report of the medical device interoperability summit. The summit was organized in october 2012 by the AAMI and the FDA.
The second one is the report of a workshop about wireless devices in healthcare. It was organized by the AAMI just after the interoperability summit.

Friday, 29 March 2013

Brain Computer Interface - the future of healthcare

Brain Computer Interface is the term used for a very advanced kind of man machine interface. They allow to send orders to a machine through thought. Sensors are directly connected to the brain of the user and a computer interpret the neural signals to transform them in orders.

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Friday, 15 March 2013

Yet another man machine interface

Until the early 2000's, the mouse used to rule as absolute king over other man machine interfaces.
Since then, touchpads, touchscreens, touchless peripherals like the kinect and other devices have appeared and conquered large territories of mouse kingdom.

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Friday, 15 February 2013

Wearable sensors: gadgets or useful medical devices?

Innovations in the field of medical devices are highly influenced by technologies like nano-sensors, bio-MEMS, and mobile platforms.
In this kind of devices, wearable sensors are emerging as the next must-have. Wearable sensors are tiny gadgets that you have permanently with you, hidden in your clothes or in a piece of jewelry. They monitor vital (or non-vital) signs like arterial pulse and transmit data to local computers or remote platforms. Data are analyzed on the receiver to control anything you want: high blood pressure...
Early adopters of such devices will surely be geeks or techno-victims, but we can bet in a few years everybody will have at least one.

A good example is the Shine by Misfits Wearables. It's a concentrate of technology that monitors body parameters and communicates with your smartphone. And it's a deliberately nice object!
For me it's also a concentrate of all buzzwords heard in innovative medical devices!

We don't know yet wether such objects will become truly useful medical devices or will remain gadgets. Wether they will change or not our habits, like smartphones did. That's the role of the market (doctors and the public) to say so.

Friday, 4 January 2013

The internet of things: let medical devices talk with us!

The Internet of Things is probably the next step of the networking of our everyday life.
The web 1.0 was the era where websites were only read-only, with very little interaction.
The web 2.0 is the web of today, with social networks and heavy interaction between web users.
We don't know yet what the web 3.0 will be. But the interaction between networked objects and between networked people and networked objects is perhaps one facet of the web of the future.

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Friday, 28 December 2012

Happy New Year 2013

If you want to know how to have a 21 CFR Part 11 compliant system, have a look at Daniel Riganati's blog:
http://riganati.blogspot.fr/2012/06/validation-its-more-than-just-testing.html

It's damned well explained! Congrats Daniel!



Merci Beaucoup!

This blog is alive since september 2011. I began with very few readers (3 per day including my family :)
Now I have 100 unique visitors per day. You break through the threshold this month in december.

You all made me a nice present at the end of 2012!

I want to thank you all and wish you an happy new year.

Happy new year

Feliz Año nuevo

Bonne Année

Frohes neues Yahr

Friday, 21 December 2012

Lifi: the next generation of wireless communication

We all use Wifi in our everyday life. When we don't have it, we growl and yowl. When we have to use a good old RJ45 network cable, we feel like a dog on a leash.

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Friday, 9 November 2012

Endeavour Agile ALM

Endeavour Agile ALM is an Open-Source solution for Agile project and resource management.

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Friday, 28 September 2012

Probability of occurence of a software failure

In two previous articles, I talked about the differences of bugs, software failures, and risks.
I left the discussion unfinished about the probability of occurence of a software failure or a defect.
I think that assessing the probability of occurence of a software failure is a hot subject. I've already seen many contradictory comments on this subject. It's also a hot subject for software manufacturers that are not well used to risk assessment.

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Friday, 21 September 2012

H+ Digital Series - Medical devices of the future by Hollywood

The scenarists of Warner Bros have unlimited imagination when they create a new series!
H+ Digital Series is the story about a computer implant that connect people to the internet 24 hours - 7 days. It's like the google glasses, with no glasses. The digital overlay is supposed to be sent direcly to the brain by cerebral waves or the like...
In their will of mimicking the reality, they've created a fake website of the company that designed the implant: Hplus Nano Teoranta and even user testimonials in the teasers of the series!
Wow! Will they have a fake booth at the world congress of neurology? :-)

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Friday, 14 September 2012

How to differenciate Bugs, Software Risks and Software Failures - Part 2

In my previous post about Bugs, Software Risks and Software Failures, I explained the concepts of bugs, defects or anomalies, and the concept of software failure.
Let's continue now with Risks.

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