An MD&DI May 1997 Column
For medical device manufacturers, FDA's new design control requirements are just one more reason why the team approach to product development is gaining ground.
In the medical device industry, the practice of bringing together a multidisciplinary team of specialists early in the development of a product has been kicking around for at least a decade. Both large and small companies have adopted the practice in order to make better use of their resources. Now, the growing competitiveness of the device marketplace and new regulatory requirements for design control are making the team concept an essential part of doing business.
Increasingly, both in-house talent and outside consultants representing manufacturing, marketing, quality assurance, and regulatory affairs are being asked to offer their expertise at the earliest--some would say most critical--stages of product development. "There is no one person in a company experienced enough to understand the whole process," says Jim Sandberg, director of quality assurance and regulatory affairs at Protocol Systems (Beaverton, OR). "So you have to look to several people to get the job done."
The team approach to product development is gaining favor because companies are coming to realize that if the contributions of staff are not organized, the result can be deadly. Bill Wood, vice president for research and development at RELA (Boulder, CO), recalls performing a postmortem on a project completed five years ago. During the two-year development of the device, there were nine major changes. "What I discovered was that as different staff joined the project, they would each initiate a major change," Wood says. "This incremental addition of staff was pretty damning. The project ended up behind schedule and over budget."
ADVANTAGES OF TEAMWORK
Involving representatives of the key disciplines in a timely, coordinated fashion not only saves money and time, but also provides advance warning to the various departments about when they will have to switch into high gear. Regulatory affairs specialists, for instance, know when a submission must be made to keep a project on track. Their assessment of the time that will be required to get through regulatory review can be used to alert the manufacturing and marketing departments about when they must be ready to carry the ball. The team approach also adds predictability to a process that is inherently uncertain. "We check and double-check everything," says Dennis Tomisaka, director of R&D at Medex, Inc. (Dublin, OH).
The practice of making quality assurance personnel a key part of the development process has grown as more and more companies have embraced the ISO 9000 family of quality systems standards compiled by the International Organization for Standardization (ISO). And that practice will likely proliferate after June 1, 1997. On that date FDA will implement its new quality system standard, which emphasizes the use of quality systems throughout the design and development process. "This regulation is going to push companies to establish formal programs that ensure quality in the design process," says Kim Trautman, quality systems expert in the Office of Compliance at FDA's Center for Devices and Radiological Health.
For development projects to succeed, companies will need the support of all key players. "Companies will have to understand the relationships among their design, R&D, manufacturing, corrective and preventive actions, and management functions," says Trautman. The new standard, she says, will "force manufacturers to integrate quality into every part of their process and to think of quality more as a system than as a discrete function."
The new quality system regulation, including design control requirements, has simply made it more desirable to adopt what has already become a best practice at many device manufacturing firms. Companies not following the team approach can easily run into problems. "What tends to happen is that when R&D staff can't meet the specifications provided by the marketing department, they create something else," says Glen Freiberg, vice president for regulatory, clinical, and quality systems at Bard Diagnostic Sciences, Inc. (Redmond, WA), which focuses on the marketing of in vitro diagnostics. "That can lead to failures in the marketplace."
In such instances, R&D personnel may rationalize their actions by concluding that the expectations established by marketing are simply unrealistic. Applying the team concept provides Bard Diagnostic Sciences the means for hashing out such misgivings. "We can put marketing on the spot and say, 'You gave us your design input but you didn't justify it. Where is your marketing study? Where is your strategy?'" says Freiberg. If the design specs established by marketing can't be met, the project might be scrapped, rather than going to market with a noncompetitive product.
But the team approach does not stop with product design. At many firms, it carries over to every step on the way to the end-user--testing, regulatory approval, packaging, sterilization, marketing, distribution, installation, and service. In the past, staff charged with these tasks were isolated from one another. Now they are being integrated. Team members versed in specific areas take lead responsibility for getting a job done, but key processes become a team effort.
Product development teams are typically formed in the same way they have been for decades--by and around R&D staff proposing technology within the state-of-the-art envelope. When the team concept is applied, however, this nucleus of engineers soon reaches out to involve others.
"The old way of developing a product was to throw it over the wall at each stage," says Tomisaka of Medex, which makes a wide range of medical devices from pressure monitors to disposables. "We used to do that, but it didn't work very well. We had a lot of hitches at the last minute. So we have formalized our development approach around what we call cross-functional teams."
Medex starts with a team leader, usually from R&D, and a senior "sponsor"--an executive who serves as liaison between the team and top management. To this core the company then adds other members, usually marketing and engineering experts, who put together a proposal and budget request. When completed, the request is sent to executive management for approval.
As the project unfolds, additional team members are selected from the various disciplines within the company. At a minimum, specialists from R&D, marketing, and quality assurance are involved early on. "You can't be just R&D driven, or marketing driven, or quality driven," Tomisaka says. "The whole company needs to be involved."
To ensure that product development remains on track, phased gate reviews are scheduled throughout the process, marking the end of such phases as the development of the prototype, design transfer to manufacturing, and process validation. Along the way, the team leader tries to build consensus. "The process is driven by the team leader and that is where management skill comes into play," says Tomisaka.
At Protocol Systems, multidisciplinary teams have been a cornerstone of the company's development process since its inception some 10 years ago. The company, whose 400 staff members design and manufacture patient-monitoring instruments, organizes the team around two lead personnel. One is an engineering project manager; the other is a marketing product manager.
Over the course of the project, the two leaders bring in different professionals as needed. "People can be in and out of the project, depending on the phase," explains Protocol's Sandberg.
The size of the team is proportional to the project. "The smaller the project, the fewer the people, and vice versa," says Sandberg.
MAKING TEAMS WORK
At Protocol Systems, a project typically begins with a nucleus of about a half dozen specialists who develop a project proposal and solicit input from others as needed to prepare the proposal for senior management. That nucleus expands in the next phase of development, when product specification requirements are established. At this point, team members try to define the product from the perspective of its customers. "There are a whole series of customers," Sandberg says. "The customer can be a regulatory agency, a distributor, or the end-user." The engineering project manager is responsible for controlling changes, as in the case of document specifications or the development schedule.
Marketing specialists must know what the end-user wants and what competitors will be offering. "If you're trying to compete against something head-on--a similar technology--you need to know how long that competing product will be on the market," says Freiberg of Bard Diagnostic Sciences. "If you're going to be competing against an evolving technology, you need to know how much longer until a similar competing product will show up."
Academic and major medical institutions provide an important source of expertise, particularly when determining a product's features. Marketing and clinical affairs specialists at Cardiovascular Dynamics (Irvine, CA) routinely survey health-care providers, conduct face-to-face visits with medical opinion leaders, and document hands-on experience by end-users to help the company fine-tune its products as they move toward full production.
Quality assurance staff are becoming increasingly important members of the team. The quality system regulation is providing the spark for including QA on the ground floor for new projects. "QA professionals aren't going to be isolated anymore; they will have to interface with management, with R&D professionals, and so on," says FDA's Trautman.
In some instances, they may be directly involved in the development of product specifications, even though the actual design is being developed by a product engineer. "In our organization, the quality team establishes the product requirements necessary to meet performance, safety, and environmental standards," says Protocol's Sandberg. "If you don't have those pieces laid out at the beginning of the project, it's going to be pretty hard to know whether a product's design will meet its objectives."
At Protocol Systems, quality assurance specialists are brought in at the very genesis of a project. "They help develop the product proposal," says Sandberg. This proposal briefly describes the product's opportunities in the market, the regulatory requirements it must meet, and any special manufacturing requirements.
Protocol Systems breaks its quality personnel into two groups. One identifies quality standards such as those developed by the government or by other standards-writing bodies. The other documents safety standards used by testing laboratories and regulatory bodies. At least one member of every quality team is assigned to look into requirements that have been specified by customers.
Manufacturing personnel must be involved to ensure that the final product can ultimately be mass-produced and that the correct equipment is available, not only for manufacture but for testing. Engineering and manufacturing personnel work together to develop the process needed to make the finished device. Specialists are assigned to establish the documentation requirements up front.
At Bard Diagnostic Sciences, all departments get involved early in planning. "Marketing should tell you what the product could sell for, and should also estimate what the reimbursement for its use may be," Freiberg says.
The company also brings manufacturing concepts to bear on the development process long before production begins. "Where we used to have a potential for certain things to pass from one department to another without an efficient transition, the quality systems department is becoming more and more relied upon to make that transition smooth," says Freiberg.
According to Freiberg, the company now uses R&D staff to develop the step-by-step procedures for manufacturing, and to set up a pilot run that will create products for clinical evaluation. A manufacturing engineer is then brought in to observe the pilot process. The R&D team documents the major steps involved; manufacturing--through its observation of the pilot--documents the necessary detailed information that correlates with those steps. "For example, if R&D has developed a 10-step procedure, by the time manufacturing is done we may have 30 steps," says Freiberg. The job of quality systems personnel is to manage the paperwork and ensure that all documentation is satisfactory, he explains.
PLANNING THE REGULATORY PROCESS
The most critical role of the regulatory affairs staff is to plan the strategy for gaining regulatory approval or clearance of products. The regulatory affairs department identifies the review process at FDA that must be used--premarket notification (510(k)), premarket approval (PMA), product license application (PLA), or a combination if the product is a hybrid between a drug and a device. The department also helps to estimate the path of least resistance to clearance or approval, and the shortest time to market. Such estimates, however, remain "more of an art than a science," says Freiberg.
With many companies looking to gain approval first in Europe, where the regulatory maze can be navigated more quickly, regulatory affairs specialists are often charged with developing a global strategy. The trick is to come up with a complementary process for European clearance that will support approval or clearance of the device by FDA, since the U.S. marketplace accounts for literally half of all medical device sales globally.
Consultants can also play a key role in the team approach to product development. Their advice may be very specific--relating to issues such as the type of electrical connector or sterilization process needed to meet regulatory requirements--or it may span a range of considerations. Consultants to the medical device industry include a varied array of specialists in R&D, design, process design and automation, manufacturing, sterilization, packaging, labeling, and regulatory affairs.
Consultants can--and often do--become intimately involved with a manufacturer's product development team through strategic relationships that make them essential to the design and development process. Consultants with Quality Solutions, Inc. (Annandale, NJ), a firm that specializes in providing advice regarding sterilization issues, routinely serve as team members for device development. In that role, they may actually function as project managers with authority for all decisions related to the selection, purchase, installation, and qualification of equipment required for product sterilization.
"On its team a company may have a wide variety of in-house staff such as engineers, quality systems experts, a registered nurse in charge of clinical trials, and an MBA handling company finances. But it might not have anyone with sterilization experience," says Paul Sordellini, vice president of Quality Solutions. "So the company hires us and turns over the entire project of planning the sterilization strategy for the device."
Quality Solutions staff often play an important and necessary role in designing a company's product. They review engineering drawings and plans for manufacturing and packaging in the context of materials and components to be used. "Certain raw materials may preclude the use of gamma radiation or E-beam sterilization, because of the way the devices would be bulk packaged," Sordellini says. "The physical configuration of a device may create other concerns."
The relationship between a company and its consultants--and their direct input into the team decision-making process--continues throughout the product development stage and into the manufacturing stage to ensure the quality of the finished device. Sterilization protocols developed by Quality Solutions and implemented either by in-house personnel or by contract sterilizers must be audited, Sordellini notes. They may also need to be adjusted if the company modifies the device. Quality Solutions, in the role of consultant, is often called in to provide that assistance.
Also available are consulting firms that focus mainly on a company's management structures and internal processes--including those used for product development. Often such firms help companies prepare for certification to one of the ISO 9000 family of standards or for the CE marking of their products. When they play a role as both consultant and assessor, a certain detachment is expected.
"The extent to which we get involved really depends on how large the company is and whether it has resources on the inside to help," says Susan Reilly, director for quality assurance and compliance at Medical Device Consultants (North Attleboro, MA). Start-up companies, she says, tend to be looking "for somebody to do a little more than hand-holding."
For the most part, such management and systems consultants remain on the outside looking in. They provide advice when asked, but exert relatively little direct influence on the decision making for a particular project. "Companies typically hire us to lay some groundwork, conduct some training, and perhaps put together a plan or system that they can implement," says Reilly. "Then when they are done--or think they are done--we come back to see if they really are."
When such consultants do become more deeply involved in development, it is usually in the role of facilitator or catalyst. "I'll go in and get everybody on the same page," says Anita Thibeault, principal of Anita Thibeault & Associates (Rogers, AR), a consulting firm specializing in the device industry. "We'll go through the nomenclature and company procedures so everybody knows what has to be done and what the rules are for doing it."
The vehicle Thibeault uses for getting to that stage is the workshop--a two-day interactive session attended by about 20 professionals representing R&D, marketing, quality assurance, manufacturing, and regulatory affairs. "These folks typically represent the team that the company plans to put together," she says. "The workshop gets them started asking the right questions." Thibeault typically holds a follow-up workshop focused on reviewing the design of the device.
A workshop serves as an event that signals the true beginning of a project, says RELA's Wood. "It makes the project real. It's like somebody ringing a bell and saying, 'You'd better get on board because the train is leaving.'"
Workshops pull together all of the company staff that hold a stake in the final product--engineers in R&D and manufacturing, as well as marketing, QA, and regulatory affairs specialists. RELA promotes workshops as a catalyst for team building to advance the design and development process. What goes on at these workshops can be remarkable, says Wood. "Often you will see discoveries being made among department personnel, a unifying among the participants about the nature of the product itself."
RELA has facilitated 18 workshops over the past 24 months. The common challenge addressed in each has been keeping participants moving toward their goal. Wood uses tricks, such as allowing each participant two 'tangent tickets.' Spending a ticket allows the person to go off on a tangent for three minutes. Then he or she has to come back to the main discussion. "I time them," Wood says. "That tends to control where we go."
The result of the workshop is a clear sense of what the team members must do to make the project progress. Direction is clarified and missing information is identified. "We have brought these people together and they now feel like a team," Wood says. RELA follows up, often within 24 hours, with a flip-book containing the key points discussed and conclusions reached. "The book captures all the things that occurred, but it is not a lengthy document that you have to wade through," Wood says. "Here is the workshop we did yesterday and here are the conclusions. Bang." Quickly putting a summary in the hands of participants enables them to continue with the project while the excitement of the workshop is still with them, Wood explains.
GOING BEYOND WORKSHOPS
Following the workshops she facilitates, the role played by Thibeault usually shifts to one that is more often associated with consultants, namely, giving advice at critical points en route to full production, such as process validation. "Companies ask me to come in to make sure they're taking the right steps--for instance, to advise them about what should be documented and how they should put that documentation together," she says.
RELA also changes direction after the initial workshop, but often to a much different track. The company is actually more a device development firm than a consulting firm. "Consultants typically write a report and leave," Wood says. "They have no stake in how things eventually turn out. We want to be part of the development team. Our stake is a long-term relationship that leads eventually to manufacturing."
The company can and often does run the entire product development process, using the client's in-house talent in a review capacity. In those instances, RELA initiates the project with a workshop and uses periodic review sessions with the client "to ensure that we are on the right track," Wood says. Under those circumstances, the client is an extension of the team, bringing to bear an extended, multidisciplinary source of feedback.
PURCHASING AS A TEAM EFFORT
The use of product development teams not only shapes a company's finished devices but also exerts significant influence over its purchasing decisions for materials, components, manufacturing supplies, and services. In small companies, which most medical device manufacturers are, these decisions have traditionally been made by manufacturing personnel. But as a company's development process becomes more sophisticated, its manufacturing personnel become more likely to call in other specialists to help make these determinations.
At Protocol Systems, the key members of the team that develops a device are also responsible for selecting its materials, components, supplies, packaging, and labeling. "This effort is a combination of design, engineering, manufacturing, and quality assurance," Sandberg says. In some cases, the team brings in a materials manager to help.
Specialists in materials management and inventory control can sometimes exercise control over the specifying and ordering of raw materials, manufacturing supplies, packaging, labeling, and software for inventory control. But the actual decision-making process depends heavily on what is being purchased and on the risk involved in its use. For example, when purchasing an off-the-shelf component or buying from a vendor with a track record, the project team can act on its own. But if a subassembly must be custom-built, then the team makes a recommendation to senior management. "Usually the vice president for manufacturing reviews the proposal," says Sandberg, "because he's the person who will be working with it throughout the life of the product."
The team approach is itself a product of the modern health-care environment. To compete effectively, companies must waste nothing of value--not expertise, money, or time. "A multidisciplinary team approach is a lot better than R&D just making a product with a little feedback from marketing and then cramming it down manufacturing's throat," says Mark Siminuk, senior development engineer at Cardiovascular Dynamics. "You end up with a product that is more marketable."
Teams also reduce the risk of losing time and money in virtually every phase of product development, from design through production. Individual savings mount up as fewer unexpected problems arise along the way. But the biggest advantage of all, says Sandberg, is that less time is needed to commercialize a new technology. "The more things you do in parallel, the faster you can get to market."