By Amy Dowell

Originally published  by PM360

Assumptions. They make an ass out of you and me—especially when you’re trying to determine the best strategies for marketing a medical device. In fact, knowing what assumptions to avoid may be just as important and even more valuable. The wrong program, an overlooked audience, or an unfounded assumption can do immeasurable harm to your brand and your revenue. The best defense is a strong offense, so take some notes from other marketing organizations that have attempted to launch enviable brands and categories—and failed—before you step into the same trap of making false assumptions.

What Not to Assume:

“I know my audience and what they want.”1

The importance of user-focused research seems unquestionable to any brand launch, but how you go about it can dictate sure-footed success or dire failure. How often do you find yourself operating under the assumption that your team knows your target better than anyone? It’s not uncommon for any of us to fall into that trap. Learn from the folly of others, like Pfizer’s 2006 launch ofExubera Inhaled Insulin. This revolutionary drug delivery system was 10 years in the making, promising a groundbreaking new way to deliver insulin without the pain and inconvenience of needles. Predicted to be a $2-billion-per-year product by 2010, the product only made $12 million in the first 12 months and was withdrawn from the market soon after. Ouch.

Why? Pfizer neglected to realize that many people with diabetes don’t mind injecting themselves with insulin—what they detest is the regular finger pricking required for blood glucose testing. Inhaled insulin delivery didn’t address this unmet need. Additionally, the device was significantly larger and more cumbersome than most small, discreet insulin pens, which made this marketing hurdle even more significant.

When products are brought to market without a clear unmet need, marketers have the greatest responsibility and opportunity. Finding creative ways to drive need creates desire and action. In addition, Pfizer’s seemingly obvious disadvantages could have been avoided with some out-of-the-box market research—like ethnographic field testing, which involves getting out from behind the one-way glass and into your patient’s living room or your surgeon’s OR. Revolutionary? No. And yet, not very common in most device marketers’ launch plans.

The Flipside for Success

Assume nothing about your users. Get out there and observe them.2

Instead of making unfounded assumptions, consider conducting ethnographic field-testing to identify the “real” problems your medical device needs to address. Coloplast, a market leader in healthcare products, is a great example of a company that decided not to jump to conclusions. The Danish medical technology company’s ostomy division was stalled despite investment in product development and sales. Coloplast, known for R&D, had filled the pipeline but couldn’t drive growth. The team realized that the fundamental market assumptions that helped the company grow for decades may not apply in today’s world. Their questions suddenly changed from “How do we capture new sources of growth?” to “What is the experience of living with an ostomy?”

The marketing team had decades of sales data and market metrics, but they didn’t really “know” the patient. They didn’t understand how an ostomy could affect self-image, social life and the activities of daily living. They decided they needed a radical perspective—from an anthropologist’s point of view. The team hired ethnographers to shadow patients’ lives for days to learn about their experience—not just with the brand, but with the condition.

Ethnographers reported back “raw, personal and firsthand” data, including videos, diaries, photographs and field notes. The patients provided profound insight. The marketers realized they misinterpreted the findings of their conventional research for years. The problem they believed they had already solved—leakage—was in fact still a tremendous issue, but because patients generally stopped complaining about leakage after a while, the marketers assumed the problem no longer existed. This is a common trap: “Confirmation bias,” the reflexive seeking of information that supports an existing position. R&D suffered from it, and so did Marketing.

Coloplast responded to this unmet need by launching a new BodyFit product line in 2010, with resounding success. Today, Coloplast’s ostomy business is growing faster than the overall market for ostomy products—all because they dared to ask a different question.

What Not to Assume:

“My device is so revolutionary, it will sell itself.”3

Cochlear implants (CI) are a category of medical devices that have long travelled the unpaved road of under-utilization rather than the super-highway of standard of care. When the FDA first approved CI in 1985, the technology was perceived as a controversial treatment for deafness. Today, it’s commonly recognized as a life-changing intervention, according to a published study inCochlear Implants International.

With three approved manufacturers in the U.S. vying for market share, a well-established body of efficacy data, demonstrated cost-effectiveness and managed care coverage, one might assume it’s a category that’s achieved the much-coveted designation of “standard of care.” But it’s not. Utilization remains incredibly low, with only an estimated 6% market penetration in the U.S. for adults and children. Compare that to 90% utilization among patient candidates in the UK and other European countries.

What is going on here? It’s multi-factorial, to be sure: Low awareness among both patients and HCPs, lack of specific referral pathways, socio-political issues within the deaf community, and financial issues related to health provisions and access. These issues might sound familiar to many medical device marketers. CI manufacturers have been struggling to overcome these challenges and recently tried banding together as an industry to create the American Cochlear Implant Alliance (ACI Alliance). This will be an important development to follow because so far the market has been unable to turn the corner on demonstrating value in a new and meaningful way.

The Flipside for Success

Relentlessly pursue “standard of care.”4,5

One industry’s done it right: Negative Pressure Wound Therapy (NPWT). In 1995, the FDA cleared a patented device called V.A.C.® Therapy, marketed by Kinetic Concepts, Inc. The technology used negative pressure to help heal challenging wounds such as chronic diabetic ulcers, pressure sores or traumatic open wounds. It revolutionized the way these difficult wounds were treated, and KCI committed to a mission: To make NPWT the standard of care in advanced wound healing. They called upon surgeons and physicians of all specialties, from orthopedic surgeons to plastic surgeons to geriatricians, to grow the market. It worked, expanding exponentially over the next decade. When KCI lost their patents and dozens of competitors flooded the market, well, that became a different problem to solve. But the mission was complete.

The road to standard of care is generally built brick by brick—not by trying to ride a wave of momentum. During those 10 years, the V.A.C. Therapy marketing team addressed every detail possible to achieve their goal—from applying a concerted focus on managed care relations, relentlessly pursing new indications, aggressively innovating the user experience of the portfolio and funding research for clinical data. And when momentum seemed to slow, the team doubled-down on applied resources rather than retracting funds—often the knee-jerk reaction of many organizations. According to Joel Pickering, a former Marketing Director for V.A.C. Therapy (now VP, Marketing & Communications at Novation), “The goal was always to reach standard of care and we invested along the way to get there. We didn’t simply look at it financially quarter by quarter but more strategically year to year to build markets and take share.”

HCB Health was proud to have been a part of this accomplishment, helping to achieve standard of care in such a hyper-demanding industry like medical device marketing. The lesson? You still have to do the hard work to demonstrate value, even if the clinical benefit seems obvious.

What Not to Assume:

“Our surgeons will do the selling for us.”6

Want a sure-fire way to lose traction in the market? Focus all your attention on the end-user—surgeons in this case—and ignore the influencers that can make or break your brand. DePuy Spine, a J&J subsidiary, made this mistake with its launch of the Charité spinal implant. This 2004 launch had all eyes on it, with its potential to revolutionize the degenerative disc disease (DDD) market as the first artificial disc in the U.S. approved to treat severe chronic lower back pain. Analysts praised the company’s pricing strategy, extensive surgeon training, sales force preparedness and available inventory.

Many surgeons were excited, and DePuy Spine was ready to go after these implanters—an audience promising very high demand. Reports even indicted that 60% of spinal surgeons advised patients to delay spinal fusion for the artificial disc. But a myopic view of the market potential proved troublesome. Surgeons couldn’t lead the way alone.

An important advantage of the Charité: It reduced hospital stays by 15% compared to standard of care (spinal fusion). DePuy Spine assumed that cost-saving data would lead to a positive response from administrators. DePuy Spine was banking on what hospitals had previously stated: They would cover any shortfall in CMS reimbursement because, “What their spine surgeons require to deliver top patient care, they get.” Those two facts led DePuy Spine to rely on the surgeon to convince administrators to buy the Charité implant—rather than proactively working with the hospitals directly in order to smooth the way to easier adoption. They didn’t fully appreciate the need to treat administration as a key influencer segment and put appropriate resources and strategies behind it. The impact? A launch that missed an aggressive goal, with sales reaching only one-third of the initial target one year after launch.

The Flipside for Success

Never overlook your influencer segment.7

Alcon, the world’s largest ophthalmic company, took a well-strategized approach for its astigmatism-correcting cataract implant—leaving no one on the sidelines. The AcrySof® IQ Toric intraocular lens (IOL) is exclusively implanted by ophthalmologists, specifically cataract surgeons. Yet the patient journey in a surgical practice involves conversations with patient care coordinators and staff optometrists before and after the consultation with the surgeon. The surgeon may recommend an astigmatism-correcting implant to a patient, but the discussions that take place beyond the ophthalmologist’s exam room reinforce the patient’s decision about their treatment plan.

Paul Smith, a former Alcon Global Senior Brand Manager for AcrySof Toric IOLs (now VP International at TearLab Corporation), felt it was important to focus on market growth. “Despite several competitors in the toric IOL market, Alcon’s focus has always been on lifting the entire category.” The strategy had to align, so the global marketing team challenged strategists at HCB Health to come up with a novel way to engage the surgical staff in understanding the value of correcting astigmatism at the time of cataract surgery. That led to the real issue we needed to address: Many patient care coordinators and staff optometrists have never personally experienced what it means to have uncorrected refractive error. Why not demonstrate that experience firsthand?

The solution was the development of a dynamic “Astigmatism Challenge Kit.” It included several pairs of glasses—with treated lenses to induce an astigmatic view—along with activity cards to guide participants in performing everyday activities, such as pouring a glass of water or reading a sign across the street. The program was successfully shared in various global markets and received an incredibly positive response within months of rollout—even surgeons were having fun with the experience. A winning strategy for engaging beyond the surgeon at multiple points of care.

Medical device marketing is becoming more and more complex, and our success will depend upon learning from others who have missed the mark. Challenging assumptions just may be our best defense.


1. Bontoft M. “The medical device is safe, but would I use it?” MD+DI. Published July 30, 2014. Accessed August 27, 2015.

2. Madsbjerg C, Rasmussen M. “An anthropologist walks into a bar…” Harvard Business Review. Published March 2014. Accessed August 27, 2015.

3. Sorkin D. “Cochlear implantation in the world’s largest medical device market: Utilization and awareness of cochlear implants in the United States.”Cochlear Implants International. 2013;14(s1):S12-S


5. Data on file. HCB Health.

6. Dirckx J. “Negative pressure wound therapy.” Perspectives. December 2008:17-18.,%20Wound%20Therapy.pdf.

7. Arida D, Kabra A, Lowe C, et al. “The Charité: lessons in the launch of a new medical device.” The Kellogg School of Management at Northwestern University. Published June 2, 2006. Accessed August 27, 2015.

8. Data on file. HCB Health.