From The Editor | June 11, 2015

How Important Will mHealth Be To Pharma?

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

Mobile Health - mhealth

The pharma industry is a hotbed for buzzwords, many of which often disappear as quickly as they spring up. One of the latest is mobile health (mHealth) technologies. A 2015 white paper released by Cutting Edge Information (Understanding the Importance of Mobile Health for Pharma) predicts this technology will not be the latest flash in the pan, though. In fact, as mHealth continues to evolve from new phenomenon to mainstay marketing strategy, the white paper’s authors,  Michelle Vitko and Sarah Ray, predict its importance in the pharmaceutical industry will continue to grow.

While numbers do not always reveal the complete story, some of the figures cited in the white paper are pretty telling. In the first quarter of 2014 the total number of mHealth applications available on iOS and Android platforms soared past 100,000 and continues to grow. Even more telling is the fact that during the past 30 months 5,000 of those apps earned revenues greater than $1 million. Mobile strategies now account for 14 percent of marketing mixes of teams that were surveyed.

Other sources seem to back up these findings. Mobile Health Market News predicts clinical mHealth spending will increase $2.5 billion from 2011 to 2016. mHealth Watch estimates the mHealth market will be worth $26 billion by 2017.

The reasons behind the growth of this technology are clear to most: It provides pharma companies the ability to connect with various audiences of strategic importance to them, from patients and caregivers to physicians and pharmacists. In an industry where information is vital and feedback from external partners so critical, the allure is certainly understandable. Still, the paper warns pharma to not overly rely on mobile technologies to achieve desired results. By using these devices to promote medical education and patient adherence, companies may better position themselves to benefit from mHealth in the long run.

Support Access To Medical Information

Today, more consumers turn to the Internet — often via their smartphones — than ever before to acquire medical information. While text message campaigns do not require smartphones, accessing the Internet does. Mobile broadband penetration is 32 percent globally; double what it was in 2011. The highest penetration rate is 64 percent in Europe, compared to just 59 percent for North and South America combined. The speed of the broadband service also must be considered, as it can vary across geographic areas. While developed countries have an average speed of 2 Mbit/s, there are wide discrepancies. The white paper notes speeds are highest in the Republic of Korea (10 Mbit/s) while lesser developed countries such as Ghana and Uganda have speeds of less than 256 kbit/s.

With smart phone and tablet adoption increasing worldwide, mHealth technologies become a preferred tool for companies to better interact with patients. Uses range from text messages to remind patients to take medicines to more interactive systems that might coordinate, for example, a glucose meter with a mobile app for diabetes patients.    

These programs do not need to be complicated to be effective. In fact, the paper notes in some cases, simplicity may lead to higher efficacy rates.

How To Get Involved

There can be reluctance by Big Pharma to get involved with new technologies, especially if they are unsure of the FDA’s stance. Vitko and Ray note the FDA has examined mHealth technologies and the extent to which it may have to regulate them. The Safety and Innovation Act of 2012 outlined which types of mobile apps would be subject to regulatory oversight, while final guidance issued in September 2013 emphasized the FDA would focus its attention on medical mobile devices. “In general, the FDA intends to exercise its regulatory oversight on mobile apps that either work in conjunction with a separate medical device or transform an existing mobile platform — such as an iPhone, Android, tablet, or the like — into a regulated medical device,” notes the paper. “Basically, if a mobile application has the potential to affect patient safety for better or for worse, the FDA intends to review it.” Other mobile initiatives will be examined on a case-by-case basis.

While mHealth is a way for pharma companies to establish themselves as patient-centric, unanswered questions on the regulatory end may still cause some companies to shy away. After all, even with guidance in place, there is no way to be sure how the FDA will enforce its final ruling. The approval by the FDA in January 2015 of a series of mobile medical applications may provide some insight. In its decision, the FDA rated the risk posed by the system as “low to moderate.” This is expected to alleviate concerns and encourage the creation of more mobile applications.

That being said, companies should not jump into the mHealth arena without fully understanding what they want to get out of an app. Vitko and Ray recommend going through the following steps to ensure you are designing an effective mobile initiative.

1. Understand what your primary goal is in creating the mobile initiative. Be sure to identify your specific objectives before designing the initiative.

2. Understand who the initiative will target. Will it be used only by patients or physicians as well? In which countries will you be targeting users? These factors will impact how the initiative is designed.

3. Be sure to collect and incorporate user feedback. Pharma companies can save a lot of time and money by ensuring their initiative is attractive to the patients and end users they are trying to attract.

4. Create a dedicated team. If you do not have dedicated staff in house, consider finding a vendor specialized in mHealth to handle the initiative for you.  

5. Develop the program internally, if possible, and touch base with end users to monitor the program and make modifications as necessary.

6. Deploy the initiative via a cohesive marketing plan. All internal stakeholders should be on board with the plan and understand the goals of the initiative.

7. Finally, Be sure to revisit and improve the initiative over time. Changes may be requested to improve the functionality of the initiative. Realize that any initiative is never fully complete. It must be continually adapted in order to stay relevant.

Keep in mind as you go through this process that no two initiatives are alike. Each one will have different goals and outcomes to be attained and may be addressing different audiences. Regardless of the initiative, developing a clear plan at the outset and closely monitoring it throughout the process is the only sure way to guarantee you plan will meet the goals you put in place.

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