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Articles from 1997 In December


The Year 2000 Bug: Another Case of Millennial Madness?

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI  December 1997 Column

When I was growing up in the 1960s, the year 2000 seemed impossibly far away. It was the province of Arthur C. Clarke and the Jetsons, and other fantastic visions of the future. Now that that distant time is almost here, I have discovered that lots of older and wiser people 35 years ago were just as convinced as I that the year 2000 was merely a fiction to read about, not a reality to plan for. The result of their failure to think past 1999 is the year 2000 problem, or millennium bug, about which we have all heard so much in the last year.

Put simply, the problem results from the efforts of computer programmers, beginning in the 1960s, to save precious machine memory by truncating dates to the last two digits—i.e., to use 65 to mean 1965. At the time, no doubt, it seemed like an efficient practice. In the year 2000, however, it could mean chaos’or something less severe’as computer programs try to figure out whether 00 means 1900 or 2000.

Given the extent to which computers are used nowadays, the year 2000 problem could affect virtually every aspect of business for a medical device manufacturer’including software for manufacturing and information systems as well as software embedded in devices. One critical area that may be affected is clinical trials, as author Sunil Kumar Gupta discusses on page 64 of this issue. As Gupta notes, this is a potentially serious problem, but it can be solved’provided that companies start dealing with it now.

To my knowledge, no one has thoroughly canvassed the medical device industry to determine the extent of the year 2000 problem’indeed, many device companies may not yet know the full impact. But in light of the potential risks, FDA has suggested a few actions in a letter from device center director Bruce Burlington (available on the Internet at http://www.fda.gov/cdrh/yr2000.html).

For future medical device premarket submissions, Burlington says, FDA will need evidence that products will not be adversely affected by the year 2000 problem. Such products would not seem to be in much danger except as they rely on off-the-shelf hardware, which may need to be revalidated with respect to the year 2000.

For current devices, FDA urges companies to conduct safety and hazard analyses to determine the extent of the problem. If a problem is uncovered, the companies should then correct it in devices in production and contact customers that have purchased the affected products to work out a solution.

Finally, for any design, production, or QC process controlled by computers, manufacturers should ensure that any problems are resolved before January 1, 2000.

With such advice from FDA, it would be extremely unwise to minimize the perils of the year 2000 problem. But neither does it do any good to overestimate them. The popular press has, at least until recently, tended to overdramatize the situation. Now, however, the backlash is starting, with articles suggesting that while the problem is real, it does not foretell Armageddon. Many companies are already addressing the problem, and many software programs, especially those embedded in chips, do not rely on two-digit date codes anyway.

The year 2000 problem is no doubt tied up with the millennial madness that Western society will experience in the next couple of years. Against this backdrop, device companies should carefully assess their exposure to this very real problem, but they should also do their best to ignore the hysteria that goes with it.

John Bethune

john.bethune@cancom.com


Copyright ©1997 Medical Device & Diagnostic Industry

Rare Harmony Marks FDA Reform Bills on Hill

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI  December 1997 Column

WASHINGTON WRAP-UP

Industry and FDA work together to draft wording of House bill.

James G. Dickinson

  • CDRH Releases Review Update, p. 34
  • Lasergate Continues, p. 35

In sharp contrast to the acrimony that plagued last year’s doomed efforts at legislating FDA reform, this year’s attempt overcame rancor and mutual suspicion to achieve an astonishing level of industry-agency harmony. In so doing, circumstances once more vindicated FDA experts’ counsel that no FDA legislation succeeds without the agency’s assent, either tacit or expressed.

This time, FDA’s assent was probably more tacit than open, philosophically driven by the many reforms already under way in FDA Center for Devices and Radiological Health (CDRH) director Bruce Burlington’s reengineering initiative, which in turn was fueled by Vice President Al Gore’s long-established (and escalating) Reinventing Government initiative.

Just how much did FDA cooperate with industry in bringing the reform bills to fruition? A good indicator was FDA’s invitation to the Health Industry Manufacturers Association (HIMA) in September to word a section of the House bill that would guard against manufacturers filing 510(k) submissions for one use of a product when they really intended to market it for another use. Not only did HIMA develop the requested wording, but a roundtable drafting conference involving FDA, HIMA, and staff members from Congressman Thomas J. Bliley’s (R­VA) House Commerce Committee accepted the language with only minor modifications.

This single provision had been the last major stumbling block to general consensus on Bliley’s device bill. The bill now has been combined with food and drug bills to match a Senate FDA reform bill, passed earlier this year, that contained a far different 510(k) scope-of-review provision. That provision had been the subject of a futile filibuster attempt by Senator Edward Kennedy (D­MA) who, prompted by FDA, argued that language originally intended to curb potential FDA regulatory aggression toward tobacco products ("drug-delivery devices") inadvertently barred the agency from demanding data on potential unintended uses of legitimate medical devices under 510(k). The Senate bill says FDA’s 510(k) reviews "shall be based on the intended use included in proposed labeling of the device submitted." Nothing more. Kennedy wanted to add "if the proposed labeling is neither false nor misleading."

FDA feared that restricting its product reviews to only a device’s intended use would prohibit it from demanding additional data when it believed a device had obviously been designed for a use other than that described in the proposed labeling. This situation happens "infrequently," Burlington says, but "we certainly don’t want to encourage it" by letting the Senate bill’s language stand.

After the Senate bill passed, the House version became FDA’s only hope. Department of Health and Human Services secretary Donna Shalala asked the bill’s sponsor, Bliley, to reassert and clarify FDA’s role in product reviews. Bliley agreed and recommended that industry be given the chance to come up with the requisite language.

At a late-night meeting on Capitol Hill attended by, among others, HIMA senior vice president Jim Benson, Medtronic Washington bureau representative Sean O’Donnell, FDA deputy commissioner for policy Bill Schultz, FDA policy research lawyer Margaret Dotzel, CDRH director Burlington, and committee staff members, HIMA’s proposed language was accepted almost unchanged after many hours of earnest discussion. The meeting showed that when asked to frame government limitations upon itself, industry can be just as stringent as FDA—and perhaps more so.

Admittedly, Shalala and Bliley had established the bill’s objective, but HIMA came up with wording that, after requiring collaborative FDA-sponsor discussion if an unintended use of a product were deemed likely, would permit FDA to "specify limitations on the device’s labeling which proscribe the use not included in proposed labeling."

Proscribe was a strong word for HIMA to offer. Merriam-Webster’s Collegiate Dictionary says it means "to condemn or forbid as harmful or unlawful" and to "prohibit."

It’s doubtful anyone present at the drafting session thought of the word in those terms. When it was suggested to Benson several days later that proscribe means ban, he seemed surprised. Likewise, Burlington thought the word’s choice was intended in an advisory sense, directed at clinicians. He urged that the term not be taken in isolation but instead be interpreted in the context of legislative history.

At the time of this writing, the final bill had not come to the floor, and it was unclear whether the word would survive. Suffice to say that both the word and the mechanism by which it came to be used reflect a degree of agency-industry cooperation that would have seemed improbable last year.


KENNEDY’S FUTILE FILIBUSTER

Attempting to sway his colleagues, Senator Edward Kennedy (D­MA) debated at length the example of U.S. Surgical Corp.’s "advanced breast biopsy instrument," a needle that is so much an enlargement of its predicate device that it might be used for tumor removal—arguably making the biopsy labeling false and misleading, or at least inadequate.

U.S. Surgical is a Norwalk, CT, firm, and Kennedy’s rhetoric attracted responses from Connecticut senators Joseph Lieberman and Christopher Dodd, both from Kennedy’s party but still willing to paint him as ultraliberal. "In effect, trying to squeeze ’false and misleading’ language into a place where it doesn’t fit," Dodd said, "means all devices would be undergoing the premarket approval process, a process that can take up to six times longer" than 510(k) clearance.

Labor Committee chair Jim Jeffords (R­VT), in floor debate on the bill, made Kennedy’s case look like an overreaching insistence that 510(k) sponsors "should be looking around and deciding and finding out all the possible and conceivable uses out there, and then they could be required to run clinical trials on all those." Comments from the Senate’s physician, Bill Frist (R­TN), sealed the debate: "We do not do that for pharmaceuticals today. . . . Should we do it for devices? I say not." The bill passed the Senate with its original wording unchanged.


A September analysis released by CDRH director Bruce Burlington predicted a 33% cut in average premarket approval (PMA) review times (from 26 months to 16) for the fiscal year ending September 30.

The report expanded on Burlington’s boldly upbeat spring report with graphs and charts showing that 36 new-technology PMAs had been approved for 1997 so far and that, for the first time in CDRH history, 12 of them had been approved in less than 180 days. Although Burlington predicted that the 1997 fiscal year total would probably not exceed last year’s six-year high of 43 approvals, the final tally reached 48.

The report said the center has begun working more closely with sponsors on investigational device exemptions (IDEs) and as a result has "dramatically shortened the time until studies may begin." Last year and to date, more than 70% of IDEs were approved in their first 30-day cycle, "the highest percentage since the inception of the IDE program," Burlington said.

The 510(k) backlog disappeared midway through FY 96 and remains at zero. Review times have also been shortened. "So far in FY 97, the average review time is 98 days, compared to a peak of 184 days in 1994," Burlington said in his report.

In an about-face from the early 1990s, when calls from industry were strenuously discouraged, Burlington’s report described an intensive effort to improve communications "early in the development of devices and throughout the process of premarket submissions. In this dialogue, which has occurred by telephone, by videoconference, and in person, we have been helping manufacturers understand what we are looking for in their submissions. We explain what information will be needed, and why, and we resolve questions on the spot.

"We have even begun sharing and discussing PMA deficiency letters before they are mailed so [that] both the company and FDA are sure what we are asking for—and [so] that we haven’t overlooked information that has already been submitted."

Burlington also pointed out that this process helps the review and "increases the manufacturer’s overall understanding of FDA’s review process, so that submissions for future products should be improved as well."

The principle of increased communication with industry has also been applied to "process improvement and reengineering," Burlington said. "We have actively sought the participation of the medical device industry, health professionals, and consumers in rethinking the basic elements of our program and in devising ways of enhancing our efficiency and responsiveness. We want our program to reflect the needs of the outside groups affected by it."

Thirteen teams are covering more than two-thirds of CDRH activities and orchestrating pilot tests of real-time PMA supplement reviews, periodic summaries of adverse event reports, decentralized recall classification, and cross-checking inspections of contract sterilization firms to avoid unnecessary reinspection. Future tests are planned for developing an abbreviated 510(k) process when device design and manufacture conform to consensus standards, product development protocols for well-understood products in lieu of new PMAs, and an adverse events "sentinel" system that would extrapolate data from selected reporting hospitals and other facilities across the nation.

The illegal leak by FDA personnel of proprietary information entrusted to the agency by two ophthalmic laser developers to a market rival in November 1995 continues to occupy members of the House Commerce oversight and investigations subcommittee even though the FBI investigators to whom they had been deferring appear to have tired of the case.

At the end of September, in the absence of any signals from FDA, subcommittee chair Joe Barton (R­TX) wrote Department of Health and Human Services secretary Donna Shalala asking for the voluminous FDA records about the review of the two devices that were the subject of documents leaked to David Muller, former CEO of Summit Technology (Waltham, MA). Those devices were the Model B and Model C lasers from Visx, Inc. (Santa Clara, CA) and a custom excimer laser being developed by Frederic Kremer, MD, of King of Prussia, PA.

Barton’s letter urged Shalala to ensure that none of the FDA records he sought would be destroyed before they were identified and reviewed by the subcommittee. The records include E-mail messages and other documents to and about Visx and Kremer by reviewers Quynh Hoang, Everett Beers, George Samaras, Bruce Drum, and Emma Knight. Knight was reassigned from CDRH to FDA’s Biologics Center after some of the leaked documents were allegedly found to bear her fax machine’s identifying header. She has denied any involvement in the leak. The other reviewers were described by Barton’s staff as potential witnesses.

Barton also sought Knight’s phone and fax records and memoranda written by her to confirm that she had no influence on advisory committee member Marian Macsai, who voted against Visx’s devices and later accepted a free laser from Summit.

Barton’s letter noted that the subcommittee will be interviewing CDRH employees Bruce Burlington, Susan Alpert, Jan Calloway, and Quynh Hoang out of the hearing of any other FDA officials. Unless the FBI objects on the grounds that the subcommittee’s actions would compromise the bureau’s own 18-month-old investigation, it is likely the subcommittee will conduct a second public hearing into what is becoming known as Lasergate.


Copyright ©1997 Medical Device & Diagnostic Industry

Advances in Neurology Stimulate FDA Device Approvals

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI  December 1997 Column

R&D HORIZONS

The market response to nerve stimulators might eclipse the success enjoyed by cardiac pacemakers.

After decades of research, neurologic devices are becoming increasingly available to patients for use against a range of maladies, including epilepsy, paralysis, incontinence, and muscle tremor. During the past six months, FDA has approved four neurostimulators, and more advanced versions are on the way.

The pulse generator transmits an electrical charge to the wire in the brain, thus reducing involuntary tremors. Illustration courtesy of Medtronic (Minneapolis)



These new technologies might transform the treatment of neurological disorders the same way pacemakers and defibrillators changed the outlook in cardiology. Given that biomedical engineers already know how to miniaturize electronics, neurotransmitter development could proceed even faster. The road ahead is not without its challenges, however. A critical component of the revolution is missing. According to William Opel, executive director of the Huntington Medical Research Institutes (Pasadena, CA), "We lack a basic knowledge about neurological mechanisms."

ENGINEERING CHALLENGES

Nowhere is that clearer than in the treatment of epilepsy. Several companies are developing products designed to alleviate epileptic seizures by regularly sending impulses to the vagus nerve. This longest of the 12 cranial nerves sends messages from the brain to many organs and relays information back to the portion of the brain stem responsible for certain epileptic seizures. For some patients, chronic, random stimulation of the vagus nerve helps relieve the frequency and severity of seizures.

"We can tell you that the treatment works, but the smartest people on the topic can’t tell you exactly why," says Shawn Lunney, vice president of marketing at Cyberonics (Webster, TX), the company that developed the first and only commercially available vagal nerve stimulator.

The brain, spine, and peripheral nervous system each present unique challenges to the development of neurostimulators. Decades of research at the Huntington Medical Research Institutes have focused on the subtle differences in the tissues that make up the human nervous system. William F. Agnew, MD, director of the institute’s neurological research laboratory, says the brain is protected by dura mater, pia mater, and arachnoid tissue. The spinal cord, although similar in composition, is further encased in a heavy sheath of crisscrossing collagen.

Understanding these subtleties is essential to the development of optimal electrodes for interfacing between human tissue and manmade technology. Researchers must consider the size, shape, and composition of the electrodes when deciding how they should connect. Depending on the nerve involved, the electrode could either wrap around or penetrate it.

Choosing the right metal for the connection is another engineering challenge. Platinum fell from favor at Huntington after Agnew and his colleagues discovered that it becomes soluble during stimulation and is deposited in tissue, causing a potentially toxic reaction in a confined area. Iridium is the current metal of choice because at a diameter of 12 µm—about a third the size of a human hair—it is strong enough to penetrate nerve tissue without buckling.

The electrode’s shape is also critical. A conical tip leading to a blunt end, says Agnew, with the electrodes configured in a ring of six surrounding one in the center, appears to be the best for penetration. Even the surgical technique has been refined to reduce collateral damage. Minimizing movement, he says, has reduced the slashing effect on the tissue, which produces the microscarring otherwise common in these procedures and which is linked to suboptimal performance of the electrode.

PUTTING KNOWLEDGE TO USE

Leveraging the research conducted by Agnew and his colleagues allowed Cyberonics to develop the electrode in the NeuroCybernetic Prosthesis, which has effectively controlled partial-onset epilepsy in a significant number of patients. Wrapped around the vagus nerve in the left side of the neck and held in place by a tether, this electrode unleashes electrical bursts every few minutes from a silver dollar­sized generator implanted near the collarbone. This technology can help many patients whose seizures cannot be controlled adequately by drugs, according to Bruce Burlington, director of the FDA Center for Devices and Radiological Health.

NeuroControl (Cleveland) pairs external and internal electronics to provide quadriplegics with a functional hand grasp.



FDA passed swift judgment on the epilepsy device. The agency received the premarket approval (PMA) application in January 1997, convened an advisory panel in midsummer, and acted on the panel’s unanimous recommendation for approval just 19 days later. Approval was based on a study of 454 patients at 45 medical centers. About half showed at least a 20% reduction in the number of seizures per day.

The device, which costs about $6000 and another $2000 to implant, stimulates the vagus nerve every few minutes to decrease the brain’s sensitivity to the stimuli that trigger seizures. Whereas neurological patients commonly require increasingly stronger dosages of a medication to maintain an effect, the opposite appears to be true for vagal stimulation. "In patients who have used the device for two, three, or four years, the efficacy seems to keep getting better," says Lunney, who believes the repeated shocks may rehabilitate the brain. "It is like a relearning phenomenon."

The success of the electrode signals has not dampened interest in a closed-loop system that would detect the early signs of a seizure and fire a preventive electrical charge. Lunney envisions the day when an implantable device will provide chronic stimulation to "strengthen" the brain and also stop seizures in their earliest stages. "Cardiac pacemakers started out as chronic pacers, then went to rate-responsive pacing, and now have on-demand defibrillators with rate-responsive pacing," Lunney notes. "So, technologically, I see parallels."

HELPING PATIENTS WITH PARKINSON’S DISEASE

Medtronic, Inc. (Minneapolis), best known for its cardiac pacemakers and implantable defibrillators, is working on a closed-loop system to detect, monitor,

and prevent seizures. Meanwhile, the company’s recent success is the Activa Tremor Control Therapy device, which blocks the brain signals that cause essential tremor, a disabling, involuntary shaking in patients with Parkinson’s disease.

"Before the implant, patients could not raise a glass of water or a spoonful of food to their mouths without spilling something or striking themselves in the face," says William Koller, MD, PhD, chairman of the neurology department and professor of pharmacology at the University of Kansas Medical Center (Kansas City), where the device underwent clinical study prior to FDA approval. "Within hours, these same patients are sipping tea from a cup and eating peas with a fork."

Activa fires an electrical charge along an insulated wire surgically implanted in the thalamus, the brain’s communication center. A lead transmits the charge from an extension wire passed under the skin to a pulse generator implanted near the collarbone. Prior to implantation, physicians evaluate each patient to determine the optimal stimulation level at which to program the generator. Patients can turn the device on and off or increase and decrease stimulation by waving a handheld magnet over the implanted generator.

Activa’s disadvantage is its limited clinical utility. Tremor is only one of several debilitating symptoms of Parkinson’s disease, and the device doesn’t alleviate those other problems. "Drug therapy helps a lot more symptoms than tremor," says Angelo Patil, MD, a neurosurgeon at the University of Nebraska Medical Center (Omaha), who evaluated the device in clinical trials. "You don’t want to subject patients to the risk of a surgical procedure if they can be managed with medication." Activa is thus restricted to patients who do not respond to medication, but Patil says many Parkinson’s patients eventually become drug refractory. Work is under way to extend the clinical reach of this neurostimulator. By stimulation of other parts of the brain, symptoms such as rigidity and dyskinesia—impairment of voluntary movement—might be relieved.

DEEP BRAIN STIMULATION

A neurostimulator designed to relieve rigidity was among the research projects featured at a mid-October closed briefing at the National Institutes of Health. A video depicted a patient with uncontrollable movement of his right leg. With great difficulty, he took small steps, shuffling laboriously behind his wife. "Then, after the implant, they showed him walking briskly across the room, swinging his arms," recalls Agnew. "Very impressive."

Agnew did not identify the research group whose work was shown in the video, but Medtronic has already achieved positive results using a stimulator. "Most of these patients are already drug refractory and their only other option is surgical destruction of the brain, which cannot be undone," says Jessica Stoltenberg, Medtronic spokeswoman. "Our probes can be adjusted or removed."

Medtronic is studying the effects of probe implantation in two sites, the sub-thalamic nucleus and an internal portion of the globus pallidus. Only one probe is implanted in a patient. The location, says Laurie McBane, Medtronic clinical evaluation manager, depends on a physician’s evaluation of the patient’s symptoms and their severity.

Brain stimulation is just one facet of the company’s research. Medtronic previously developed and began marketing two pain management stimulators in the United States—the Itrel 3 and Mattrix. Both are fully implantable in the spine, and the dual-lead Mattrix allows independent control of the two leads to block difficult-to-treat bilateral pain patterns.

OTHER APPLICATIONS OF NERVE STIMULATION

In late September, FDA approved Medtronic’s Interstim Continence Control Therapy, which stimulates the sacral nerves to manage urinary urge incontinence. Interstim fires electrical pulses into the sacral nerves, located at the base of the spine, to help avoid or reduce accidental urination. Physicians can tailor treatment to the patient, adjusting stimulation frequency and strengths to maximize therapy benefits.

Three of four subjects in the clinical trials experienced at least a 50% reduction in leakage episodes and severity of leaks, according to Steven Siegel, MD, of Metropolitan Urologic Specialists in Minneapolis. "These individuals could see some real improvement in their quality of life, not only regaining control of their bodily functions but also regaining self-esteem and confidence," he says.

NeuroControl Corp. (Cleveland) also has a sacral nerve stimulator, the Vocare, which it is evaluating at 10 clinical sites across the United States. The company already has another neurologic device on the market—its Freehand System, which restores partial movement to some quadriplegics. "Patients are now able to feed themselves, write, operate a computer, and answer the telephone," says Ronald Podraza, NeuroControl president and CEO. "These are people who once needed assistance with everything and who now have substantial independence."

FDA approved the use of the Freehand System in August for adult quadriplegics with C5 or C6 (fifth or sixth cervical vertebrae) spinal cord injuries. These patients have retained some upper body mobility because the portion of the spinal cord that controls the upper body is above the injured area and can thus still communicate with the brain. Freehand uses both external and surgically implanted electronics. A position sensor, mounted on the chest and shoulder, translates small movements into a control signal. An external controller, usually mounted on the wheelchair, processes this signal into radio commands that are beamed to a microprocessor implanted in the chest. When the eight electrodes wired into the paralyzed hand and forearm muscles receive stimuli from the microprocessor, the muscles contract—for example, making a finger and thumb pinch together—providing the person with a functional hand grasp.

ENHANCING QUALITY OF LIFE

One of the challenges facing NeuroControl was demonstrating device efficacy to meet FDA requirements for approval. "We had patients perform activities of daily living," says Julie Grill, manager of clinical studies and regulatory affairs. Their ability to manipulate objects was documented with the device turned on and then turned off. "One of the advantages of the device is that you can turn it off," Grill says. "We were able to have the patients act as their own control subjects."

Engineers are now expanding the device’s capability. At present, Freehand enhances motor control for only one side of the patient, and its eight channels stimulate a limited number of arm muscles. "Our next step is to extend the stimulating channels so we can recruit more muscles," says Zi-ping Fang, PhD, director of R&D at NeuroControl. "We want to get into the muscle of the hand itself."

Fang hopes to expand the patient population that might benefit from the Freehand System to those with C4-related paralysis. Their spinal cords are injured farther up than those with C5 and C6 injuries, so they have even less mobility. Eventually, Fang would like to develop a closed-loop system to provide the sensory feedback needed for precise finger and wrist control.

As engineers exercise more finesse in their approaches and designs, this evolving technology will become even more appealing. Opel believes that electronics and biochemistry will eventually merge into a technology that is neither tissue nor device. Electrical activity in the nervous system is chemically modulated, as in the transmission of a signal across the synapse or the depolarization and repolarization of the neuron. "Ultimately, we will be able to establish a bias state chemically and use electronics to do discrete switching of signals," Opel says. Such a merger of microchemistry and microelectronics into a manmade technology, he predicts, "will lead us to better therapy of the nervous system."


Copyright ©1997 Medical Device & Diagnostic Industry

Setting a Profitable Sales Strategy

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI  December 1997 Column

BOTTOM LINE

What medical product manufacturers need to know to expand their businesses.

Before the end of the decade, not only will medical product manufacturers have witnessed a number of significant structural changes in their selling relationships with health-care institutions, but they also will have initiated some new ways of conducting business themselves.

In fact, most manufacturers have already experienced a few of the structural changes that will affect their selling efforts for the remainder of the 1990s and well into the next millennium—a reduction in the number of suppliers, an increased number of administrators with purchasing responsibilities, and greater emphasis on delivery speed, global pricing, and contract negotiation. In addition to these buyer-related changes, manufacturers will also see changes in the ways in which they compete—new marketing options will arise, alternative methods of selling will develop, customer service activity will increase, selling to customers based on how products and services will affect their bottom lines will be taken to a new art with sophisticated financial models, and the use of outcomes data will become even more prevalent.

As experienced manufacturers might surmise, market segmentation, customer selection, efficient value creation and delivery, and effective selling are a few of the keys to charting a course to profitable growth in this shifting landscape. Such are the findings of a new poll conducted by Sibson & Co., an international management consulting firm based in Princeton, NJ, in cooperation with Medical Device & Diagnostic Industry magazine. Medical device industry professionals with executive responsibility in the areas of sales and marketing were queried about how managed care and integrated health-care systems have affected their sales strategies, including the tools and messages they use when communicating with customers, how much sales efforts are costing their companies, and how they are striving to meet customer needs. Eighty-five professionals responded, and their answers offer insights into sales strategies in the industry.

THE CURRENT ENVIRONMENT

Changes in acquisition practices by health-care institutions—such as increased purchasing under contract, decreased or level contract compliance, an increased number of administrators with purchasing responsibilities, or a greater emphasis on price—can severely restrict a firm’s ability to grow profitably, let alone maintain market share.

Responses to this survey suggest that health-care buyers’ negotiating power is increasing significantly because of changes in acquisition practices. As a result, overall sales growth is spotty (only 55% of participants have experienced sales growth), in large part due to more intense competition for market share and higher customer turnover. In fact, when respondents were asked to select a company goal from five provided objectives, "grow market share" garnered the most first-place votes, while "build customer awareness/loyalty" followed in second place. "Build adaptive/flexible organization," "product development," and "reduce customer cost" were the other objectives offered. (See Figure 1 for details on managed care’s impact on manufacturers’ sales and strategies.)

Figure 1. Managed care and integrated health-care delivery systems are changing sales methods, increasing manufacturers’ activity in these charted areas.



Participants also indicated that account penetration is shallow (two-thirds of respondents have seen no growth in sales from group-purchasing contracts), signaling that manufacturers are having difficulty amassing greater share within accounts. Finally, survey responses suggest that administrator prominence in the buying center is increasing significantly, resulting in increased emphasis on price, particularly in pharmacy, surgery, radiology, and pediatrics.

SELLING RESPONSES

In the wake of this arduous, low-yield progress, it’s not surprising that many firms have attempted to increase their negotiating power by focusing on value-added programs, team selling, interactive relationships with customers (consultative selling), outcomes data, customer service, and new sales methods. For example, 35% of the respondents indicated that they had increased the importance of value-added programs, while 54 and 53% have increased their use of team selling and consultative selling, respectively (Figure 1). Eighty-four percent of respondents who conduct outcomes research report that they do so to add value to the selling effort (Figure 2). These responses to changes in the selling environment are typical of those from all types of medical product manufacturers surveyed.

Figure 2. Survey respondents collect outcomes data for a variety of reasons.



Still, efforts to increase sales aren’t working consistently, despite the considerable time and resources invested in these areas. This added cost is reflected by survey participants; more than half said sales costs were increasing as a result of higher compensation costs and an increased number of reps in the field. This often plays itself out as follows: When a manufacturer pursues business with this new sales formula, a layer of acquisition cost is added that places a premium on winning business at a reasonable margin. The trouble is, as medical product manufacturers know all too well, little business—particularly new, high-volume national account business—is won at stellar margins. In fact, it may take years to mine the value of a national account and cover a company’s acquisition costs—or even to break even.

As managers become more attuned to the national or new-account phenomenon through the application of new sales models, they inevitably ask themselves a series of questions: "How can I increase returns on this effort? Should our sales strategies be changing? Should our delivery system be enhanced? Should we redistribute our selling effort across new and existing accounts? Or should we explore new, lower-cost channels of distribution?"

The responses to this survey provide some answers to these questions. First, in their interactions with new and existing accounts, participants indicate that they have focused their discussions with buyers on three points: products (74%), cost savings (64%), and quality (62%). One possible reason: an effort to enhance their selling propositions. The good news is that this approach seems to help manufacturers get contracts with institutions. In fact, respondents report that the quality of their product (65%) and low prices (62%) most often secure a place on a buying group’s preferred-provider list (Figure 3). In addition to discussing products, quality, and savings, half of the manufacturers that responded to this poll frequently offer solutions development.

Figure 3. Manufacturers must talk quality and cost to close the sale.



Second, customer service is an increasing source of leverage for manufacturers seeking to enhance their delivery systems. The survey results indicate that not only are manufacturers increasing the number of customer service personnel—45% have increased the size of customer service—but they are also expanding customer service’s role (Figure 4). Nearly 65% of respondents indicated that expanding their service offerings is a critical ingredient in customer service. This expansion often takes the form of complimentary, value-added services that are strategically positioned to offset price pressures. For example, to ensure their customers’ machines operate at peak performance, a number of diagnostic equipment manufacturers offer more-frequent calibrations or consumption audits to high-volume users at no additional cost. In other cases, manufacturers are using customer service as a selling resource: 55% of the respondents indicated that they were increasing customer service’s role in selling. While the results of the survey do not clearly articulate whether customer service agents are selling to new or existing customers, or both, it is clear that most manufacturers are using customer service reps to increase their market share with existing customers.

Figure 4. Customer service departments are expanding their scopes.



Third, although the use of alternative channels of distribution has received significant attention as a key ingredient of managing sales cost, this strategy has not proliferated in medical manufacturing. Respondents to the survey said that they have explored the addition of contract reps, telemarketing, manufacturers’ sales reps, and on-line purchasing. However, fewer than one-third of participants have increased the use of these channels. Surprisingly, however, 37% have increased their use of distributors despite manufacturers’ inability to share a significant proportion of the asset and pricing risk with distributors. Previously, manufacturers have also shied away from distributors because of a lack of willingness to offer distributors incentives, through price concessions, to report end-user data.

THE NEW COURSE

When viewed collectively, the survey results paint a picture of tremendous change in sales of medical products: the number and types of buyers are increasing dramatically, manufacturers are struggling to sell value and are increasing their focus on existing accounts while working hard to wrest share from competitors, and new sales methods are slowly being evaluated.

To harness the energy of these changes to drive profitable sales growth, manufacturers must:

  • Focus their team and consultative selling efforts. To sell effectively employing these efforts, firms must concentrate on the right buyers, including senior executives, and ensure that all value interests—including costs, marketing, operations, and clinical outcomes—are addressed. One successful medical product company recently modified its sales organization to sell across physician and management ranks by deploying clinical specialists to make the clinical and operations case for its products and senior account managers to make the cost and marketing case with management. Selling from the top down and bottom up has enabled this manufacturer to forge relationships that allow it to address clinical, operations, cost, and marketing value interests in the purchasing process. For this manufacturer, reorganizing to address each of these interests has reduced selling costs, increased account retention, and improved the firm’s ability to differentiate itself from the competition.
  • Effectively bundle selling propositions and create a total solution (addressing products, quality, and cost savings) for health-care institutions. To construct a complete bundle of selling propositions, manufacturers must develop specific, quantified value propositions to articulate how their products, quality, and pricing will help health-care institutions make money. To ensure maximum effectiveness, value propositions are usually combined in a financial model that accounts for the full range of value created by a product and its accompanying services.

    To assemble an initial diagram of value as it aligns with customer profit drivers, one leading manufacturer created value trees that tie its products specifically to customer economics, enabling its sales reps to quantify value associated with each profit driver and the overall impact of its products on its customers’ profits. With this selling tool, the company has been able not only to protect its margin, but also to differentiate itself with financial buyers and management.

  • Learn each purchaser’s minimum acceptable level of value and the resources required to deliver that value. In addition, sales reps must be prepared to gather data to determine the amount and type of resources required to deliver the proposed value. Once thresholds and resource requirements are known, the right delivery system (be it customer service or another delivery system) can be created to deliver enduring value to customers.

    By pinpointing the threshold value and resource requirements from its customers’ perspectives, another manufacturer was able to focus specialized service resources on its accounts instead of on more-expensive sales people who had previously performed the service role at a higher cost with lower customer satisfaction.

  • Determine which order characteristics (buying processes and behaviors) make customers profitable. Many leading medical product manufacturers have performed ABC cost analyses and profitability modeling to answer this question; however, sophisticated analyses may not be necessary to identify the largest and most controllable order characteristics affecting account profitability.

    Armed with an understanding of the relative profitability and determining order characteristics of its customers, a manufacturer of surgical supplies was able to quickly make decisions about how to deploy its sellers across its account base. Interestingly, the firm found that its largest and fastest gains in profitability came from improving the profitability of existing accounts by altering the ordering characteristics of its largest buyers. Sibson & Co.’s (Chicago) experience suggests that, on average, 40% of an organization’s customers are unprofitable, creating significant opportunity to increase profits while avoiding the higher acquisition costs associated with new customers.

  • Discover what sales methods customers prefer for product purchase. Although this prescription sounds trite, most manufacturers do not have a clear understanding of their customers’ purchasing requirements, and they have even less understanding of the service level requirements. Until this understanding is reached, manufacturers will have an extraordinarily difficult time matching service requirements with order characteristics and, finally, aligning sales methods with the most profitable customers. As a result, it should come as no surprise that leading manufacturers know how to use numerous cooperative sales strategies to focus the right resources on the most profitable customers.

    A leading diagnostic device manufacturer recently learned, through intensive customer and rep interviews as well as cost analysis, that many of its customers wanted to buy from reps who worked directly for the medical device manufacturer. With this finding and a detailed understanding of the customers’ service requirements, the firm was able to move 20—30% of its revenues to a lower cost of sales while meeting customers’ need for an alternative channel.

CONCLUSION

Although structural change in health care is unavoidable, a tighter course to profitable sales growth can be charted. The key to employing these recommendations lies in an organization’s ability to assess which recommendations can be supported by sales staff and the organization. To gain momentum on this new course, remember what many leading manufacturers have learned: start with quick wins, maintain a customer-oriented perspective, and continue to apply key lessons from success stories. And, don’t forget profitability growth is a long-term proposition, requiring incremental adoption of new techniques.

Thomas G. Knight is a senior consultant, specializing in sales effectiveness, for Sibson & Co. (Chicago). Kelley Johanning is an associate consultant for Sibson & Co.


Copyright ©1997 Medical Device & Diagnostic Industry

Determining the Size of a Medical Device Market

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI  December 1997 Column

A vice president at the health-care investment banking firm BT Alex. Brown (Boston) and a member of MD&DI’s readers board, explains how to calculate market size for a new medical device.

Some colleagues and I have developed an idea for a medical device company. How do we determine the size of a market for a particular device?

This is a key question for a start-up company because it helps determine the feasibility of product development. If the target market is too small, the effort may not be worthwhile. Market size also affects how easy it will be to raise capital as well as the eventual disposition of the company as public or private. A large market can support a public company, whereas smaller markets may not. Many small markets can still support a healthy private company, which could be an attractive acquisition target.

Preexisting Markets. Published market indicators already exist for a variety of devices, such as pacemakers, balloon catheters, and monitoring equipment. U.S. market data on these and other products are available from IMS Global Services and consulting firms such as Frost & Sullivan (see sidebar). Other sources include equity research reports published by investment banking firms, information from trade associations such as the Health Industry Manufacturers Association, and even annual reports from companies within the industry.

Information on international market size is a bit more difficult to obtain. Many products are sold through local distributors, and many international markets are small and fragmented. The rule of thumb has been to assume international markets for a device, in aggregate, are equal in size to that of the U.S. market. This could be a conservative estimate because the international market for medical technology is growing as Asia and Latin America invest heavily in health care.

When evaluating an international market, one should also consider cultural and pricing variations among countries. For example, Japan may have a cultural bias against transplants, but reimbursement for medical devices in Japan can be several times higher than that provided in the United States.

Potential Markets. For a device still in the conceptual stages, one can estimate unit demand and then multiply by the expected unit price to obtain a potential dollar market size. To estimate market size for capital equipment, use the number of facilities as a starting point and then estimate the number of equipment placements per site.

If the device will be used with a specific surgical procedure, the number of procedures carried out annually, multiplied by the number of devices per procedure, can be used for an initial estimate of demand. Procedure statistics can be obtained from professional organizations or published resources such as the Universal Healthcare Almanac. In addition, patient populations are frequently tracked by fund-raising organizations, such as the American Heart Association and the American Diabetes Association. Almost every disease has an advocacy group that can provide statistical data on affected populations.

Imagine developing a new electrophysiology ablation catheter device for treating the debilitating condition of atrial fibrillation. The number of patients affected by atrial fibrillation can be obtained from sources such as the American Heart Association. About 2 million people are affected by this condition, and 140,000 new diagnoses are made each year in the United States alone. If two of the new catheter devices are used in each treatment, there is a potential preexisting market of 4 million devices and an ongoing market for 280,000 new catheters each year. Assuming a unit price of $500 each, this device could represent a $2 billion market opportunity in the United States today. The market outside the United States could be equally as large. This is clearly a significant business opportunity, and a number of companies are actively pursuing it.

Market assessment projects such as this are ideal part-time assignments for MBA students. Many such students have prior consulting or industry experience, so one can often draw upon a strong pool of skills for a relatively low cost—and, perhaps, also discover a few talented new employees.


MARKET STUDY PUBLISHERS

Financial Times
14 E. 60th St., Ste. 1206, Penthouse
New York, NY 10022
212/888-3469

FIND/SVP
625 Avenue of the Americas, Dept. FNF
New York, NY 10011
800/346-3787

The Freedonia Group, Inc.
3570 Warrensville Center Rd., Ste. 201
Cleveland, OH 44122-5226
216/921-6800

Frost & Sullivan
2525 Charleston Rd.
Mountain View, CA 94043
415/961-9000

IMS Global Services
660 W. Germantown Pike
Plymouth Meeting, PA 19462
610/834-5000

Medical Data International, Inc.
2 Park Plaza, Ste. 1200
Irvine, CA 92614
800/826-5759

Theta Reports
1775 Broadway, Ste. 511
New York, NY 10019
212/262-8230


"Help Desk" solicits questions about the design, manufacture, regulation, and sale of medical products and refers them to appropriate experts in the field. A list of topics previously covered can be found in our Help Desk Archives. Send questions to Help Desk, MD&DI, 11444 W. Olympic Blvd., Ste. 900, Los Angeles, CA 90064, fax 310/445-4299, e-mail helpdesk@devicelink.com. You can also use our on-line query form.

Although every effort is made to ensure the accuracy of this column, neither the experts nor the editors can guarantee the accuracy of the solutions offered. They also cannot ensure that the proposed answers will work in every situation.

Readers are also encouraged to send comments on the published questions and answers.


Copyright ©1997 Medical Device & Diagnostic Industry

Compatibility of Medical Devices and Materials with Low-Temperature Hydrogen Peroxide Gas Plasma

Manufacturers can draw from a broad spectrum of techniques to sterilize and disinfect medical devices, and new physical and chemical processes continue to be developed. A leading reason for this continued search for new methods is to meet the needs of an increasing number of cost-conscious, managed-care hospital and clinical environments, which are forgoing the use of single-use, disposable devices in favor of devices that can be used more than once.




Radio-frequency energy generates plasma from vaporized hydrogen peroxide. Illustration by Advanced Sterilization Products (Irvine, CA)

While traditional methods of sterilization, like steam and ethylene oxide (EtO), successfully treat many devices, new techniques can sterilize a broader range of materials in a single system. Some of the newer sterilization techniques currently on the market or under development include low-temperature hydrogen peroxide gas plasma (Sterrad system, Advanced Sterilization Products, Div. of Johnson & Johnson Medical, Inc., Irvine, CA), low-temperature peracetic acid gas plasma (Plazlyte system, Abtox, Inc., Mundelein, IL), vapor-phase hydrogen peroxide (Steris, Mentor, OH), chlorine dioxide (Johnson & Johnson, New Brunswick, NJ), and high-intensity visible light (PureBright, PurePulse Technologies, San Diego).

Very little information has been published to date on materials compatibility with these processes; therefore, recently more than 600 individual resterilizable devices from more than 125 medical device manufacturers were tested for compatibility and functionality with the Sterrad system. Overall, approximately 95% of the devices tested could safely be sterilized by low-temperature hydrogen peroxide gas plasma.

TRADITIONAL PROCESSES

Various sterilization processes have different characteristics and will also have different effects on materials and devices. For example, contrasts can be seen between applications for the newer low-temperature gas plasma technique and those for the older, established processes of steam and EtO gas sterilization. Sterilant type and concentration, cycle time, temperature, and pressure parameters will differ among the various processes, and these parameters will determine in part the types of devices and materials that each process can sterilize.

For example, materials and devices that cannot tolerate high temperature and humidity, such as some plastics, electrical devices, and corrosion-susceptible metal alloys, may not be recommended for steam sterilization. Some materials, like certain plastics, such as plastic optical fibers, cannot withstand radiation. EtO is not recommended for use with materials that absorb or react with it. Liquids and some devices that can be physically damaged or changed by exposure to vacuum cannot be processed by EtO and low-temperature gas plasma.


Figure 1. Sterilization and disinfection processes afford different degrees of protection at varying costs.

The relationships among some of these processes are illustrated in Figure 1, which plots various methods as points on a two-dimensional map of relative cost and degree of disinfection or sterilization. Some techniques, such as liquid immersion methods, can be considered disinfecting or sterilizing, depending on the length of the cycle.1 Relative costs vary, depending on facility requirements (e.g., shielding in the case of radiation, or space and exhaust vapor handling in the case of EtO), cycle time (which can affect the number of duplicate instrument sets needed), materials compatibility (which can determine the types of instruments sterilized), packaging, and so forth.

COMPARATIVE ADVANTAGES AND DISADVANTAGES OF STERILIZATION PROCESSES

Steam. Steam is the oldest and most common method for hospital sterilization of medical devices. Some of its advantages include speed, low cost, and low environmental impact; however, the high temperatures associated with steam may cause damage and lead to safety concerns, and steam can corrode surgical alloys and cutting edges. Chrome stainless-steel surgical blades and other related devices have developed pitting and dulling of the cutting edges after multiple steam sterilization cycles, while low-temperature gas plasma has shown no detrimental effects.2 Also, most plastics cannot withstand high temperatures.

EtO. A long-established and widely used method, EtO provides a low-temperature environment (enabling many heat-sensitive devices, such as modern electronic instruments, to be processed), widespread availability, a long track record, and a wide range of compatible materials. Its disadvantages include toxicity, environmental threat from hydrochlorofluorocarbons, long aeration and total processing time, high costs, custom facilities requirements, and residual EtO in materials.

Hydrogen Peroxide Gas Plasma. The Sterrad system offers a short cycle (averaging 75 minutes), low temperature and humidity, no aeration requirement, no chemical residues, negligible environmental impact, and wide compatibility with materials. Its drawback is an inability to process liquids, powders, or strong absorbers (e.g., cellulosics).

Some lumen restrictions also apply. For long and narrow lumens, the time it takes for the vapor to travel through the lumen can exceed the length of the diffusion cycle. Thus, guidelines have been developed for lumen diameter and length to ensure adequate penetration and efficacy for the given cycle parameters. Care must also be taken to ensure that the walls of the restricted area are not composed of materials that may absorb or decompose vapor and thus decrease sterilization efficacy.

Other Low-Temperature Processes. Published information on the compatibility of materials with vapor-phase hydrogen peroxide (VHP), low-temperature peracetic acid vapor gas plasma sterilization (Plazlyte), and other new processes is limited.3 However, one common theme is a shift toward processes that are more oxidizing.4 Thus, oxidation effects on materials may be similar for both low-temperature hydrogen peroxide gas plasma and other new processes.

THE HYDROGEN PEROXIDE GAS PLASMA CYCLE

The new low-temperature hydrogen peroxide plasma technology system sterilizes in five phases: vacuum, injection, diffusion, plasma, and vent cycles.

During the vacuum stage, the chamber is evacuated to 0.3 mmHg pressure. Items to be sterilized, which are typically placed into the chamber in a tray covered with a double layer of nonwoven polypropylene fabric wrap or a Tyvek pouch, must be thoroughly dried first. Excess moisture in the instrument load will prolong the evacuation phase because of continued evaporation of the moisture and can lead to cancellation of the cycle.

A dose of liquid peroxide is then injected into the evacuated chamber through a heated injector nozzle, which both evaporates the aqueous hydrogen peroxide solution and disperses it into the chamber. The chamber temperature is controlled at a point somewhat warmer than room temperature, not exceeding 40°—45°C, to reduce the chance of condensation. The chamber pressure rises slightly during the injection phase as the hydrogen peroxide evaporates. The process can be considered fairly dry, since the relative humidity stays between 6 and 14%, and the equilibrium vapor pressure of water at 40°C is about 60 mmHg.5

During the diffusion phase (approximately 50 minutes in duration), the hydrogen peroxide vapor is allowed to permeate the chamber and completely expose all surfaces of the load to the sterilant. At the completion of the diffusion phase, the chamber pressure is reduced to 0.5 torr, and the radio-frequency plasma discharge is initiated, which lasts for 15 minutes. In the plasma state, the hydrogen peroxide vapor breaks apart into reactive species that include free radicals. The combined use of hydrogen peroxide vapor and plasma safely and rapidly sterilizes most medical instruments and materials without leaving toxic residues. Following the reaction, the activated components lose their high energy and recombine to form primarily oxygen, water, and other nontoxic by-products.6

In the final phase, the chamber is vented to atmosphere through a high-efficiency particulate air (HEPA) filter, reevacuated, and vented again. The vapor purged from the chamber is vented to the atmosphere through a catalytic filter to decompose all remaining traces of hydrogen peroxide into water and oxygen vapor.

FUNCTIONALITY AND COMPATIBILITY TESTING

The Association for the Advancement of Medical Instrumentation has developed a guideline for evaluating resterilization of reusable medical devices,1 and a testing program that adheres to this guideline is under way at ASP for evaluating material compatibility of medical devices with the Sterrad system. The functionality and compatibility testing program subjects devices to a preestablished number of reprocessing cycles—typically, up to 100—and includes visual and microscopic evaluation of the effects of processing, functionality assessment by the device manufacturer, and a final report. Functionality testing may include evaluation of electrical function, optical function, mechanical function (i.e., changes in strength, fit, or dimensions), and appearance.

A wide range of different device types have been tested, including flexible and rigid endoscopes, fiber-optic light cables, laser handpieces, power drills and saws, and ophthalmic devices. As mentioned previously, approximately 95% of the devices tested could safely be sterilized by low-temperature hydrogen peroxide gas plasma. Those devices that appear incompatible exhibited cosmetic changes such as fading of dyed anodized aluminum components and of some colored plastic identification rings (which are not required for device functionality), and some chipping of paint coatings. Embrittlement of some adhesives has been noted, as well as chemical changes in some organic and polymeric sulfides.


Metals

Stainless steel 300 series, aluminum 6000 series, titanium

Nonmetals

Glass, silica, ceramic

Plastics and Elastomers

Polyethylene (LDPE, HDPE, UHMPE), polypropylene copolymer, polymethylpentene, Tefzel, chlorinated polyvinyl chloride, polystyrene, polyethersulfone, polyvinylidene fluoride, polyetherketone, Viton, trifluorochloroethylene resins, fluoroelastomer, polypropylene, polyphenylene oxide, Teflon (PTFE, PFA, FEP), polyvinyl chloride, polycarbonate, polysulfone, acrylonitrile butadiene styrene, polyetherimide, most silicones and fluorinated silicones, ethylene-propylene rubber


MATERIALS COMPATIBILITY ISSUES

Fading of Anodized Aluminum. To address the issue of fading with some anodized aluminum products, electrocoloring techniques were evaluated. Electrocoloring differs from conventional type II anodization processes in that instead of dyeing the component and then sealing the dye in the porous anodized oxide layer that is electrochemically grown on the aluminum, the part is immersed in a second electrolysis tank following initial clear anodization. The second electrolysis tank typically contains specific metal salts, such as stannous sulfate, for coloring.7 The coloring effect is believed to be due to the deposit of extremely small crystals or particles, such as metal or oxides, in the pores of the electrolytic oxide film. Such deposits can lead to coloring or shading due to the optical effects of absorption. In repeated testing this type of electrocoloring resists oxidation and bleaching for a minimum of 500 cycles.8

Adhesives. Many types and categories of adhesives are used in fabricating medical devices, and the hydrogen peroxide gas plasma system was tested with a variety of adhesives. Many compatible adhesives were identified, as were some mechanisms and guidelines for predicting incompatibility of certain adhesives. A partial list of adhesives that were tested for stability after 500 cycles is shown in Table I.

Adhesive Type Rating Rank
Loctite 363 Modified acrylic; USP VI, medical grade Excellent compatibility 1
Dymaas 128-M Urethane acrylate; USP VI, medical grade Excellent compatibility 1
Dymax 20288 (625-M) Urethane acrylate; USP VI, medical grade Excellent compatibility 1
Dymax 136-M Urethane acrylate; USP VI, medical grade Excellent compatibility 1
Dymax 197-M Urethane acrylate; USP VI, medical grade Excellent compatibility 1
Dymax 186 UV One-part solid Excellent compatibility 1
Epotek 353ND Epoxy (two-part) Excellent compatibility 1
Epotek 320a Epoxy Excellent compatibility 1
7520 A/B Urethane, A/B urethane Excellent compatibility 1
Dow Corning Silicone Good compatibility 2
Devcon 14270 Epoxy Good compatibility 2
TyRite Urethane (two-part) Good compatibility 2
Tra-Con FDA 2T Epoxy Good compatibility 2
B2086 Nusil Silicone (two-part) Good compatibility 2
Sylgard 186 Silicone (two-part) Good compatibility 2
GE #103 Silicone, medical grade Good compatibility 2
DP 105, Clear Epoxy,a 3M Clear epoxy Good compatibility 2
Araldite PY 302-2b Epoxy (two-part) Compatible 3
Araldite PY 302-6b Epoxy (two-part) Compatible 3
Epotek 354c Epoxy (two-part) Compatible 3
Epotek 314 Epoxy (two-part) Compatible 3
Epotek 377 Epoxy (two-part) Compatible 3
Hysol 9340 Epoxy Compatible 3
Castall 343 A/B Epoxy (coating) Compatible 3
Eccobond UV 1190 UV acrylate Compatible 3
Eccobond 1962-31 Epoxy (one-part) Compatible 3
Electrolite ELC4M31 UV, medical grade Compatible 3
Master Bond EP42HT Epoxy Compatible 3
Epotek 301 Epoxy (two-part) Fair compatibility 4
Epotek 302 Epoxy (two-part) Fair compatibility 4
Epotek 305 Epoxy (two-part) Fair compatibility 4
Epotek 310 Epoxy (two-part) Fair compatibility 4
Master Bond EP30HT Epoxy Fair compatibility 4
Eccobond 45/15 Epoxy (two-part) Least compatible 5
Eccobond 45LV Epoxy (two-part) Least compatible 5
Stycast 2651 Epoxy (two-part) Least compatible 5
PRC PR 1422 Polysulfide Least compatible 5
3M EC 301 Polysulfide Least compatible 5
Rank 1: No material damage after 200 cycles; no leakage on the fixture after 500 cycles.
Rank 2: No material damage after 200 cycles; not leak tested; samples received fully cured.
Rank 3: Minor material changes after 200 cycles; leakage after 100 cycles.
Rank 4: Material damage after 100 cycles; leakage after 200 cycles.
Rank 5: Material damage after 60 cycles; leakage after 100 cycles.
a Exception: Adhesives were tested for only 100 cycles, without leak test.
b Exception: Araldite adhesives showed material damage after 200 cycles; no leakage after 500 cycles.
c Epotek 354 was totally debonded; no material deterioration after 200 cycles; no leakage after 500 cycles.

Table I. A partial list of adhesive compatibility for up to 500 cycles of hydrogen peroxide gas plasma sterilization.

Adhesives that use large proportions of amines as curing or cross-linking agents tended to be incompatible. It was previously reported in the literature that the epoxy matrix of a graphite-epoxy composite deteriorated after lengthy immersion in liquid hydrogen peroxide because of the breaking of amine cross-links securing the polymer network, a breaking that resulted from an attack on secondary and tertiary amine linkages by hydrogen peroxide.9 This theory was supported by infrared spectroscopy analysis of the epoxy before and after immersion as well as by other work that indicated hydrogen peroxide reacts with secondary and tertiary amines.10

ASP’s finding that some epoxies were more adversely affected than others in the low-temperature hydrogen peroxide gas plasma system is consistent with these data. For example, most room temperature­curing epoxies with approximately a 1:1 ratio of resin- and amine-type curing agents exhibited low compatibility. These epoxies are cross-linked mainly by amine groups.

In contrast, some high-temperature-curing epoxies that use small amounts of catalytic curing agents showed better compatibility. An example was imidazole-cured resins (such as Epotek 353ND or Shell 828 resin with EMI-24 catalyst). Imidazole curing agents cure largely by homopolymerization, with relatively low proportions of curing agent to resin, leading to relatively low levels of amine cross-linkages. Homopolymerization operates through catalytic opening of the epoxy group of the uncured resin, leading to formation of an ­OH group, which can then react and form a cross-link with an unreacted epoxy group.11

Sulfides. Because of the tendency of sulfur-sulfur linkages to react with hydrogen peroxide, some materials containing these linkages—such as certain metal sulfides and organic sulfides—are susceptible to degradation. Some adhesives, such as polysulfides, also degrade due to oxidative attack by sulfur-sulfur linkage, leading to depolymerization and deterioration.12

DESIRABLE CHARACTERISTICS FOR COMPATIBILITY
WITH HYDROGEN PEROXIDE GAS PLASMA

Considerations and issues for designing devices compatible with sterilization and reuse include materials choice and packaging, component design, application purpose, manufacturing processes, and the user environment.

The primary materials guideline for designing reusable devices is to select materials that are compatible with various sterilization processes. Materials that are good candidates for low-temperature hydrogen peroxide gas plasma sterilization possess hydrophobic character, are chemically stable, and resist oxidation and moisture.

If devices will be sterilized in trays, special design considerations are required because of the trays’ large surface area. Devices are typically loaded into trays that have been validated for the process. These trays have been tested to confirm that good sterilization efficacy is achieved through optimal choice of the tray material and design. For example, the hydrogen peroxide gas plasma process, like many other processes, depends heavily on adequate diffusion of sterilant through the load. Therefore, the trays must be designed with sufficient open area and gas pathways to permit unimpeded diffusion. The trays can also be double-wrapped in a nonwoven polypropylene to provide a sterile barrier, allowing the sterilization load, which is completely dry after processing, to remain sterile until use.

For industrial or terminal sterilization, as well as for hospital applications, individual devices can also be separately pouched in heat-sealed Tyvek-mylar pouches, which allow adequate diffusion around the device. Large amounts of paper products or cellulosics cannot be used because they can absorb and immobilize excessive quantities of hydrogen peroxide.

The relative compatibility of various materials with liquid hydrogen peroxide and EtO are tabulated in several reference sources.13-15 These sources can be used as guides to gaseous hydrogen peroxide compatibility as well, since published information in this area is rather limited.

Component design can also influence materials compatibility. Materials that may not be compatible with the process may remain undamaged if contained within or shielded by another component. However, materials that decompose or catalyze decomposition of hydrogen peroxide, including certain transition elements such as copper, silver, and manganese, should be avoided within sealed areas. If a small amount of hydrogen peroxide is diffused into the enclosed area, high internal pressures may be generated, possibly damaging components.

Similarly, using materials that decompose or absorb hydrogen peroxide is not recommended in diffusion-restricted areas such as lumens or deeply recessed, blind openings due to localized hydrogen peroxide depletion or efficacy considerations. When designing such features for devices, it is best to avoid decomposers—such as silver, copper, and copper alloys—and absorbers, such as polyurethane, nylon, and cellulosics. Noncatalytic, nonabsorbing materials such as PTFE, polyethylene, stainless steel, or low-copper/aluminum alloys are recommended.

Application purpose is another important aspect in designing devices. For example, some materials with only moderate compatibility may be completely adequate in devices intended for a limited number of resterilization cycles.

Material compatibility also can be significantly affected by the manufacturing process, particularly bonding. Selecting compatible adhesives is critical; adhesives such as epoxies, cyanoacrylates, UV curables, and silicones can all be used, although specific formulations can vary in their compatibility.

Joint design influences bond longevity as well, particularly the amount of exposed surface area of the bond relative to the amount of bond material shielded between the adherends. A greater amount of exposed material may shorten the bond life, while more shielded material will extend the life of the joint through multiple cycles.

Proper thermal processing may be another issue. Adhesives that require elevated-temperature cure conditions must be chosen carefully so that other materials used in the device will not be damaged by heat during manufacturing. Thermal annealing and stress relieving can play a major role. For example, some grades of plastics, such as polymethylmethacrylate, acrylonitrile butadiene styrene, and polycarbonate, may be subject to stress cracking after multiple cycles, causing fine surface microcracking, which can affect mechanical strength and optical clarity. However, proper stress relief by thermal annealing can reduce the incidence of these changes.

Other processes may use dry solid lubricants, such as molybdenum disulfide, during component assembly. These lubricants remain in the device and can lead to eventual deterioration. A two-stage mechanism may occur where, in the first stage, small amounts of hydrogen peroxide may diffuse into the part and reach the lubricant. The lubricant reacts with the hydrogen peroxide, oxidizing the sulfur and leading to sulfuric or sulfurous acidic residue formation. The second stage occurs when the acidic residues attack materials, such as plastics and adhesives, from within the device, leading to eventual weakening and leakage.

In addition to purely materials issues, effects on appearance should be considered. As mentioned previously, type II anodized aluminum with a black organic dye is often used in medical devices. Typically the dye oxidizes or bleaches within a few cycles, fading the black anodized coating almost colorless. Fading can be prevented by using an electrocoloring or two-step anodization process, which resists bleaching because the dark color is obtained from internal metal oxide deposits in the anodization layer and not from an organic dye. This type of process is most commonly used in architectural applications on the exterior of buildings, where it resists fading and bleaching from oxidation and UV exposure.

CONCLUSION

New sterilization processes such as low-temperature hydrogen peroxide gas plasma are generally compatible with most of the materials used in medical devices. However, many of these new sterilization techniques use oxidizing agents like hydrogen peroxide, ozone, peracetic acid, and chlorine dioxide, which can damage cell walls and membranes as well as affect genetic material and other systems.16 As always, manufacturers should use care in selecting materials and designing components and devices, remaining aware of how materials may interact with various sterilizing processes. This concern with compatibility will, in turn, ensure longer life cycles and better cost-effectiveness for users in today’s managed-care market.

Converting Clinical Data Management Systems: The Year 2000 Challenge

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI  December 1997 Column

YEAR 2000 SOFTWARE

The clock is ticking toward the next millennium. Will your data survive, or is there a time bomb programmed into your management system?

The "year 2000 software crisis," as it has come to be known, poses a serious risk to the integrity of data being collected and analyzed in clinical studies. The problem arises from the two-digit notation used by many computers and software applications to denote years in dates, such as 10/01/97. Current software will be unable to process dates correctly after December 31, 1999, and processes that use dates in key fields, calculations, comparisons, sorts, and projections may potentially report inaccurate, missing, or incomplete information. Statistical conclusions drawn from these faulty data to support clinical studies could have harmful effects on human lives.

This article outlines a structured approach to overcoming the year 2000 problem as it relates to the management of clinical trials. A planned strategy, properly implemented, is necessary to ensure that the operations and functions of existing computer systems will continue well into the next millennium.

DATES AS DATA

Dates play a fundamental role in clinical trials because of their relation to the starting point, duration, and primary and secondary end points of a study. Key conclusions and statistical statements often depend on time-related events. A survival analysis, for example, identifies the life expectancy of an event based on date-dependent measurements.

Dates often serve as the key fields when merging data files and are also used to sort and search for study compliance. The sorting routines in most programs will not be able to handle "00" dates, because 00 is less than 99. As a result, a program might place the data collected for a patient visit in the year 2000 before the data for a patient visit in 1997. Trends and analysis based on patient follow-up data can lead to inaccurate conclusions if this is not corrected. Dates are used to calculate age, follow-up time, and time-to-event. They can also be used to compare most recent measurements with baseline values.

In investigational sites, patient enrollment dates are often used to project follow-up visits based on the protocol’s compliance schedule. Patient calendars and monthly reminder lists are generated to assist the site personnel in scheduling patient examinations. Having a system to track patient visits is essential to maintaining high compliance.

Dates also play an important role in the resolution of data queries and anomalies. Often, a separate database will contain information on the types of queries sent to the sites and track their resolution using the date the query was sent, the patient visit date on the case report form, and the date the query was resolved. Given the integral role dates play in clinical trials management, the need to make computer systems year 2000 compliant should be of primary concern to device manufacturers.

PROJECT MANAGEMENT

To develop a strategy for becoming year 2000 compliant, manufacturers must have a thorough understanding of their current clinical data management systems and the methods and tools available to correct the problem. Only then can a structured approach be defined, progressing from inventory to planning, conversion, validation, and implementation.

Manufacturers can begin by performing a business-risk or impact assessment, starting with an inventory of computer software systems. Managers need to ask: How many applications, programs, languages, lines of codes, and data fields are there? Does any documentation identify the source programs that generate the reports used in the clinical trial? Are any applications and programs outdated? Which applications and programs are most frequently used? What tools are available to help with the inventory? For each application and system, the objective is to identify all the areas that could possibly be affected by the century rollover. An inventory of all programs, files, databases, computer screens, and related systems should be compiled.

The next step is to develop a plan to make the computer system year 2000 compliant. A project team with key people from all departments affected should be assembled, and funds allocated for purchasing software tools and consulting services. It will be essential for the project manager to recruit individuals with the right skills to minimize start-up time. The key skills include technical software expertise, biostatistical and clinical affairs knowledge, a regulatory background, and project management leadership.

Based on the initial inventory, the project team should develop a time line for adjusting systems and determine how the code and data files should be changed. For each application, a number of options exist; the project team can decide to leave it alone, redesign it by conversion, rehost it to a new platform, replace it with another application, or retire it from operation.

For software applications slated for redesign by conversion, the team needs to determine the most appropriate conversion method. The unaffected or outdated software applications can be replaced or archived. Each converted software application must be tested and validated to minimize the risk of introducing programming or data errors. Once the system is completed, it needs to be implemented to ensure user acceptance of the conversion process.

It is important to realize that the year 2000 problem is not a technical problem but a business enterprise problem. The challenge is to make all clinical data management systems understand dates in the next century before it is too late. Software tools by third-party vendors are available to assist in monitoring and automating the conversion process. Since fewer than 730 days remain to complete this project, all available options should be considered.

DATABASE MANAGEMENT

The process of converting systems and applications in each functional area cannot begin without an understanding of how date fields are stored and processed. For example, are dates entered and stored as numbers or characters? In what format? With two or four digits for the year? Are the dates transformed in any way before being saved to the data set? These questions need to be answered to determine what needs to be done and at what stage. The process presents a good opportunity to standardize and document the clinical data management system. To standardize dates, manufacturers can refer to ISO 8601, which specifies that numeric dates be represented as ccyy-mm-dd where cc = century, yy = year, mm = month, and dd = day. Examples of this notation are 1997-10-01 and 2001-01-01.

FUNCTIONAL AREAS

For clinical trials data management systems, the functional areas to investigate include data entry, statistical analysis, and report generation. The focus should be on date-sensitive applications and data files. The year 2000 will appear as mm/dd/00 on many computer screens and reports unless corrected.

Data Entry. In general, information is collected into a case report form and transferred to the data management center through one of four methods: hard copy, fax, diskette or tape, or modem. Each method is susceptible to the year 2000 problem. A review of the data-entry system should examine system application and files, external files, data-entry screens, and operational procedures.

The system application defines the date fields for entry into the data sets. The date fields need to be numeric and need to allow four digits for years for all new studies. In addition, any possible logical checks on the dates should be programmed. Examples of these logical checks include confirming that the three-month patient visit date is after the one-month visit date and that the patient’s birth date is before the enrollment date. All screens should display all four digits for the year to avoid confusion by the data-entry operator. The conversion team must also consider the compatibility of any data being merged with the clinical database from an external file and take steps to ensure that all dates in the database remain consistent. Operational procedures such as double-key entry and audit trails rely almost entirely on dates to determine when events occurred. Whether these functions occur by batch or interactive process, dates are recorded and used to minimize and identify any data-entry errors and to document changes to the clinical database.

Data backup and recovery procedures must not be overlooked. Managers should make sure that a system knows what dates are the most current so that it does not override a current backup with an older backup.

Statistical Analysis and Report Generation. The review of the statistical analysis and report generation functional areas must examine the statistical data set, printed reports, and output flat files. Statistical data sets comprise all the key fields from all the data sets in a clinical study. Often, the primary and secondary end points are tabulated in the statistical data set, which is used as the input data set for most of the statistical analysis programs for the study. Dates used to define when events occurred play a critical role in the statistical analysis.

In clinical studies, follow-up information is often collected to monitor patient progress. Because data are collected over time, typical reports might include most recent visit, mean difference in efficacy between visits, and improvement from baseline. These reports not only display dates in the listing but also depend on accurate dates to determine the patient’s most recent visit as well as the visit with the best response rate.

In most programs, the logic is designed to use a two-digit year in comparisons and calculations. Because 00 is less than 99, this logic will no longer work. Many programs assume that there is no year larger than 99. In addition, programs may have "19" hard-coded into them to assume that we are in the 20th century.

The data sets and programs used for statistical analysis deserve the highest priority in the conversion process. For new studies, the case report forms should be designed to facilitate the collection of accurate data. In general, four-digit years should be requested wherever dates are recorded.

CONVERSION STRATEGY

All items in the inventory must be reviewed to determine which are affected by the century rollover and when the impact will occur. All applications can then be categorized by those that need attention and those that do not. Remember that the mission-critical systems deserve the highest priority.

The best conversion strategy for achieving year 2000 compliance is determined by time and money. The easier solutions may take less time to implement and work fine in the short term, but may require greater maintenance costs. The harder solutions may take longer to implement, but may last longer without additional maintenance.

There are three basic approaches to correcting the year 2000 date-field problem: Fix the data, fix the code, or do a combination of the two. Whatever the approach, three conversion strategies should be considered: four-digit date expansion, the fixed/sliding window technique, and encapsulation. Figure 1 provides a decision tree for determining the most appropriate approach.

Four-Digit Date Expansion. Four-digit date expansion entails changing the two-digit year notation to four digits. This modification usually applies to the data files. In addition, minor modifications may need to be made to the programs in order to read the dates in the new format. Four-digit date expansion may be the first option to consider because it makes the most sense and is the most final solution; however, depending on the extent of the problem, there may not be enough time to expand all applications to the four-digit notation. In addition, complex files and program relationships may prevent the use of the field-expansion strategy.

Fixed/Sliding Window. A good alternative to four-digit date expansion is the fixed and sliding window technique. The basic idea is that by setting a date in a computer system—e.g., 1950—the system can then have a 100-year window defined—in this case from 1950 to 2049; two-digit year representations are not ambiguous: 49 is 2049, 50 is 1950, 51 is 1951. This works well for systems that have dates within 100 years of each other. This technique is attractive because it should be applicable to more than half the applications and programs that need to be changed. Most important, it is straightforward and easy to apply. It requires no change to the data structures (in flat files and databases) and only top-level changes to the program, usually only once. Major fourth-generation languages have a statement that sets the window at the top of the program, and the window dates need to be added only once. Even sliding windows are easy to install, where the window moves to stay relatively positioned over the current year.

For example, in SAS applications (SAS Institute; Cary, NC), time-span calculations and database storage of date values have been year 2000 compliant from their inception. In addition, the YEARCUTOFF option allows an easy 100-year window of two-digit representation of years. For many companies, this method is appropriate for 70 to 99% of their SAS programs and systems. When working with several SAS programs that access the same data file, the YEARCUTOFF option should be consistent in each SAS program to preserve data integrity.

Encapsulation. Basically, encapsulation is a means of preventing modification of either the program or the data file, depending on which is more important. In program encapsulation, the program remains unchanged while the data are modified. In data encapsulation, the reverse is true.

If program encapsulation is chosen, then an option is to "time shift" the data by subtracting 28 years from each date before doing any calculations and then adding 28 years to the result. A constant 28, or a multiple of 28, is used because every 28 years, the days of the week are the same for any given day in the year. Since all the dates will be shifted back by 28 years, any date calculations will avoid the century rollover problem and generate accurate results. In addition, the method requires no other logic change to the program.

If data encapsulation is desired, then an option is to read and write the data storage using hex to retain the old record layout. This involves changing the format of the date entered to accept four digits and storing the four digits as a two-digit representation. Hex storage will preserve the original length requirement of the data file. Two hexadecimal bytes can represent year values from 0 to over 65,000, removing the 100-year limit. This method has the advantage of obviating the need to redesign old file structures, with the added benefit that other languages can also read the files.

Each application must be looked at individually to determine the appropriate method for correcting the century rollover problem. Different applications could each require a different fix. A schedule needs to be developed to define each application’s start date based on the programming resources and the number of programs affected.

Figure 1. This decision tree, written in pseudo code, outlines the steps that must be taken to determine the appropriate year 2000 compliance strategy for each application.

PROGRAM FOR SELECTING A YEAR 2000 COMPLIANCE STRATEGY

(1) Do . . . Examine your system/program/data:

(2) If the representation of years is OK, and there is
no: 1. time-span calculations,
nor: 2. year-sorting,
nor: 3. year-comparisons,
then you could consider leaving it . . . AS IS

(3) If (Priority > Difficulty) then expand all date fields;

  • From two-digit to four-digit year fields;
  • In all programs/screens/data/printed reports;

(4) ELSE IF

    you use standard 4GL date functions, and
  • your dates are close together (<100 years) then consider the FIXED WINDOW in that language.

For SAS programs it is:
OPTION YEARCUTOFF=ccyy (like 1950);

(5) ELSE IF you prefer a sliding window: use system calls based on the system current year:

For SAS programs it can be:
%EVAL(%SYSFUNC(YEAR(%SYSFUNC(TODAY())))-90);

(6) With choices (4) and (5), doublecheck output reports and input/output screens to ensure they are to your liking (and your customers’), i.e., four-digit years;

(7) Else if (other languages use files) or (years spanned are too diverse) then use an encapsulation method

  • which can pack four-digit values into two columns;
  • which can temporarily time shift your data for processing;

(8) Last resort (sometimes best) is to reengineer: to place program features into other systems—possibly year 2000—compliant off-the-shelf or turnkey software.



TESTING AND VALIDATION

Even though the repair of a two-digit field is relatively simple, testing the result involves a massive process to ensure that new problems were not introduced into the application and to verify that errors were not introduced into data files. Maintaining consistency in designing, executing, and documenting is vital. Programs need to work today and after the year 2000. The strategy is to develop a simple yet effective method to complete the testing objectives in a structured and controlled environment.

To ensure system compliance, manufacturers must perform unit testing, system and integration testing, and acceptance testing. In defining the acceptance level, testing managers must strike a balance between the risk of missing an error and the rewards of having a thoroughly tested system. The highest level of compliance involves testing for four different points in time. The first is before the year 2000—for example, December 31, 1999. The second is in the year 2000, such as January 1, 2000. The third is after the year 2000, such as January 1, 2001. The fourth covers a transition into the year 2000 and back, such as December 31, 1999, to January 1, 2000, to December 31, 1999. This last test assesses the ability of the application logic to cross from 1999 into 2000 and from 2000 back to 1999. More extensive testing, if needed, can involve several business cycles that move across the change of century. Also, a system must be implemented for continuously monitoring the compliance and satisfaction of all members of the clinical study.

CONCLUSION

For health-care companies, clinical data are a valuable resource. If a system needs conversion to continue functioning into the next century, then the conversion must be accurate. Mistakes from processing dates can invalidate the conclusions of any clinical study.

FDA requires validation for any software or computer system that manages clinical data for clinical trials. FDA submissions such as annual reports, clinical updates and amendments, 510(k)s, and premarket approval applications all need to be error-free. Moreover, the submission should not have confusing information about dates and calculations. The Division of Small Manufacturers Assistance within FDA’s CDRH has information about the device regulatory issues concerning the year 2000 computer problem. More details can be found on CDRH’s home page at http://www.fda.gov/cdrh/yr2000.html

The year 2000 problem imposes a fixed deadline, and only limited resources exist to address the programming issues involved. Because of the urgency and significance of this problem, senior management must make a commitment to immediate action. There is no simple solution. Implementing a successful year 2000 conversion will require effective project management and considerable teamwork.

Sunil Kumar Gupta is senior consultant and founder of Gupta Programming (Simi Valley, CA) and cofounder of Millennium Technologies Institute, Inc. (Spring Valley, CA).

Illustration by Tim Teebken


Copyright ©1997 Medical Device & Diagnostic Industry

Small Can Be Better&#151;It's a Matter of Choice

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI  December 1997 Column

Allen Oelschlaeger finds excitement working for small companies.

Edward E. Waldron

Allen Oelschlaeger decided years ago that he is, by nature, a small-company person. He enjoys the challenges and dynamics of smaller businesses. That's one of the reasons he recently decided to join MicroPulse, a young company in Kalamazoo, MI, as one of three vice presidents.

"In a smaller company," Oelschlaeger says, "you do just about everything. There is not a lot of support structure in place, and it tends to be much less bureaucratic than a larger company. That makes for faster decisions and, I think, more innovation.

"Big companies are generally stable; they have a history, a track record. Everyone knows what the company is all about—where it's been and where it's going. There is structure. Some people need that comfort level. Others, like me, crave a little more adventure."

A NEW OPPORTUNITY

Oelschlaeger's current adventure will see him focus on completing clinical trials for MicroPulse's new product, raising additional funds for the company, and initiating product sales. MicroPulse, which opened its doors in September 1994, is developing an innovative surface for hospital beds, and possibly other areas, that will help prevent and treat pressure sores. Each year, as many as one million people in the United States develop pressure sores, and more than a billion health-care dollars are spent on support surfaces in an attempt to prevent and treat this condition. Although several products already on the market seek to prevent or treat skin breakdown for people who are confined to one position for extended periods, Oelschlaeger believes the MicroPulse product offers unique assistance.

"Our clinical results are very encouraging," Oelschlaeger says. "So far we have seen zero incidence of pressure ulcers on the MicroPulse surface. However, the real benefit of this new technology will be that we can offer it at a price that will allow it to be used for pressure-ulcer prevention rather than just treatment. I see a great deal of potential for this product in health-care facilities and in other settings where people have limited mobility."

Oelschlaeger's enthusiasm for his new position is typical of his career. He has worked in the medical device industry since 1983, when he joined Physio Control Corp. in Redmond, WA. His initial training was in pharmacy, and when he earned his MBA, he concentrated his studies in marketing and hospital administration. During a summer internship with Eli Lilly (Indianapolis), however, he made an important discovery.

"I realized that I enjoy the industry side of health care more than the provider side," Oelschlaeger recalls. "From that point on I concentrated on working for medical device companies. I picked Physio Control because, at the time, they were the premier sales and marketing medical device company.

"You might recall," he adds, "that in the early 1980s companies were still making green boxes with black knobs and selling them through technical sales teams. Physio Control was one of the first companies to use a customer-centered approach. They brought a strong industrial design focus to their products and offered direct sales and service to their customers."

Over the last 15 years, Oelschlaeger has moved from marketing to management, holding increasingly responsible positions at several medical device companies. He was a business-unit director and director of marketing at Marquette Electronics (Milwaukee). He then served as vice president of cardiology for MedAcoustics, a Raleigh, NC, start-up, and earlier this year he joined Meridian Medical Technologies, Inc. (Columbia, MD), as a general manager.

"At Meridian Medical Technologies I was responsible for their cardiopulmonary systems division, which has a small operation in Belfast, Northern Ireland. I had responsibility for the Northern Ireland operation, but it was still located within a larger company structure.

"When I got the call from a good friend to join MicroPulse," Oelschlaeger continues, "I jumped at the chance to work in a small, entrepreneurial company again."

Oelschlaeger has a straightforward philosophy about finding a place in the business world: "It's important to step back and think about what it is you like to do and what you're good at," he says. "Once you decide, then you choose which environment works for you. You have to learn for yourself where you fit in best."

Edward E. Waldron is a freelance contributor to MD&DI. He is based in Tampa, FL.


Copyright ©1997 Medical Device & Diagnostic Industry