Software in Medical Devices, a blog by MD101 Consulting

To content | To menu | To search

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.

Continue reading...

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.

Continue reading...

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.

Continue reading...

Friday 9 November 2012

Endeavour Agile ALM

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

Continue reading...

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.

Continue reading...

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? :-)

Continue reading...

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.

Continue reading...

Friday 7 September 2012

How to differenciate Bugs, Software Risks and Software Failures - Part 1

A bug can lead to a software failure.
Having bugs is a risk.
Having a software failure is a risk.
A software failure is not necessarily a bug!

Do you follow me?
If not, let me give you some more explanations.

Continue reading...

Friday 24 August 2012

Blog changing

Hello,

I run this blog on a free platform, it is going to be full and I'll be soon unable to use it any more. I spent most of my time to port the blog on a new PAAS this week. I continue with the same blog engine (dotclear), to maintain the architecture and the URLs. It's very important to keep my google rank!
I should be able to release it in september, when all bugs are fixed.

One important thing happened this week: the ASEAN countries released a draft of ASEAN Medical Device Directive (AMDD), see here . This is a bit like the CE medical devices directive, with one set of regulations for many countries.
It gives me the opportunity to introduce the concept: Develop once, Certify anywhere
It means that, with the convergence of regulations, one set of documents is enough to create a technical file submitted in many countries. For example, data submitted to the EU authorities would be also submitted to the ASEAN member countries.
I'll post more details on this concept later on.
Bye.

Post edited August 29th 2012:
Here is the new blog platform!
No big changes for you, only a new layout.
I let it run for one week in beta test to see if everything's ok.
The previous blog is still active, for backup: EDIT previous blog platform link removed, blog closed.

This blog is registered on technorati with code: W4S4GJXCQPTP

Friday 10 August 2012

Miscellaneous of August

Hi everybody,

I was out of the office, I didn'it have time to write anything relevant about our favorite subjects.
Here is an interresting article of The Economist (link will be dead after a while) about open-source software.

Seen on the newsletters I receive for vigilance, the recall of a defibrillator due to software failure: here on MHRA website and here on ANSM Website (in french).

For those who spent their vacation on Mars and haven't heard about Proteus ingestible biomedical sensor yet, have a look at this article. This is a double performance: technical with an ingestible sensor, and regulatory with clearance through the new "de novo" FDA process.

And to end with a bit of futurology, this new article of EMDT about the future of medtech.

Bye.

Friday 13 July 2012

Happtique App Certification Program

Happtique, an appstore for mobile medical devices has drafted an App Certification Program.
This not a program or a process but a list of functional and non functional requirements that mobile health apps should respect to be certified - according to Happtique. It' a bit like the requirements of Apple to be authorized to place an app in the Apple Store. Happtique publishes your app on its store if you are compliant with its certification program.
There is a lot of work behind this document, and a lot of knowledge. However I don't think this is enough to make a certification program. This document focuses on the results, whereas all software development standards focus on the processes. FDA focuses also on the processes when its auditors verify compliance to 21.CFR.
In the scale of precedence of documents, I would put it here:

  1. Legal (choose your country): 21.CFR, 92/42 EEC (essential requirements), CMDCAS, ANVISA, KFDA...
  2. Medical devices general standards ISO 13485 and ISO 14971
  3. Software development standards: IEC 62304, IEC 60601-1, and the like
  4. Guidances: GPSV, IEC/TR 80002-1, ISO/TS 14969
  5. Generic functional and non functional requirements: Happtique App Certification Program.

It's obvious that Happtique wants to make some noise with its certification program (and it has reached his goal, you're reading this post). But I have to recognize that this document contains a big source of information for software requirements. The content of this certification program is a perfect source of ideas to write a software requirements specification (SRS).

The world of mHealth is moving fast. In the same kind of article, I have found Tech Barbarians at the Medtech Gates, this article is a good summary of antagonist forces at stake. On the one hand, the regulators and their, so called, ante-Flood rules. On the other hand, the software industry with its new world of mHealth. Guess who's going to have the last word? If, like me, you don't have the answer, continue to apply the standards and regulations...
Bye.

Saturday 30 June 2012

Prometheus medical pod

After a long series of posts about agile methods, let's continue with something less serious!
If you saw Prometheus, the sci-fi movie about a team of astronauts who search for human origins, you were probably amazed by the Weyland Corp Medical Pod 720i. Like me.

Continue reading...

Monday 23 April 2012

Class A, B or C (continued)

I didn't have time to post anything worth it this week.
To give a side view of my last post about software classes, here is a link to DO-178B on wikipedia. It is the reference about software embarked in aircrafts.
If you take time to read this document, you will see that it goes very further than what we have today in IEC 62304. The constraints about design on high classes are very very hard to respect. That's normal, when you think that software is used in flight commands and other stuff in the cockpit.
It has some side effects, mainly to stretch software development projects, and to ban software from some parts of the plane, for cost-driven reasons.
For example, a microcontroler plus software plus electric motors would be perfect to memorize and retreive the position settings of the pilot's seat. But the cost to develop such software is very high, as the pilot's seat is seen as a critical component. Aircraft manufacturers prefer replacing software and microcontroler by good old analogic electronics to do the same task on some models.
In my humble opinion, the constraints of the two highest classes for software in aircrafts would be to high for medical devices. There is always a pratician, or an emergency medical service, able to "catch" the patient if something goes wrong. Whereas there is nobody to "catch" a falling plane if its flight commands fail. The consequences of risks are far higher in aircrafts, with potentially hundreds of victims in an accident.
That is why classes A, B and C, and their design constraints are enough for medical devices.

Next week, I'll talk about exemptions of ISO13485 for standalone software medical devices.
Bye.

Friday 6 April 2012

Inflation of software medical devices - part 3

This article is the last of three articles which deal with the concept of "inflation" of medical devices. The first one was on inflation of standards, the second about inflation of regulations. This one, the most interesting to my eyes, is about multiplication of apps on mobile devices, especially smartphones and tablets.
More that 6000 apps are classified in the "heath", "heathcare" or "medical" categories of the Apple or Android appstores. Many of these apps are classified as medical devices and are in the scope of regulations like FDA and CE Mark. Note that some apps may be regulated the FDA but not the CE Mark or vice-versa.

Continue reading...

Thursday 5 January 2012

Pfizer recalls Rheumatology Calculator smartphone App

Dozens of companies recall their medical devices every month. A recall happens when something wrong happened with the device, like a bad labeling or a bad sterilization. It's the responsibility of the manufacturer to warn ALL their customers and the government agencies that a given lot or batch of products has a defect. The batches shall be destroyed or sent back to the manufacturer for further analysis.
That's what happened to Pfizer with its Rheumatology Calculator, a smartphone app used to compute a score to assess the desease of patients according to complex algorithms. There is a bug in the app and it gives wrong results.

Continue reading...

page 2 of 2 -