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Medical-Grade Adhesive Technology Cures Using Visible Light : Prefabricated Hard-Wall Cleanrooms Offer Flexibility : Multilayer Manifold Stands Up to Harsh Chemicals


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Medical-Grade Adhesive Technology Cures Using Visible Light

A new technology enables a company to cure adhesives completely using visible instead of ultraviolet light. This eliminates operator exposure to UV rays, generates less heat, minimizes equipment costs and requirements, and reduces maintenance costs.

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Prefabricated Hard-Wall Cleanrooms Offer Flexibility

From fast food to drive-through banking, consumers crave quick solutions that don't compromise quality. And the manufacturing industry is no different. Clean Air Products (Minneapolis) has heeded this call with its 560 vertical-flow modular hard-wall cleanrooms.

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Multilayer Manifold Stands Up to Harsh Chemicals

Eastern Plastics Inc. (EPI; Bristol, CT) offers a custom perfluoroalkoxy (PFA) manifold that resists corrosion and heat in aggressive-chemistry applications. "The manifold can be used anywhere chemicals would attack or damage plastic," says Larry Dawson, vice president of marketing. Medical uses include DNA synthesis and analysis equipment.

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Copyright ©2006 Medical Product Manufacturing News

Data Collection System Goes Wireless


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Data Collection System Goes Wireless
Shana Leonard

Wireless phones and Internet have infiltrated our daily lives, supplying convenience, mobility, and freedom from constricting cables. Because wireless technology has achieved such success, it makes sense to apply this concept to any device that would benefit from wireless operation. The L.S. Starrett Co. (Athol, MA) has modeled its wireless data collection system with this in mind.

"We are excited about the new system technology," says Jeff Wilkinson, general manager of the company's advanced technology division. "Manufacturers finally have access to a reliable system that is simple and robust, permitting accurate and portable data collection."

Comprised of three main parts, the DataSure system includes end nodes that connect to the electronic tools, a gateway that plugs into a PC, and routers that extend the product's range. A single router has a range of 100 ft; however, users can add routers to extend its range.

The management tool time stamps and logs each measurement as it is received, maintaining an organized database. Furthermore, a signal is emitted to indicate that the host computer has received the data. In the event that a measurement can't be transmitted, the system stores up to 10 readings and continues resend attempts until the reading is processed. An additional system safeguard includes a constant battery status display for each element in order to avoid disastrous battery failure surprises.

The system is suited for the manufacturing floor, metrology lab, or any environment in which measurements are taken using electronic metrology tools. The firm heralds the efficacy of the system amid the everyday hubbub of a manufacturing floor.

One such chaotic issue affecting operation on the floor is that of EMI. Though EMI can factor into the system's equation, the problem is solvable, according to Starrett. The monitor application enables users to identify which routers are hopping frequently, an indication of EMI. This knowledge can then be used to track down the single source of the interference.

Compatible with most major brands of electronic measuring tools, the system is designed for use with PCs equipped with Windows XP Professional. The data management tool operates within the Microsoft Internet Explorer browser, and can export in a variety of formats, including Excel.

Copyright ©2006 Medical Product Manufacturing News

Legal Fight between Inverness and Acon Labs Ends with a Purchase

Rapid-diagnostics manufacturer Inverness Medical Innovations Inc. (Waltham, MA) has entered into a definitive agreement to purchase Acon Laboratories Inc. (San Diego) for $175 million, subject to adjustment for working capital and net indebtedness. The acquisition adds to Inverness's already dominant position in the $630 million pregnancy and fertility consumer diagnostics market, and ends more than three years of legal wrangling between the two companies. In a 2002 lawsuit, Inverness and its Unipath Diagnostics unit claimed that Acon's test-strip products infringed its patent for colored-particle immunoassays.

As part of the deal, Inverness will also acquire Acon's newly built manufacturing facility in Hangzhou, China. Inverness has announced a strategy to lower production costs by moving much of its manufacturing operations to China over the next few years.

"We're extremely excited about this acquisition. We're the market leader in many ways, but to offer low-cost distribution . . . is extremely advantageous for us," said Inverness CEO Ron Zwanziger during a presentation earlier this month at the Lehman Brothers Global Healthcare Conference. Inverness currently operates a plant in Shanghai, China. Through a pilot program with the government there, the company expects to produce about 30 million tests this year.

Since it was formed in 2001, Inverness has seen an enormous jump in sales, due in large part to a flurry of purchases. Between 2001 and 2005, annual revenues increased from $47.3 million to $421.9 million. However, during the same period, the company's gross margins fell from 48% to 36%.

Doyle

Doyle: Resourcefulness amid adversity.

"During the three years that the patent litigation raged in Boston, Acon demonstrated its skill in producing lateral-flow products in China, and Inverness's need for a lower-cost manufacturing solution grew over that same time period," said David Doyle, an attorney at Morrison and Foerster, the law firm that represented Acon in its patent litigation and advised the company on its acquisition. "It was the intersection of Inverness's need for lower-cost manufacturing and Acon's impressive track record of lower-cost manufacturing in China that drove the litigation settlement and resulting business transaction." In addition, the purchase will help Inverness make inroads into the drugs-of-abuse testing market.

The claim filed against Acon centered on Inverness's so-called '982 patent, which covers much of the lateral-flow technology behind the company's pregnancy and ovulation tests. Over the last few years, Inverness has brought suits against a number of companies in the United States and abroad that it claims have infringed its patents.

Turning the Corner

Originally Published MX March/April 2006

COVER STORY

Interview by Steve Halasey

For an emerging medical technology company, having access to a platform technology—an intellectual property portfolio that offers a wide range of potential medical applications--isn't a bad way to begin. That was certainly the starting point for RITA Medical Systems (Fremont, CA), which was founded in 1994 to develop the medical applications of a technology for radio-frequency interstitial tissue ablation (hence the acronym, RITA). After receiving a general FDA clearance for the use of its technology in ablating soft tissue, the company began to explore additional applications and received clearance for intended uses against unresectable liver tumors.

But the blessings of a widely applicable technology can also become a company executive's worst nightmare. With limited staff time—and sometimes even scarcer funding—prioritizing company efforts to conduct clinical research, gain regulatory approvals, approach a wide variety of clinical specialists, and gain reimbursement coverage can become an all-absorbing challenge.

RITA Medical's president and CEO Joseph M. DeVivo on turning acquisition and integration into sector leadership
Photo by KENT CLEMENCO

Boston Scientific Juggling Guidant Deal, FDA Warning

Originally Published MX March/April 2006

BUSINESS NEWS

While the bidding war raged over the acquisition of Guidant Corp. (Indianapolis), it was generally acknowledged by members of the investment community that whichever company emerged as the victor would have to spend a great deal of time and money addressing Guidant's widely reported product quality problems. Yet just hours after Boston Scientific Corp. (Natick, MA) bested rival suitor Johnson & Johnson Inc. (J&J; New Brunswick, NJ) and nailed down its $27.2 billion bid, the company learned that, in addition to cleaning up the problems at Guidant, it now has to get its own house in order.

In a strongly worded warning letter from FDA's Center for Devices and Radiological Health (CDRH; Rockville, MD), Boston Scientific was notified of "serious regulatory problems" with medical devices produced at its facilities in Natick, MA; Maple Grove, MN; and Spencer, IN. The letter also referred to three earlier warnings regarding the company's production plants in Watertown, MA; Glens Falls, NY; and Quincy, MA. According to FDA, Boston Scientific's inability to address these issues in a timely manner indicated a "systemic problem with the entire corporate quality management system."

Planning for the Future

Originally Published MX March/April 2006

BUSINESS NEWS

Johnson & Johnson (J&J; New Brunswick, NJ) has completed its acquisition of insulin-delivery company Animas Corp. (West Chester, PA) in a transaction valued at about $518 million. Animas will operate as a stand-alone entity within J&J's subsidiary LifeScan Inc. (Milpitas, CA), which manufactures blood glucose-monitoring systems.

Customers at the Core: Assembling an Expert Design Team

PRODUCT DEVELOPMENT INSIGHT

Medical devices, like other products, have both tangible and intangible attributes. These include how the product looks, how it feels during use, how well it functions, how much it costs, and how the customer obtains it. In skill-defined industries such as medicine, how a product is designed—and who designs it—can also be an attribute. A product designed by experts in the field enhances the user's perception of quality.

When designing a product, involving customers who are noted in the field can add further credibility to the product and can assist in driving its adoption. It is important to avoid going too far in the other direction, however. Designing with the help of highly skilled peer leaders can result in the development of tools that only real experts can use. A team whose membership represents a balanced cross section of intended end-users helps ensure broad adoption. This relates to both a product's feature set and its price point. In some cases, it can influence promotional method as well. Where price is concerned, for example, some user subsegments may possess greater buying power. Team members from those segments may desire a more-extensive, or more-expensive, feature set.

Customer-Expert Teams

When releasing products, companies routinely claim involvement of the customer in their design. In reality, however, participation in a design is often limited to casual involvement, such as a focus panel during some phase of the design. True customer-centric design requires a deeper level of customer involvement than focus panels provide. Customer-expert teams should be assembled early so that they participate in the part of the design process normally reserved for company employees. Such involvement allows thorough design input.

This article discusses the assembly and use of a customer-expert team that participates actively through all phases of product design. Such a team offers advice on desired feature sets, tests crude and production-level prototypes, and serves as product trainers if necessary once the project is complete.

Customer-expert teams are often confused with focus groups. Focus groups can be important at milestones during the design process. They are valuable in gauging initial reaction to concepts or prototypes. However, such groups are reserved for research aims and are arm's-length, typically anonymous, panels that do not participate in multiple phases of design.

By contrast, a customer expert on a team may be willing to continue on after the completion of the development project in an endorsement or advisory role. If the product embodies new technology or a new technique, such customer experts are the best candidates to train new users when the product is released.

In the medical-surgical market, product endorsers have typically been high-visibility persons who merely lend their name to a product. Salzman et al. theorize that skeptical customers require more than just arm's-length endorsement to confer quality and suitability to a product.1 For an endorsement to be relevant, the user group must have some sort of genuine attachment to the product's development.

Figure 1. (Click to enlarge) Different teams participate in various phases of development. Customer experts can be appointed to phase-specific groups depending on the project's requirements.

Involving a logically selected group of end-users in the design from start to finish is much less common than using customers in a way normally associated with experiential market research. In this model, customer experts do not run the project or dictate feature sets. They participate in early user research, attend meetings of the larger team along with representatives from marketing and research and development, and communicate routinely by phone, e-mail, and intranet. They essentially become an extension of the company (see Figure 1). A customer-expert team is analogous to a compass: they do not direct activity, but they do confirm whether a chosen direction is correct.

The Model in Practice

In one project, Gyrus ENT involved 32 customers directly and several dozen more as part of primary market research used to validate hypotheses about the project.

The project involved development of a device in a mature market segment with a dominant competitor, and it was unclear whether a new product entrant could be successful. Assessment of both the market and company indicated that the project required an expert team to ensure market acceptability.

The company engaged customers in every phase of design. Customers participated in seminal exploratory interviews, concept generation, crude prototyping, evaluation of shape explorations and functional prototypes, and finally, actual use of production-level prototypes.

Surgeons were involved in two traditional exploratory research exercises. A core group of six surgeons was selected to work elbow-to-elbow with the business and engineering team from start to finish. Three others joined in the latter stages of design for laboratory testing, and nine more assisted in clinical beta testing of production-level prototypes. Representatives from ancillary groups such as nursing and reprocessing were brought into the project when specific direction from that type of user was required. The customers participated in the redevelopment of what ultimately became the recipient of a gold IDEA Design Excellence Award for Design Exploration and a silver Medical Device Excellence Award.

A challenge for the project leader lies in getting the most design input possible from people whose professional expertise is not product design or development. The project leaders from the sponsor should conduct design exercises that encourage fresh thought and that help overcome preconceptions of what a given device should be. This is especially true when working on product improvements and on next generations of in-kind products. Examples of these methods are well documented in the design literature. Users become accustomed to the presence of certain features and inconveniences associated with a given type of device. It is up to the leader to find ways to break through barriers of preconceptions. Asking members of the group to describe their dream device without respect for its feasibility is one method for doing so.

Integrating Customers into the Inner Workings of Design

Candid assessment of a company's strengths must be done before a project can begin. Many companies must look outside to professional designers or individual contractors to fill the skill gaps. Customer experts can provide valuable information throughout the project, but other positions on the design team, such as human factors and engineering, must be filled with competent professionals in those fields.

Customer experts can provide insight and perspective. As part of the design and testing effort, customers develop a psychological and emotional bond to the end product. Future users of the product in turn tend to view the product more favorably because of their peers' involvement. Casual involvement in individual phases of development cannot create this deep attachment.

By contrast, ongoing advisory panels tend to lose their objectivity. The difference between an expert team and an advisory panel lies in the duration of their involvement. An advisory group that remains in place and is called upon for project after project can morph from a design team to an adjudicating body, passing judgment or rendering opinions rather than actively participating in development.

Customer experts can be assembled into teams that work closely with the traditional business disciplines, or they may participate less formally. In either case, these are not passive groups that serve as product review boards or focus panels. Customer experts review concepts, drawings, and prototypes. They attend design meetings and even participate in creative sessions for promotional materials.

Customer-expert design teams, as described here, function as an integral part of the larger design team along with the company and perhaps an outside design entity. These teams are participants in the design effort. They are not merely asked to endorse a product once it has already been designed.

The more integral a role customer experts play in the project, the more their affiliation can be associated with the product. Being able to genuinely claim meaningful design input from real customers creates a powerful message to the target market. The reputation of the team's membership can even serve to enhance the image of the product itself.

Because customer groups of this sort in essence work alongside the traditional business disciplines of R&D, marketing, production, regulatory, and sales, much depends on how these individuals are selected for the team.

Finding customers to participate in a design project rarely presents a problem. Customers frequently enjoy the mental stimulation and occasional notoriety that accompanies working on products. Finding the ones best suited for the task presents challenges, however.

Assembling a Customer Team

It is essential to develop a selection protocol that identifies individuals who can contribute to design projects and who work well together during all phases of a project. The same protocol can be applied to selection of candidates for the test-market team.

A multifaceted protocol begins by considering the market objective and how the customer team members will interact with each other and with the business team. (The business team may include an outside firm hired to fill in gaps in company expertise or to enhance the resource pool. This was true for the Gyrus project, where the company lacked human factors, electrical engineering, and software engineering disciplines.)

A protocol should include the following attributes for consideration:

• Market measures. These include notoriety, skill in use of the product, skill in the professional specialty and area of interest, and prior design team experience.
• Project suitability measures. These include team chemistry, availability and accessibility, geographic orientation, and team size.
• Other considerations. These can include legal aspects and timing considerations.

Developing the List. Exploratory research helps identify the influencers among the target market. Primary research should occur weeks before recording the list of possible expert-team members. Personal interviews work well for this purpose. Interviews do not necessarily need to be blinded, but good survey writing and interview techniques should be used to eliminate bias. Interviews should be conducted by individuals who most likely will not be part of the design team.

The research data should be carefully analyzed to select the initial list of names. That information should then be reviewed with the core design team members from the company and refined to a short list of final candidates.

Team membership should not be treated as a reward mechanism or an enticement to do additional business with the company. Involving users in attempts to turn them into paying customers is a mistake when assembling customer-expert teams. Depending on the arrangement, this can also be illegal.

Market Measures. Aaker defines branded energizers as product attributes, affiliated promotional material, or associations that enhance the perception of the target brand.2 Identifying a product with key opinion leaders validates the product. Both the customer expert, and the process itself, can be used as branded energizers. Even when the user design team is kept anonymous, customer-centric design resonates with future users by demonstrating the importance the company places on involving its customers. Beyond just name reference, describing the process in sufficient detail can give the prospect additional confidence in the product's suitability.

Perception of quality and expert design help fuel a positive reception for a product. Customer involvement in the design of a product adds a dimension that is much more powerful than an endorsement by an uninvolved personality, even if that person is an expert in the field.

Two aspects of customer-centric design are key to how it will affect the marketing effort: the reputation of the customer experts and the description of the process itself.

A customer-centric approach to product development, when used as a product attribute, can serve as a proxy for user reference. Early adopters routinely purchase products without the benefit of references from others who have tried or purchased the product. The early adopter group makes up only a small percentage of total users. Followers, or customers outside the early adopter group, rely on references to help shape their buying decision. They look to the icons and their early-adopter peers for product advice. Some also await supportive clinical evidence.

Endorser Notoriety

It's not uncommon to hear customer prospects ask, “Who worked on this product?” It is assumed by the market that companies somehow involve customers during product design, however casual or brief the involvement. A company that wants the market to strongly perceive the customer-centricity of its product should clearly define the relevance of its customer-expert team. How candidates are measured for this criterion depends on how much the product will be associated with the design team once the product is released. It is critical to determine whether it is important for the product to be associated with names in the business, or whether it is merely important that the product be known to have involved a number of customer experts in its design.

Name association falls into one of three subgroups:

• Solitary designer endorsers.
• Designer-endorser teams.
• Anonymous contributors.

Solitary Designer Endorser. Some products are usually associated with pioneers in a field, also called icons. These are specialists who are instantly associated with an area of expertise. In the medical-surgical area, products sometimes begin as custom-manufactured items, then gain popularity from the strong name association with a single iconic designer or from a designer who publicizes the device or a related technique.

Products associated with a single person require that the name be recognized universally as an innovator or icon in the specialty, without negative associations. Companies that are lesser known in a product segment find that publicizing strong associations with clear leaders in the field helps endow immediate credibility.

In this scenario, the association with the experts can serve as a proxy for product suitability and quality. A prospective user tends to prejudge the product as excellent based upon the association with the iconic designer. The product must, of course, deliver on the perception. The onus for quality and relevance still clearly falls to the company.

Designer-Endorser Teams. In this model, the design team comprises thought leaders in a particular specialty. The design team members are well known, although they may not be icons.

Single team members have a particular area of expertise or interest within the larger specialty that makes them suited to contribute in a specific area of the project. Each designer endorser's involvement, when promoted, adds credibility to the finished product by virtue of that person having been intimately involved.

In a truly collaborative environment, no one member develops an unhealthy attachment to his or her own ideas. It is natural to have strength of conviction, but the overriding goal should be the final product. Ideas from each member become ingredients in the final product. All of this underscores the necessity of carefully screening team candidates before inviting them to participate.

Anonymous Teams. In this model, the names of customer experts may never be released publicly. When the company is building upon an established, strong brand, known endorsers or designers are less important. Describing a customer-centric design process can be enough. When the product or brand is strong, its appeal may be enhanced by giving it an everyman association.

Skill in Product Use

Power users are natural candidates for membership on the customer-expert team. Unless the project focus is more on research than on creating a product upgrade or a next-generation product, skill in the use of similar products should be considered. If the end product will function similar to, or replace, an existing technology, assessing a person's skill in the use of that product type becomes important. Highly skilled users may include faculty members in teaching centers or those involved in professional symposia. A review of brochures from society meetings and continuing medical education courses can help a company assess the skills of potential team members.

The product being developed may ultimately be targeted only for users of exceptional skill or for very specific uses. Customers who are highly skilled in the use of similar products may be less particular about product features than lesser-skilled users. It is wise to balance the team with users who are representative of the average user along with those having more substantial expertise. Expert users can often compensate for user-unfriendly features and may not feel strongly enough to object publicly during design exercises.

Skill in a Focus Area

Specialties frequently segment into subspecialties. Some users might have expertise in a subspecialty but not work solely in that area. Consider whether an expert's work is so specialized that its applicability may be limited.

The team should have representation from all relevant users. The Gyrus project, for example, was designed to be used by several types of ENT specialists, so it made sense to include laryngologists, general ENTs, and rhinologists as customer experts on the design team.

If a product such as a powered surgical device will be used and maintained by several different types of customers, all subgroups should be included in the design exploration. In the Gyrus example, surgeons in practice interacted with the powered surgical handpiece but were often unaware of the workings of the power generator, to which the circulating nurse must attend. So, circulating nurses were the better resource for user input concerning the power generator. Likewise, the reprocessing department could address the ease of cleaning and sterilization of the device and was consulted during the design exploration. It is easy to overlook these key constituencies when designing a product. Soliciting input from all user groups is important when considering variables that could stymie a product's success later.

Prior Design Team Experience

When measuring experience, customer experts fall into two basic categories: the user experts with design experience, and those without design experience but who are representative of the target market for the finished product. Either of these may or may not actually be customers of the company at the moment they are considered. In fact, there is benefit to engaging customer experts who currently purchase little or nothing from the company. This assumes that there is no built-in animosity toward the firm.

Knowledge of how projects unfold probably means candidates will be familiar with timelines, deadlines, and the routine path that development customarily follows. Such experts probably also have an interest in product design. Team members who understand the design process increase the product's probability of success.

Some users may have established themselves as product designers and may already be known in the industry as having contributed to multiple designs. Some may even have engineering or MBA degrees. Since they may have had experience in working with companies, they may also expect fee-for-service arrangements. Some medical professionals have formed professional consortiums that work jointly on research and development projects.

Customer experts who have worked on similar projects may be in high demand by competitors. It is advisable to find subject-matter experts who have either been overlooked by competitors or have previously refused to work with those competitors.

The drawbacks to customer experts with previous design experience may not be obvious. For example, their ideas may not be novel and may have been incorporated into other devices in the competitive set. Though well intentioned, these experts can emerge as informal leaders during the project. Such team members may dominate discussions, perhaps inhibiting less-experienced team members. They may also come with ready-made demands for compensation, complicating the formation of the team.

In their most advanced form, the customers with design experience are those that are inventors. Although successful device companies have been launched by product designers, a self-styled inventor may be the least well suited to participate on a design team. Because good design comes from thorough user and experiential research, the customer inventor frequently proposes complete product solutions prematurely. Too often, an attempt is made to skip from the design problem directly to the answer and to contribute solutions rather than articulating needs or sharing product experiences.

Valuable customer experts clearly state features or product characteristics they like and dislike, even in unrelated products. They might say something basic such as, “A prism-shaped grip is very comfortable for me. My favorite pen has that kind of three-sided grip.” They share critical events or single occurrences that shape product loyalty for better or worse. Few truly winning ideas emanate from a single intellect. There are always exceptions, and the exception here is the single designer who has spent time in discussions with colleagues and listened to their product likes, frustrations, and expressions of desired features.

Conducting brainstorming exercises using methods tailored to encourage creativity can infuse fresh perspectives and assist nondesigners in thinking about the design problem in new ways. In one project, the original, crude prototype for what was ultimately the final design was made from miscellaneous objects found around the office. Kelley described this process in his book on innovation.3

Novices to the Design Process

The advantage of users with no previous design experience is the freshness of the perspective they can add. They approach the work unencumbered by preconception.

Novice customer experts are not always younger, less-tenured professionals, but they can be. Resident physicians can make terrific design team participants. Customers who are novices to design can benefit the development effort in other ways than design input. They can be sought for early design exploration or user research and later in the project for alpha or beta testing.

Project Suitability Measures

Team Chemistry. For a group to work, it must be made up of team players. How the team members interact with each other and with the company influences how well the design effort goes. It also influences the team's ability to meet deadlines. Team members who bicker unduly may cause the loss of precious time in the development cycle.

The personalities of candidate experts influence how well they may gel with the rest of the team. This is true especially in industries or product segments where key constituencies are well known. If experts are giants in their field, their input can eclipse that from other members of the team, even when that effect is unintended. Less-renowned team members may defer to uber-users out of reflex.

Availability and Accessibility. Membership on a design team is time-consuming. The customer experts should be expected to commit reasonable time to the project. The willingness to be available for meetings with reasonable notice influences how closely deadlines can be met. The team members should be willing to take time every weekday to return calls or e-mails and to spend adequate time reviewing drawings and prototypes.

It is important to set specific dates that the team will physically meet. Picking milestone dates that coincide with professional conferences most of the team will attend anyway can help ensure attendance.

Geographic Orientation. The geographic orientation of a group depends on the specialty. It can be helpful to include representation from other countries if the product will be used outside the United States. Geography can also be used as a consideration when attempting to decide between two equally qualified candidates.

Team Size. The number of members on a design team influences the amount of input provided and how easily group meetings can be held. The more members on the core team, the more input. And the more input, the better the wealth of information made available. But larger teams are more difficult to manage than smaller ones. Coordinating schedules and meeting planning becomes more complicated as the size of the group grows. More opportunity for conflict exists as well.

Legal Aspects. If the team will be compensated, legal counsel should be consulted to help structure the arrangements. All consulting and professional services arrangements require review by competent counsel. Legal counsel, whether internal or external, can construct appropriate agreements with the team considering all applicable law, particularly the Stark Act and antikickback laws and regulations.

Confidentiality agreements are absolutely essential when the project is more one of research without a defined market release date or when the project is blacked out (developed in as much secrecy as possible). Even if the project is for otherwise-routine upgrades, confidentiality or nondisclosure agreements are important documents to have in place.

Timing Considerations. Customer experts can be appointed to phase-specific groups, participating in development at various points during the process. Customers can be used in three discrete phases:

• Exploratory phase: market research and preproject planning.
• Design phase: design, concept, and prototype review.
• Test phase: Lab testing, field beta testing, product refinement, and test marketing.

Each phase can have its own distinct group of customer experts. Their level of involvement, as well as the number of members that each phase requires, can vary.

Because the exploratory phase includes conventional methods of market research, it should, by nature, include more participants. By contrast, the core design team is required to work closely with the company. This involves attendance at meetings, consistent communication, and quick decision making. Therefore, fewer members can be a part of the core team. The test phase involves less centralization and requires a fresh perspective to evaluate the resulting products. The core team can be a part of this group, but the test group must necessarily have more members outside the core team for adequate sampling.

How to Invite an Expert Team

Smart people are attracted by projects that are intellectually stimulating. Further, emotional and psychological involvement in the project introduces a mission to the work, and having a mission intensifies the passion with which the team approaches the project. The belief that the project will indeed improve life makes it more engaging.

Projects that compel are ones that seek to be truly innovative and whose goal is to develop a product that offers real improvements, not merely incremental x + 1 or x + 2 advances. Incremental advances, sometimes called feature creep, are usually born of projects aimed at catching up to the innovator in the competitive set. The innovator introduces a paradigm-changing device, and the follower then attempts to copy the features that resonate with customers.

When a project is compelling, the product that is ultimately released to market will usually provide benefits to its users. And, at the close of the project—if it was a success—the customer experts will likely ask, “When can we do that again?”

The following is an effective method for inviting customers to participate on a customer-expert team.

• Approach each candidate for membership individually.
• Have confidentiality and nondisclosure documentation in place.
• Send written information that clearly conveys key elements of the project.
• Allow sufficient time for each candidate to review the materials.
• Follow up with a phone call to gauge interest.
• Schedule and make a personal visit if a candidate is interested. If the project is broad in scope or magnitude, a member of senior management should be present for meetings with prospects.

Conclusion

Assembling and using a customer-expert team can help ensure a product's market success. It is essential that this team participate actively through all phases of product design. When designing a product, involving customers who are noted in the field can add further credibility to the product and can assist in driving its adoption.

It is possible to design products that function well and that enjoy widespread adoption without the active involvement of a single end-user. Companies that are already market leaders with entrenched specialty product lines stand a better chance of getting by without user-centric design approaches than do their less-dominant competitors. Clearly, though, to establish a credible position of customer involvement and customer centricity, end-users must be included in at least some phase of product research or design. Deep and integral involvement of an intelligently assembled design team that includes credible members of the user community goes a long way toward ensuring success.


References
1. M Salzman, I Matathia, and A O'Reilly, “The Buzz about Buzz Marketing is Building,” in Buzz: Harness the Power of Influence and Create Demand (Hoboken, NJ: Wiley, 2003), 18.
2. D Aaker, “Energizing and Differentiating the Brand,” in Brand Portfolio Strategy (New York: Free Press, 2004), 145.
3. T Kelley, “The Perfect Brainstorm,” in The Art of Innovation (New York: Doubleday, 2001), 62–63.

Perry Mykleby is senior director of marketing at Gyrus ACMI ENT Div. (Bartlett, TN). Contact him via e-mail at perry.mykleby@gyrusacmi.com.

Copyright ©2006 Medical Device & Diagnostic Industry

B. Braun and Curlin Medical Extend Pump Agreement

OUTSOURCING NEWS

Braun will remain
a supplier for Curlin
infusion pumps.
B. Braun Medical Inc. (Bethlehem, PA) and Curlin Medical LLC (Huntington Beach, CA) renewed a deal to continue providing infusion pumps to healthcare professionals. The exclusive agreement will maintain national distribution, training, and technical support for a range of Curlin Medical's infusion pumps. B. Braun will remain the sole distributor of the pumps for three more years.

Clinicians use the company's ambulatory pumps to preset doses for patient self-administration. The devices deliver therapies that include intravenous (IV) fluids, pain management, anesthetic, nutrition, and antibiotics.

“We've never engineered an ambulatory pump that's geared for use in patients who are mobile,” says Eric Melanson, director of marketing of infusion systems at B. Braun. “With Curlin's design, we sell a healthy amount of that volume to the home infusion-therapy market.”

The initial three-year agreement brought both companies strong market share growth. “The market seems to appreciate the product, because it has a good reputation for reliability and a very low failure rate,” says Melanson. “Some companies haven't improved their product or changed their approach to the delivery of narcotics, for example. This year we saw one of our main competitors withdraw an ambulatory product from the market, and that obviously created an opportunity.”

Melanson added that the pump is easy to use. Its single-board design is housed in a machined aluminum cage. “We believe that [design] confers excellent long-term benefits in terms of how it's used in places like home infusion, where it goes into patients' homes and could be dropped.”

The contract extension will also help the companies jointly develop new products for hospital and alternate-care areas. “Sometimes a distribution agreement gets a bad rap, but in reality, we're experts at sales, marketing, and clinical support, so we can dedicate our resources to do that,” says Melanson. “Curlin can focus on improving the product, supporting it from a regulatory standpoint, and optimizing the manufacturing and quality. It's a way for both of us to participate in the market to do what we do best.”

The companies increased their field staff and sales force in North America to serve major hospitals, group purchasing organizations, and alternate-care home infusion customers. In response, Curlin also expanded its production capacity for pumps, IV administration sets, and accessories. This expansion will help them meet the higher demand for innovative wireless technology, data monitoring, and guideline software.

Copyright ©2006 Medical Device & Diagnostic Industry

Investing in a New Specialty

Originally Published MX March/April 2006

COVER STORY

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Turning the Corner

RITA Medical (Fremont, CA) is a silver-level sponsor of the first World Congress of Interventional Oncology, which will be held in June on Lake Como in northern Italy. Organizers say the event will mark the birth of a new interdisciplinary branch of medicine that draws distinguished specialists from a multitude of fields, including radiology, medical oncology, surgical oncology, hepatology, and radiation oncology.

According to Joseph DeVivo, chief executive officer of RITA, a silver-level sponsorship is a significant investment for a small company such as RITA. But given the company's position as the only medical device company that focuses solely on cancer therapy, it is completely appropriate, he adds.

Relating to Medtech Customers

Originally Published MX March/April 2006

ADVERTISING, DISTRIBUTION, & SALES

Medtech firms are reexamining the benefits of customer relationship management systems and finding implementation easier this time around.

Debra Kurtz

Customer relationship management (CRM) was the much-heralded topic of the last decade, especially for companies seeking greater customer focus in their organizations. Yet now, amid reports that the postimplementation scorecard for CRM is, at best, mixed, many medical technology executives are left wondering what to expect from CRM and whether such initiatives can truly benefit their organizations.

This article explores why organizations pursue CRM initiatives and what can be expected from these efforts. Various technology approaches and software options are reviewed, and tips are provided from medtech executives who have implemented CRM initiatives.