FDA Loosens Regulatory Reins on Digital Devices

File under: Healthcare innovation, Mobile Health, Patient Engagement

Over the past year there have been a series of draft letters from the FDA on the approval process for medical devices, particularly in the arena of digital health. After several years of being a hyper-vigilant regulatory agency and effectively slowing down the approval process for new products, the FDA has begun to relax its approval requirements, especially for digital health products.

FDA3Historically, the FDA has divided medical devices according to device classification and risk to patient and user. Class I includes devices with the lowest risk such as an activity tracker like a Shine or Fitbit and Class III includes those with the greatest risk such as pacemakers or implants.

The class indicates what level of premarket approval is necessary. Most Class I and Class II devices are exempt from the 510(k) Premarket Notification application. Most Class III devices require full Premarket Approval (PMA), which generally requires clinical data to support claims. Read Full Article Now »

Expectations on the Rise for Digital Marketing in Pharma

File under: Global Pharma Marketing, Multi-Channel Marketing, Patient Engagement, Pharma innovation, Relationship Marketing

ExpecatationsI’ve begun to observe among our clients a distinct shift in expectations for the role of digital marketing. Even though pharma marketing budgets continue to invest in the traditional channels of television and print, I’m seeing a change in how digital is viewed, and that’s a positive sign.

Smarter Marketing Talent
The caliber of marketing talent in key pharma leadership roles has improved, bringing higher expectations for technology and digital-based marketing. Marketers in both so-called centers of excellence and at the brand level are demanding measurable goals for what technology can be and should be doing for their company and their products. They reward success and fire agencies or technology partners that don’t meet expectations.

The Amazon Effect
Online retail and social media companies have raised the bar of consumer expectations for access to information and the ability to search and buy in a very seamless way. But until recently, consumer expectations didn’t impact pharma. Now, the online consumer experience is raising the bar on healthcare.

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Traits of a Healthy Marketing Agency

File under: Global Pharma Marketing, Multi-Channel Marketing, Relationship Marketing

As closerlook passed 100+ employees last  year, I began to reflect on what makes (and keeps) an agency healthy. Although there are many qualities that one might attribute to a healthy agency, I’ve boiled it down to four main traits or characteristics that I think are key, at least in my experience.

traitsBusiness Clarity
The first trait of a healthy agency is clarity. The agency should be clear about what they do and don’t do. A healthy agency’s focus is rooted in deep expertise and a clear understanding of its business value.

In other words, a healthy agency knows what role they play in the business of their client. They know what kind of influence they have. Healthy agencies don’t think of themselves as just executors of strategy, but thinkers — they have brains, not just hands. Successful agencies want to have impact. They want to move the needle, not just deliver on tactics. They really see themselves as a business partner for their clients. Read Full Article Now »

Pharma and its Love of Deal Making. All Good This Time.

File under: Global Pharma Marketing, Patient Engagement, Relationship Marketing

3-wayThe recent 3-way deal between GSK, Novartis and Lilly represented a major transaction for all three companies. The deal has been scrutinized by the Street like a master chessboard swap of assets, in this case, molecules. Obviously, it took a fair bit of corporate development work to make these deals happen, so it’s actually pretty impressive from that perspective. But what’s more interesting to me is the strategy that these moves belie. It’s another clue to how pharma is changing.

For the past thirty years, pharma companies rose or fell based on their ability to develop or acquire a drug with blockbuster potential. Sometimes blockbusters just showed up, as did the disappointing blood pressure medication with unusual side effects called Viagra. Or the also-ran cholesterol-lowering drug that was almost cancelled because it would be the fifth drug in its class and that went on to become the largest drug in history. Read Full Article Now »

Publi-com: the whole was less than the sum of its parts

File under: Global Pharma Marketing

publicom3The dissolution of the Publicis/Omnicom merger
(or was it the Omnicom/Publicis merger?) provides a helpful cautionary tale for all of us. The moral of the story is not that you should decide your CFO or your merger documents before you make the announcement. More fundamentally it’s a question of who your most important stakeholder is.

For many years I taught a business school class on CRM, and one of my observations was that the center of gravity for successful entrepreneurial companies was always the customer. No customer value, no company. But as firms got larger, the center of gravity gradually moved internal because of the many pressing organizational needs. Mergers and acquisitions are particularly distracting, to the point that many corporate managers never even interact with customers. Read Full Article Now »

Is pharma doubling down on TV? Really?

File under: Global Pharma Marketing, Multi-Channel Marketing, Patient Engagement, Pharma innovation, Relationship Marketing

The data is out on consumer ad spending in 2013. It wasn’t a surprise that TV and magazine ad spending was down significantly while digital spend was up. If you own a TV network, you can’t ignore the handwriting on the wall. You feel the pain.TV.jpg

Unless you are selling to pharma.

It appears that pharma is trying to single-handedly bail out traditional media. Pharma’s TV ad spending was up more than 12% last year, and magazines were up more than 6%. And digital? The channel to which every other industry is moving their spend?

For pharma, digital spend was down more than 14%…

The total pharma DTC spend last year was $3.8 billion, and of that, it spent about $60 million on digital ads last year. That doesn’t even qualify as a rounding error. Of the top 20 pharma brands, 16 didn’t even spend more than $1MM on digital advertising.

I’m left scratching my head. Why the heck is pharma bucking the global trend to digital? Does it know something the rest of us have missed?

I have a couple thoughts on this trend. First, I have to give props to TV and magazine sales executives. Obviously, they haven’t surrendered to digital, at least among their pharma clients. They make the argument that cable TV allows for better targeting, an attractive argument for brands that are trying to reach a mass audience.

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Achieving Escape Velocity from Pharma Corporate Inertia

File under: Healthcare innovation, Pharma innovation, Relationship Marketing

After a few recent client meetings I’ve begun to reflect not just about the challenges facing pharma, but the nature of those challenges. More specifically, I wonder if they reflect normal cyclical ups and downs or the impact of social and political evolution? Or do they represent a secular change?

I happen to believe we’re at the cusp of a secular change in pharma, one of those major paradigm shifts in an industry that only happens once every 10 or 20 years, or once every generation. A shift in which the industry will experience a major transformation. Retail is going through a change like this, energy is in the middle of transformational change, and I think this is also happening to pharma right now. No political or regulatory or scientific shifts will bring back the good old days of pharma.

escape velocity

Impact of Secular Change
Jim Collins has written extensively about what happens when massive change hits an industry. When it all shakes out, there are a handful of companies that are the undisputed leaders, while the majority simply meander in the middle of the bell curve.

We don’t need to recite here the product, access and margin pressures our industry faces – everybody knows that the power center is shifting. The real question now is, how do we control, channel and predict that change? Or do we just let it happen to ourselves?

Many people that I talk to within pharma are pretty discouraged, because they feel like their companies are slow and morbid and there’s too much inertia to really make change happen. Yet, when I talk to people at the most senior levels, they do want to make change happen, but feel constrained by the mid- and lower levels. Oftentimes, when the senior level tries to make change happen, the people at the mid- and lower levels dig in their heels. It’s reminiscent of when politicians try to make significant changes and the civil servants respond, “Well, he’ll only be around for a few years, and then we’ll go back to business as usual.” In some ways, that attitude prevails in pharma.

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Closed Loop(s) Marketing – It’s More Than Pharma Sales Rep Tablets

File under: Big Data, Global Pharma Marketing, Multi-Channel Marketing, Pharma innovation, Relationship Marketing

As I re-read a recent Gartner report on Closed Loop Marketing (CLM) in pharma, it struck me that while Gartner was very focused on the shortcomings of current tablet-based sales applications for closing the sales rep-physician loop, they missed two other equally important brand-customer loops.

closed loops editedI’d suggest that there are three “loops” that need to be closed. And closing them would provide a lot more effectiveness in marketing.

First, let’s briefly touch on the sales rep-physician loop that Gartner’s analyst Dale Hagemeyer focused on and that most brand teams and agencies think of when they talk about CLM.

The Sales Rep – Physician Loop
Gartner’s point is that sales forces are underutilizing tablet technology and that this major investment in mobile presentation devices has not resulted in any true brand differentiation. In fact, for most companies Gartner talked to there wasn’t even a good business case for investing in sales rep tablets. According to interviews with 63 pharma clients, Gartner was consistently told, “We don’t have a business case. We simply have to have them because everybody else is getting them.”

As a result of this non-strategic implementation of interactive detailing, it’s no surprise that the tablets are simply another show-and-tell device, and with 85% of sales forces now equipped with the technology, their use provides no competitive advantage. The real power in tablet technology is the ability to collect individual physician data for analysis and the generation of insights at both the individual and aggregate level. This is a major missed opportunity and is one reason why the ROI on CLM hardware investments has not lived up to its promise.

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Creating Pharma(x)

File under: Healthcare innovation, Mobile Health, Pharma innovation

pipe1Mention change in the pharma industry today and you’ll get raised eyebrows along with a sarcastic alliterative remark suggesting you must be Sherlock Holmes…

No, the question is not whether change is happening, it’s how you predict, control and channel change to your advantage. Or acquiesce and allow it to happen to you.

Secular industry change is risky and challenging. But it’s only through market-defining challenges that companies and people come out stronger and better poised for the road ahead. Embracing risk and creating ambitious goals is what keeps companies moving forward and ultimately leads to new and exciting discoveries.

Larry Page, co-founder and CEO of Google, recently commented that as Google takes even more ambitious and costly bets, one would expect their failure rate to go up. But in fact, it hasn’t. And even when they may not achieve an ambitious goal, the path they take often leads to important things. Read Full Article Now »

Bold Leadership in Healthcare

File under: Healthcare innovation, Patient Engagement, Pharma innovation

What’s happening at CVS Caremark is an emerging business case study in visionary leadership.

CVS made headlines for its decision to discontinue selling cigarettes, capturing the gratitude of many people, including the White House.
cvs logoThere was chatter among analysts that this move will trim $2 billion from the company’s revenue, a fact that only seemed to add to the feelings of goodwill among current and potential customers. The widespread response from consumers was, “This is a wonderful thing that CVS did. They didn’t have to do it. They’re doing it not in the best interest of the business, they’re just doing the right thing.”

From a PR perspective, it created a real sense of warm fuzzies towards CVS, increasing pressure on other chains like Walgreens and Rite Aid to follow suit. It has been assumed that management calculated that goodwill towards CVS would result in more customers and more foot traffic, and eventually these new customers will replace the lost revenue. (In fact, trimming $2 billion in revenue, while meaningful, likely will have a modest effect on the stock price. It reflects less than 2% of total revenue, and its contribution to net income is roughly $70 million. Given that the new policy won’t even take effect until October, it will have negligible impact on 2014 company performance.) Read Full Article Now »