Author Archives: Carroll Ray

Be True to Your Brand

January 5, 2010 | Author:

We spend a lot of our time creating clear and compelling brands for our clients. We develop the positioning and craft the messaging and design. We work with our clients to launch their brand and develop the tools necessary to be sure that the it’s implemented consistently. Recent developments in the news demonstrate how fruitless it all is if the company does not live up to the brand promise that it makes.

Whose brand was more finely crafted, and more tightly managed than Tiger Woods? It was crystal clear what the Tiger Woods brand stood for — Excellence. Character. Determination. Discipline. That’s what we were sold and that’s what we believed. Then it all went wrong. But why is his story so much worse than the countless others we have heard?

Professional athletes are in the news on a regular basis for a broad range of indiscretions, but rarely does it have the impact on their career as this recent scandal has had on Tiger Woods. Is that because of the nature of the “crime”? Many athletes have cheated on their wives, and many have done far worse. Yet nearly all manage to return to their sport with a clean slate. It seems there is no offense that cannot be overcome with a tearful apology in front of TV cameras and of course, a loyal wife sitting quietly by their side. The reason we are so quick to forgive is that we are not surprised. In fact, an athlete misbehaving is being true to their brand. An athlete cheating on his wife is about as surprising as a rock star on drugs.

I believe the power of the Tiger Woods story is not so much in the acts themselves, but in the fact that they are in direct opposition to the Tiger Woods brand that we had been sold.

And the lesson for those of you who live in the B2B world is to make sure that the brand promise you make is one you can deliver upon. Nothing is more damaging than to make a claim that proves not only to be wrong, but to be in direct contradiction to the truth. If you claim to be committed to service, make sure your service operation is top notch. If you stake out a position as an innovator, you better have a pipeline full of innovative products.

Branding is only effective when it is true.

Broken English

June 3, 2009 | Author:

The English language is broken. I’ve been planning to blog on this topic for some time and as I was working on my next article for Designochology, I ran into it again.

Nearly every positioning assignment I work on presents challenges because of the misuse, or overuse of a particular word or phrase within the client’s market. It seems when it comes to marketing and advertising, the dictionary definition of a term is not good enough. We need to create our own definitions.

A couple quick examples:

Integration. For some companies, integration is an important issue. Whether it’s integrating various hardware platforms, service offerings or applications, it’s important for many companies that they provide an integrated solution. The problem comes when you research the marketplace and find that every company in that space that claims to provide an integrated solution has applied their own definition, one that coincidentally matches their own particular set of offerings. That’s fine, but it means that companies in that space cannot use integration to differentiate themselves. The term has been rendered meaningless.

Automatic. Another word that has been lost is “automatic”. My client may have the only truly automatic solution, but they can’t say that because for years, companies within that market have used the term, and every possible variation of the term, to define their own products. There are automatic, semi-automatic, highly automatic and really, really automatic solutions. So, even though my client’s product really is the first fully automatic solution, the word has lost its value.

Branding. And we’ve done it to ourselves too. The term “branding” probably has more unique definitions than another other word in the English language. Everybody does it and everybody has created their own definition. For the record, here’s mine. A brand is the collective perception of a company and/or product which is created as a result of every interaction that an individual has with that product and/or company.

Push/Pull Marketing. This is the one that just sent me over the edge. The article I’m writing is on Social Media, and how it fits into a company’s marketing plan. And just to be accurate, I thought I would look up the true definition of Push and Pull Marketing. So, with the help of Google, in no time I had 577,000 search results to choose from for a definition. I tried the first 10 and found 10 completely unique definitions. It’s going to take me a while to sort through the other 576,990 sites.

Cheerios Needs to Mind Its Oats

May 19, 2009 | Author:

What could a cereal company possibly have in common with a pharmaceutical or medical device company? If you had asked that question a couple of weeks ago, people would have been hard-pressed to see a connection beyond “uh, well, they’re both companies.” But after the media explosion this week, most everyone could answer that question pretty quickly — They all have to watch their advertising claims… especially regarding public health.

In case you haven’t heard about this topic already or it has been clouded in your mind by media hype, I’ll summarize. The FDA sent a warning letter to General Mills’ Chairman of the Board and CEO Ken Powell on May 5th, 2009. In the letter, the FDA said that they reviewed the label and labeling of General Mills’ Cheerios Toasted Whole Grain Oat Cereal and found it in violation of the Federal Food, Drug, and Cosmetic (FD&C) Act and applicable 21 CFR regulations. Based on the claims made on the label, they determined that Cheerios was being “promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease.” By claiming to reduce your cholesterol level 4% in 6 weeks, Cheerios crossed the line into saying that their product is intended for use treating the disease hypercholesterolemia. Intentional or not, this marketing claim put the cereal into the class of being a drug promoted without FDA approval.

General Mills spokesperson Tom Forsythe responded to questions regarding the FDA’s warning letter by saying the cholesterol-lowering claim has been featured on the Cheerios box for more than two years and that the heart health claim was approved by the FDA 12 years ago. But what he failed to mention or understand was that Cheerios has kept pushing the envelope on their marketing claims over the past two years until they finally were slapped on the wrist by the FDA for overstepping the line.

Back in 1989, studies began to show that intake of oat bran may reduce cholesterol levels in the body. In 1996, Cheerios was able to meet the American Heart Association’s nutrition guidelines for its food certification program and they began to feature the AHA seal and checkmark on their packaging to publicize this endorsement. In 1997, the FDA announced that Cheerios, oatmeal, and oat products can lower the risk of heart disease when eaten as part of a diet low in saturated fat and cholesterol. In 1998, the FDA solidified this claim by allowing the phrase “can lower” to change to “in fact lower” cholesterol levels as part of a diet low in saturated fat and cholesterol.

If you look back at the Cheerios packaging over the last 2 years, you will see what I mean by Cheerios pushing the envelope on their health claims. Here is the progression on the wording on their packaging:

All General Mills Cereals are Made with Whole Grain (banner); Three grams of soluble fiber daily from whole grain oat foods, like Cheerios, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Cheerios has one gram per cup. (small type)

Oats Help to Naturally Lower Cholesterol (banner); Three grams of soluble fiber daily from whole grain oat foods, like Cheerios, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Cheerios has one gram per cup. (small type)

Cheerios May Reduce Your Cholesterol (banner); As part of a heart-healthy diet, the soluble fiber in Cheerios may reduce your cholesterol. Three grams of soluble fiber daily from whole grain oat foods, like Cheerios, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Cheerios has one gram per cup. (small type)

• Clinically Proven to Help Reduce Cholesterol (banner); A study showed that two 1-1/2 cup servings daily for 6 weeks reduced bad cholesterol about 4% as part of a diet low in saturated fat and cholesterol. Three grams of soluble fiber daily from whole grain oat foods, like Cheerios, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Cheerios has one gram per cup. (small type)

• Join the Challenge — and Lower Your Cholesterol 4% in 6 Weeks (banner); Three grams of soluble fiber daily from whole grain oat foods, like Cheerios, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Cheerios has one gram per cup. (small type)

You Can Lower Your Cholesterol 4% in 6 Weeks (banner); Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is the only leading cold cereal clinically proven to lower cholesterol. A clinical study showed that eating two 1-1/2 cup servings daily of Cheerios reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol. —- BAM! The FDA takes notice and generates a warning letter about this wording saying that General Mills is promoting Cheerios for conditions that cause it to be a drug.

What General Mills didn’t yet seem to understand (but I’m sure now does) is that even if they have done clinical testing and found that data to be true, a company can’t run around promoting it until they receive clearance from the FDA who validates the claim and offers guidance on what the can say to the public. Herbal and homeopathic remedies must always have asterisks next to their curative suggestions that declare “this statement has not been evaluated by the FDA.” The disclaimer must also announce that the product is not intended to “diagnose, treat, cure or prevent any disease,” because only an approved drug can legally make such a claim.

In the FDA warning letter, the FDA instructed General Mills that it would have 15 days to detail the specific steps it would correct the violations and specify the date by which it would complete the corrections with a statement of reason for any delay. The FDA sends out dozens of warning letters each year, so this is not disastrous news for General Mills, but they must quickly resolve the problem or face product seizes and other penalties — just like a pharmaceutical company would have to do.

And for those who think that the FDA is singling out the popular Cheerios brand for correction, just this past April it had warned Kellogg about its Frosted Mini-Wheats claim. Frosted Mini-Wheats asserted in their marketing that the product enabled children to be 20% more attentive than those who hadn’t eaten breakfast. A possible outcome of Kellogg’s own research studies, but not substantiated by the FDA and therefore in violation of the FD&C Act and applicable 21 CFR regulations.

The new FDA administration is sending a message to food manufacturers that they are watching labeling claims and are ready to enforce the Act, so they’d better mind their oats.

Invest in Your Brand

May 11, 2009 | Author:

At a recent event held by The Medical Development Group (MDG), a panel of speakers spoke to device startups about the state of M&A activity in 2009.

Daniel Lepanto, Managing Director of Mergers and Acquisitions for Leerink Swann spoke about the availability of investment money to make deals. Amarpreet Sawheney, PhD, President and CEO of I-Therapeutix spoke from the entrepreneur’s perspective on how to make your company more attractive, and generate competition among suitors. And Don Haut, PhD, Senior VP Strategy and Business Development for Smith and Nephew Endoscopy spoke from the buyer’s perspective about what exactly takes place behind closed doors during a deal, and why it takes so long.

The panel presented a compelling picture of the dynamics involved in an acquisition, but my interest is in branding and marketing, so you might think there was little to take away from the presentation. Two points were made that speak to the importance of branding.

1. In this market, there are just not that many companies looking to buy and those who are are in a clearly advantageous position. Dr. Sawheney cautioned entrepreneurs not to simply jump at the first offer, and in fact, to be prepared to go back and continue to build the business. To me, that not only means research and development, it also means that companies must continue the work of positioning and branding their products.

2. As someone personally responsible for acquisitions for Smith and Nephew, I asked Dr. Haut whether or not the state of a company’s brand is taken into account when determining its value. He replied, “A company with a strong brand is nearly always more valuable than one without a strong brand.”

It seems that branding is one of the last things that young companies think about. And who can blame them with so many other pressing issues on their plates? But companies who get it right add real value to their business.

Branding is an investment that will show real returns whether the company chooses to take their device to market, or whether they ultimately find themselves in a position to be acquired.

The World Changed. Now What?

May 6, 2009 | Author:

In the April issue of our newsletter, Designochology, I discussed the impact that the “gift ban” regulations will have on the marketing of medical devices.

Volumes have been written about the new state and federal regulations, and how they’re changing the sales process for medical device companies. Doctors are less receptive to seeing representatives and device companies are struggling with how to support physicians CME needs while staying within the letter of the law(s). 

I’ve seen much less written on the impact that new regulations will have on the marketing mix that device companies choose to employ. Will they turn more and more to online tools like Webinars and social media, or do traditional marketing tools play an even more important role considering the limitations on personal contact with physicians?

One trend has been noted that’s worth watching. In the MDD Exec report, Selling Devices and Diagnositcs: The World is Changing, 150 medical device and diagnostic executives were surveyed and data showed that a shift is happening in the buying process within hospitals. Physicians have traditionally been the key decision makers for any new device purchase. And though the physician was identified as the key customer by 57% of respondents, almost a third identified the patient, the payor or hospital administration as the key customer.

This fact is worth considering when developing your value proposition. The economics of your solution may need to take a more prominent role in your messaging, and the movement toward Direct to Patient (DTP) communications means marketing messages can’t get so wrapped up in the technology that they forget the diagnostic and therapeutic benefits that patients need to hear.

A Welcome Addition to the Medical Device Market

April 27, 2009 | Author:

A new web-only publication was recently launched to serve the Massachusetts medical device market.

You might ask, do we really need another publication to serve the life sciences industry? But the problem with nearly all of the currently available sources is that coverage tends to be dominated by pharma and biopharma news. And though they’re often linked together by the media and by governing bodies, there are important distinctions between the pharmaceutical and medical device industries.

Massachusetts’ medical device companies deserve the focus, and the resources that this new site intends to give. Not only is the state the center of the medical device universe (a $8.3 billion industry in the state, according to, it now must operate under the nation’s most restrictive regulations governing industry payments to physicians. 

Best of luck to We’ll be watching.

Off-label Marketing at Trade Shows

April 23, 2009 | Author:

The current headlines about three Stryker Biotech employees being charged and pleading guilty to medical device misbranding has become a major discussion of late in the medical device industry. With trade shows commonly subject to FDA enforcement efforts, the prosecution of the Stryker sales reps and manager serves as a warning to the industry.

In case you haven’t heard about the Stryker case, I’ll recap. It has been unfolding since last fall. In November 2008, a former Stryker Biotech sales rep pled guilty to misbranding a medical device. This past February and just this month, a second former rep and a third former employee pled guilty to the same charge. The devices they misrepresented are the OP-1 and Calstrux bone-healing products. The charges state that they encouraged medical professionals to combine the bone products in a way not approved by the FDA. To further validate the FDA charge against Stryker, it was discovered that the distributed brochures giving instructions for mixing these bone products.

In addition to illegal promotion of OP-1 and Calstrux, the FDA is also investigating the company for possible false reporting of the number of patients that were treated under one of the company’s Humanitarian Device Exemptions.

To learn more about scientific exchange of information versus promotion and deeper exploration into acceptable trade show practices, I suggest you check out the Promotion at Trade Shows and Medical Meetings: Not If, but How archived audio conference sponsored by BioWorld Today and Medical Device Daily.

FDA – Not One Big, Happy Agency?

April 22, 2009 | Author:

Recent news articles bring to the forefront the fact that the FDA is not necessarily a united agency with a common set of goals. In May 2008, Frank Torti joined the FDA as Principal Deputy Commissioner and new Chief Scientist. Many were encouraged by this appointment since Torti’s background is academic, not political — seemingly the perfect selection for a position charged with oversight of this federal agency.

Under Torti’s direction, by the end of summer 2008 the FDA had added 1,300 people to the agency’s ranks. Torti promoted the additions by saying it represented the first incremental hiring for the 11,000-person agency in “many, many years. The regulatory agenda for the FDA has grown substantially in the last 20 years while its work force has remained largely flat,” he added. Torti definitely has a point there. Technologies have been changing at lightning speed and the FDA is responsible for oversight of this broadening array of devices, drugs and advances. Nanotechnology developments and their applications to possible disease treatment is leaving the FDA with the puzzle of deciding whether to class them as devices or drugs.

And beyond the technology advances, 2008 ended up providing a string of food and drug emergencies that kept the agency hopping… Tainted peanuts. Unsterilized syringes. Salmonella originally thought to be in tomatoes and then ultimately in Mexican chili peppers. A contaminated blood thinner from China that sent patients into life-threatening shock.

In March, Torti sent a confidential memo warning FDA staff about leaking confidential information. (A memo which was itself rapidly leaked to the public!) Shortly afterward, Torti sent a farewell memo to the FDA staff urging them to “Take the FDA back.” Humorously for the general public (not the agency), this memo was also leaked to the public in short order!

Here is an excerpt from Torti’s farewell memo after his less-than-one-year stint with the FDA: “The FDA is now defined by others. You must speak up and take the FDA back. It is yours, not theirs. You do more good, day in and day out, than most others, inside or outside government. FDA has a mission, of course. But what you give the FDA is character and class.”

The hope of promise with Torti’s appointment and his rather quick exit amid the cloak-and-dagger text of his farewell memo leaves us wondering what could possibly be going on within the agency walls.

Banned from Branding

April 20, 2009 | Author:

The term “I like…” should be banned from the business of branding. It’s fine to use the word in our personal lives — to like pizza, or to like a particular song, or like blue more than green. But when evaluating a brand design or a corporate position statement, judgement needs to be based on more than whether the proposed solution is liked.

In no other part of the medical device industry does subjective taste matter. You will get funding if the product is viable and able to turn a profit. You’ll sell the product if you can prove it’s better than the available options. You’ll succeed as a business if revenues outpace expenditures. But for some reason, when it comes to developing one of the company’s most valuable business assets — your brand — logic and reason are often overlooked in favor of personal preference. 

Taste is subjective. Effective communication is not. Color, shapes, words and images communicate particular messages, and they need to be chosen properly to achieve the objectives. Good creatives understand the principles behind the decisions they make and should be able to explain their reasoning.

The use of the phrase “I like” is a habit — just as a teenager uses the word “like” to start every sentence… or someone uses “ummm” to fill every pause. But it’s a habit with consequences. The decisions you make regarding your company and product brands will have a significant impact on their success or failure. 

So, next time someone is evaluating creative — whether it’s a logo, a position statement, or an ad campaign — encourage everyone to replace  “I like it because…” with “It works because…”. This forces everyone to verbalize their reasoning, and consider whether the proposed solution achieves the stated objectives.

Putting Things in Perspective

April 16, 2009 | Author:

Recently, I visited a family member in the hospital who had had complications with childbirth. As I waited for my opportunity to visit, a stream of doctors and nurses came and left. I paced back and forth from the hospital room to the nursery where the newborn was gamely battling an infection. Through the nursery window, I could see the baby boy connected to an automatic IV drug dispenser and surrounded by state-of-the-art monitoring equipment. Countless medical device carts were scattered along the hallway, ready to be deployed — an AED, blood pressure monitors, ECG monitors, numerous laptops fired up, and ready to go. Though there was nothing I could do to help the mother or the baby, it was mildly comforting to know that what I do for a living was, in a very small way, connected to the efforts that were going on there. By helping good companies get the best devices into hospitals, maybe I’ve done all I can.