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A Pharma Marketer’s Guide Getting Started in Mobile Marketing 1 Edition (February 2011) Authored by: Klick

A Pharma Marketer’s Guide

Getting Started in Mobile Marketing

  • 1 st Edition (February 2011)

Authored by: Klick Pharma

Digital Strategy . Experience Design . Data & Technology . Online Media


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Klick Pharma is a full-service digital marketing agency that specializes in the healthcare and pharmaceutical sector. With a focus on measurable results, Klick Pharma’s talented subject matter experts create and execute data-driven digital strategies that maximize their clients’ online investments. The team’s years of pharma experience have resulted in a unique understanding of proven strategies at all stages of a brand’s lifecycle and the know-how to deliver innovative and effective programs within a complex regulatory environment. Klick Pharma offers custom end-to-end digital solutions to meet a variety of client needs, including strategy, experience design, technology, media, and learning solutions.

Visit KlickPharma.com to learn more.

Jay Goldman

Pharma speaker and Klick’s Mobile and Social Media expert

Brian O’Donnell

Eye for Pharma chair and

Klick’s lead on Digital Strategy



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2011 will go down in history as the year of the smartphone. There has never been a better time for your organization to make the dive into mobile and to leverage the considerable consumer and HCP interest in smartphone and mobile web platforms.

This guide aims to provide pharma marketers with an overview of the key issues and challenges surrounding mobile marketing, as well as some potential solutions for effectively leveraging this channel within the complex regulatory environment.

Employing real data and pharma case studies, this guide will explore the common challenges faced with the core strategies most frequently deployed in mobile: optimized websites, native apps, and advertising. This guide will provide an overview of each tactic, the associated legal/regulatory issues, and potential approaches to help marketers implement programs successfully.

In reviewing each tactic, we will address concerns and questions commonly cited by pharma marketers.

Mobile Optimized Websites

• Introduction to mobile testing and optimization

• Overview of mobile browsers • Driving traffic • Mobile challenges

Native Mobile Apps

• Overview of the mobile app opportunity • Understanding hardware vs. operating system vs. ecosystem • Apps for pharma and healthcare

• Design considerations

Mobile Advertising

• In-app advertising • Mobile ad networks • Fair balance and ISI When you’ve finished reading this guide, you will hopefully have a much clearer picture of the major

challenges facing pharma marketers in mobile, understand what other brands are currently doing in the marketplace, and get some ideas on what you can potentially do to better leverage mobile within the regulatory framework. While not exhaustive, it should at least provide a starting point for discussion with your internal regulatory teams.

A note on recommendations

Recommendations appear throughout this document in the following format:

This is a strong recommendation.











The Mobile Marketing guide is provided by Klick Pharma as an informational reference and subject to change without notice. Any opinions published here are those of the author(s) and are not meant to be exhaustive guidelines for online marketing compliance. The recommendations cited here have been developed based on Klick Pharma’s interpretation of what is currently happening in the marketplace and where the category appears to be going. Every effort has been made to present accurate and reliable information, but Klick Pharma assumes no responsibility or liability for any errors or inaccuracies that may appear in this document. Furthermore, this guide was not reviewed or developed in consultation with the FDA, and therefore all suggested approaches should always be vetted by your internal regulatory/compliance teams and receive appropriate FDA approvals. All brand names used are the trademarks of their respective owners. All of this information is provided “as is” and Klick Pharma disclaims any express or implied warranty, relating to the use

of this information including warranties relating to fitness for a particular purpose, compliance with a specification or standard, merchantability or

non infringement.



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It is well worth defining some important terms before we dive into the practical aspects of mobile

marketing. Even the word “mobile” has different connotations depending on who you speak to.

These definitions are provided in broad terms with specific deviations noted throughout the document.

Mobile (device): a battery-powered handheld computing and telephony device.

Desktop: a traditional, desktop-based computer. This term can also refer to a laptop, in the sense that laptops run software written for the ‘desktop’ rather than for mobile devices (e.g. it’s useful to draw a distinction between desktop and mobile web browsers).

Featurephone: an older mobile device consisting primarily of a phone with a limited data connection (generally at EDGE speed), and sometimes with the ability to run primitive third party applications (generally written in Java). Featurephones generally fall into either the ‘candybar’ or flip hardware formats and almost never have a full keyboard (most featurephones include a system like T9 for inputting text using the keypad without having to laboriously repeat keys to type each letter).

Smartphone: a modern mobile device consisting of a phone, an always-on data connection (generally at least 3G speed and increasingly 4G), and the capability to install and run third party applications. Smartphone web browsers are increasingly quite sophisticated and rival their desktop counterparts for speed and the ability to render complex, interactive websites. Smartphones generally fall into either touchscreen (e.g. iPhone) or keyboard (e.g. BlackBerry Bold) devices, with some hybrids (e.g. BlackBerry Torch) becoming increasingly popular.

Older touchscreen smartphones don’t support multitouch, meaning that only one finger is

recognized by the display at any time (Apple’s iPhone pioneered the use of multitouch for

gestures like pinching to zoom, which is now a widely accepted standard).

Tablet: can refer to either a first generation or second generation tablet device. The first generation are generally Microsoft Windows-based laptops with screens that can be rotated into tablet position. These devices often require a stylus for use on the touchscreen and are considerably bulkier and more limited than their newer cousins. Second generation

devices were defined by the launch of the Apple iPad in April 2010, which eschewed the

laptop format for a much lighter device built entirely around a touchscreen with no physical keyboard or stylus. 2011 will see the release of more than a hundred Android-based tablets, as well as the much anticipated BlackBerry Playbook from RIM.


2011: Year of the Smartphone

This is an exciting time to be a digital marketer. 2011 promises to see a critical milestone in the growth

of mobile: smartphones are expected to eclipse featurephones in US penetration by Q3. This is a very significant point from a marketer’s perspective, as it represents the time at which advanced technologies

can be deployed in a cost-effective manner, reliably reaching the majority of consumers in their pockets and hands in a far more personal and persuasive fashion than more traditional digital tactics.












87% 86% 84% 83% 81% 79% 76% 73% 69% 65% 60% 55% 51% 49% 45% 40%
Feature Phone
Source: The Nielsen Company

2011 also represents a significant shift in the way that consumers are accessing online information.

Some key statistics:

According to Google, 75% of consumers research symptoms online first and then go see their doctor, while 70% research online after being prescribed a med. 1

Yahoo! and Nielsen report that 48% of respondents to their study on The Role of Mobile

Devices in the Shopping Process are interested in seeing healthcare or medical-related content on their internet-enabled mobile devices in the next 12 months. 2

The Pew Internet and American Life Study on The Social Life of Health Information likewise found that six in ten patients (61%) use the Internet to search for health information. 3 Perhaps more critically for marketers, the study found that these searches had an impact on the users’ decisions and actions.

  • 1 Google & OTX, Health Consumer Study, December 2009. http://bit.ly/klick-googleOTX

  • 2 eMarketer: Consumers Eager for Mobile Shopping Info. http://bit.ly/klick-healthinfo

  • 3 Pew Internet: The Social Life of Health Information, 2009. http://bit.ly/klick-pewsocial



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These trends are only going to continue as broadband penetration increases, but will differ from the reported numbers in the manner in which the content is accessed.

Google reports that searches on mobile phones have grown more than five times in the last two years and surged 130% in the third quarter of 2010. 4 They expect to see 250 billion+ searches from mobile in 2011, matching the same levels of search seen on desktops in 2007. The difference is in the trend line, showing an accelerated rate of mobile search that will cross desktop searches in the next few years.

450 400 350 300 250 200 150 100 50 0 Desktop searches Smartphone searches Searches per
Desktop searches
Smartphone searches
Searches per device (billions)

Source: Google

We are at the beginning of a move away from desktop computers toward a mobile-focused world, and pharma/healthcare will be no exception. Morgan Stanley estimates that 50% of all web traffic will come from mobile devices by 2013. 5 The Global Mobile Health Market Report estimates that 500 million people will be using healthcare smartphone applications by 2015. 6 Innovators and early adopters are there now, as seen in the 3500+ healthcare apps already available for download on iPhone and Android. Depending on the target for your campaigns, the early majority may already be there as well, particularly for younger audiences (29% of 18-29 year olds already use their mobile devices to access health information online). 7

Finally, we see an expanded future for ‘mobile’ as the world adopts tablet devices with open arms. The trend started by the iPad will continue solidly over the next five years, with Forrester Research calling for tablets to grow as quickly as MP3 players. 8

  • 4 Google Mobile Searches Soar as ‘Thumb Shopping’ Gains Steam. http://aol.it/klick-mobilesearch

  • 5 Morgan Stanley: Mobile Internet Report, December 2009. http://bit.ly/klick-morgan

  • 6 Global Mobile Health Market Report 2010-2015. http://bit.ly/klick-globalmobile

  • 7 Pew Internet: Mobile Health 2010 report. http://bit.ly/klick-pewhealth

  • 8 Forrester Research: US Tablet Sales Will More Than Double This Year. http://bit.ly/klick-tablets

100 82.1 76.1 80 67.7 60 50.7 40 44.0 42.3 39.8 26.0 35.1 20 24.1 10.3
Total Tablet PC Users (US)
Total Tablet PC Sales (US)

Source: Forrester Research Report “Tablets Will Grow As Fast As MP3 Players”

Forrester expects sales of nearly 25 million tablets in 2011, with the lion’s share going to Apple (and continuing to do so through 2012). They expect 82 million American consumers – one third of the total

online audience – to have a personal tablet by 2015. This trend has definitely started to take root in the

pharma world, with a growing movement toward arming sales reps with tablets (iPads for the most part).

Capitalizing on the Mobile Opportunity

The mobile opportunity is so new that there are no established, hard rules to build on. Everyone in this space is experimenting and learning as they build successful campaigns and reach new audiences. One of the only things we do know for sure: this is not a question of “if” but rather of “when”. We may be at the beginning of an adoption curve that’s climbing increasingly, but there is no question that it points directly at the future of marketing.

Now is the time to take part in those early experiments and build mobile subject matter expertise internally, the same way marketers adopted earlier mediums and tactics like print, radio, television, and the Web. Deciding on your level of involvement is one of the most important questions you’ll face in getting started in mobile. The spectrum for displaying your content on mobile ranges from mobile tested/ optimized sites at the simple end all the way up to native apps at the more complex end. The following sections will help you to map out your starting point and your path forward.



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Mobile tested and optimized websites are the simplest way to get involved in mobile marketing. At the most basic level, this involves testing your existing website on the most popular mobile devices and browsers to ensure that it displays and functions correctly — what we refer to as a ‘mobile-tested website’. At a more complex level, this can involve rethinking your existing website to produce a ‘mobile- optimized website’, which presents a presentation layer laid out and designed for the mobile experience on top of your existing content.

Given the sharp increase in traffic from mobile devices, a mobile- testing plan should be considered a basic requirement for all digital campaigns.

Our own klickpharma.com website demonstrates best practice for mobile sites. Visiting the site from

your desktop browser delivers a rich media experience suitable to browsing on a large screen, fast

connection, and focused environment. Visiting the same URL from a mobile browser automatically

delivers a mobile-optimized version of the site that omits the Flash video and focuses on a simplified

menu offering direct access to the content visitors are most likely seeking.

Always provide a link from mobile-optimized sites to the full version of your site. Not all mobile users want a simplified experience and browser detection technology is not a perfect science.

The basic concept is an important one to understand. Think of your existing website as a series of stacked layers:



Dynamic websites often use a Content Management System (CMS) to make the content easily editable

and manageable by non-technical team members. The Presentation layer sits on top of that and defines

what the website actually looks like and how the content gets displayed. The best approach to building mobile-optimized sites is to add additional Presentation layers:


Think of this as a book that’s available in different editions: the underlying text doesn’t change but each

edition looks very different from its peers. Two hardcover editions are more similar than a hardcover and paperback — a fairly accurate way to think about the difference between a big, heavier desktop version and a much lighter, smaller, mobile version.

It is important to note, from a pharma perspective, that the FDA DTC regulations (especially those related to branded vs. unbranded sites) still very much apply in the mobile world. Some of those regulations, like fair balance, are made more challenging when dealing with smaller screen sizes, so it is especially important that your mobile campaigns go through the same rigourous review process as your desktop sites. That may prove to be a challenge in and of itself as many MRL reviewers will want to see the site in context of the devices it is designed for, so you should plan to have some sample devices available during the review process.

Mobile Browsers

Web browsers on mobile platforms are not significantly different than they are on desktops like Windows

or Mac OS. The major mobile operating systems — iPhone, Android, and BlackBerry — all ship with

their own default browser, the latest versions of all three being nearly as fully featured as their desktop

cousins. Users of Android and Maemo (the operating system used by some Nokia smartphones and

tablets) have the option of installing Firefox Mobile on their devices, while users of Android, Maemo, Windows Mobile, BlackBerry, and iOS have the option of installing Opera.

edition looks very different from its peers. Two hardcover editions are more similar than a hardcover
edition looks very different from its peers. Two hardcover editions are more similar than a hardcover
edition looks very different from its peers. Two hardcover editions are more similar than a hardcover

An important note on mobile browser compatibility: the underlying technology that handles actually rendering websites in the iPhone, Android, and BlackBerry (starting with BlackBerry OS 6) web browsers is called WebKit, and is the same technology that powers Safari and Chrome on the desktop. This makes testing considerably simpler since a site that displays correctly on one platform is very likely to display correctly on the other two (though you should still test across all three since this is not a guarantee).

Driving Mobile Traffic

A significant portion of your mobile traffic will come from visitors who directly access your mobile-

optimized site from their device. That said, many web surfers still have an expectation that they will not be able to browse websites from their mobile devices and so simply avoid trying.

There are a number of ways to drive traffic to mobile sites, including advertising (see the Mobile Advertising section in this document), distinct URLs on product packaging (e.g. http://m.klickpharma.com), and QRCodes printed on promotional material. QRCodes are the evolution of traditional one dimensional barcodes (simple vertical lines

as seen on groceries, etc.). Their complexity allows them to encode more information,

including complex data like URLs, address book entries, etc. The QRCode at right,

edition looks very different from its peers. Two hardcover editions are more similar than a hardcover



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for example, is a link to the Klick Pharma website. Most smartphones (with the notable exception of

iPhones) include the ability to scan QRCodes automatically.

Mobile Website Challenges

Anyone who has ever looked at a website on a mobile device is no doubt familiar with some of the challenges involved in correctly displaying sites intended for desktop browsers on handhelds. The best approach to resolving this is to build mobile-optimized sites that have been tested across a variety of devices and operating systems. Some of the important considerations:

Browsers: older featurephones use WAP (Wireless Access Protocol), a simplified version of the HTML that underlies all websites. More modern mobile devices, including iPhones, Androids, and newer BlackBerries, have more modern browsers capable of rendering more complex websites. It’s important to consider who will be accessing your site and what level of technology they have access to.

Flash: support for Adobe Flash is far from universal in the mobile world. Apple has taken a very strong stance on this issue, declaring that iOS (the operating system that powers iPhone, iPad, and iPod touch) will not provide Flash support. RIM has likewise not provided Flash support even in BlackBerry OS 6.0, the latest version of their popular operating system. Android gained support for Flash in their 2.2 release, though performance and

battery life remain significant issues when displaying Flash.


Avoid using Adobe Flash on mobile websites. HTML5 provides much of the same functionality and should render and function correctly on most modern smartphones. Existing Flash animations and interactive pieces can be converted to HTML5 and re-deployed on desktop and mobile platforms.

User Interface: many websites, particularly those built on Flash, require a mouse and/or full- time keyboard for use. Those are unavailable on almost all mobile devices, which will require affected sites to be redesigned for mobile.

Context of use: traditional websites are designed with a desktop or laptop user in mind — typically someone with a comfortable chair, solid work surface, constant power and network connection, low level of distraction, and good availability of audio. They also tend to have more time available and focus available, resulting in a substantially different range of feasible tasks. This can impact everything from the design to the functionality of a website. Mobile users are rarely in those circumstances, which may require you to rethink your visitors’ goals and what they can realistically achieve on the mobile version of your site.


Apps are at the more complex end of the mobile marketing spectrum, requiring development of custom software for each platform. The numbers alone attest to the importance of this opportunity:

Gartner expects mobile users to download 17.7 billion apps in 2011, a 117% year-over-year increase, and are calling for an astounding 185 billion apps by 2014. 9

As of January 2010, Apple has more than 400,000 apps available in the iTunes App Store, with over 10 billion downloads across the iPhone, iPod touch, and iPad. 10

The Google Android Market has more than 200,000 apps available in 34 countries worldwide. 11

86% of mobile users aged 35-44 report having downloaded an app, followed by 85% of those aged 18-24. 12

Truly understanding the mobile app opportunity means understanding the underlying technology and marketplace. Mobile apps really apply to the smartphone market. In North America, the market is divided

between Apple, RIM, and Android, with RIM historically enjoying the largest share but now facing a

continued decline as it loses ground to the other players (Android specifically).

40% 38% 39% 37% 35% 36% 36% 35% 35% 31% 34% 29% 29% 32% 30% 29%
38% 39%
RIM BlackBerry
Apple iOS
Google Android
Market Share
Oct 2009
Nov 2009
Dec 2009
Jan 2010
Feb 2010
Mar 2010
Apr 2010
May 2010
Jun 2010
Jul 2010
Aug 2010
Sep 2010
Oct 2010
Nov 2010
Dec 2010


The worldwide market is less evenly divided, with Nokia still owning a significant share in some markets

  • 9 Gartner: Forecast: Mobile Application Stores, Worldwide, 2008-2014. http://bit.ly/klick-gartner

    • 10 Apple’s App Store Downloads Tops 10 Billion. http://bit.ly/klick-appstore

    • 11 Wikipedia: Android Market. http://bit.ly/klick-androidmarket

    • 12 eMarketer: How Mainstream are Mobile Apps? http://bit.ly/klick-appsbyage



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(notably Asia, Africa, and Eastern Europe). Players outside of the big three have yet to really capitalize on the app opportunity, and so the decision for marketers rests on which one of those platforms best match your target audience.

We expect to see the Android trend very much continue this year as the number of available devices

expands. Several carriers and manufacturers, including T-Mobile in the US, have committed to releasing

sub $100 Android handsets before the end of the year, which will drive considerable adoption across all

market segments. It is our expectation that Android will become the dominant smartphone platform by market penetration, but that Apple and RIM will continue to hold sizeable portions of the consumer and enterprise markets respectively.

It can be difficult enough to design and build the right app without having to worry about getting it right across three platforms. We recommend releasing your app as a pilot for one operating system, refining, and then releasing across the platforms with highest penetration in your target audience.

Hardware vs. Operating System vs. Ecosystem

It is equally important to understand the difference between hardware platforms, the operating system that runs on them (think of the hardware as the body and the operating system as the brain), and the app distribution ecosystem that surrounds them. All three of the big players have a different approach.

Apple iOS

Apple’s operating system is called iOS and is currently available on three hardware options, all made by Apple: iPhone, iPod touch, and iPad.

(notably Asia, Africa, and Eastern Europe). Players outside of the big three have yet to really

Applications written for the iPhone will run on the iPod touch (and vice versa), but should take into

account differences in hardware capabilities (e.g. no GPS on the iPod touch). They will likewise run on the iPad, but will display in an iPhone-sized box in the center of the iPad’s screen with the option to

magnify 2x (and with a resulting loss of clarity and sharpness). Apps can be written to be ‘Universal’,

in which case they can run on the iPhone/iPod at a smaller size and on an iPad at a larger size to take advantage of the extra display size. Finally, apps can also be written as iPad only, in which case they won’t run on an iPhone/iPod (and often have “HD” appended to their name to indicate the higher resolution).

Apple keeps the iOS ecosystem under a notoriously tight lock down, requiring developers to register an account with Apple, pay a yearly membership fee, limit the functionality of their applications to approved areas, and submit their applications for approval before they can be sold in the App Store (which can take up to a few weeks). The most recent release of iOS opens this up for developers who are building apps for internal use within their company, providing an Enterprise account option that enables applications to be distributed directly without going through the app store.

Google Android

Google Android Android is an Open Source operating system made by Google and available on a

Android is an Open Source 13 operating system made by Google and available on a very wide variety of hardware options.

Although Google has partnered with HTC to design and market two of their own phones (the Nexus and Nexus S), Android handsets are mostly produced by other device manufacturers. Samsung and HTC have been leading the way to date, with some very promising announcements from Motorola suggesting that they will become much more involved in this market. Given the number of manufacturers and model numbers, building applications for Android is more complicated than building for iOS since your app has to account for more screen sizes, hardware features, and manufacturer/carrier customizations.

Google has recently announced a new operating system, called Chrome OS, which will power netbooks and laptops. It is far too early in the lifetime of that product to make any solid recommendations toward it, and so marketers should plan on Android releases with an eye toward evaluating Chrome OS at a later date.

The app ecosystem for Android has been relatively strong since launch, lagging behind Apple but showing genuine promise. The Android Market has recently been relaunched to provide a much more robust shopping experience and to offer developers additional flexibility with regard to international customers and in-app purchasing — two options Apple has had for some time now. Developers are much freer on Android and can build almost anything they can imagine without needing to go through an approval channel to distribute their apps.

RIM BlackBerry OS

Google Android Android is an Open Source operating system made by Google and available on a

RIM has recently launched BlackBerry OS version 6, a much improved version of their popular offering that fully integrates touchscreen devices into the BlackBerry experience. Most of their older devices still in market are running BlackBerry OS version 5, with 6 now available on the Torch, Bold, and Curve.

RIM has also recently announced a new operating system called QNX, which will power their

forthcoming PlayBook tablet. They have committed to QNX gradually replacing OS 6 across all of their

future devices, but have yet to provide a timeline.

Apps written for BlackBerry OS 6 should run correctly on QNX, and so we recommend that marketers not wait for the next generation of hardware if BlackBerry use is high in their target audience.

Developing apps for the BlackBerry platform brings a unique set of challenges. There have been a

significant number of BlackBerry devices, many of which have different input options (e.g. scroll wheels,

track balls, track pads, and touchscreens). The different devices have very different screen sizes, some

  • 13 Open Source means that Google provides the source code for the software at no charge so that other companies and

people can use it on their devices as well as to contribute fixes and improvements back to Google.



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in portrait orientation and others in landscape. Each major release of BlackBerry OS has also brought

new functionality into the mix, meaning that apps have to be planned and tested for a very specific set

of supported hardware from the outset. Although it is well worth making these decisions given the size of the market, it should be factored into any BlackBerry app plans.

App distribution on BlackBerry OS has traditionally been achieved through the use of third party websites and app catalogs. RIM released the App World store in April 2009, providing a subset of the features found in Apple and Google’s offerings. BlackBerry users are starting to install more apps as the concept becomes familiar, though the size of the store and richness of the offerings lags behind the other platforms.

Cross-Platform App Development

There are a few third party toolkits available that claim to allow you to build your application once and

have it run on multiple platforms (particularly iOS and Android). The market leader in this field is Phone Gap 14 , which supports iOS, Android, BlackBerry OS 4.6 and higher, HP WebOS, Microsoft Windows Phone 7, and Nokia’s Symbian. Your app developers build your app using standard HTML, JavaScript,

and CSS as though they were building a website and the toolkit wraps the app into a native package for distribution through the various app stores.

This may be a viable alternative for some apps, though it is important to note that mobile users are

notoriously fickle, insisting on apps that match their expectation for the platform. It is very difficult to achieve a platform native look and feel when not actually writing code for that platform. You will also be

dependent on the third party toolkit to keep up to date with the latest features of each platform in order to use them in your app, which will be a limiting factor for particularly advanced apps.

Apps for Pharma and Healthcare

The Pharma and Healthcare industries have been relatively slow to include apps in their marketing plans, largely out of a desire to avoid regulatory issues and a concern that smartphone users would not

download and install them. There are definite FDA considerations that must be taken into account, but

the good news is that consumers have strongly indicated their preference to access health and medical information on their phones (see the Introduction & Overview for more information).

FDA Regulations Case Study: MIMvista Mobile MIM

The FDA has yet to issue any regulations specific to the app market, though they have been active in

policing it. Marketers should proceed with cautious optimism, taking this as an opportunity to release apps that carefully follow the DTC regulations they would follow with any other digital campaign (particularly with regard to branded vs. unbranded apps and fair balance).

Mobile does introduce some new considerations, some less obvious than others. As an example, consider the case of MIMvista, who released their Mobile MIM application over two years ago.

Although still available in the U.K., Australia, Hong Kong, Singapore, and India, the app has not been

available to American radiologists since shortly after its release.

MIMvista released the app in the safe harbour of “non-diagnostic use”, a regulatory grey zone that precludes FDA review for products that will never be used for diagnosis. Realizing that radiologists were

likely to use the app for that exact purpose, MIMvista submitted a 510(k) application to the FDA under

the belief that it was sufficiently equivalent to their existing products to not require additional approval.

The FDA responded with a Not Substantially Equivalent (NSE) letter in January 2010, stating “your device has new technological characteristics that could adversely affect safety and effectiveness and

raise new types of safety and effectiveness questions…Therefore, this device is classified by statute into

class III (Premarket Approval).”

The decision was “based on the fact that your device has a new indication for displaying medical images for diagnostic use on a mobile/portable device.”

Mark Cain, MIMvista’s Chief Technology Officer, believes this applies to any mobile

or portable device, including tablets and laptops, and that the FDA will view all of those devices as class III.

“Their emphasis was purely on portable and mobile devices,” he said. “The way I read this, laptops, iPads, anything that is carried around and used for diagnosis has no predicate and, therefore, is a class III device.”

available to American radiologists since shortly after its release. MIMvista released the app in the safe

The FDA granted 510(k) clearance for Mobile MIM on February 4th, 2011, clearing the app for sale in the US. 15

Getting to Medical Regulatory Legal Approval

Every company’s MRL process will differ enough to make generalizations difficult. Some important

considerations as your pursue approval for your mobile app campaigns:

Mobile apps are uncharted territory for many pharma and healthcare companies. It is well

worth involving your review panel as early as possible, ideally seeking their pre-approval at

early, conceptual milestones rather than waiting to show them the finished product.

Your approvers are likely reviewing one of their first mobile apps, and will therefore need a

fair amount of background information to consider the context of use. If allowable, consider having your development partner present during the MRL process to help answer questions.

Reviewers are likely to want to see the application running on the devices it is built for rather

than in the abstract context of screenshots and documentation. You may therefore need

to convene in-person meetings of your review panel and consider how to document that

process for archiving in your electronic review process. Reviewers may not have access to the hardware required to complete their reviews,

particularly for multi-platform apps. This will also be true during the User Acceptance Testing

(UAT) phase of development, during which your staff will need to test the app.

  • 15 FDA press release: http://bit.ly/klick-510k



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You may therefore need to have some example devices available during the review and

testing process, which you should budget for at the outset of your program.

Pharma companies will want to consider the impact of app store reviews on their Adverse Event (AE) SOPs. The three major app stores (as well as the third party Android stores

operated by Samsung and Amazon) provide a free form field for anyone to provide a review

of your app. There is no way to disable this functionality or to require pre-approval before publication. Although it is highly unlikely that anyone would use this space as an opportunity to report an AE (especially one that met the FDA’s reporting criteria), it is well worth noting and preparing a policy to handle.

Design Considerations

Designing a mobile app can be a very foreign experience for those marketers who are new to the field.

There are many parallels to designing other types of digital campaigns that will feel familiar, but there are a number of new considerations that need to be accounted for.

Confidentiality and Privacy

Marketers should consider the type of information their app is going to collect and ensure that the app is properly designed to protect it. Many pharma and healthcare apps take advantage of the omnipresent nature of mobile devices, designing experiences around data collection and logging (e.g. food/symptom/ weight logs). The general best practice is to have apps launch without requiring any form of password protection, but you should consider offering that functionality if users are likely to want to keep their information secure.

Take Full Advantage of the Device

Rebuilding your website as a mobile app is a costly expenditure that delivers little additional value. Mobile devices have many properties that set them apart from the desktop world, including being omnipresent in users’ lives, having always on data connections, including phones for tap-to-call 16 functionality, being able to deliver push notifications, and being filled with sensors like microphones,

cameras, GPS, accelerometers, gyroscopes, etc. Take full advantage of these properties to deliver an experience that users couldn’t have elsewhere and they will make repeated use of your app.


Mobile advertising is a relatively new field, emerging as the mobile platforms have gained higher and higher penetration rates. There are two significant opportunities available to marketers aimed at

promoting your product, driving traffic to your mobile site, and leading would-be users to download your


In-App Advertising: there are four major networks offering in-app advertising, reselling the inventory provided by other app developers. Although we would not recommend providing inventory within pharma and healthcare apps, purchasing media within other very targeted apps can be an excellent way to attract users to your own app. Look to Millennial Media and Apple iAd as the premier networks in this space, both offering the richest capabilities for dynamic ad formats. Both are familiar with the DTC regulations and can provide ad formats that allow for the inclusion of Important Safety Information (ISI). Some networks may provide inventory on a Cost-Per-Acquisition model (CPA), which will be higher than their CPM rates but may ultimately be more cost effective as you only pay when someone clicks and ultimately installs your app.

Mobile Ad Networks: all of the major ad networks now provide the ability to target web-

based ads at mobile users, displaying them only to mobile devices that meet specified criteria. CPM rates are quite similar to those you would find for desktop inventory. This can

be an excellent method to reach consumers outside of the desktop, as this graph illustrates:

11pm 1pm 8pm 7am Time Desktop use Smartphone use Traffic
Desktop use
Smartphone use

Source: Google

Your media partner should have relationships in place with vendors of both types of ads and be in a

position to advise you on the best strategy for your campaign.



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Now is the right time to make an investment in mobile marketing. Even the recent recession has not kept consumers from voting with their wallets, demonstrating an extremely high level of demand that is making smartphones some of the fastest adopted technologies in history. 2011 promises to only reinforce that trend, with Android likely to become the dominant smartphone operating system, tablets

exploding onto the scene, traffic shifting increasingly to mobile devices, and app downloads breaking

new records. We also expect that pharma and healthcare content, including sites and apps, will play

an increasingly large role on mobile as consumers and HCPs become more comfortable with the technology and build a greater level of trust with its place in their lives. It is an exciting time to be a

pharma or healthcare marketer and we hope you will embrace the mobile revolution with open arms!

How to Embrace the Mobile Revolution with Open Arms

  • 1. Make mobile website testing a mandatory step in every web-based campaign you undertake going forward.

  • 2. Develop a mobile-optimized version of your site in parallel with the desktop version or as a second phase. Make sure to keep the considerations listed in the Mobile Websites section of this document in mind as you’re planning it.

  • 3. Build an app for iOS as a pilot, followed closely by Android when it has matured to version one. Build a BlackBerry app at the same time if BlackBerries are prominent in your target audience.