Industry Roundtable: In Search of an Earlier Payday

Moderated by Steve Halasey

To learn more about the industry experts involved in this roundtable, click on the names below
Robin Bostic, Smith & Nephew Inc.
Kim Norton, Vertis Neuroscience
Randel Richner, Boston Scientific
Jo Ellen F. Slurzberg, Cypress Bioscience Inc.
The litany of complaints that have been heaped on the Medicare coverage, coding, and payment system is no doubt familiar to most U.S. medical device manufacturers. Last September, those industry views were formalized in a report titled The Medicare Payment Process and Patient Access to Technology, which was commissioned by AdvaMed (Washington, DC) and compiled by the Lewin Group (Falls Church, VA).

Not surprisingly, the Lewin Report is highly critical of the Health Care Financing Administration (HCFA, Baltimore). In some detail, the report builds the industry case against HCFA's operation of the Medicare reimbursement processes, which it says are "complicated and time-consuming, impeding patient access and discouraging innovation of breakthrough technologies."

Robotics and Electronics Research Aid in Building "Smart" Prostheses

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published January 2001

William Loob

A complicated assemblage of pneumatic tubes and metal rods hangs in the BioRobotics Lab at the University of Washington (Seattle). It vaguely resembles a human arm that has been stripped of its skin to reveal the underlying musculature and skeletal structure. And that is exactly how it should look, according to the team of research engineers and scientists who built the contraption. A fully functioning version of the machine is the goal of the lab's Anthroform Arm Project—one of two current research efforts aimed at developing robotic components that are capable of imitating biological systems.

The Anthroform Biorobotic Arm uses McKibben artificial muscles, bundles of pneumatic actuators that exhibit many properties found in human muscles.

Although the original intent of the project was not to improve on existing prosthetics technology, the effort could someday lead to development of an artificial arm that enables an amputee to regain the full range of motion offered by a natural arm. The lab's director, Blake Hannaford, PhD, states that, in this case, creating a more effective robotic system required the engineers to learn from other technical fields. One practical benefit of such an interdisciplinary approach might well be a more efficient prosthesis design.

Increased efforts to address the problems associated with unexploded land mines in some parts of the world have focused attention on the field of prosthetics and orthotics. Greater consciousness about amputee quality of life has also promoted research efforts to develop a new generation of products. Some of the technology being explored for use in advanced prosthesis designs is being drawn from disciplines outside of conventional orthotics and prosthetics development.

The complexity of human limb movements has posed difficult challenges to prosthetic-limb designers. Restoring the functions of a natural arm or leg has been difficult, and most designs for artificial limbs are generally able to perform only the simplest functions of the missing extremities. The technologies now in development are expected to address such limitations in conventional systems. In addition, specialized prosthesis designs are emerging to meet the needs of amputees who are involved in a range of physical activities.

One of the persistent problems of prosthetics development is designing a suitable method for attaching the prosthesis to the remaining stump. The goal is to maximize comfort yet retain firm and stable contact for controlling the limb. Use of rigid materials means that the fit of a prosthesis will vary over the course of the day as the stump tissues swell or shrink. The result is often discomfort and reductions in controllability. Sores can also become a problem and may limit the length of time an amputee can wear the prosthesis.

Prosthesis designs can have a significant effect on an amputee's normal gait and the physical responses to prosthetic limbs. Researchers analyzing the gait of patients using prosthetic legs have found that amputees often compensate for the loss of their natural walking gait with unnatural body movements to accommodate the prosthesis. Tailoring a design to restore more-natural movements for the amputee not only would increase comfort, but also could actually reduce fatigue.


Prostheses can be fabricated from materials selected to provide characteristics suited to the specific mechanical requirements of a given activity. An amputee often needs to switch between different prostheses, however, to engage in different activities. Some firms are incorporating "smart" materials and components into prosthesis designs in an effort to expand the range of environments in which a prosthetic device will perform most efficiently.

A prosthetic leg developed for above-knee amputees by Biedermann Motech (Schwennigen, Germany) uses an array of sensors in the artificial knee component to detect force and moment exerted on the prosthesis and the angular position of the knee joint. The mechanism also includes a damping device filled with a magnetorheological fluid that can adjust rapidly to changes in external forces. Input from the sensors and software algorithms control the damping qualities of the device. The fluid, which was developed by Lord Corp. (Cary, NC), is designed to change consistency—from a fluid to a near-solid state—in response to the strength of a magnetic field applied to it. According to the company, the time required to react to changing forces is 20 times faster than systems that use passive fluids. Such results more closely match human neural response times than hydraulic mechanisms with motor-controlled valve systems, according to the firm.


Development of systems that emulate biological models promises to yield significant advances in prosthetics technology. Efforts to mimic human anatomy with mechanical systems at the BioRobotics Lab have focused on the use of actuators bundled into what is called the McKibben artificial muscle. The pneumatically operated actuators provide a high force-to-weight ratio, the researchers indicate. In addition to the arm project, the lab is engaged in developing a prototype of a lower-limb prosthesis that is also powered by these actuators.

"We started with the robotic arm development project, and prosthetics is a natural application for such an arm," Hannaford says. "We wanted to see how far we could go with this idea." The early work on the project, which was focused more on robotics, led the lab's team to seek out medical researchers working with prostheses. The lab is also collaborating with the Veterans Administration Medical Center in Seattle to develop potential applications of the system for below-knee amputees.

Researchers at the BioRobotics Lab became intrigued by the physical energy requirements of conventional prostheses. "We learned that for an amputee with a conventional prosthetic, the rest of the body is compensating with energy: The amputee is working harder to walk at the same pace as a normal person." A power-assist system capable of replicating the function of natural muscle seemed to be a logical solution to the problem, Hannaford explains. "We thought that the gait of a prosthesis wearer would be more natural if we could replace some of the power of the lower-leg muscles." The team is still building a functional prototype of the powered prosthetic leg, but the main design effort is complete.

After the working prototype is finished, Hannaford says, the project team will move on to the next phase. They will assess how well an amputee adjusts to using this type of device and whether it can save energy for the prosthetic wearer. "We still need to take measurements and ask: 'What does an amputee's gait look like using an active limb replacement, versus how he or she uses a passive prosthetic?' and 'How much energy is the amputee using?'"

The development of a workable power-assist system would be a significant advance in the state of limb-prosthesis technology. The artificial muscle is easy to make, Hannaford says. The amount of strength per unit of weight and area is within a range to make the mechanism practical in this application. "It is actually a little stronger than human muscle, and the weight is comparable to the natural muscle mass." The bundle of actuators is capable of equaling the power supplied by the natural muscles that move the foot at the ankle joint. Hannaford admits, however, that the actuator bundle must also compensate for the weight of the compressed-air source. Also, the artificial muscle has a shorter range of motion than human muscle.


Researchers at Sandia National Laboratories (Albuquerque, NM), working in collaboration with engineers at the Russian nuclear weapons lab at Chelyabinsk-70 and the Seattle Orthopedic Group (Poulsbo, WA), are taking a more inclusive approach to addressing the most common problems for amputees. The international research team began a project this year to develop a prosthetic leg capable of adjusting itself to an amputee's gait, and of adapting to changes in the stump shape caused by tissue swelling.

Sandia's synthetic lower limbs are expected to provide the foundation for the next generation of prostheses.

Sandia is developing the set of sensors and microprocessing chips that will provide information to the "smart leg," then calculate the optimum movement of its components to support the walker's gait. The system will be capable of altering the wearer's gait in response to changes in terrain.

Like Hannaford's group, the Smart Integrated Lower Limb Project will focus on reducing the energy an amputee will need to exert to walk with a prosthesis. The smart leg will be designed to simulate the human gaits used on uphill and downhill slopes, or on less-predictable and irregular terrain.

One set of sensors placed along critical points in the prosthesis components will feed data to microprocessor-based Controls used to govern hydraulic joints and piezoelectric motors that power the ankle- and knee-joint mechanisms. A second group of sensors in the leg socket will enable the device to compensate for any changes that occur in the diameter of the stump over the course of a day. Designing the prosthesis with a self-adjusting socket for attachment to the stump is a major goal that researchers believe will enhance overall efficiency. Not only are pressure sores a nuisance associated with lower-limb prostheses, discomfort can affect the wearer's physical posture and gait. Researchers expect the complement of improvements in performance to extend the effective time of use for leg prostheses.

"The majority of lower-limb prosthetic devices are based upon passive technologies," says Dave Kozlowski, a Sandia robotics specialist. Without powered systems to operate moving parts, passive prostheses rely on inertia to open the knee joint as the thigh moves forward so that the shin can then swing forward. The amputee must generally wait for the assembly to lock into its new position before the prosthesis can support the body as it moves forward.

This series of functions does not allow for a natural gait, Kozlowski explains. Without powered components, prosthetic legs "require far more energy for amputees to cover the same distance as nonamputees." Achieving proper limb motion will ease the physical effort of using an artificial leg—rather than draining energy from the wearer, he says.

One of the more difficult challenges of the project is developing a power source that is light enough to be practical, yet adequately robust to operate all of the required systems, according to the group. The Sandia researchers estimate that a marketable version of the system may be developed within about two years.


The user's ability to control a prosthetic limb has been a particularly difficult problem to overcome with upper-limb prostheses. The range of motion required for arms, hands, and fingers involves the use of a complex set of variables that must be addressed by prosthetic mechanisms, and a correspondingly complex control interface to communicate with the device and direct its movements.

Animated Prosthetics (Greensboro, NC), a company specializing in prosthetic-control circuits, has developed systems to allow amputees to exert myoelectric control of hand and wrist movements in the prosthesis. The firm's Animation Control Systems circuits are based on use of different algorithms to respond to myoelectric signals from a patient's stump. The circuit response depends on the strength of the signal that is received. Gaining conscious control over the minute electrical signals generated by the muscles can be a difficult task for amputees to learn. To facilitate learning, the company designs its circuits to opt for a simpler operational algorithm to control the prosthesis when the signal is weak, as it is when the patient is still learning to regulate the signals sent to the device. Under those conditions, for instance, the circuit controls the grasping function of the hand with a simple, open-and-immediately-close operation. As the amputee learns to control the signals better, the algorithm adapts to keep the grasping appendages open until it receives a close command.

The Edinburgh Arm System uses self-contained modular actuators.

Researchers are working on more advanced interfaces, however, which will be capable of returning full control to the patient. A number of research groups are exploring development of direct neural interfaces that will link the thought of an action with a signal that can be directly interpreted by a robotic device. One such project currently being conducted at the Georgia Institute of Technology's Biomedical Interactive Technology Center (Atlanta) is investigating whether signals recorded from micromachined electrodes implanted in the motor cortex can be reproduced to instruct robotic systems to prompt the movements associated with a conscious thought of the corresponding actions.

Neural signals associated with defined arm and hand movements are processed using pattern recognition techniques to determine the intended movement of an individual's arm. The same signals are then used to instruct a robotic arm to move according to control parameters derived from the neural data. Researchers at Emory University (Atlanta), who are collaborating in the project, have tested the system on a group of rhesus monkeys. Project funding from the NIH Neural Prosthesis Program is supporting the research and the development of similar technologies.


An intriguing application of sensor technology is being used to feed information back to the amputee. Two systems invented by John Sabolich at his lab, Sabolich Research and Development (Oklahoma City), are designed to restore an amputee's temperature sensitivity through a prosthetic arm and pressure sensitivity through a prosthetic foot. The Sense of Feel Sensory System connects a pair of pressure transducers in the sole of an artificial foot to a circuit that conveys a signal to electrodes in the leg socket where it contacts the skin of the stump.

The circuit delivers a "tingling" sensation to the skin, which varies in amplitude corresponding to the force detected by the transducers. The ability to sense the difference in signal strength between the front of the foot and heel enables the patient to learn to interpret whether body weight is balanced over the foot. In the system developed for artificial hands, temperature sensors deliver signals corresponding to a hot or a cold sensation as interpreted by an onboard microprocessor. Both systems are being tested currently on amputees. Sabolich states that new patients are generally able to begin interpreting the signals as the proper sensations after only a few minutes of use.


Only a few years ago futurists and science fiction writers speculated about the potential of smart prosthetic devices to improve the quality of life for amputees. They visulaized the promise of creating prosthetic mechanisms capable of more naturally emulating the appearance and function of human limbs. Today, the development of advanced prostheses is benefitting from increased collaboration between old competitors, and by the use of new materials technology, as well as emerging processing and mechanical concepts.


Efforts to develop advanced prosthetic systems are clearly benefitting from the rapid changes occuring in the materials and computing sciences. The end of the Cold War and the refocusing of the nation's technological capabilities away from weapons research and toward helping the victims of war has become a significant factor in the development of prosthesis technologies.

In 1999, a unique collaboration was initiated between nuclear laboratories in the United States and Russia. The arrangement between Sandia National Laboratory and the Russian laboratory known as Chelyabinsk-70 called for the two former adversaries to work together on the joint development of advanced prostheses.

One of the driving factors behind the collaborative effort was to provide advanced treatment options for victims of land mines. "Someone in this world loses a limb to a land mine explosion every 20 minutes. Our work, though only remedial, will help land mine survivors and other amputees," said Sandia chemist and project leader Mort Lieberman when the project was announced. He added that, "We will have created the world's biggest research center for lower-limb prostheses in a Russian laboratory." Lieberman also serves on the executive board of the International Institute for the Prosthetic Rehabilitation of Landmine Survivors.

The first collaboration, aimed at development of an artificial foot, resulted in significant improvements in motion over currently marketed prosthetic feet. A subsequent project, a mechanical polycentric knee, was based upon Sandia's electronic expertise and Russian materials knowledge. The partners' efforts were focused on creating, respectively, the brains and shape of the knee. "The work is a good fit with the capabilities of both labs," according to Lieberman. "It involves stress analysis, mechanical testing, reliability testing, microprocessor control, and materials analysis."

Sandia Laboratory's mechanical polycentric knee weighs 1.37 lb and is 4.12 in. tall.

Under the collaborative agreement, the Ohio Willow Wood lab (Columbus, OH) was responsible for defining the requirements for parts and for performed final laboratory and clinical testing. The Russian lab designed the titanium housing, and Sandia's robotics researchers designed the knee's internal workings and electronics. The project received approximately $1.4 million in initial research and development funding.

The researchers emphasize that a knee must offer a variable speed of response. It must also lock to keep the wearer from falling when standing. They explain that the knee is more than a simple hinge. It must offer adequate control and stability to the wearer.

The ongoing U.S./Russian project is also expected to help the prosthetics industry as a whole. The industry has typically been dominated by small companies, which have relatively limited support. Most often, they lack the necessary resources to perform the type of testing that is possible at the nuclear laboratories.

The current research project, development of the "smart" leg microprocessor-controlled prosthetic to help lower-limb amputees obtain a more natural gait, is only one of the proposals that have been submitted by the Sandia and Chelyabinsk-70 researchers to various funding organizations. Other proposals deal with the creation of sockets capable of adjusting to the swelling and shrinkage of an amputee's stump during the course of the day and knees that can help prevent falling when a wearer stumbles.

William Loob is a medical writer living in Brooklyn, NY.

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Copyright ©2001 Medical Device & Diagnostic Industry

Improving Investor Relations

Originally Published January/February 2001

Maintaining open communications can keep shareholders happy—and dollars flowing.

Joanne Stephenson

It never ends. From the initial public offering to the latest product offering's anticipated effect on the bottom line, investors want to know what a business is planning—and they want to hear that information directly from the company. Medical device companies' investor relations strategy should be threefold: 1. Communicate. 2. Communicate. 3. Communicate.

In the short term, clear, honest, and well-thought-out communications can help companies' financials. "A company that doesn't provide meaningful information to investors will face a significant discount in value," Michael A. Rocca, CFO of Mallinckrodt Inc. (St. Louis), told MX earlier this year. "Companies can lose 1 to 2 P/E points, or more in some cases, simply because they are not providing adequate information." In the long term, having trusted, well-maintained relationships with investors will stand medical device firms in good stead when the inevitable, unforeseeable problems or delays occur.

Integrating Innovation Into Medical Device Companies

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published January 2001

Stacey L. Bell

Far more than the latest passing management fad, innovation is a concept that, if used properly, will propel medical device companies and their shareholders to a higher level of profitability. This article lays out the steps for establishing an "innovation culture" within a company to help reduce operational costs and increase market revenue.


People often use the words creativity and innovation interchangeably; however, there is a distinction. "Creativity is the process of developing new or interesting ideas, and innovation is implementing those ideas into valuable or profitable solutions," says Gerald Haman, founder of SolutionPeople (Chicago). Haman adds, "Innovation is how firms profit, gain value, or make money from creativity."

"Innovation as a concept has always been around," says Ruth Ann Hattori, vice president of marketing for Innovation Network (Denver), "but it's been associated with new inventions. These days, innovation is a broader term that encompasses not just new products and new applications, but new business models and concepts."

"Businesses and industries as a whole are latching onto the notion of innovation as the next technique to move them into the future—just as they did with total quality management (TQM) and other management techniques of the past," says Hattori. She points out that the fundamental difference between innovation and TQM is that the concept of innovation is centered on creating new streams of revenue and reducing costs, while TQM only focuses on the latter.


Many medical device companies may think that their current management practices encourage creativity and imagination, but that may not be the case. In order for a company to survive and thrive in the future, Hattori suggests that market leaders must ask themselves several questions to help imagine the future and determine a new way to fit into the world. Her questions include:

  • What will the future look like in not 5, not 10, but 20 years?
  • How will people live then?
  • How does our company fit into that picture?
  • Will our current business model and products take us there?

Even in an industry such as medical device manufacturing, which is well known for technological innovation, there are compelling reasons to reevaluate a company's innovation practices, says Haman. As one example, he notes that "product innovation is the easiest type of innovation to steal. Other types of innovation— process innovation, the way people are managed and the resulting culture, and marketing innovation—are more difficult for other companies to borrow."


"When companies launch a new initiative, they often expect to see a turnaround in six months," says Andrea Woodward, vice president of sales for Innovation Network. "But that's not a reasonable time frame for reshaping a company's culture and making it more amenable to innovation. Those kind of changes could take two years to show real results."

The first place to start to foster an innovative workplace is with top managers. Tom Kelley, general manager of IDEO (Palo Alto, CA), whose firm has worked with clients to invent and refine insulin pens and blood analyzers, says, "Companies must let employees know the value placed on innovation, and then evaluate employees' contributions in this area during performance reviews." Also essential to creating a climate that allows innovation to happen are being open and listening to new ideas, tolerating risk taking, and fostering trust and respect for others in the workplace.

Innovation is nourished by both the social and physical environments in the workplace. "Innovation is a team sport," says Hattori. "A great idea contributed by an individual can be improved by the thinking and contributions of a group. But for ideas to be shared, people need to know they'll be heard and respected."

Physical environment plays a part as well. Haman warns of "cubicle creativity"—where employees are stuck in small, sterile spaces—which constricts their capacity for innovation. Ideally, individual offices would be clustered in neighborhoods surrounding a team meeting room or table.

Haman, a former recruiter for Procter & Gamble and Arthur Andersen, relates that "innovation can also help companies recruit better people and increase their employee retention rate. People don't leave their organizations necessarily for greater compensation or managerial reasons; they leave because they want an environment that lets their creativity and imagination soar."

  • Innovation University in California, run by Innovation Network (Denver), enrolls 20 fellows in a yearlong program that brings people from diverse industries and companies together to pursue innovative thinking and processes and tour innovative organizations. Professionals from Baxter, Becton Dickinson, and Eastman Kodak have participated."No company is absolutely innovative," says Andrea Woodward, vice president of sales for Innovation Network. "The discussion that occurs between diverse companies in diverse industries is the richest part of the program." Innovation Network also offers on-line community-building tools; an annual conference called "Convergence"; and various interactive creativity stimulators, including the new Innovation University game, at its Web site,
  • SolutionPeople (Chicago) is creating THINKubators in major cities throughout the United States. Companies send groups of 10 to 30 employees to THINKubators—wide-open lofts filled with tools, toys, beanbag chairs, an aroma odorizer, a jukebox, and a team-brainstorming area that converts to a disco—to develop an Idea Bank and learn about tools to turn those ideas into reality.
    SolutionPeople's KnowBrainer Creativity and Innovation Tool consists of 100 colorful cards that guide users through the four-step Diamond Solution Process: identifying a goal or need, creating ideas, evaluating solutions, and activating solutions. Key words ("explore," "senses," "leadership"), probing questions ("What should people know?" "How might people overcome potential obstacles or challenges?" "What is the potential return on investment for each of the top ideas?"), and quotes trigger ideas. Recent tests at Northwestern University and Wayne State University show the KnowBrainer technique increased the volume of ideas generated by more than 500% over traditional brainstorming methods. Professionals at Amgen, Baxter, and Abbott have used the Diamond Solution Process to generate breakthrough technologies.
  • IDEO, which serves the innovation needs of clients as diverse as consumer goods manufacturers, movie studios, and automobile manufacturers, also focuses heavily on medical device industry projects. For these diverse clients, IDEO staff consult their Technology Box, in which they've collected every interesting technology they've heard of, to see how these technologies may apply to the project at hand. "We scan the world for unique materials, low-cost components, and innovative technologies to use," says IDEO general manager Tom Kelley.


Once a culture that encourages innovation has been set, it's time to add tools and techniques (see "Tools of the Trade") that can help the process. The THINKubator, KnowBrainer, Diamond Solution Process, Technology Box, Innovation University, and Technovation Room may sound like fanciful diversions, but these are just some of the tools and techniques that could help companies earn and save millions.

Brainstorming. One of the most common techniques for sparking creativity is brainstorming. "Everybody thinks they brainstorm," reports Kelley. "A survey of Fortune 500 companies a few years ago asked people, 'Do you brainstorm?' Eighty-five percent of the responses were 'Yes.' The follow-up question asked how often they brainstorm: 'once a day,' 'once a week,' 'once a month,' etc. The average response was 'once a quarter.' If you're brainstorming 'once a quarter,' you're not a brainstormer."

"At IDEO, we practice brainstorming as a religion," says Kelley. "We've stenciled 'rules of brainstorming' in six-inch-tall letters on signs that are posted throughout our meeting room." The rules include:

  • Defer judgment.
  • Build on the ideas of others.
  • Work with one person at a time.
  • Go for quantity. (The IDEO goal is 150 ideas within 30 to 45 minutes.)
  • Encourage wild ideas.
  • Stay focused on the topic.

Customer versus User Feedback. Once ideas are gathered, IDEO focuses on prototyping and collecting customer feedback, with the mantra "more is better." Kelley adds, "We believe every product can be made better—even the one we just shipped. Our goal is to make as many prototypes as we can before we ship a product out the door. You'll learn something from each one."

In regards to medical device companies, Kelley says that the biggest mistake made in the product development process is in turning to customers for product reviews. "That's not their forté. For successful product testing, you need real users who are unassisted. Give them a product and see what they do with it. Watch what they puzzle over, and that's what you need to fix."

IDEO specializes in making products user-friendly. The company worked with Heartstream, now part of Agilent, to bring to market a defibrillator that could be used by anyone, anywhere. Hattori says, "In the past, companies focused on creating the next generation of a product. Now the focus is on the medical problem and the patient, and 'Is this current product the best solution, and is it being delivered in the best way?'"

The project team brainstormed on the topic of helping patients who suffered cardiac arrest, and ended up creating a user interface for defibrillators that features audio instructions, a red-and-green off-and-on button, large numbers on buttons that correspond with the order in which they should be pushed, and a screen that provides text instructions. "The ultimate test was when I took it home to my then-6-year-old daughter and asked her to take a look," says Kelley. "Without any instructions or assistance, she was able to move through all the steps, which proved how easy to use the product was."

Hattori adds, "By coming up with the concept of making this technology available to everyone, they created a value stream and source of new revenues that didn't exist before."

Turn to Other Industries. Spending time with people in other professions can increase the number and quality of ideas. Haman explains, "One of the greatest breakthrough medical products we've helped a company develop was originally the idea of an artist who knew nothing about the medical device industry."


In an October 1999 survey of 500 CEOs, the American Management Association found that CEOs' number-one answer to the question "What must companies do to survive in the twenty-first century?" was "practice creativity and innovation." Only 6% felt their companies were doing a good job in that area. Additionally, a 1998 study showed that the 25% of Fortune 500 firms with the highest growth rates focused on innovation as a guiding principle. Approximately 52% of all organizations with more than 100 employees will offer creativity training during 2001 to promote growth through the practice of innovation, according to a Training magazine report.

Two years ago, Andrea Hunt, vice president of shared values for Baxter Healthcare Corp. (Deerfield, IL), attended Innovation Network's Innovation University as a sponsor of the program. "We, like many companies, focused on operational excellence through the 1980s and early 1990s." Says Hunt, "We tried to become the most efficient, lowest-cost producer. But in the mid-1990s, we saw we needed to move out of that phase and into one of growth and innovation. It takes much longer to implement an innovation mentality throughout a large organization than you might think. The behaviors that earn you operational excellence are different from the skills you need to excel in innovative thinking."

Hunt found the time spent at Innovation University useful in her quest to help shape Baxter's future. "The beauty of the Innovation University program was the interaction with people outside of the medical device industry," says Hunt. "You're exposed to other industries, technologies, and ways of thinking that can have a dramatic impact in your own company."

Hunt and her team are working to integrate innovation more thoroughly into Baxter's culture through a variety of projects. "We're implementing processes to launch nontraditional innovative ideas—that is, those ideas that in the past may have been rejected for very good reasons will instead be pursued in incubator environments where we'll be able to decide more quickly if they are, in fact, viable. We're also studying ideas that are outside of our traditional lines of business," says Hunt.

"Secondly, people will be held more accountable for being innovative," says Hunt. "We've had goals in the past that X% of new products should account for X% of sales. We're now increasing that number and focusing more on everyone's contribution to the innovation process. And we're encouraging people to look at projects and technologies that aren't related to what they're currently working on. In some parts of the company, employees spend up to 10% of their time learning about new technologies through seminars, conversations with peers in other industries, etc."

Perhaps the most visible symbol of Baxter's continued commitment to innovation is the creation of a Technovation Room intended for team meetings in the renal division. "It's filled with fun stuff—lava lamps, toys, nontraditional furniture—to inspire fresh thinking," reports Hunt. "Innovation allows people to be much more creative and empowered—to take ideas to the next level."


This critical progression is especially important for medical device companies. Haman agrees that medical device firms are highly creative, but he notes that they "aren't always as innovative as they could be—bringing products to market quickly or turning them into truly profitable solutions. It's innovation that will allow them to stay ahead of the competition, that will take them to the next level, and solidify their leadership in tomorrow's marketplace."

Stacey L. Bell is a freelance writer and editor based in Tampa, FL.

Illustration by David Tillinghast/SIS

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Copyright ©2001 Medical Device & Diagnostic Industry

A New Family of HF-Weldable Polyolefin Films

Originally Published January 2001

Robert Kelch

High-frequency (HF) sealing technology has long been recognized for producing superior weld integrity in a variety of critical applications. As a result, the medical industry has used HF sealing—which is also known as radio-frequency (RF) sealing or dielectric sealing—for the manufacture of fluid-delivery and fluid-collection bags, inflatable devices such as air mattresses and air splints, and for sealing of both flexible and rigid packaging. Flexible poly- vinyl chloride (PVC) has been the predominant HF-weldable film substrate for many years. Recently, however, there has been a growing desire in the medical industry for alternative plastic films that could be sealed with HF energy. Thermoplastic polyurethane (TPU) and ethylene-vinyl acetate (EVA) resins have increasingly been used to produce films that could be readily HF welded.

Collection bag used to develop HF-weldable polyolefin films.

While both TPU- and EVA-based films contain no halogen or added plasticizer and exhibit lower density than PVC, which results in more film area per kilogram yields, both also have limitations. TPU films exhibit excellent strength, toughness, and high water-vapor permeability, as well as rapid HF seal rates. However, TPU films are generally from three to six times more expensive than PVC films on a weight basis, and may be over-designed for some applications. EVA films offer a 25% yield improvement due to their lower density compared with PVC, but typically exhibit much lower HF activity than PVC films and thus take longer to HF seal or weld. Increasing the percentage of polar vinyl-acetate comonomer in the EVA will increase HF activity, although this typically reduces the melting point of the EVA resin and film, reduces the film strength, and increases the tackiness or tendency of the film to block.

Coextruded polyolefin films have been developed in recent years to replace PVC for medical infusion bags and blood storage containers. These films are typically based on coextrusions of polyolefin skins—such as polypropylene (PP) or linear-low-density polyethylene (LLDPE)—with HF-active core layers, such as polyester (PET) or nylon. Additional PP films comprising blends or coextrusions with styrene-ethylene/butylene- styrene (SEBS) or TPU have also been developed.1–4 Although these films exhibit good physical properties, barrier properties, HF weldability, and, in some cases, autoclaveability, they have apparently not yet found widespread commercial use because of their high cost.

The development of metallocene single-site-catalyst technology over the past decade has resulted in the production of polyolefin resins with very low densities and narrow molecular-weight distributions.5 Films made from these resins have demonstrated high toughness, impact strength, clarity, elasticity, and heat sealability, which make them quite suitable for many medical device and packaging applications.6,7 These nonpolar resins, however, have insufficient dielectric properties to render them HF active, although they can be readily heat sealed. As a result, the metallocene films inherently cannot be sealed with existing HF welding equipment. It is possible to HF weld these metallocene polyethylene (mPE) films using "catalyst" or buffer technology, wherein a reusable HF-active catalyst film is employed to essentially convert HF welding equipment into a thermal sealer so that the metallocene film can be welded.8

It was the desire to achieve the performance properties of polyethylene films with HF activity comparable to that of flexible PVC that has led to the development of a new family of HF-weldable polyolefin films. The term "family" is used to indicate that a variety of films—including different structures (asymmetric and symmetric film structures), different film chemistries, and different performance attributes—are being developed to meet a multitude of end-use applications. The films described in this article are developmental products that are available from The Dow Chemical Co. (Midland, MI), and will be commercialized as Covelle HF-weldable polyolefin films. Additional films with property characteristics similar to those of TPU, as well as rigid film and sheet with characteristics similar to those of glycol-modified polyester (PETG), are also being developed so as to provide a full complement of HF-active products.


The potential of a material to be HF weldable is based on properties inherent in the polymer. During HF welding, high- frequency electromagnetic energy in the form of an alternating electric field will cause polar molecules to oscillate very rapidly. This molecular motion can result in molecular friction, with the resulting generation of heat. If sufficient heat is generated within the polymer, the material will melt.9 The amount of heat generated by the HF energy is determined by the polymer dielectric loss factor (DLF), which can be used as a screening tool in evaluating resins, blends, and compounds for HF weldability.

In general, materials with a DLF of less than approximately 0.05 are considered to be HF inactive, while those with a DLF from 0.05 to approximately 0.1 are considered to be weakly HF active. Materials with a DLF greater than 0.1 are HF weldable, with those exhibiting values greater than approximately 0.2 being very active, and thus potentially quite weldable. Although the high-frequency range is typically considered to encompass from 0.1 to 10,000 MHz, the predominant frequencies of interest in sealing fall within the RF range of roughly 1 to 300 MHz, with most commercial sealers operating at 27.12 MHz.9,10

During the course of the investigation described in this article, the relevant properties of many materials were evaluated to determine their potential as HF-weldable film components. Additional consideration regarding film structure and issues of composition design versus cost was required in order to balance performance properties with commercial viability. Current film development reported herein was directed toward achieving HF weldability greater than that of EVA and comparable to that of PVC and TPU films.


One-Side-Weldable (Asymmetric) Film. Initial HF-weldable polyolefin films were developed for a medical collection-bag application. The goal was to produce a polyolefin film with HF weldability at a cost comparable to that of commercial flexible PVC films that were being utilized in collection-bag manufacture. A commercially available EVA-based film that was being converted into collection bags was also used for comparative purposes.

The initial film developed was a multilayered film with one-side HF weldability. This asymmetric film structure requires that two plies of film (from two rolls of film) be brought together with the seal side of one ply toward the seal side of the second ply, such that the two film plies can be HF welded together (Figure 1). This 4.0-mil (100-mm) film, denoted as HF Polyolefin (HF PO), exhibited physical properties comparable to those of the 4.0-mil (100-mm) PVC film and the 6.0-mil (150-mm) EVA film that were being used in collection-bag structures (Table I). The asymmetric HF polyolefin film exhibited much lower water-vapor permeability (better water-vapor barrier) than both the EVA and PVC films and lower oxygen permeability (better oxygen barrier) than the EVA film. Although the HF PO film was the same gauge as the flexible PVC, the olefin exhibited an approximately 25% reduction in density, or 25% improvement in yield per square meter.

Figure 1. HF welding of one-side-weldable films.

Physical Properties Test Method Machine Direction (MD)/
Cross Direction (CD)
HF Polyolefin PVC EVA
Film gauge (mil)   4.0 4.0 6.0
Film density (g/cm3) Pycnometer 0.94 1.26 0.95
Ultimate tensile strength (psi) ASTM D882 3190/2900 3200/3190 3200/2900
Ultimate elongation (%) ASTM D882 630/695 235/250 540/660
Tensile modulus, 2% secant (psi) ASTM D882 14,200/14,900 9400/9400 7500/7000
Elmendorf tear strength (g/mil) ASTM D1922 200/375 85/150 40/85
Spencer impact strength (g/mil) ASTM D3420 450 550
Water vapor transmission (g/m2/day/mm thickness) ASTM F1249 0.6 6.6 3.7
Oxygen permeability (cc/m2/day/mm thickness) ASTM D3985 218 132 273
HF polyolefin = HF-weldable polyolefin film.
PVC and EVA films tested are commercially available and are used for medical collection-bag products.

Table I. Comparative properties between HF-weldable polyolefin, PVC, and EVA films.

The HF polyolefin film was successfully run on a medical collection-bag welding line at lower power and faster rates than the EVA-based film. The line was fitted with a slightly heated bag die and included a tube-welding attachment. With a slightly lower power setting on the HF welding generator, a 20% reduction in seal time versus EVA film was achieved. In addition, the plate (or anode) current reading was approximately 20% lower with the HF PO film versus EVA.

The finished bags, shown on page 82, passed all standard quality control tests. No air leakage at sealed seams or at the tube seal was observed when the bags were inflated with air to 125 mbar (1.8 psi) and immersed in water; the inflated bags were also subjected to a 75-kg platen-press burst test, without rupture of the inflated bag. The bags then underwent ethylene oxide (EtO) sterilization prior to testing according to the ISO 8669-2 urine collection-bag standard. (Although the film can be sterilized by EtO, it is not autoclave or steam sterilizable.) Bags made from the HF PO film passed all prescribed test requirements. The outer surface of the film was successfully printed on a commercial flexographic printing line using conventional inks suitable for polyolefin printing.

Several one-side HF-weldable polyolefin films have now been developed. One such film is described in Table II as XU 66130. The toughness and high tear strength of the HF PO film and XU 66130 result in less "tear-sealability" versus PVC and EVA films at welded edges. In an effort to develop better tear-seal characteristics and lower film modulus, the XU 66127 film was developed for general-purpose packaging structures (Table II). Both XU 66130 and XU 66127 films have asymmetric structures and are one-side HF weldable or sealable—that is, HF energy will only activate one side of the film to provide weldability.

Physical Properties Test Method XU 66130 XU 66127
Film gauge (mil)   7.0 7.0
Film density (g/cm3) Pycnometer 0.94 0.99
Ultimate tensile strength (psi) ASTM D882 3480/2880 3100/2470
Ultimate elongation (%) ASTM D882 1000/1040 1015/1045
Tensile modulus, 2% secant (psi) ASTM D882 16,400/16,400 12,500/12,400
Elmendorf tear strength (g/mil) ASTM D1922 420/490 430/500
Spencer impact strength (g/mil) ASTM D3420 420 425
Water vapor transmission (g/m2/day/mm thickness) ASTM F1249 0.6 0.9
Oxygen permeability (cc/m2/day/mm thickness) ASTM D3985 221 254
XU 66130 and XU 66127 are asymmetric, coextruded polyolefin films that are one-side HF-weldable, exhibiting high flexibility, tear strength, and HF activity. XU 66130 has contact clarity, whereas XU 66127 is translucent.

Table II. Physical properties of XU 66130 and XU 66127 polyolefin packaging films.

A 2.0-kW Callanan HF sealer fitted with a 0.125 x 8-in. brass bar seal die operating at ambient room temperature (72°F) was used to seal two 7.0-mil plies of film together, with the adhesive side sealed to the adhesive side of the adjacent ply. Using a 1.0-second seal time with 50% power setting resulted in weld strengths in excess of 8.5 lb/in. when tested according to ASTM D903, with films breaking prior to bond failure. It should be noted that all films can also be thermally welded with conventional heat-seal techniques.

A very-low-modulus, "soft" HF-weldable film was developed for applications needing greater flexibility and improved tear-seal properties (Table III). XU 66133 is a coextruded film based on metallocene polyethylene and exhibits many of the properties of MDF 7200 and similar metallocene films. XU 66133 features a 2% secant modulus that is about one-third the value of previously discussed films, as well as very good impact strength. The film exhibits good clarity, although somewhat lower barrier properties than films such as XU 66127 and XU 66130. HF welding using a 2.0-kW Callanan HF sealer resulted in excellent weld strength in as little as 1.0 second, with adhesion strength in excess of 8.0 lb/in. During HF welding, the film demonstrates good tear-seal properties when appropriate tooling dies are used.

Physical Properties Test Method Machine (MD)/
Cross (CD)
Film gauge (mil)   7.0
Film density (g/cm3) Pycnometer 0.95
Ultimate tensile strength (psi) ASTM D882 3625/2980
Ultimate elongation (%) ASTM D882 375/690
Tensile moldulus, 2% secant (psi) ASTM D882 4800/4900
Elmendorf tear strength (g/mil) ASTM D1922 225/300
Spencer impact strength (g/mil) ASTM D3420 >925
Water vapor transmission (g/m2/day/mm thickness) ASTM F1249 2.9
Oxygen permeability (cc/m2/day/mm thickness) ASTM D3985 370
XU 66133 is asymmetric, coextruded polyolefin film, one-side HF-weldable, exhibiting low modulus, high impact strength, good clarity, high HF activity, and tear seal properties.

Table III. Physical properties of XU 66133 low-modulus, soft HF-weldable film.

Two-Side Weldable (Symmetrical) Film. In many cases, it is desirable to be able to weld both sides of a film, either as a film-to-film weld or for attaching fitments to the film. A two-side, HF-active film was developed to provide this versatility, which is typically inherent in monolayer EVA and PVC films. The XU 66126 film is a symmetrical film, with both sides exhibiting good HF weldability as well as thermal sealability (Table IV). The film can be directly fabricated into bag or packaging applications. In addition, the film has been formulated such that both sides can be thermally adhered to a variety of other substrates when heated above approximately 212°F (100°C), the minimum adhesive-activation temperature.

Physical Properties Test Method Machine (MD)/
Cross (CD)
Thickness (mil)   2.0 and 5.0
Minimum activation temp. (°C) DSC 100
Ultimate tensile strength (psi) ASTM D882 3330/2320
Ultimate elongation (%) ASTM D882 890/930
Tensile moldulus, 2% secant (psi) ASTM D882 7800/7400
Elmendorf tear strength (g/mil) ASTM D1922 225/300
Spencer impact strength (g/mil) ASTM D3420 475
XU 66126 is coextruded, polyolefin film, two-side HF-weldable, exhibiting high flexibility, adhesion to a wide range of substrates, and high HF activity. The film can be thermally laminated to non-HF- active substrates to impart HF weldability.

Table IV: Physical properties of XU 66126 polyolefin packaging and lamination film.

Conventional hot-roll lamination, flame lamination, or heated- press lamination can be used to thermally bond the XU 66126 film to substrates such as paper or cellulosics; polyolefins; most polar polymers such as nylon, urethane, or polyester; nonwovens or fabrics; and cellular-foam materials (Figure 2). Thinner film gauges (2.0-mil, 50-mm) can be first laminated to a porous or breathable substrate such as a nonwoven, cloth fabric, or foam in such a fashion as to melt the film sufficiently to develop porosity, which can be beneficial when moisture or air breathability is desired. Thicker films can be used to laminate if a nonporous barrier is desired. At ambient room temperatures, the film exhibits low tack and little blocking (or cling).

Figure 2. Thermal lamination of film to substrate.

Non-HF-active substrates or materials that otherwise have no melt-weldable characteristics can be thermally laminated with HF-active adhesive to permit welding. A spunbonded, polypropylene nonwoven of 1.0 oz/square yard (34 g/m2) basis weight was thermally laminated with 2.0-mil XU 66126 adhesive film at a temperature of 300°F (149°C). The film was well adhered to the nonwoven and attempts to peel the film from the spunbonded nonwoven resulted in cohesive destruction of the nonwoven. Similarly, a soft, open-cell polyurethane foam of 0.04 g/cm3 density was laminated with 2.0-mil XU 66126 adhesive film. The film also exhibited good adhesion to the foam, and attempts to delaminate or peel the film from the foam resulted in cohesive failure (or destruction) of the foam.

Both laminates were then subjected to HF welding using a 2-kW Callanan sealer fitted with a nonheated (ambient room temperature) 0.5 x 8-in. brass flat seal die. Two plies of each laminate were sealed, with the film side to the film side of the respective materials (Figure 3). As described in Table V and shown in Figure 4, HF welds were achieved for each of the three laminate combinations. By comparison, even with longer weld times, neither the original PP spunbonded nonwoven nor the polyurethane foam substrates (which had not been laminated with the adhesive film) could be HF welded.

Figure 3. Laminate structures of non-HF-active substrates with XU 66126 HF-weldable film.


Laminate Structure Weld Time (seconds) Adhesion Level
XU 66126 film
prelaminated to
PP nonwoven/film//film/PP nonwoven 3.0 Welded—attempts to peel result in cohesive failure of PP.
PU foam/film//film/PU foam 4.0 Welded—attempts to peel result in
PP nonwoven/film//film/PU foam 3.5 Welded—attempts to peel result in cohesive failure of PU and/or PP nonwoven substrates.
No adhesive film
prelaminated to
PP nonwoven//PP nonwoven Up to 10 No sealing—PP nonwoven will not HF weld together.
PU foam//PU foam Up to 8 No sealing—PU foam will not HF weld together.

Table V. Laminate HF welding results. Comparison of PP nonwoven and PU foam substrates with and without prelamination of XU 66126.

Figure 4. HF-welded laminate structures.

A similar evaluation was made using paper. A photocopy grade of coated paper of 20-lb bond weight was thermally laminated with 2.0-mil XU 66126 adhesive film at a temperature of 230°F. The 2-kW Callanan HF press was used to seal different composites of the adhesive film–laminated paper and the original nonlaminated paper (Table VI). HF seals were readily accomplished with a ply of laminated paper sealed to a ply of nonlaminated paper, and also with two plies of film- laminated paper sealed together. Weld times of 0.7 seconds were achieved. By comparison, paper is not HF weldable, as it cannot melt or fuse. HF welding of nonlaminated paper actually resulted in burning of the paper.

Laminate Structure Weld Time (seconds) Adhesion Level
XU66126 film
prelaminated to paper
Paper/film//paper (one-ply prelaminated) 0.7 Welded—attempts to peel result in cohesive failure of paper.
Paper/film//film/paper 0.7 Welded—attempts to peel result in cohesive failure of paper.
No adhesive film
prelaminated to paper
Paper//paper Up to 4 No sealing—Paper will not HF weld, some paper burning occurred.

Table VI. Laminate HF welding results. Comparison of paper substrate with and without prelamination of XU 66126.

The use of HF-active adhesive lamination films that can be applied to another substrate by heat or HF, and then subsequently reactivated by heat or HF, provides great potential in the medical device, apparel, textile, and packaging industries. In such a manner, non-HF-responsive materials can be welded together. The low melting-activation temperature of the XU 66126 allows it to be thermally applied to one surface of many substrates without thermal degradation, melting, or deorientation of the substrate. As HF energy is subsequently applied through the entire composite structure, the HF will generally not affect the non-HF-active substrate, thus concentrating the HF energy and thermal generation at the film-to-film interface where it is desired to cause bonding. By comparison, conventional heat sealing of similar substrates would require heat energy to be passed through the entire thickness of the substrate, thus potentially damaging, degrading, or melting the material.

In the lamination trials cited above, neither the spunbonded PP nonwoven textile nor the polyurethane foam were distorted or melted. Indeed, attempts to heat seal these materials together with sufficient temperature to affect melting at the interface would result in melting of the entire substrate thickness.

Pouch Testing of Film HF Weldability. Various developmental films were subjected to independent testing by an industry consultant to evaluate their HF weldability compared with that of commercially available films of other polymers, including flexible PVC, EVA, ethylene-methyl acrylate (EMA), and TPU. A 4-kW Thermex Thermatron welder fitted with a one-liter rectangular pouch (bag) die and preheated to 150°F (65°C) was used in the study. All HF welding- process parameters were kept constant except for power level and HF seal time, which were varied in order to obtain optimum welds. The power setting was initially started at typical PVC seal conditions, with the power level gradually increased in order to achieve a strong pouch seal. Optimum conditions were determined by taking each welded pouch and manually inflating it with an 80-psi air hose to determine if any leakage or debonding occurred. If the pouch exhibited good edge or seam bonding, then the power setting was maintained and the seal time reduced until minimum weld parameters (optimum in terms of shortest time and lowest power to achieve a strong pouch seal) were obtained.

Comparison of optimum weld parameters of six developmental weldable polyolefin films (5.0- and 7.0-mil XU 66127, 7.0- and 10.0-mil XU 66133, and 2.0- and 5.0-mil XU 66126) and five different commercially available films (6.0-mil flexible PVC "A," 11.0-mil flexible PVC "B," 4.5-mil TPU, 11.5-mil EVA, and 7.5-mil EMA) is provided in Table VII. The XU developmental films required less power than the TPU, EVA, and EMA films and lower current than all of the comparative films in order to achieve a strong bond. While PVC films required slightly lower power settings than did the developmental HF-weldable XU films, all of the XU films sealed in equal or less time compared with PVC, with less current flow required. The EVA film necessitated the longest weld time (6 seconds total) of any film, and required significant power and current to achieve a good weld. The TPU film was quite HF active, and could be sealed in only 2 seconds total seal time. The EMA film was also sealed readily in 2 seconds, but required the greatest power and current flow through the plate of any film to achieve this seal.

Big Ideas, Big Returns

Originally Published January/February 2001

Stacey L. Bell

Some companies just seem to do everything right. Regulators approve their products quickly, their market shares skyrocket, their profits soar. How do they do it?

MX recently asked U.S. Bancorp Piper Jaffray Inc. (Minneapolis) to determine which companies (with base sales of at least $30 million) had the largest growth in revenue for the years 1997 through 1999 (see Table I). Among the companies belonging to this select group, the top 15 companies' average compound annual growth rate (CAGR) was a staggering 117.6%—all the more impressive when you consider that the average growth rate in the medical device industry ranges from 7 to 10% per year for larger companies, according to Thomas J. Gunderson, managing partner and senior analyst for Piper Jaffray.

Symbol Company Revenue (Latest year; million $)Compound Annual Growth Rate (%)
IMTIImagyn Medical Technologies105.5191.5
CYBXCyberonics Inc.29.9 176.4
PERCPerclose Inc.43.3 160.3
SBTKSabratek66.9 154.9
FUSEFuisz Technologies Ltd.61.2 121.2
HMPSHorizon Medical Products Inc.75.4120.3
CYTCCytyc Corp.81.1 114.7
STESteris Corp.797.6 106.0
MBMolecular Biosystems Inc.26.0 103.4
ARTCArthroCare Corp.48.7 100.7
GLIAGliatech Inc.28.0 93.2
SCHKSchick Technologies Inc.45.6 88.5
SLFInverness Medical Technology125.987.6
HGRHanger Orthopedic Group346.8 73.1
BIOXBiomatrix Inc.79.7 72.3

Mergers and Acquisitions:What Every Company Should Know before Saying "I Do"

Originally Published January/February 2001

Ralph W. Carmichael

With so many businesses in every industry joining forces through mergers and acquisitions, deciding whether to enter into such agreements must be an essential part of strategic planning for any company. Analysts estimate that during 1999, some 6877 companies in all industries were acquired at a total value of more than $971.8 billion.1 By fall 2000, 6312 companies had been sold for more than $1 trillion.

Making the Most of Media Relations

Originally Published January/February 2001

Nancy Coffey

Every executive wants to see his or her company's products and organization portrayed positively in the press. It's good for business and for the soul.

But great media coverage doesn't happen by accident. Not only must a company have a great product, it also must cultivate good relationships with reporters. "Good relationships with reporters" doesn't mean that every time a reporter calls, company executives must drop everything and provide every piece of information sought. Instead, it means that when a reporter contacts a company, someone on staff immediately returns the call, is cordial, and respects the reporter's deadline. Companies that help reporters and are available to them help themselves as well.

The Payoff

ERP Systems Cue Employee Retention

Originally Published June 2000

Thomas R. Cutler

In medical technology manufacturing, the cost of recruiting and training a senior executive is in excess of $50,000. Retaining these employees in a tight job market is critical. One effective strategy for attracting and retaining quality employees in medical technology manufacturing is the adoption of enterprise resource planning (ERP) systems. In a comprehensive study of 369 executive-level medical technology manufacturers, more than two-thirds (68%) said that the use of an effective ERP software program results in improved job satisfaction ratings and increased employee retention (see Figure 1).

Figure 1. Importance of ERP manufacturing software to job retention among medical technology executives.