Medical Device Link.

Originally Published MX May/June 2003

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

Gatherings of medical professionals can make ideal venues for launching a new medical technology, but developing an effective communications strategy is an essential prerequisite for success.

Judith Filek

A company's new medical product or technology has been approved by FDA and is ready for launch. A large medical symposium or an associated satellite conference provides an outstanding occasion for introducing the innovation to its market. The meeting will be attended by thousands of healthcare professionals and representatives of their group purchasing organizations.

Mere announcement does not automatically mean successful product introduction, however. The company will find many competitors at the event attempting to do the same thing. Its executives need something more than a marketing and advertising strategy.

Medtech company leaders should prepare for such a critical moment by developing a communications strategy well in advance of the conference, one designed to ensure that, regardless of who is talking or under what circumstances, the message being disseminated is consistent.

Maximizing the Opportunity

An important first stage of the product introduction communication strategy is to identify all the opportunities for speaking about the new product that the targeted convention offers, and to plan how to take advantage of as many of them as possible. Typically, such opportunities exist in the scientific sessions (papers that discuss the technology), at satellite conferences (should the company be organizing one), at press conferences, and within the exhibition hall if one is set up in association with the meeting.

To ensure that the company can fully benefit from these opportunities, responsible executives must be conversant with the conference protocol for submitting abstracts, specific disclosure requirements, deadlines, and any other compliance issues. Rules and regulations can vary from conference to conference. Those pertaining to a particular meeting are usually posted on the Web site of the sponsoring association. The Radiological Society of North America, for example, displays on its site (http://www.rsna.org) all the procedures necessary to attain session accreditation and to comply with disclosure requirements. In addition, this association posts other rules that apply specifically to participating manufacturing companies, such as prohibitions against contests or raffles.

The satellite session is a potentially strong opportunity to focus attention on a new technology, but carelessness can squander it. Physicians have a tendency to walk in and out of satellite conferences unless continuing medical education (CME) credits are provided for attendance. The product manufacturer's launch team must work closely with the CME coordinator of the medical school providing the credits to ensure that the session can be approved for credit on the basis of substantive content, fair balance, and noncommerciality. Through such foresight, the educational value of the satellite symposium will not be questioned.

Choosing the Best Speakers

Part of an effective strategy is taking special care to choose appropriate session speakers. Since those who speak for a product at its launch in a way represent that product and can thus affect the audience's reception of it, the choice of speakers must be considered carefully.

Anyone selected to speak officially about the product—even at a booth in the exhibition hall—should be scientifically competent to discuss it. Each spokesperson must also be an excellent communicator. Any session speaker should have strong platform skills; a commanding presence at the front of the room will prevent audience attention from waning. A good way to judge the speaking ability of any potential presenter is to observe the person speaking at a local or national conference or even within the medical institution that employs the prospect.

If the scientific information delivered and the speakers' presentations have been compelling, physicians attending a conference session will likely remember what they have heard and be interested in learning more about the technology or device. Strong presentations, whatever the topic or purpose, are the result of not only content, but also delivery (see sidebar).

Good candidates for medical conference speakers include clinical researchers, site investigators, and key executives of the product company. The more people who are permitted to speak, the more exposure the company and its product receives at this critical moment. Realistically, however, there is often opportunity for only one speaker representing the company to make a presentation. When this is the case, a clinical investigator probably should be selected. Such a person would have been closely involved in any modifications of the developing device and can speak to its merits from personal experience.

Esam Dajani, PhD, adjunct professor of medicine at Loyola University's Stritch School of Medicine (Maywood, IL) and founder of IDDC Corp. (Long Grove, IL), a company specializing in providing preclinical and clinical research and development services for pharmaceutical and biotechnology companies, has been involved in many product launches, as both a researcher and a consultant. He believes any investigator chosen to speak as a product advocate must be a recognizable thought leader. This physician or scientist should have a national reputation, should hold or have held positions of stature in an esteemed medical institution, and should have published extensively. The person's reputation should be untarnished by fraudulent research and, ideally, the speaker should have no financial ties to the launch company (see sidebar).

Perfecting the Message and Its Delivery

In addition to selecting presenters with care, manufacturers must attend closely to what these speakers say about the products being launched. The message must be informative, correct, and relevant to a variety of target groups.

Consistency and Correctness. There can be no unsubstantiated claims, no anecdotal speculation. Speakers and sales representatives chosen for the launch must be completely educated about the product and must understand fully the strict parameters within which the medical device has been tested and licensed. In their presentations, they must be crystal clear about exactly what the test results prove. The message cannot vary from speaker to speaker.

Company executives and legal counsel must examine in advance the text of any speaker's presentation for accuracy and should remove possible exorbitant claims of efficacy or safety. Competitors will be listening for any claims not supported in the original study or approved by FDA, and will report them to the regulatory agency. Fraudulent statements can be costly, even disastrous. This is particularly so for a small or midsized company.

Not only can FDA fine or reprimand companies, it can also require firms to clarify or correct such misrepresentations or to take corrective action in the form of labeling changes, product recalls, or withdrawals. FDA may also elect to notify health professionals and others of such important information through medical alerts, safety alerts (for medical devices), the FDA Medical Bulletin, and 'Dear Doctor' or 'Dear Health Professional' letters.^1–3 Virtually any such agency actions could significantly undermine the launch of a new product, so manufacturers must pay attention to statements that could run afoul of FDA regulations.

The Audience within the Audience. Most major medical conferences attract others besides physicians. Session speakers would do well to craft their message in relatively simple language so that everyone with an interest will be able to understand. Members of the audience may include nurses, clinicians, hospital administrators, and technicians, as well as doctors. These people, too, want to know why the new device merits consideration, but from their own perspective, not that of physicians. A presentation that demonstrates how the product being launched can improve job performance for all these groups is preparing a stronger market.

Conciseness and Accessibility. Company spokespeople must discuss their experiences pertaining to the device in a very logical, convincing manner, substantiating any claims with the research data. Attempting to be thorough, however, they risk burying listeners in detail. Although therapeutic and economic analyses are important elements of a presentation, too much information can confuse the audience. A speaker walks a fine line. The best approach is to report the data as concisely as possible.

Because the audience consists of people at various knowledge levels, and because the information is technical, PowerPoint presentations and even videos can be essential to making the results of clinical studies understandable (see sidebar). Here again, because of the danger of inconsistencies or erroneous statements slipping into the audiovisual materials, the company's executive team and legal department should review all slides or videos before they are used.

Audience Questions. For people to be persuaded, their questions must be answered. It is a good idea for the executive team of the product-launching company to brainstorm possible questions and practice answering them aloud. Such rehearsal will not only ensure that speakers make accurate statements, but also enable them to speak with conviction. It should be made clear to any speaker advocating the product that members of the manufacturer's research team will be in the audience should there be a need to involve them. No one should ever guess at an answer. Those in the audience who are asking questions sincerely want true and accurate answers from the speaker, so it is acceptable to call them subsequent to the meeting when an informed answer is in hand. It is always good to begin or end any response to a question with a statement acknowledging the confines of the study.

When physicians inquire about how the new device might function under conditions not covered in the study, salespeople can distribute reprints of studies suggesting other indications for the device. That these off-label indications were not measured in the approved trials must be made clear, however. Before any such printed materials are distributed, the legal department should carefully review them to ensure truth in advertising and to excise deviations from approved labeling. (A First Amendment controversy relating to off-label product uses and the distribution of reprints has grown in response to an FDA proposed rule published in 2002.⁴ A discussion of the issues raised in public comments, with citations of relevant legal precedents, is available at the Web site of the Washington Legal Foundation.⁵)

Much is at stake when a product is launched at a medical symposium. It can be very helpful for the entire launch team to take guidance from a communications coach and be videotaped rehearsing. This can make them more confident and comfortable in their role as news-bringers under constraint of a defined message. Practiced individuals can handle with aplomb the impromptu 30-second "elevator pitch" delivered to a professional while walking down a corridor. Coaching assistance could be extended to the selected speaker or speakers also.

Conclusion

A successful product launch does not automatically follow because the device happens to be terrific. It takes years of careful planning, and then months of developing a solid communications strategy just before the official launch. Success depends partly on selecting outstanding communicators who understand the device and the conditions under which it has received FDA approval. If medical technology companies take the time to follow the suggestions recommended here, they will be pleased by their new product's reception and likely enjoy benefits accruing at the bottom line.

References

1. "Protecting the Identities of Reporters of Adverse Events and Patients; Preemption of Disclosure Rules," Federal Register, 60 FR:16962–16968 (April 3, 1995).

2. Federal Register, 58 FR:35959 (July 2, 1993).

3. "Overview of Office of Compliance: Organization and Delegations," transmittal no. 97-35, in CDRH Home Page [on-line] (Rockville, MD: Center for Devices and Radiological Health, FDA, 25 June 1997 [cited 31 March 2003]); available from Internet: http://www.fda.gov/cdrh/function/1252_1.html.

4. Federal Register, 67 FR:34942 (May 16, 2002).

5. Washington Legal Foundation, Comments on Submissions Concerning First Amendment Issues, Docket No. 02N-0209, [on-line] (Washington, DC: WLF, 28 October 2002 [cited 31 March 2003]); available from Internet: http://www.wlf.org/Litigating/casedetail.asp?detail=207.

Judith Filek is president of Impact Communications Inc. (Long Grove, IL), a firm that specializes in communications strategies and presentation skills training for technology companies.

Copyright ©2003 MX