Medical Device Link.

Originally Published MX May/June 2003

TOPSPIN

Getting a head start on product communications requires early planning.

Richard J. Linder

Richard J. Linder is president and CEO of Rubicon Medical Inc. (Salt Lake City).

At the recent annual scientific session of the American College of Cardiology (ACC), held in Chicago, three leading cardiologists delivered separate presentations featuring the Rubicon Filter, an embolic filtration device being developed by our company, Rubicon Medical (Salt Lake City). Almost simultaneously, a similar presentation was delivered in Salt Lake City at the annual meeting of the Society of Interventional Radiology (SIR).

Medical technology executives will recognize the significance of such presentations by leading clinical experts—especially for a growing company. Not only do such presentations help broaden the awareness of clinicians to clinical products currently in development, they also provide a significant underpinning for a company's investment base (whether private or public). They also help set a future marketing and communications groundwork for the product. Moreover, they do so with a clinical credibility that a company cannot achieve in any other way.

Although a certain amount of luck and fortuitous timing may be involved, achieving the goal of such communications does not occur by accident. Rather, a significant amount of careful planning is required to position a company so that it can take advantage of presentation opportunities at major meetings of healthcare professionals. To be effective, however, such efforts must begin early—often much earlier than company executives usually begin to think about them. In fact, the earliest stages of developing a successful communications strategy for a new medical product take place so early in the product development cycle that they barely look like communications efforts at all.

Following are some of the key steps that led Rubicon to its recent successful series of presentations at the ACC and SIR events.

The Right Market, the Right Product

Savvy executives never start product development without first conducting a thorough market analysis, including an in-depth evaluation of clinical needs as well as current and future competition. Rubicon's first step was therefore to research and analyze the marketplace for embolic protection therapies and devices. This effort led us to believe that clinical understanding of the challenges presented by embolic events will continue to grow, presenting a similarly growing market opportunity for the right product, marketed the right way.

Fortunately, we also believe that we have such a product. Rubicon believes the Rubicon Filter is the world's smallest-profile embolic filtration device. It is designed for use in medical procedures downstream from a blockage in a bloodstream to allow the capture and removal of dislodged embolic material. It is deployed on a guidewire without a catheter, making it smaller and easier to navigate through blood vessels. It is expected that the filter's small profile should considerably decrease trauma to the body as well as the risk of dislodging particles during passage of the filter through a blockage in a blood vessel.

Naturally, it's rare to be the first to market with any product or service. Moreover, it is sometimes beneficial to be second. In the medical device marketplace, once the first product is introduced addressing a specific need, the next generation of devices falls somewhere on the "medical device continuum," delivering incremental benefits beyond what was provided by the prior device.

Assuming that all such devices meet essential business and market requirements—including clinical effectiveness, patentability, freedom to operate, ability to prevent competition, and so on—it is generally the last product on the continuum that wins. This is the strategy that we have adopted for the Rubicon Filter, a device that we believe will represent the ultimate endpoint on the medical device continuum for embolic protection technology. The response from the marketplace following the ACC and SIR meetings suggests that we're on the right track.

A Bias for Action

In the medical device marketplace, a company cannot realistically swing for the fences unless it pulls together the right team. In keeping with this approach, Rubicon assembled a design and development team made up of individuals with a bias for action—those predisposed to act and uncomfortable with a slow pace—led by an individual with a background in the high-tech industry. It was important to me that the company have a team leader with such a background, to help us achieve developmental speed and turnaround times more like those in the high-tech field—arguably the fastest on the planet—than those typical in medical device manufacturing.

The same approach also guided the company in assembling a team of clinical experts for its medical advisory board—an effort that actually grew out of the company's initial market analyses. Those early inquiries enabled the company to identify a group of relevant experts who would be appropriate for its medical advisory board. Not surprisingly, the group included clinicians who were already actively presenting findings at industry events, publishing peer-reviewed articles, and leading comparable clinical studies. A company that has done its homework to discover the leading experts in its field is also well on its way to identifying and selecting the right professionals to lead its clinical studies and the best locations for those studies.

Additionally, such professionals are often perfect evangelizers—individuals ideally suited for educational leadership roles among their peers. Their professional expertise helps to position an invaluable plank in the company's marketing and communications platform.

Segment and Communicate

Many marketing failures result from a company's inability to correctly identify and segment the prospective target audiences it must communicate with and sell to or through. The more tightly one can define such market segments and their specific interests, the greater the likelihood that success can be achieved in marketing to and communicating with the members of those segments.

To address such varied audiences and their subsegments, companies require a wide variety of printed and audiovisual marketing materials. These tools should be crafted to educate and communicate to the marketplace the potential for a company's new device, the markets it will serve, and the unmet needs it is intended to fulfill. A good time for a company to begin developing such materials is when it is preparing to assemble its medical advisory board. This is the stage at which a company must begin to create a public face for itself and its device.

In fact, members of the medical advisory board will be severely hamstrung unless the company is prepared to provide them with certain marketing materials. Without such assistance, it will be impossible for these leading clinical experts to present compelling information and data about the company's device at important clinical conferences.

Thought Leader Outreach

With all of the preceding activities completed—and assuming that product development has continued apace—a company can undertake its first true market outreach efforts. At this early stage, still some time before its product has received marketing clearance or approval, the company must ensure that it observes the legal and regulatory restrictions on what can be said about its device. Materials created by the company should always be reviewed by the company's regulatory counsel, and should clearly identify the status of its device in the regulatory pipeline.

While remaining within the legal boundaries, companies can nevertheless undertake a number of outreach activities, including writing and distributing news releases; placing articles in appropriate trade, business, and consumer media outlets; and participating in and presenting at conferences, seminars, and workshops.

Such early marketing and communications efforts should be designed not for a broad audience, but to reach the thought leaders in each of the company's target market segments. The support of such clinical leaders can often provide greater credibility for a product than its manufacturer can. And, in turn, this can lead to opportunities for publication in prestigious medical journals, and for having influential clinicians present information about the device at important meetings of healthcare professionals.

When all of these efforts are properly aligned—and with a little luck and good timing—a company can gain some significant benefits. Such has been the case for Rubicon, which has enjoyed increased visibility as a direct result of physician thought leaders presenting the company's technology at conferences such as the ACC annual meeting mentioned earlier.

At that meeting, Eberhard Grube, MD, chief of cardiology at Heart Center Siegburg (Siegburg, Germany), introduced the concept that the Rubicon Filter could be effective in the treatment of acute myocardial infarction. Rubicon has asked Grube to be the principal investigator for the upcoming CE mark clinical study of the Rubicon Filter in Europe.

In the same session, Martin Leon, MD, president and chief executive officer of the Cardiovascular Research Foundation (New York City), discussed the Rubicon Filter in a presentation on currently approved and investigational devices. And in a separate session focused on vein graft interventions, Simon Dixon, MD, an interventional cardiologist at William Beaumont Hospital (Royal Oaks, MI), included the Rubicon Filter in his presentation entitled "Update on Filter Devices." (It should be noted that Drs. Grube, Leon, and Dixon have not received any compensation from Rubicon Medical.)

The combination of these presentations at one of the world's most prestigious annual events for cardiologists has created a palpable interest and excitement level for the potential of Rubicon's device, even before it has entered clinical studies. Unquestionably, such presentations help to prepare medical professionals for the coming generation of medical devices.

Nevertheless, company leaders must remember that their ultimate success in the marketplace will come when their product achieves regulatory approval and becomes the last product on the medical device continuum. Hence, each of the steps outlined above—market analysis, product development, team building, selecting medical advisory board members, target audience segmentation, creating marketing materials, and beginning thought leader outreach—is only a part of a larger marketing and communications plan that is itself subservient to the goal of obtaining regulatory clearance so that actual sales efforts can begin.

Future Efforts

The Rubicon Filter is currently in the final stage of the design phase and has not yet received regulatory approval. Rubicon intends to initiate CE mark clinical studies of the filter this year and anticipates approval near the end of 2003, permitting the filter to be marketed in Europe.

Naturally, a great deal more will need to be done in order to successfully launch this new medical device. But with Rubicon's success at ACC and other professional meetings, a solid framework for future activities has already been established. In the future, other medtech companies could successfully deploy a similar marketing and communications strategy, making use of the key elements outlined here.

Copyright ©2003 MX