I think that starting with a regional website approved under a single pharma code and localizing it over time under country-specific codes is a good way to start being digital quickly and become more customer-centric in time.

So, some examples to show you that this approach is actually done in real-world practice:

www.xarelto.com

global.pradaxa.com

www.forxiga.eu

onglyza.eu

Let me know if you know of any others!

Thanks to @DominicTyer and MediLexicon for the suggestions.

* I know that some companies do not allow this and there are differences in opinion about the need to approve content under multiple different codes.

Digital River, a major supplier of eCommerce solutions whose clients include Adobe, Electronic Arts, Kodak, Logitech, Netgear, Phillips, Western Digital, Lenovo and Microsoft has just had their domain go down. Have a look: www.digitalriver.com *

This means that you may not be able to purchase from anyone using their eCommerce solution. Oops.

I can only imagine the number of sales missed due to this outage.

* Edit: Looks like they fixed it, though due to DNS caching, it may be a while before everyone can see it.

We’ll be asking her to write her first blog post early next week. Watch our blog to hear more.

“For doctors, Appraisal is a continuous process of reflection on one’s performance and it forms an important part of continuing professional development. It is the basis for Revalidation, the recently launched process by which doctors will have to demonstrate on a five yearly basis that they are up-to-date and fit to practise.  The general consensus is that it involves a lot of work.

Various toolkits have been available for this, with the first ones being made available free by the NHS.  Others have been piloted, including those of the medical Royal Colleges.  One benefit of using the same toolkit each year is that background information is automatically updated.  Changing toolkits is time consuming as this all has to be redone.

When the NHS toolkit was withdrawn unless I paid a fee, I used a generic Word-based one in feeble protest.  Last year I helped the Royal College of General Practitioners test its decidedly pilot toolkit.  This year there is another fee so I sought another solution.

And so I wish GPtools all the best.  Their site does what it says on the tin.  It provides what is needed to make the process as pain-free as possible.  And so far it is free.  I have donated to the cause so that I can test the App on my ‘phone.

The cynic in me is prepared for the possibility that it may not remain free forever, but the combination of simple technology and seemingly honourable principles has me sold for now.”

We are were recruiting a Scientific Advisor or Medical Liaison to support both our digital consultancy and our digital technology (medBoard, medCrowd and new products in development!).

Responsibilities will fall within two main areas within the Pharmaceutical Industry:

Digital Content Development and Maintenance

• Editorial strategy and planning
• Medical, scientific and copy writing
• Conducting review and approval under ABPI and other pharmaceutical codes
• Script and storyboarding for digital media, such as videos
• Community and discussion moderation

External Expert Engagement

• External engagement strategy and planning
• Expert selection and management
• Advisory board management, including contracting and payments
• Strategic advisory reporting, including analysis

What is required?

• Scientific writing.

What is desired?

• Experience conducting ABPI internal approval within pharmaceutical companies.
• Experience creating and managing digital activities such as website development, Facebook pages or Twitter accounts.
• Experience with external expert engagement.
• Experience working within medical information.
• Experience working within pharmacovigilance.
• Experience working within clinical research.

What is not required?

• ABPI signatory status.

What qualifications are need?

• Pharmacy or life science degree.

Where is the work?

You will be able to work from home or our new office in Esher. You may be required to work at our clients offices from time to time which may involve international travel.

How much will be paid?

Get in touch to discuss your salary and any other requirements.

How can you apply?

For a confidential discussion please phone Felix Jackson on 020 3239 3998. We will only consider candidates with EU work authorization.

Update 18-Mar-13: We have now recruited an excellent candidate for this position so applications are now closed but, as a small company that is expanding fast, don’t be afraid to get in touch if you’d be interested in working with us anyway!

You never know… by the time you read this we could be looking for someone just like you.

Keywords:

Scientific Advisor, Medical Liaison, Scientific Communications, Scientific Affairs, Medical Affairs, ABPI, Digital

Find out more about medDigital.

We’ve got an exciting year planned with an updated medBoard, a new version of medCrowd and two other products on the way, we’re going to be busy.

Felix is now living back in the UK which will make things a lot easier and Paul has recently moved house so he can get a better broadband connection that actually works faster than a 56.6k modem.

We’d love to hear from you if we can help you with your projects or if you’re interested in ours. Just get in touch.

I will be living in Thames Ditton as medDigital is still based in the Barley Mow Centre, Chiswick. Please get in touch as I’m really looking forward to catching up with everyone in the new year.

Merry Christmas and Happy New Year!

I didn’t know how much I used the map on my phone until it stopped working. I mean really stopped working.

As I blogged before, the Apple iPhone application might look pretty and give lovely directions. But a map that doesn’t have data just isn’t really a map.

I have since discovered that using postcodes sometimes worked, taking me back to the days of my Palm Pilot with a TomTom GPS unit balanced on my dashboard and arriving at the office postal address rather than the actual destination.

But now Google has fixed it with their nice new Google Maps turn-by-turn app that integrates seamlessly with my saved desktop Google Maps. Thank you.

Although I was actually looking forward to my Christmas present to myself, an Android Samsung Galaxy Nexus. Maybe Santa will remember for next Christmas.

The app could transform the mobile into a device or be an accessory to one. An example is a mobile used to measure blood pressure, either by connecting a cuff directly or by indirectly controlling a blood pressure machine.

Also, calculators for patient-specific doses, scores (eg Glasgow Comma Scale) or prognoses that aid a clinician in making a diagnosis or selecting a specific treatment for that patient are likely to be considered a mobile medical device.

Importantly, the FDA says:

“Mobile apps may be subject to medical device regulation if they are intended for use in the diagnosis or the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man.”

Therefore, a mobile medical app like other medical devices may be classified by the FDA as class I (general controls), class II (general and special controls with premarket approval) or class III (general controls and premarket approval).

In Europe, medical devices may be classified as class I, class IIa, IIb and III, with class III covering the highest risk products. The higher the classification the greater the level of conformity assessment required by notified bodies.

Examples – mobile medical devices

Some examples of certified mobile medical devices are:

Mersey Burns

A clinical tool for physicians and the first mobile app to be classified by the MHRA as a Class I medical device under the remit of the EU Medical Device Directive.

Withings Blood Pressure Monitor

A blood pressure cuff that can be attached to and controlled by a mobile. Enabling users to graphically view their results and share results with doctors and personal health records. It is certified as a device by the European Commission, by the FDA (class II), in Canada (class 2) and in Australia and New Zealand (TGA class IIa).

AirStrip Solutions

A suite of patient monitoring apps for healthcare professionals that are FDA cleared and received CE Mark certification for use in Europe earlier this year.

Mobile MIM

A diagnostic radiology app for healthcare professionals, now cleared by the FDA as a Class I medical device. MIM was one of the first medical apps available in Apple’s AppStore but also the first to be pulled from the store because of regulatory concerns.

Care4today

Treatment adherence app for US patients developed by Janssen, cleared as a Class I medical device by the FDA.

Examples – not mobile medical devices

The following apps are likely not to be considered as mobile medical devices:

• Reference information or educational materials, eg medical textbooks.
• Record keeping or trackers for general health and wellness, eg diet log with recipe suggestions.
• Automation of clinic operations, eg appointment reminders or billing transactions.
• General tools that are not intended for a medical application, eg magnifying, voice recording, note-taking.
• Electronic and personal health records.

Sources

MHRA’s explanation of medical devices classification.

FDA draft guidance on mobile medical devices (or as PDF). Jul-11

EC guidelines on standalone software in healthcare. Jan-12

EU directive on medical devices (PDF). Jun-93

EC guidelines on medical devices (PDF). Jun-10

Thanks to Sally Leon for her help with this blog post.

medBoard’s new positioning ‘extend a traditional advisory board’ (developed by our customers in a medBoard about medBoard) is working like a dream. People get it in seconds, instantly understanding the benefits of getting more value from time with experts.

We have just begun a major new rework of medCrowd. We know it isn’t quite working at the moment, although there has been lots of interest, so we’ve worked out a new approach and are just starting again from scratch. More about that later!

We have two other products in development. One which is undergoing internal testing and we have ‘broken ground’ on the second but intend to hold it until the New Year after medCrowd is released for external testing.

Our consultancy work is going a bit crazy with more clients than you can shake a stick at. We’re finding that companies like our digital medical expertise, not only relating to codes and regulations, but also our understanding of how companies can appropriately exchange scientific information with healthcare professionals online.

Get in touch to find out more about our projects or if we can help you with yours! It’s good to tweet/message/text/post/like/share/connect/comment.