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ResearchKit Is A Game Changer, Just Not The Way You Think

phone-homeAs you no doubt have read by now, Apple announced Monday an open-source medical platform named ResearchKit. The platform, which runs natively on an iOS device, provides medical and scientific institutions the ability to conduct real-world investigations using anyone who wishes to opt-in to the studies. At launch, there were apps from Mount Sinai (for Asthma), University of Rochester (for Parkinson’s Disease), Massachusetts General Hospital (for diabetes), the Dana-Farber Cancer Institute, UCLA Fielding School of Public Health, Penn Medicine, and Sage Bionetworks (for breast cancer), and Stanford Medicine and the University of Oxford (for cardiovascular disease). You can read more about the platform and what it entails here. Read More…

The pharma implications of the FDA’s policy on low risk devices

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On January 19th, the FDA released draft guidance about wearables dated January 20th, proving not only do they have access to a time machine, but they are totally willing to rub our noses in it. The document, which you can download here, relates to the FDA’s policy on what it deems as “low risk devices,” i.e., wearables.

Low risk devices, by the FDA’s definition, are those that, “involve claims about sustaining or offering general improvement to conditions and functions associated with a general state of health that do not make any reference to diseases or conditions.” And, more specifically, a general wellness device has,

1)  intended uses to promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions; and,

2)  intended uses to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.

Read More…

The 10 Commandments of Digital Marketing

ItMoses of Digital’s that time again. Brands are starting their annual cycle of planning for the coming year. One of the quirks of pharma, that I haven’t experienced when working with other industries, is that brand managers responsible for digital turn over (through promotion or responsibility change) at an alarmingly high rate. As such, the institutional knowledge and learning for the role gets easily lost. Since a decent portion of pharma marketers enter a digital management role with little or no actual digital marketing experience, I thought it would be helpful to provide some edicts to ensure fruitful digital marketing campaigns for the years to come. Enjoy.

1. Thou shalt put no other strategy before thy brand strategy.
Too often for brands, digital strategies are created in a complete vacuum from the overall brand strategy, or worse, no digital strategy is crafted at all. Since digital is the glue that ties the entirety of a marketing plan and tactics together, anything that happens online needs to ladder up to the higher objectives of the brand. An effective digital strategy is typically composed of a group of sub strategies to effectively plan and account for owned, earned, shared, and paid assets. Take a look at your plan. If you can’t clearly articulate how your digital strategy (or objectives) ladder up in the overall brand, you need to rethink your approach.

2. Thou shalt not make for yourselves any shiny idols.
Most brands have some form of goal around innovation. And that’s important because innovations drive the business forward. But innovation doesn’t mean new, it means better. Your strategy should help you select your tactics, not the other way around. If you are seeking to use a tool or platform because you think it’s cool or innovative, and can’t identify how or why it works for your audience, you’re worshipping the shiny object and are destined to fail.

3. Thou shalt remember thy user and put no interests before theirs.
I can’t stress this enough. Too often marketers approach digital from the mindset of their own (or their brand) objectives. Users crave value, utility, and having their needs met. This is especially true online where fractions of a second can make or break a potential engagement. Instead of focusing on your needs, try and determine what your users want and how you can insert your brand or your content into their lives in a way that makes sense. It may mean you have to produce less banner ads and create more of something else. Read More…

Creating An App-Panic

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iMedicalApps.com published an article detailing Apple’s ‘new’ development policy which will reject any app that includes dosing information for a medicine. Normally I wouldn’t comment on an article from another site in this much depth, but given the way headlines suddenly become ‘insights’ in this business, I thought it would be helpful to clarify a few things.

The article starts with an ominous headline “Apple is now rejecting new medical apps that include drug dosages.” Apple is not doing this across the board. One or two devs got rejected. Which by the way, happens all the time, for all kinds of reasons.  The article goes on from there, “It appears that a number of developers have struggled recently to get medical applications into the App Store.” It doesn’t say how many developers or how wide spread the problem is. And, without any kind of context as to what the app was, or any insight into it’s functionality, it’s impossible to draw any conclusion as to why it was rejected. Given the amount of apps currently in the app store that reference dosing information (mostly by manufacturers) I seriously doubt this is a widespread issue.

A simple reading of the actual rejection sent by Apple illustrates where the developer(s?) went wrong.

“We found that the Seller and/or Artist names associated with your app do not reflect the name of the manufacturer of the medicine referenced in your app or its metadata, as required by the iOS Developer Program License Agreement.

Section 1.2: 

“You” and “Your” means and refers to the person(s) or legal entity (whether the company, organization, educational institution, or governmental agency, instrumentality, or department) using the Apple Software or otherwise exercising rights under this Agreement. For the sake of clarity, You may authorize contractors to develop Applications on Your behalf, but any such Applications must be submitted under Your developer account.

We can only accept medical dosage information submitted by the medicine’s manufacturer.

If you have published these apps on behalf of a client, it would be appropriate for your client to enroll in the iOS Developer Program, then add you to their development team so you can develop an app for them to submit under their developer account.”

I actually see this as a good thing for users. First, the developer in the article clearly didn’t follow the metadata practices of Apple’s guidelines, which is a no-no. Apple has been very consistent on making sure apps are what they say they are and aren’t playing games with metadata to boost rankings. Already I’m suspicious of the developer(s?), since they seem to be unwilling to follow or correct this issue now that Apple has pointed out it’s a problem. Second, if you are publishing dosing information and aren’t doing it on behalf of the manufacturer, you may be publishing the wrong information. Since pharma has so many checks and balances on it’s content, Apple can be assured that anything with a manufacturer’s name on it would have the content verified for accuracy.

As part of gathering the info for the Mobile App Wiki, I spent quite a bit of time in the Android store. Let me tell you, it’s hard to know who’s published what. The requirements are very flimsy for publishing an Android app, and I couldn’t tell if an app was legit or not (see the Bob in IT example).  To be clear, Apple is not asking for the content to be verified, but does have some controls to ensure the veracity of content. Given the importance Apple has placed on medical content and audiences, this seems like a logical restriction to ensure quality for it’s users. So if you are developing an app for a pharma client, or doing it in house, you should be fine.