Design SuccessTakes Collaboration,Communication

Originally Published MDDI June 2005

Cover Story - Outstanding Design Teams

Design Success Takes Collaboration, Communication

The medical device industry is a haven for inventors and entrepreneurs. It may take only one person to come up with an idea, but it takes many to bring that idea into the real world.

The medical device industry is a haven for inventors and entrepreneurs. The image of a lone genius working up a product in his garage and going on to found a multi-million-dollar company is a pervasive one. But the reality is that few, if any, devices succeeded without teamwork. It may take only one person to come up with an idea, but it takes many to bring that idea into the real world. Without collaboration across a number of disciplines, outstanding product design is not likely to happen.

In the pages that follow, MD&DI recognizes some of the industry's most outstanding design teams. As you will see, excellence comes in many forms. Some teams coalesce within a single company, while others are a partnership between two or more companies. Some teams have been together only long enough to produce one outstanding product. Others have collaborated on a number of products over many years. Some overcame tremendous technical challenges. Others were able to streamline the design process so efficiently that the product got to market faster.

These teams' stories might impart lessons about the medical device design process. What is the best way to structure a design team? How do you find team partners from outside firms? What tools can team members use to better communicate? Who needs to have input? Do many hands make light work, or do too many cooks spoil the soup? How tight should management keep the reins on the team? What should be tried when a problem seems insurmountable? There is no single solution to any of these issues, but here are some ideas that turned into excellent results.

Design Teams

The Ekos Team
The Midmark Team
The College Park Team
The Dade Behring Team
The Clozex Team
The Sorenson Medical Team
The Baxter–Insight Team
The Tech Group–Bionix Team
The Key Technologies Team
The IMS–WRAIR Team
The VidaCare–BC Tech Team
The Innovative Spinal Design Team
The Epicor–Aubrey Team
The Restore Medical Team
The Fresenius Design Team
The Medtronic–Metaphase Team

Improbable Technology Not an Impossible Task

Erik Swain

The team from Ekos Corp. (Bothell, WA) that designed Lysus, a product that delivers drugs and ultrasound to dissolve peripheral vascular clots, exemplifies the cliché of outside-the-box thinking. This is not just because they came up with a system that was a radical departure from previous therapies. The idea was so unprecedented that the team had to invent new tools just to be able to test it. Yet despite persistent doubts from within and outside the firm, plus a number of setbacks, Lysus not only became a reality, but also a success.

The system dissolves the clots by delivering drugs and ultrasound through a catheter. Delivery of ultrasound through a catheter had rarely been attempted before and presented numerous design constraints. In fact, the ultrasound transducers the team designed for the system went against almost every rule of transducer design.

“There were no experts in the field anywhere in the world that had encountered this particular method of use,” says Rick Wilson, a product development engineer. “Every expert in transducers that we found said they were absolutely certain it would not work. But if we had done everything the normal way, we never would have solved the problem.”

Also unusual was that no measurement tools existed to test the design. So, among other things, the team built a special tank for making acoustic measurements, and a robot that could make clots.

At one point, the company informed the team on a Monday that it would pull the plug on the project that Friday. They decided to try one last idea, and by Wednesday, they knew it would work.

Regulatory strategy was unconventional as well. The firm assumed a PMA would be needed, but through a twist, only a 510(k) was. “During our project, another peripheral vascular product got approved,” says Jocelyn Kersten, director of regulatory affairs. “Our project had 30 ultrasound elements, but we were able to break it down and develop a simpler version with one element, and use the competing product as predicate. Then, when the full project was ready, [our simplified version] became the predicate for it.”

How was the team able to meet the challenges? “One of the keys to success is that we are a very organic and flat organization,” says Bob Wilcox, who, as Ekos' director of peripheral vascular products, oversaw the team. “We do not suffer from structural overload. Everybody can do everything, and everybody contributes to everybody else's work.”

Such a loose structure was perfect for Ekos because team members had lots of experience in a wide range of disciplines. “Everyone's background is quite varied, even if our job titles make us sound like a typical device firm,” says Ron Haas, product development engineer. “There is a lot of depth here.”

Also crucial was the team's persistence. “Everyone stuck with it until it worked,” says Wilcox. “The team always talked about how we believed in the idea and were committed to helping this group of patients. If we were in it for the money, the team would have dissolved long ago.”

The Ekos Team

Carver Anderson, engineering
Claude Baker, quality engineering
Steven Coles, engineering
Edward Evans, design engineering
Ron Haas, product development engineering
Jocelyn Kersten, director, regulatory affairs
Rochelle Phelps, production supervisor
Jean Rempel, manufacturing engineering
Azita Soltani, preclinical research
Richard Sommercorn, product development engineering
Bob Wilcox, project director
Rick Wilson, product development engineering

Elevating Design to a Customer's Level

Maria Fontanazza

The design team at Midmark Corp. (Versailles, OH) was determined to create a medical exam table that looked good and was comfortable. To achieve that, the team restructured how they interacted with potential users and with each other.

Midmark had almost everyone from the project team, regardless of department, sit near each other. The team had never worked together in this fashion, but the shift broke down barriers and improved relationships. “One of the synergies was that you could get real-time feedback about the manufacturability and function of the design as it was being developed,” says Rick Turner, Midmark's new product development team leader.

Communication with the outside world was key, too. Market research involved going to suppliers, clinicians, and customers for feedback. “Just as collocation helped the core group effectively communicate, face-to-face visits with suppliers were another valuable step,” says Turner. “We visited some local universities that dealt with people with disabilities, where we allowed potential users to come into exam rooms with wheelchairs. They couldn't get onto the table. Their involvement in the validation was essential.”

During parts of the research process, the team sat behind one-way glass to hear customer comments on five product concept models. This gave the team a mental picture of the customer as they developed a solution. Doctors and nurses also provided feedback. “In just a couple of days, we gained invaluable knowledge. It was money well spent, and we're continuing that methodology.”

Making a power table at a low cost was difficult. The specifications required it to perform better and have a higher lift capacity than previous models. Fitting the lifting mechanism underneath the chair, while ensuring enough power to smoothly pick up a heavy patient, was a technical challenge. “We didn't know if we could do it at an acceptable cost,” says Turner.

The team divided the design into sections. Throughout the project, engineers simultaneously worked on different design concepts to meet the same requirements. “We didn't exactly know how the final product was going to look until it all came together fairly far through the project,” says Turner.

The end result exceeded the team's expectations on manufacturing efficiency and overall product cost. They created an exam table that holds up to 400 lbs. It has a collapsed height of 18 in. and fully extends to 37 in.

“It's been a tremendous success. I can't tell you how good it feels,” says Turner. “We were able to do things that couldn't get through the organization before.”
Plans to team up again are already in the works. “We're running about four projects like this right now, instead of just one,” says Turner. “We're building on our success.”

The Midmark Team

Jeff Cochran, manufacturing
Leo Hanus, mechanical engineering
Rod Hyre, electrical engineering
Bart Milbourn, mechanical engineering
Jeff Robbins, mechanical engineering
Joe Schlater, tooling engineering
Mark Shank, industrial engineering
Art Smith, mechanical engineering
Linda Steinbrunner, purchasing
Tom Treon, electrical engineering
Rick Turner, team leader
Jon Wells, product manager

The Name of the Game

Heather Thompson

At the beginning of 2003, the design team at College Park Industries (Fraser, MI) was in a bit of a bind. They were disorganized, understaffed, and facing several large projects, including the development of a low-cost, high-performance, prosthetic foot. To meet these challenges, says engineering manager Mike Leydet, “we were forced to take a second look at how we were organized as an engineering department.”

The group began by conducting a series of interviews with staff to identify problem areas to see where improvements could be made. Each person discussed how he or she fit into the team and noted any areas they felt needed change.

A major issue among the staff was confusion about job duties. “The most consistent theme derived from these interviews was that management had not clearly identified areas of responsibility,” says Leydet. “The difficulty for us was figuring out how to create these distinct separations of responsibilities and specialties, while retaining the sense that we were still a team.”

“Sometimes semantics can be annoying,” Leydet says, and sometimes they can instill a greater meaning to promote an effective working environment. The engineering team at College Park called the distinct areas of responsibility sectors. The term sectors, he says, gives the impression that each person is part of a whole.

Once sectors were defined, leaders were appointed and the sectors were staffed with the appropriate personnel. The only operational change, Leydet says, was that each employee was given a clear understanding of roles. Responsibilities within the team structure were assigned, and members were better able to multitask.

The reorganization worked because it enabled individuals to focus their efforts, not only on talents, but where the needs were greatest. “We became like a relay system,” explains Leydet. Each person was responsible for a certain leg of development and then could pass it on to the next team member. “It's the whole team that wins,” he says.

The main project for the team under the new structure was a prosthetic foot known as the Tribute. Leydet is proud of the device's success. Today, 90% of the lower-limb amputees sent to the Walter Reed VA hospital in Maryland from the Iraq war are receiving College Park feet, he says.

The College Park Team

Lars Chrisman, proficient engineer
Dave Dunlap, DaD Works Inc. representative
Chris Johnson, director of product engineering
Michael Leydet, engineering manager
Kevin L'Heureux, product engineer
Kimberly Light, program manager
Michael Meldrum, engineering technician
Allen Parker, engineering technician
Aaron Taszreak, product engineer
Mark Wahoske, engineering technician
Kenan Wollborg, product engineer

The Sum of Its Parts

Heather Thompson

Sometimes a product is more than its design. When a design team is finished, others take over—and sometimes those people make a product mean much more than originally intended.

In 1998, Dade Behring (Deerfield, IL) created a high-sensitivity C-reactive protein (CRP) assay. Initially, the device was merely a very good second-generation product. That is, until a persistent marketing champion gathered the clinical and regulatory experts and helped redefine the market.

CRP assays have been frequently performed for more than 20 years, and they are used extensively in Europe. Initially, the test was used to identify routine inflammation. The assay, however, did not have high sensitivity, which limited its use. “The initial CRP assay had a lower value of 20 mg per liter,” says Mary Lou Gantzer, PhD, of clinical and scientific affairs for Dade Behring. “That is not sensitive enough to look at cardiovascular risks.”

However, new theories had linked inflammation with cardiovascular disease. And, simultaneously, new technology gave Dade Behring the opportunity to create a more-sensitive product.

The company worked closely with Nader Rifai, PhD, of the Children's Hospital in Boston, and Paul Ridker, MD, of Brigham and Women's Hospital in Boston. Ridker and Rifai had worked on other applications for CRP assays. The higher sensitivity, however, allowed the researchers to go further. They published studies in peer-reviewed journals that established a possible link between C-reactive protein and cardiovascular disease.

But even with the research, says Gantzer, Dade Behring would have probably put out a run-of-the-mill CRP assay were it not for the efforts of marketing manager Thomas Luhr. Gantzer explains: “Tom was our champion for using this assay for cardiovascular applications. He is the one who pulled together the appropriate clinical and regulatory people to get the information for 510(k) filing.”

From the beginning, Luhr saw the potential for marketing the assay. He found ways to make the data collected by Ridker more approachable for physicians and helped Dade Behring bring out the true value of the high-sensitivity technology. “In many ways it's about being in the right place at the right time, but you also have to keep your eyes open for opportunity,” Luhr says.

The product took more than a year to get to market, but in 1999, Dade Behring got clearance for the first highly sensitive automated CRP assay marketed specifically for use in the cardiovascular arena. “Any time you develop a new product,” Luhr advises, “you also have to develop a pull-through strategy. You have to give physicians a way to more successfully treat patients.”

The Dade Behring Team

Becky Ayash, regulatory
Kathleen Dray-Lyons, regulatory
Mary Lou Gantzer, PhD, clinical and scientific affairs
Hans-Peter Harthus, PhD, research and development
Thomas Luhr, marketing
Goetz Walter, PhD, research and development

Multicompany Team Did It Fast and Did It Right

Erik Swain

Start-up company Clozex Medical LLC (Wellesley, MA) had an idea for a needle-free wound closure device but no idea how to make it a reality. Clozex officials went to the 2003 Medical Design & Manufacturing East trade show in New York City looking for people who could help. By the end of the show, they had found the core of the multicompany team that would design the device and the equipment to make it. The group worked so well together that despite several setbacks, Clozex was able to launch the product just nine months later.

“We're a very small company, so we had to use the resources of other companies to get us to the right place,” says Ray Barbuto, Clozex's vice president of manufacturing. “We had the patent but not the materials or the process. At that show, we found everyone who helped us get there or led us to other people who could help us get there.”

How was the project able to move so quickly? “The secret was that we found a company [Baril Die Co. of Haverhill, MA] that had the ability to make dies on the spot, which allowed us to quickly sense what materials and designs were going to work,” Barbuto recalls. “We got them involved right away with each of our potential suppliers.”

Adhesives Research Inc. (Glen Rock, PA) handled the materials. Delta Industrial Services Inc. (Minneapolis) took charge of designing the manufacturing equipment. Roman Stienss, president of Sterile Technologies Inc. (Queensbury, NY), took responsibility for sterilization issues and led Clozex to the Minneapolis facility of STERIS Corp.

“I set up the relationships and put the team members in touch with each other. I told each of them what we wanted and would visit each of them with our techs when there were problems,” says Barbuto. “But eventually, they worked so well together that they would handle the little issues without me. We'd be able to make changes with lightning speed.”

The team went through several materials and design configurations before hitting upon one that worked. The device required special adhesives to affix breathable attaching pads securely to the skin adjacent to the wound, and to lock it in a closed position. Determining which adhesives to use and how to incorporate them into the device was a major challenge. But the process never slowed down because each team member always knew what to do, and who to talk to.

“I learned long ago that if you reach out to the workers, they can move the earth in ways that the people on top can never know,” says Barbuto. “And that's what happened with this team.” The group remains intact, working on the product's next generation.

The Clozex Team

Clozex Medical LLC
Ray Barbuto, manufacturing
Michael Lebner, inventor
Adhesives Research Inc.
Mark Keller, materials chemistry
Connie Rogers-Newcome, materials sales

Baril Die Co.
Daniel Baril, die and process development
John Weymouth, engineering

Delta Industrial Services Inc.
Ron Ganner, process engineering
Joel Oakes, design engineering
Dave Schiebout, equipment design and development

Sterile Technologies Inc.
Roman Stienss, sterilization consulting

STERIS Corp.
John Valukus, sterilization operations

Smaller + Cheaper + Easier = Better

Maria Fontanazza

People are always looking for things that are small, cheap, and easy to use. Why shouldn't that apply to infusion pumps, too? Members of a design team at Sorenson Medical Inc. (West Jordan, UT) found a way to accommodate those needs without compromising quality or safety.

“In medical design, we have to operate within an entire universe of regulatory standards,” says Bob Hitchcock, vice president of R&D. “The team's knowledge of the regulatory world allowed them to fairly quickly develop a pump that completely satisfies the needs of the marketplace. They really hit the bull's-eye.”

The team surveyed customers and realized that electronic ambulatory pumps with all the necessary safety features were too expensive. They were also difficult to use. “When you've just come home from surgery, you might need to make some changes in your bolus therapy. You need a degree in science to use other programmable pumps,” says Hitchcock. “This one is easy to use.”

Focus groups provided input on how programming could be simplified. From that information, the team created software that enabled users to interact with and intuitively program the pump. The devices went through a lot of testing to ensure their ruggedness and durability under just about any condition. “Every step of the way was a challenge,” says Hitchcock.

The team took advantage of the latest design technologies, from solid modeling to hard tooling, to manufacture a better product. Strategic partners helped develop prototype molds and get feedback on early designs.

The safety aspect was one of the larger design hurdles. “Imagine a consumer appliance in your hands that puts a solution into you, from chemotherapy to narcotics,” says Hitchcock. “You need a number of redundant safety circuits within the system to ensure that if something goes wrong, the pump will fail safely.”

The team explored every aspect of product design, right down to making a simple on-off switch that could be used by people whose health was compromised. This attention to detail paid off. The end product, ambIT, which stands for ambulatory infusion therapy, is a powerful intravenous programmable pump that costs under $500. Four other IV pumps also came out of ambIT's basic design.

“There's been great market acceptance with this product. It has a very low customer complaint rate, and we've had no regulatory problems,” says Hitchcock. The pump's acceptance even extends to Afghanistan and Iraq, where it is being used to help treat battlefield injuries.

The Sorenson Medical Team

Steven Bandis, project and mechanical engineering
Cassie Buck, testing
Kevin Gordon, electrical engineering
LeVoy Haight, engineering
Warren Harris, electrical engineering
Mike Stout, clinical marketing

Steady Partnership Pays Long-Term Dividends

Erik Swain

When two firms combine to develop 16 successful products over 15 years, there must be something special about the partnership. That is certainly the case with device maker Baxter International Inc. (Deerfield, IL) and product development consulting firm Insight Product Development (Chicago).

The relationship began in 1990 when the firms combined to design a peritoneal dialysis machine that worked so well that it remained on the market for almost a decade. The team has remained fruitful ever since. In fact, three of its projects have won Medical Design Excellence Awards in the past five years.

“The partnership began in a classic cold-call scenario,” recalls Craig Scherer, senior partner at Insight. “Baxter had a design-centric project but no in-house industrial design at the time.” The partnership has continued for many reasons, including that Insight has grown and evolved to adapt to Baxter's needs. “We have brought in additional disciplines and hired people with a wide range of educational backgrounds and technical skills. Our teams have really meshed well. Sometimes our projects are truly collaborative; sometimes we're just extra hands and do what we're told. Many times we can bridge the gaps in their expertise.”

Not surprisingly, Baxter divisions that have used Insight often recommend it to other Baxter divisions. “From the start, they recognized the value of outsourcing development work,” says Scherer. “That was very forward-thinking in the early 1990s.”

In the late 1990s, the team started using a Web-based project management system before those caught on in the mainstream. This enabled a level of collaboration previously not possible without a personal visit.

The firms' most recent MDEA winner, the Alyx portable blood collection system, was as close a collaboration as they have ever done. “It had six subsystems. We took responsibility for developing three, and so did they,” Scherer says. “Communication was key. We were on the phone at least once a week. Their project manager probably spent more time in our office than he did in his own. We were able to put proposals, deliverables, engineering drawings, and other materials on a secure Web site that could be accessed 24/7.” The end product incorporated a pneumatic pumping system, onboard separation of blood components, two-unit collection, and leukoreduction.

Their other MDEA winners were the Colleague volumetric infusion pump and the Syndeo syringe pump. If the partnership maintains its consistent success level, more could very well follow.

The Baxter–Insight Team

Baxter International Inc.
Fletcher Belt, engineering
Randy Meinzer, program director
Mike Platt, engineering
Jan Stewart, program director
Sandy Thom, marketing
Rohit Vishnoi, technology resources

Insight Product Development
Doug Brewer, senior partner
Dave Brown, R&D design
Jeff Condon, engineering
Scott Dallmeyer, industrial design
Ed Geiselhart, industrial design
Scott Alan Godoy, interface design
Matthew Jordan, research, interface
Elizabeth Lewis, research director
Craig Scherer, senior partner
Brian Woodard, engineering

Some Like It Lean

Erin Bradford

Members of the design team from The Tech Group (Scottsdale, AZ) and Bionix Development Corp. (Toledo, OH) love lean manufacturing. They found success by giving the engineers from both companies long leashes and the freedom to make decisions. “It was just a matter of Josh Noble [from Bionix] and Julie Pajot [from The Tech Group] talking back and forth and working through the issues,” says James Huttner, MD, cofounder of Bionix and vice president of new product development. “They were acting autonomously within their own group on the project, which really helped expedite changes.”

The team designed and developed a lighted ear curette, which illuminates the ear canal for easy wax removal by physicians. “This was not a technically simple project,” says Huttner. “What looked to be a fairly straightforward design issue turned out be very complex; that was not apparent until we got well into the tooling and manufacture of the device.” As work began, the team found that subtle intricacies in the design dictated strict critical dimensions.

Solving the problems came down to cycle time, says Huttner. Because there were no obvious solutions, prototypes were trialed, evaluated, and then trialed again. Each cycle was kept to a bare minimum, so the team was able to go through a number of project options very quickly—in a period of weeks—which greatly reduced time to market. “It really was an iterative process,” explains Huttner. “Each issue required a rapid response. Josh and Julie were allowed to make those changes without having to go back up the corporate ladder and get permission to do a tooling or a design change.”

“It was refreshing to have a lean project team,” says Shari Krusniak, marketing manager at The Tech Group. “Some teams can become very cumbersome, and the whole process can really get weighed down. The lean approach really helped expedite our communication and cut through a lot of red tape.”

But the collaboration went beyond design. The Tech Group got involved with the manufacturing and reproducibility, too. When team members from The Tech Group inspected Bionix's tooling and found that the design was not optimal for the device, they were able to create a better design and make a case for redesigning the tooling. The Tech Group then automated certain manufacturing processes. “That's what made the curette a manufacturable option,” says Noble.

“This is what happens when two companies work well together,” says Chris Tompkins, business development manager at The Tech Group. “They accomplish great things and new innovative products get put on the market quickly.”

The Tech Group–Bionix Team

The Tech Group
Shari Krusniak, marketing manager
John Kotwick, QA manager
Brian Meines, engineering manager
Julie Pajot, lead engineer
Chris Tompkins, business
development manager

Bionix
Susan Brangham, project coordinator
James Huttner, MD, new product development
Ed Markewitz, product development engineer
Josh Noble, lead engineer
Jamie Schlorff, product development engineer
Ted Turner, head machinist

An Accelerated Path to Success

Sherrie Conroy

Creating a handheld device for measuring blood hematocrit is a great accomplishment. Doing so in just nine months is amazing. In that short time, the design team at Key Technologies (Baltimore) came up with a novel technology that put the accuracy of a lab-grade instrument into a handheld hematocrit device.

“We work closely together in the same office on all of our projects,” explains Keith Lipford, who was in charge of regulatory compliance for the device. “Our environment is wonderfully conducive to close interaction, easy communication, and creative thinking.” He says the high ceilings, low walls, and shared spaces in Key Technologies' offices promote an atmosphere of open communication. Lipford also says he believes this team has a unique combination of “talent, wackiness, and humility.”

The UltraCrit, a handheld device that measures hematocrit levels in blood, is designed for use in point-of-care settings like doctors' offices, emergency rooms, and blood banks. The device fits in the palm of your hand and completes the measurement process in about 20–30 seconds.

“Tests of the handheld ultrasound technology showed accuracy levels that are comparable to large, lab-based automated cell-counting systems that cost hundreds of thousands of dollars,” says Lipford.

Part of the team's success can be attributed to the research it conducted before starting. “We conducted scientific research to understand the relationship between blood properties and ultrasound, and we researched the user need for a handheld device capable of lab-grade accuracy,” says Lipford. With this information, the team developed a novel, disposable cuvette that allows direct contact between blood and ultrasonic signals. To make it work, the team also had to develop affordable ultrasonic circuitry and signal-processing algorithms for the device.

Sam Reed, the hematocrit device's project manager, was responsible for keeping everyone on task for the project, says Lipford. “He used frequent—but short—team meetings.” Team members also held one-on-one discussions throughout the process.

Employees at the company undergo extensive evaluations of professional and personal skills to ensure that each person is a good match for the company as a whole, Lipford explains. “Design teams come together, dissipate, and rebuild on a project basis, so members need to be talented, open, and inquisitive.” He says that effective performance is a must because the company requires constant, open communication.

“We combine the discipline of detailed product specifications up front with early and frequent input from the product's end-users.” The team stays focused on a project by keeping the specs for the device and the end-users' needs in front of them. “We keep them with us while we work, consulting them at least once a week. Challenges are identified and shared honestly and openly, allowing us to attack them fast,” he says. “Admitting what you don't know accelerates the path to success.”

The Key Technologies Team

Scott Corey, inventor and electrical design lead
Eva Dixon, performance testing and clinical evaluations
Reuben Johnston, embedded system software design
Josh Keller, embedded system design
Ben Lane, mechanical design lead
Brian Lipford, project oversight and sales strategy
Keith Lipford, regulatory compliance
Brian Murphy, mechanical design
Sam Reed, project manager
Chad Schneider, mechanical design

Unusual Partnership Gives Rise to Innovative Device

Erin Bradford

After conducting and analyzing war scenarios following Desert Storm in 1993, the Defense Advanced Research Project Agency (DARPA) gave the Walter Reed Army Institute of Research (WRAIR) a mission. They were to create a man-portable life support system in which the equipment would be automatically controlled by sensor inputs coming from different medical devices.

But before the system had automation, it needed integration. DARPA generated a request for proposal (RFP) for an integrated system that contained both monitoring and therapeutic systems. Although the RFP was sent out to many companies, including device manufacturers, in 1994, it was awarded to Northrop Grumman Corp. (El Segundo, CA), an aerospace company. The company joined with WRAIR, and a team was born. In 1999, Northrop Grumman created Integrated Medical Systems Inc. (Signal Hill, CA) specifically to design and build the system.

Odd bedfellows for making a medical device, you say? Not really, says Frederick J. Pearce, PhD, chief of the department of resuscitative medicine at Walter Reed. “WRAIR provided the medical expertise while Northrop Grumman provided the integration,” Pearce explains.

But that's where the easy part ends. Team members came across many obstacles, such as space constraints, weight requirements, and cost. And, because the systems were to be used to transfer patients from the battlefield using helicopters, the team also struggled with electromagnetic compatibility, shock, vibration, and acceleration issues. “We had to make sure that we didn't affect the avionics of the aircraft,” Pearce says. Plus, to enable full access to the patient, all the equipment had to fit underneath the bed—a 5-in. high space.

The team did eventually get a few breaks. They integrated off-the-shelf items into the system, which cut down on development time for the team and training time for the users. Also, coming from a defense and aerospace background, the companies were used to dealing with multiple suppliers and protecting different companies' proprietary information. “We were working with half a dozen different suppliers of medical equipment in the integration,” says Todd Kneale, vice president for program management at Integrated Medical Systems.

The team conducted the FDA process while it was still a part of Northrop Grumman. Once FDA reviewers got through Northrop's security checkpoints, they found that the design environment was very compatible with the controls that FDA has for medical device manufacturers. The team was already working at a design level consistent with agency expectations, so when Integrated Medical Systems spun off as a separate, stand-alone medical device company, it was familiar with strict process control.

The system received FDA 510(k) clearance in 1998 and CE mark approval in 2001. But the team isn't finished yet—its members are continuing to work on next-generation systems. “It's been 10 years since we started this,” Pearce says. “We joke that it seems like forever, but in the context of product development, I'm learning that it's not such a long time.”

The IMS–WRAIR Team

Integrated Medical Systems Inc.
Richard Bongiovanni, pneumatics
Terry Domae, information systems
Don Hanks, information systems, medical subsystems
Trinidad Hernandez, medical subsystems, sustaining engineering
Todd Kneale, program manager, design team leader
Keith Laband, information systems
Susan Marosek, information systems
John Quillen, quality
Iralynn Rumbaoa, medical subsystems, engineering documentation
Bill Sobko, electrical
Erik Smith, mechanical

U.S. Army Walter Reed Army Institute of Research
Alison Garcia, data structure
Ken Johnson, MD, clinical feedback
Jaime Le, information systems
Lawrence McBean, training and evaluations
Frederick J. Pearce, PhD, design team leader

Creative Thinking Could Save Lives

Sherrie Conroy

When a design team creates the world's first powered intraosseous (IO) drug- and fluid-delivery system, they have a reason to be proud.
“We created a system that provides a highly significant time savings to IO delivery,” says Chuck Schwimmer, the director of design and human factors for BC Tech (Santa Cruz, CA). “This device is revolutionizing vascular access for emergency care. Extra seconds may literally mean the difference between life and death to a trauma patient.”

The design team for the IO device was made up of a special blend of experts from BC Tech and from Vida-Care (San Antonio, TX). Members included an emergency medical physician, EMT practitioners, mechanical engineers, industrial designers, human factors specialists, and electrical engineers.
“The team knew that to be successful, the IO device had to meet the broad needs and rigorous demands of EMT practitioners,” says Schwimmer.

According to Schwimmer, the team balanced these diverse points of view by maintaining focus on the aspects of the device that related to their own expertise. For example, he says, “The EMT practitioners contributed information that led to product requirements for what the end-users needed, such as small size, commonly available battery type, impact resistance, and so on.”

Likewise, he says the mechanical engineers contributed design features for durability, reliability, etc., and the human factors specialist contributed input such as the ideal angle between the handle and grip area and the needle. This process also included input from focus group participants. “With regular input from the practitioners, the team produced numerous design iterations,” he says.

“When any input conflicts arose, which was infrequent, it was the job of VidaCare's president, Larry Miller, to make a decision regarding a direction,” says Schwimmer. This was especially true, he says, if the decision might affect cost, time to market, or the ability to optimize usage for any particular end-user, such as military medics versus civilian EMTs.

“The caliber of talent and level of professionalism of this team is the greatest that I have ever been a part of,” says Schwimmer. In particular, he notes that the team members had extensive experience working on device development for the medical industry. “That extensive experience combined with the professional expertise led to smooth and efficient development work and helped to ensure a smooth, rapid FDA 510(k) allowance process.”

The VidaCare–BC Tech Team

VidaCare
Scotty Bolleter, EMT-P, educator
Stan Marett, project manager
Larry Miller, MD, president and CEO
Robert Titkemeyer, director of operations and regulatory affairs

BC Tech
Jerry Allen, CNC machinist
Matt Bentley, industrial designer
Ben Clawson, president
Brad Craig, shop manager
Jay Daulton, senior mechanical engineer
Paul Hsei, senior mechanical engineer
Andrew Letton, senior mechanical engineer
Pete Lombrozo, mechanical engineer
Chuck Schwimmer, director, design and human factors
Takashi Yogi, senior electrical engineer

Up-Start Engineers Bolster a Start-Up

Maria Fontanazza

As if a start-up company doesn't face enough obstacles, Innovative Spinal Design (ISD; Jupiter, FL) took an unusual path by hiring two engineers with no medical experience. It may seem like a risky move, especially considering that three surgeons own the company, but these outsiders became part of a team that developed 12 patent-pending fusion and nonfusion spinal implants in two years.

“It was difficult for everyone to come to grips with making a successful design team without using engineers with a medical background,” says Leigh Cowden, VP and COO of ISD. “It sounded out-there, but we thought it would be worth the investment.”

ISD was looking for engineers who could formalize the creative ideas of its director of design and development, Matt Baynham. After a year of searching, the company found two men, Pete Conway and Layne Johnson, who were undersea robotics engineers. They didn't have a medical background, let alone knowledge about the spine. “It was a shot in the dark, but we went outside the industry and made it work for us,” says Cowden. “They brought Matt's designs to a whole new level.”

The team spent a lot of time showing Conway and Johnson how the spine works on a model. They focused the education on a project-by-project basis to avoid overwhelming the engineers.

The two men brought a unique design perspective, because they thought outside of the box without even trying. There could be similarities between the mechanical concepts of the robots and the way spinal hardware comes together, Cowden says.

ISD's engineers don't fit a stereotypical mold either. These Floridians wear flip-flops to work and surf in their free time. “We try to keep a comfortable and casual work environment so that people enjoying coming here,” says Cowden. “Everyone feels like they're part of a family.”

Cowden's role is to provide the outside patient perspective. “Engineers can get caught up in the mechanics of how things work,” says Cowden. “It helps to have a nonattached person, an outside person willing to tell them that their baby is ugly.”

The flexibility of the design team enabled them to make changes under intense pressure. “We'd order in lunch or dinner, go over the drawings, and come up with a solution in a very short period of time as a supportive team,” says Cowden. “These men are so technical, yet so open-minded. Oftentimes, I think engineers are portrayed as being in love with their design, and unyielding when it comes to listening to other design input. It's just not that way with our group. They're the unsung heroes.”

ISD's first spinal product is a delivery device licensed to Zimmer Holdings Inc. (Warsaw, IN). The company also just received 510(k) approval for its anterior cervical plate.

The Innovative Spinal Design Team

Matt Baynham, design and development
Pete Conway, design engineering
Leigh Cowden, VP and COO
Tony Cunningham, prototype design
Layne Johnson, design engineering
Bill Schmeig, prototype design

Innovative Design without Precedent

Erik Swain

Easing atrial fibrillation (AF) is a tough challenge for the makers of cardiovascular devices. The ablation system pioneered by Epicor Medical Inc. (Sunnyvale, CA) proved so promising that it piqued the interest of an industry leader. Not long after the device ablation system, called a High-Intensity Focused Ultrasound (HIFU) ablation system, was finished, St. Jude Medical Inc. (St. Paul, MN) made a move. Having invested $15 million in the company in May 2003, it purchased the remainder of Epicor Medical for $185 million in June 2004.

Epicor designed the basic system, involving a ring of ultrasonic transducers that deliver energy to the heart muscle, and a cabling system. To design the console that drives and controls the device, Epicor enlisted an outside design firm, Aubrey Group Inc. (Irvine, CA). The console had to deliver the high-power ultrasound to the transducers, which produce the myocardial lesion.

“If lesion formation is controlled properly, arrhythmias can be eliminated,” says Vytas Pazemenas, Aubrey Group's president. “The challenge is both generating the appropriate signal and coupling it to heart tissue. Compensating for the inherent variations in the physiology presented enormous challenges.”

Epicor designed the transducer and cabling system. Not only did Aubrey Group have to design the drive console, it had to integrate it with the transducer system. Epicor had given Aubrey a list of requirements, but otherwise gave it free rein. Close communication and teamwork were essential. “Power and focus must be controlled very accurately,” says Pazemenas. “There are complex electronics for setting, controlling, measuring, and focusing the power delivered to the transducers. Since the power requirements were high, the output stages had to be very efficient. This type of system had not been designed before. Therefore, there were no examples to follow.”

Epicor gave its and Aubrey Group's engineers plenty of leeway during the design process. For the console, Epicor provided product requirements, but Aubrey Group's engineers had to develop a design that worked. Communication between the two firms was constant, and Aubrey Group's team developed a close working relationship with Epicor's project manager, Tim Ciciarelli, who reported to Epicor's vice president of R&D.

The team met all the challenges and the product became a success. James Cox, MD, a pioneer in AF surgery, was effusive in his praise. “I find the Epicor Medical approach the most compelling technology available to surgeons,” he said in 2004. “[It] has the potential to open up entirely new patient populations to procedures . . . not previously available to clinicians.”

The Epicor–Aubrey Team

Epicor Medical Inc.
Tim Ciciarelli, project manager
Mike Holzbaur, mechanical engineering
Jon Podmore, mechanical engineering manager

Aubrey Group Inc.
Jahnavi Lokre, senior software engineering
Randy Ponitzman, senior electrical engineering
Bruce Sargeant, project manager
Milan Trcka, director, electrical engineering

Unique Approach, Unique Result

Maria Fontanazza

Do you think that comparing a mouth's soft palate to part of an airplane would lead to a treatment for sleep apnea? The design team at Restore Medical (St. Paul, MN) did, and that idea resulted in the first FDA-approved implantable treatment for mild to moderate obstructive sleep apnea (OSA). Its success shows how exploring an unusual point of view can pay off.

The team had an aeronautical engineer develop a wind tunnel to simulate the throat and airway. This approach associated the palate with an airplane's wing structure during changing wind conditions. The initial model used a leather tongue and a Shop-Vac vacuum. “We were able to demonstrate how the placement of our implant would dramatically affect the flutter of the soft palate,” says Phil Radichel, director of quality and systems. In fact, Restore Medical videotaped the experiment and posted it on a Web site to help explain the concept to physicians.

Convincing doctors to adopt a new method for treating OSA wasn't easy. “Most physicians felt that successfully treating OSA required removing tissue from the airway,” says John Sopp, vice president of operations. “Our procedure isn't one that removes tissue. We actually add something to the soft palate to restore the tissue's structural integrity.” The Pillar Procedure uses palatal implants to help prevent airway blockage and lessen the vibration caused by snoring.

Turning doctors on to their actual concept didn't happen overnight. “Most physicians are often skeptical of new products and procedures, and rightly so. For any new medical device company, it's very important that you have a science-based development approach,” says Sopp.

The team developed different training models to familiarize doctors with the procedure. The most elaborate was a full-sized human head with a simulated soft palate. It enables a doctor to position the head in any manner, as if it were a real patient. After practicing, the doctor can open up the model and examine the placement of the implants.

Good organization within the company also helped maintain team momentum. Its intranet system contained documents and experiments about projects, keeping them up-to-date with design changes to avoid backtracking. “As well as having access all the time, the team worked closely together,” says Radichel. “Whoever was available to do something did it, whether in quality, engineering, or production.”

Despite being part of a relatively new company, the team took a risk with their unique method and were rewarded with a product that was the first of its class to market. “We have a different approach than a lot of start-up companies,” says Sopp. “Rather than a technical push, we look at market, determine what technology meets that need, and then develop the technology. It's a very different way of looking at things.”

The Restore Medical Team

John Foster, commercial operations
Kurt Krueger, development engineering
Ed Numainville, clinical/regulatory
Phil Radichel, quality and systems
John Sopp, operations
Larry Walter, manufacturing engineering

Cheaper by the Dozen

Brendan Gill

Releasing three dozen products at once sounds daunting, but for Fresenius Medical Care (Lexington, MA), it was essential. The company, a branch of the German Fresenius Medical Care AG (Bad Homburg, Germany), released 36 peritoneal dialysis products for people living with end-stage renal disease. The products, part of the company's Stay•Safe and Newton IQ System, were designed to give patients more freedom from the clinic.

“We created a system that makes it easier for patients to perform peritoneal dialysis at home,” says Tom Williams, peritoneal dialysis product manager at Fresenius, “instead of coming into the clinic and spending the better part of their day hooked up to a dialysis machine.”

“The Stay•Safe and Newton IQ System allows them to do it at home on their own time,” he adds.

Team unity was important to the staff at Fresenius. Weekly video- and teleconferences were the norm throughout the design process, as were regional and international trips. Also, Fresenius engineers from Germany traveled to the United States to work closely with their American counterparts. The multinational collaboration was important, Williams says, because the company wanted to break into more than just the U.S. markets.

“Working with the members of the Bad Homburg engineering team allowed us to learn,” Williams says. “It helped us come up with a design that will be accepted and embraced by other markets.”

The Fresenius Design Team

Chris Chau, project engineer
Lynn Jensen, project manager
Debra Mollicone, clinical manager
John Oliver, project engineer
Lisa Parker, project engineer
Tom Williams, product manager

It's the Little Things That Count

Brendan Gill

One goal of the design team at Medtronic Inc. (Minneapolis) when they developed the Straightshot M4 Microdebrider was to improve ergonomic features. As a result, the Microdebrider's curved, rotatable blade affords surgeons greater access to the frontal and maxillary sinus for removal of polyps, bone, and diseased mucosa.

“Our device has a curved, rotatable blade that no one in ENT has,” says Bo Lewis, marketing director at Medtronic. “With the Microdebrider, surgeons can cut sideways, rotate the entire nose, or rotate [the device] 360°.”

Other features of the device include grooves and clips in the handpiece's side to aid in tubing management, and an integrated blade-locking function. The device also features a sculpted design and a “chin” on the handpiece for multiple hand positions.

Speed and improvisation were keys to the project's success. The manufacturing engineers' ability to craft working prototypes also contributed to the Microdebrider's 7-month concept-to-launch development cycle. Metaphase Design Group Inc. (St. Louis) also helped design the device, emphasizing a “people-first” approach to ergonomics. “If I don't understand how people think, feel, and behave,” says Bryce Rutter, CEO of Metaphase, “then I don't know how to design a product that's going to be successful.” One of Metaphase's important contributions was to accurately predict key needs for a range of users, including small-statured female surgeons.

“One thing we did was to have two small female surgeons come into our cadaver lab [to try out the device],” Lewis says. “They do tend to have a little less leverage, so there's a chin on the front end of the handpiece to increase that.” he says. “So, we tested that out with modeling clay. We attached some modeling clay to the handpiece, which allowed the surgeons to use it the way it was designed.”

The Medtronic–Metaphase Team

Medtronic Inc.
Mike Ferrell, senior manufacturing engineer
Ron Graves, designer
Joel Hembrock, senior designer
Reuel Ignacio, designer
Bo Lewis, director of marketing
Jerry Norman, principal mechanical engineer
Chip Perry, designer
Dale Slenker, R&D engineer

Metaphase Design Group Inc.
Brian Bone, director of ergonomics
Bryce Rutter, founder and CEO

Copyright ©2005 Medical Device & Diagnostic Industry