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National Alliance for Health Information Technology

Originally Published MX September/October 2004

SPECIAL REPORT: IT IN HEALTHCARE

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Visions of the Future

One of the more recently established organizations in the healthcare IT world is the (NAHIT), which was founded in 2002. The group's genesis stems from a growing recognition that adoption and implementation of IT in healthcare is not merely a matter of technology; it will also have a massive impact on clinical care.

(click to enlarge)

The Manufacturing Edge

Originally Published MX September/October 2004

SPECIAL REPORT: IT IN HEALTHCARE

Creating the advanced IT-based healthcare system of the future starts with the building blocks used in everyday operations.

Christina Elston

The key for getting medtech manufacturers to take advantage of information technologies lies in a single word: compliance. Whatever cost-efficiencies or quality benefits IT systems may promise, medical device manufacturers will be slow to adopt systems that are not certified to be compliant with applicable regulations.

Moving device manufacturers in such a direction also promises benefits for the healthcare system as a whole. IT systems that reduce manufacturing costs make it possible to keep healthcare technology spending down. Systems that improve the design of medical products and monitor manufacturing operations help to improve patient safety. IT systems that remotely monitor the performance of diagnostic or treatment systems can minimize downtime and reduce expenses for healthcare providers.

Milestones

Originally Published MX September/October 2004

MILESTONES

Rita Medical Systems Inc. (Mountain View, CA) announced in late July that it has completed its merger with Horizon Medical Products Inc. (Atlanta). The combined company will continue to operate under the name Rita Medical Systems Inc. and have headquarters in Mountain View, CA. "We are gratified to have received the overwhelming support of our stockholders in approving this merger," said Joseph M. DeVivo, president and chief executive officer of Rita. "We look forward to building a company that will lead the market in medical oncology devices."

Ordoñez

Beyond Brainstorming

Originally Published MDDI September 2004

Product Development Insight



Implementing a systematic approach to product definition can improve the efficacy of idea-generating sessions.

Bill Evans and Jonathan M. Wyler

Bill Evans
Jonathan M. Wyler

How can product development be conducted more effectively to achieve success in the marketplace? Studies suggest that the leading cause of superiority is product uniqueness, which is most effectively implemented through the use of a high-quality process that defines product value.1

Product value is defined in the earliest stages of new product development. These early stages are also when strategies are created to ensure that such value drives the design process. Paradoxically, they are also the least-expensive stages of development. To achieve maximum product value and marketplace success, developers need to spend more time determining what specifically should be developed, and not just how to develop it. A modest amount of targeted prep work can dramatically affect concept development activites, laying a foundation for products that offer meaningful advantages.

Most people recognize brainstorming as a bread-and-butter tool for generating innovative ideas. However, brainstorming means different things to different people. Some believe that brainstorming is a waste of time or that it is politically motivated. When managers do decide to organize a brainstorming session, they often find little more than personal experience to use as guidance. How then does one learn to manage such specific efforts and ensure that the process generates effective concepts that will lead to a competitive product?

This article addresses the first two stages of concept development management, taking into account that brainstorming is only one part of a larger product development process (see Table I). A subsequent article will explain the process of turning all the up-front work into a productive idea-generating session and concept deployment process. 

An effective concept development process combines innovative approaches with simple analytical and research tools. It is ideal for any medical product developers needing to revitalize a team's creative abilities. Taking a more strategic approach that focuses on customer value and technical solution space, managers can improve the efficacy of brainstorming sessions and increase potential product success.

Power through Knowledge 

Three variables influence brainstorming success. These variables are: the nature of the problem, a group's potential for creativity (this includes the facilitator), and a group's understanding of the problem. A problem's fundamentals are a given and cannot be influenced. The potential of a group can be orchestrated somewhat by choosing a good combination of participants and by having a skilled facilitator who can lead them in a favorable environment. But the most significant factor that can be influenced is the team's understanding of the problem.

A common myth is that to inspire breakthrough thinking, one needs to wipe the slate clean, withholding a project's background information from a group. Some think that keeping a brainstorming group in the dark will increase the group's likelihood of pursuing novel solutions. Although including group members from outside the company can often break organizational inertia, depriving a team of fundamental information can stone-wall innovation. Studies performed in the 1960s determined that more than 90% of patents solved problems with existing solutions. Current research supports this finding. Therefore, accepting the mantra that “all design is redesign” is crucial to successful ideation. 

An informal study comparing the creative performance of well-briefed groups and naive ones also gives credence to this assertion. The unbriefed groups launched into a creative outpouring on how to design an energy-efficient light bulb. The other groups first spent two hours reviewing samples of 30 different bulbs and evaluating their design issues. Both groups reported a significant number of ideas, but the ideas presented by briefed groups were of higher quality and contributed more to the bulb's final design.
 
Brainstorming, a topic covered in the upcoming installment of this series, is essentially about making connections between existing ideas. Participants should be inundated with information and allowed to filter and evaluate this information according to their interests. This way, they are more likely to develop new insights or interpretations of the given problem. Concept development should be considered as much a learning process as one for generating ideas.

Forming a Team for Innovation

The composition of an early-stage concept development team greatly affects the ideas that are generated and pursued. A team should include 8–12 participants. Team hierarchy should be flat—a single experienced facilitator should establish an environment in which all contributors' ideas are valued equally. Diversity is critical in assembling a brainstorming team. Having representatives from different fields, different sexes, and different levels of experience is obvious, but diversity of personality type and background is often more important. It can be highly profitable to involve people with broad nonprofessional interests, or a personal connection to the medical use of the device being developed.

Table I. Stages of the concept development process. The process deliberately cycles between activities requiring diverging and converging thought, and between large and small groups of participants (click to enlarge).

Encourage participants to step outside their roles as experts and to think outside their disciplines. Everyone can be a designer; many innovative suggestions come from participants who are not used to creating product ideas. Humor also breaks a lot of ice, so bring in someone who can precipitate laughter. Temper narrowly focused specialists with some generalists too. 

Incorporating outsiders in brainstorming sessions can present some challenges. For example, in a recent session for a sutureless anastamosis implant tool, a company invited two surgeons to participate in a brainstorming session. These experts attracted much of the attention of the group, turning the session into an educational question-and-answer meeting, and few ideas were actually generated. 

Therefore, carefully consider the role of outsiders: are they contributing ideas or educating the team? Use their expertise specifically for its intended function. In the above example, the surgeons' expertise might have been more appropriate for use in briefing sessions than brainstorming. Including outsiders is valuable, but such outsiders must be selected carefully. 

Product Definition

Participants should understand the specific approach to concept development they will be using. One major challenge in concept development is identifying and understanding the problem. This challenge makes product definition a critical phase of concept development. It is the phase in which designers conduct research and analysis to identify and understand the basic design parameters and develop a value model. In this phase, designers should also provide a strategic basis for ideation and product improvements. A thorough product definition can determine the success of brainstorming. After all, it's difficult to solve a problem without first understanding it. 

Many companies already use some definition tools, but perhaps not as strategically as they could use them. For example, some teams focus their efforts and resources on the most complex, but not necessarily the most important, aspects of a design. Other teams spread themselves too thin trying to cover every part of a design. The sidebar “Product Definition Activities” on page 48 describes ways to address project-relevant objectives. 

It is helpful to view product definition as a filtering process. A team starts with potential access to vast amounts of relevant information, including research studies, individuals' experience, and consumer data. It must distill the information down to the most important points using objective analytical methods. This filtered list then forms the basis for an intelligent design strategy, and focuses a team on critical and specific topics for ideation.

One or two designers can conduct the following activities over a 2–4-week period. These activities lead up to a presentation to an entire development team of 8–12 participants. Those conducting the up-front research and analysis are responsible for organizing all activities in the concept development project. However, their voices are equal to those of the rest of the group in the generation and selection of concepts.

Planning. In concept development, planning is the most important step for getting a team onboard in terms of developing a set of common expectations and priorities. Is the goal to minimize time to market? To advance the technology to a certain level, regardless of time? A team should develop, document, and formalize its priorities and its strategy for addressing trade-offs. 

At this stage, a helpful activity is to poll participants to determine each person's most important objectives. It is common for a group's objectives to differ at the start. Presenting these differences to the entire team and pursuing a consensus is an important first step.

Learning. It is essential to conduct research and present background information about the product, the market, the use setting, the user, and the manufacturing and operations issues. An emphasis on benchmarking and observation is often overlooked, but can provide information that reveals an opportunity for a competitive edge.

Benchmarking is a powerful two-part tool to help understand competitors and customers. First, it can be used to formally evaluate and quantify product differences, both in technical metrics and customer-satisfaction levels. Second, it provides a method to look beyond similar products and serves as a brainstorming event of its own. It enables a team to investigate new and exotic materials, manufacturing processes, and products from completely different industries. Benchmarking also enables a team to cross-pollinate ideas from these other technologies or processes. 

Some teams buy product samples that might lead to ideas or provide inspiration. It is essential to have samples available to dissect, reverse engineer, experiment with, and play with during the brainstorming sessions. A minimal investment at this stage can produce important ideas. For example, while developing an intraocular lens-folding tool, one team came across some Chinese finger cuffs. The toy led to the development of a set of solutions based on contracting a membrane by pulling on it.

Observational research is increasingly becoming the secret weapon of successful product designers. Seeing products used in the field is an invaluable experience. This observation affords a team the opportunity to recognize subtle issues and challenges that others have overlooked. With this insight, a team can develop a more meaningful appreciation of what customers want. To gain the most from this task, group members may need to think like cultural anthropologists, industrial engineers, or behavioral psychologists. Observational research complements broader quantitative market surveys. Demographic metrics alone often miss the subtleties of the user environment. A connection with the design challenge can motivate a team to create improvements upon existing products.

Analysis. To begin systematically focusing on the scope of the project, it may be helpful to use what might be termed an analysis lite approach. The idea is to use many relevant analytical tools to dissect the problem, but to get the most out of them in the least amount of time. For example, quality function deployment (QFD) is a method for processing product information and generating outputs that drive product development. However, QFD can be an enormously time-consuming process and, if done poorly, may be of little value. But if a team focuses on only directly relevant QFD processes, the resulting data can be very helpful. By using selected QFD processes to record information and to strategically generate discussion, a team can develop a basic output on which to focus.
 
In a recent two-day session for a well-understood product, the team completed only the planning and requirements part of the QFD method. But on a more technically challenging project, it focused also on the tools for identifying design interactions and for structuring technical benchmarking. 

At a minimum, the preparatory-analysis phase should include the following tasks:

Figure 1. Creating a Pareto chart of requirement weights is one way to visualize the relative importance and contribution to the value model. Often the top four or five 
requirements will account for about 80% of the product value based on project emphasis (click to enlarge).

• Identify the customer. This may not be as straightforward as it seems. It requires a team to map out the entire supply and value chain, identify the key players and their stakes, and assess how money and information flow through this system. For example, financial management makes decisions on some hospital products, whereas clinician preferences may be more important for others. The model can be simplified for other definition activities.
• Generate a list of about a dozen fundamental customer requirements. (Put aside the 50-page design requirement documents. They are often overly constraining and lead people to think in terms of features and metrics rather than the customer's voice.) A team should rank or weight these fundamental requirements to focus on brainstorming topics and to use later for concept evaluation. Figures 1 and 2 illustrate different ways to rank requirements. This ranking activity should involve input and discussion from all disciplines.
• Develop a similarly weighted list of business filters that defines the constraints and opportunities related to objectives within the organization. These could include the bill of materials (BOM) costs, development risk, process development, reimbursement, inventory control, and intellectual property.
• Identify technical objectives. They can be general or specific. Examples include increasing quality, making the product a specific length, decreasing mass, reducing the BOM cost, eliminating failure modes, or reducing assembly time. The team should then rank the importance of the objectives.
• Conduct analyses specific to the problem. For example, on a cost reduction redesign, a team might run a design for assembly analysis that evaluates assembly-time improvement. For emphasis on reliability, it might conduct a failure mode and effects analysis on similar or earlier products.

These weighted lists and analyses form the basis of a value model that will help focus ideation activities.

Briefing. One of the final steps in the product definition process requires coordinators to brief the entire team. Those charged with conducting definition activities can then create a two-hour presentation that educates, answers questions, incorporates guest specialists, and shows samples. Two key points are important at this stage. First, the presentation should clearly focus on the design problem, not just impart a large amount of information. Second, it should be interactive. 

Team discussions may be the most valuable aspect of the briefing process. Afterward, participants should be able to easily express the design's most important requirements and objectives. To avoid overwhelming participants, the briefing should take place at least one day before the brainstorming session.

Figure 2. Developing a list of requirements is one way to focus and structure brainstorming. Here, a 1, 3, 9 weighting 
system was used for strong differentiation. Other scoring and calculations reflect specific emphasis for a particular project (click to enlarge).

Participants should be encouraged to start thinking of ideas before attending the brainstorming sessions. Independent ideation can often be more effective than group brainstorming.2

Conclusion

The concept development process is an effective approach to engaging multiple functional groups within your organization as a single team with a common goal. The initial investigation and product definition activities are critical to defining a value model that will guide the design process. Furthermore, these activities will help to motivate the team for subsequent stages by unifying them around a clear mission.

The second installment of this article will cover the subsequent stages in concept development, namely ideation, concept selection, and refinement. The success of these stages in generating and deploying concepts to a competitive product is ultimately based on the team's ability to leverage the knowledge and understanding they have developed in the initial stages.

Product Definition Activities

Customer Value-Chain Analysis—A marketing-based tool for identifying the customers and understanding the dynamics of the supply chain.
Value Engineering—An encompassing methodology for identifying, understanding, and delivering product value in the most efficient way by clarifying the hierarchy of requirements flow-down.

Quality Function Deployment—A broad-reaching method for logically linking customer requirements to technical metrics to product features to process development, etc. It incorporates benchmarking, marketing analysis, and design-interaction identification. This rigorous method may be more relevant for complex systems.

Design for Assembly—A methodology employing several analytical tools and design guidelines to reduce assembly cost, reduce assembly time, and increase quality.

Failure Mode and Effects Analysis—A tool for identifying potential failure scenarios and eliminating them through design changes.

Service Modes Analysis—A method for examining and evaluating issues of serviceability. It may prompt design considerations to reduce later-stage life-cycle costs. It is appropriate for more-complex reusable systems.

References

1. James F Burley, Richard Divine, and Greg Stevens, “Creativity + Business Discipline = Higher Profits Faster from New Product Development,” The Journal of Product Innovation Management 16, no. 5 (1999): 455–468.
2. Scott G Isaksen, A Review of Brainstorming Research: Six Critical Issues for Inquirys, Monograph #302 (Buffalo, NY: Creative Problem Solving Group, 1998): 11–12. 

Copyright ©2004 Medical Device & Diagnostic Industry

Hey, Everybody! Let's Put on an Integrated System!

Originally Published MX September/October 2004

SPECIAL REPORT: IT IN HEALTHCARE

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Visions of the Future

How can manufacturers determine whether their products—and their competitors' products—can be effectively integrated into IT-based healthcare systems?

In some cases, a product's interoperability may not be fully known until a real-world installation is under way, which can be a bad time for problems to surface. So, for manufacturers of medtech products, the chance to try out such links in a strictly exploratory mode can be valuable indeed.

For companies that do business in the healthcare imaging, cardiology, and clinical laboratory markets—and those specializing in tools for the healthcare IT infrastructure—just such an opportunity is coming up in January of next year. The event, called the "IHE Joint Connectathon," involves a week of interoperability testing for medical products. Participating companies prepare ahead of time using special applications developed for the purpose. Then, when the manufacturers gather, information is exchanged among their products.

Medical Device Marketing

Originally Published MX September/October 2004

ADVERTISING, DISTRIBUTION, & SALES

Medtech marketers share their winning strategies for successful campaigns.

Courtney Harris

In today's landscape, medical technology marketing is experiencing change. New FDA policies regarding direct-to-consumer (DTC) advertising, for instance, are forcing marketers to adjust their approach. Fortunately, there are expert agencies that are ready to meet these demands.

Each year at its annual meeting, the Medical Marketing Association (MMA; San Francisco) presents the winners of its International Awards of Excellence (In-Awe) competition, honoring the best agencies and campaigns in medical marketing. In this article and accompanying sidebars, winning medical device marketing agencies describe their campaigns and strategies for success. For descriptions of more winning campaigns in the 2004 In-Awe competition, visit the expanded version of this article on the MX Web site at www.devicelink.com/mx. A complete list of In-Awe winners in medical device categories can be found in the sidebar.

User-Fee Increases Draw Strong Industry Reaction

Originally Published MX September/October 2004

BUSINESS NEWS

Although rate hikes were widely expected, FDA's nearly 16% increase in FY05 user fees for reviewing medical technologies has drawn swift and sharp responses from the device industry's two leading associations.

Pamela Bailey, president of AdvaMed (Washington, DC), said that "the FY 2005 increase, coupled with the significant rise in user fees sustained in FY 2004, set a pace that cannot be maintained. AdvaMed will examine all potential remedies, including legislative options." The association's response was posted several days before the rates were published in the Federal Register.

Mark Leahey, executive director of the Medical Device Manufacturers Association (MDMA; Washington, DC), also suggested that Congress might have to revisit the issue. Noting that industry absorbed a 35% increase in user fees during FY04, Leahey said that the increases for the coming year "strengthen our case that the structure of the program is inherently flawed and legislative modifications are needed to stabilize the fees."

Comparative Claims: Legally Permissible, But Proceed with Care

Originally Published MDDI September 2004

Regulatory Outlook



Promotional claims comparing one device with another are common and legal. But companies should carefully consider possible pitfalls before making such claims.

Jeffrey K. Shapiro
Hogan & Hartson LLP

Jeffrey K. Shapiro

Legally, medical device companies may promote their devices with claims of superiority over competing products—or over previous versions of the company's own products. However, FDA scrutinizes such claims carefully. The agency views comparisons with suspicion, believing that they are potentially misleading and seldom complete. Over the years, 
FDA has issued numerous warning letters alleging that comparative claims are false, misleading, or otherwise 
violative.

Therefore, although manufacturers are free to make superiority claims, it is important to know the legal constraints that FDA imposes. This article reviews the most common legal pitfalls of making comparative claims. It also discusses how to support such claims.

False or Misleading

Under section 502(a) of the Federal Food, Drug, and Cosmetic (FD&C) Act, a medical device is misbranded if its labeling is in any way false or misleading. (For more on labeling, see the sidebar “Labeling” on page 56.) Furthermore, a device is misbranded if its labeling contains a false or misleading representation with respect to another device.

Under section 502(q) of the FD&C Act, “restricted devices” are misbranded if their advertising is in any way false or misleading. FDA may classify a device as restricted by regulation or in a premarket approval (PMA) application order.2 And, while FDA has no jurisdiction over the advertising of nonrestricted devices (any device cleared under the 510(k) process), the Federal Trade Commission (FTC) does. FTC generally requires substantiation of all claims and prohibits advertising that is false or misleading.3

The bottom line is that comparative claims must be truthful and nonmisleading. This legal requirement is easily stated but not so easily applied. FDA has not issued regulations or guidance documents defining what constitutes a false or misleading claim. Without such general guidance, perhaps the best insight comes from analyzing FDA's warning letters.

Analysis of Warning Letters

FDA has long required adequate data to support specific superiority claims. For example, in a letter to Carrington Laboratories in 1994, FDA wrote that claiming a wound-care product was not cytotoxic implied an unsupported claim of superiority in the absence of data showing other wound-care products to be cytotoxic.

In 2002, Helio Medical Supplies claimed that its silicone-free acupuncture needles were safer than competing needles with silicone. One promotional piece asked: “When there is a better alternative, why take the silicone risk?” FDA's warning letter said that this comparative claim misbranded the product, because there was no evidence that silicone needles were unsafe.

The requirement for data to support a claim applies even when a manufacturer compares a new product with its own older product. This point was illustrated in FDA's warning letter to Sunrise Technologies in 1993. The letter said that, without adequate supporting data, it was false or misleading to claim that the firm's “upgrade package” rendered the modified device superior to the original device.

What types of data are adequate to support a superiority claim? It appears that FDA generally requires head-to-head comparative studies. In a warning letter to Pharmacia & Upjohn in 2001, FDA stated: “Comparative claims in general are only appropriate if there are data resulting from head-to-head comparative studies.” Likewise, in a warning letter to Sulzer Spine-Tech in 2000, FDA advised that “the agency has determined that before a manufacturer may make a direct comparison of their orthopedic device with that of another manufacturer, randomized, controlled, head-to-head clinical trials would be required.” In a warning letter to ELA Medical Inc. in 1992, FDA alleged misbranding in the absence of “adequate and well-controlled studies comparing the [product] to others in studies designed to support comparative statements of superiority.”

Even truthful comparisons of product characteristics may be considered misleading without head-to-head data. For example, in the Sulzer Spine-Tech warning letter, FDA objected to the company's promotion of its spinal fusion device with a claim that the Sulzer product had larger holes than a competing product. The company had cited a baboon study suggesting that smaller holes made it easier for fibrous tissue to block or impede fusion. FDA said that this claim implied that the larger holes of the company's fusion device would lead to a more successful clinical outcome. The comparison was misleading, FDA insisted, because there was no evidence that the larger holes in Sulzer's product caused better overall fusion results compared with the competitor's product.

FDA's warning letters also indicate that comparative claims must be based on approved uses for both products in a comparison. The agency may consider it misleading to compare an unapproved use of one product with the approved use of another product. For instance, in 1998, Bayer Corp.'s prostate specific antigen (PSA) assay had been cleared for monitoring cancer treatment. The company had claimed that the assay had greater specificity than other PSA assays. FDA alleged that Bayer's statements constituted an unfounded claim of superiority, because the other assays were approved for cancer detection rather than cancer monitoring. As another example, in 1999, Thoratec Laboratories Corp. allegedly compared its ventricular assist device with one sold by Abiomed. FDA insisted that the comparison was misleading because Thoratec's device was intended as an intermediate-to-long-term bridge to transplant, while the Abiomed device was approved for a different, short-term use.

Valid head-to-head studies are generally required to support comparative claims. The presentation of the testing results must be fair and balanced. In particular, companies should fully disclose relevant test conditions and the results for all clinically significant points of comparison. Of course, the overall product comparison also must be fair and balanced, not just the presentation of the test results. Finally, if other comparative studies are available that point to a different result, it may be necessary to provide the results of those studies as well.

New Intended Use

FDA also reviews comparative claims to determine whether they indicate that a device requires a new 510(k) clearance or premarket approval (PMA). FDA's position is that both labeling and advertising for any device are relevant to a determination of its intended use.4 Therefore, if labeling or advertising promotes a device for an unapproved use, it may misbrand or adulterate the device.5 This reasoning applies equally to comparative claims. For example, in the Carrington Laboratories warning letter discussed above, FDA stated that promotional claims of “faster epithelization” and “acceleration of healing” for a wound-care product went beyond the scope of its 510(k) clearance, and thus the device required a new 510(k) clearance or PMA.

Recommendations

Comparative promotional claims should undergo a thorough FDA compliance review. Such a review should consider the following points:

• In general, comparative claims may not be false or misleading, either in terms of a specific representation or the overall impression created by the comparison. Information should be presented in a truthful and balanced manner. All comparisons should be clinically relevant and consistent with the approved indications for use of each of the compared devices. 
• All comparative product claims should be supported by reliable, sound scientific data on file at the time the claims are made. This includes any text, photographs, tables, charts, or graphs.
• Comparative claims about clinical outcomes generally require a scientifically valid head-to-head clinical study directly comparing the two products with respect to the claim. The head-to-head comparison should involve products with similar approved or cleared indications for use. Additionally, the study should include only patients who are within the indications for use of both devices.
• The comparison of clinical study results should disclose all end points for which a relevant difference was observed—not just those end points that favored the company's product.
• It is usually considered scientifically invalid to present a sideby-side comparison of results from two different studies because of likely differences in protocol, end points, or patient populations. 
• In general, a comparison of published performance or technical specifications is legally defensible unless for some reason the comparison is known to be false or misleading. For example, the comparison would be misleading if the test or evaluation methods used for the two products were known to be materially different.
• Sometimes, published specifications for the competing products cannot be fairly compared, or specifications are not available for both products. In those situations, it is probably legally defensible to compare the specifications via testing conducted under the same conditions and methodology for both products. The test methodology should be disclosed with the comparison. However, an unfortunate conundrum may occur—FDA may object if such testing produces results that do not match the specifications in a product's labeling.
• FDA could also object if test results are extrapolated, either explicitly or by implication, to clinical performance. If the context of the comparison implies a clinical superiority based on bench-test results, an appropriate disclaimer may mitigate the risk of FDA objection. For example, a disclaimer could state that information such as bench-test results or technical specifications are “not necessarily indicative of clinical performance.”

There is no absolute legal barrier to comparative claims if they are fair, balanced, and data-supported. On the other hand, this area is fraught with legal risk and has been a fertile field for warning letters. Companies should expect that maligned competitors will complain to FDA. Therefore, it is crucial that manufacturers exercise caution and common sense before proceeding with a promotional campaign that includes comparative claims. 

References

1. Code of Federal Regulations, 21 CFR 801.6.
2. Federal Food, Drug, and Cosmetic Act (FD&C Act), Sections 515(d)(1)(B)(ii), 520(e).
3. Federal Trade Commission Act, Section 12, “FTC Policy Statement Regarding Advertising Substantiation” (August 2, 1984).
4. Code of Federal Regulations, 21 CFR 801.4.
5. FD&C Act, Sections 301(a), 501(f), 502(o). 

Copyright ©2004 Medical Device & Diagnostic Industry

What Will Providers Want Next?

Originally Published MX September/October 2004

SPECIAL REPORT: IT IN HEALTHCARE

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Visions of the Future

Finding out what healthcare providers are looking for in medical IT systems doesn't have to be difficult, thanks to the Medical Records Institute's survey of electronic health record trends and usages.

The survey is conducted annually among knowledgeable healthcare and IT professionals, including physicians, CIOs, and technology officers. The very specific queries and replies provide insights into what types of applications buyers regard as most helpful, what their toughest problems are, and what functions they intend to add in the very near future.

According to the most recent survey, for example, only 44% of providers are currently able to capture and review records of patients' medications. But an additional 24% of respondents plan to add that capability and, of those, about three-fourths plan to do so within one year. Only 31% currently have mobile access to patient records, but another 26% are planning to implement that function—and over three-fifths of those intend to do so within a year.

Putting a Human Face on Therapy Denial

Originally Published MX September/October 2004

ADVERTISING, DISTRIBUTION, & SALES

Return to Article:
Medical Device Marketing

One of the medical technology industry's giants, Medtronic (Minneapolis) operates around the world, including a large presence in Canada. Two years ago Medtronic's diabetes business in Canada—Medtronic MiniMed Canada (MMC)—saw a need to raise awareness about the benefits of insulin-pump therapy in the province of Alberta.

Public service advertising for the Diabetes Network of Alberta Foundation developed by Medtronic Neurological's creative services group won a gold award in MMA's 2004 In-Awe competition.
(click to enlarge)

Neither the general public nor healthcare decision makers (who control Canadian healthcare budgets) seemed sufficiently cognizant of the social and economic costs of diabetic complications that can be prevented by appropriate therapy.