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CDRH Committee to Review Home Use of Devices

Originally Published MDDI January 2003


Many advanced devices, first cleared by CDRH for use by trained caregivers, are also used by laypeople under prescription. Unintended side effects, such as death and injuries, are an ever-present risk. But FDA believes that home-use of the devices poses added hazards. To improve the safety of home-use devices, CDRH plans to form an advisory committee to address the issue. Representatives of agencies that deal with such devices will meet with consumers to discuss the risks of home use. CDRH will use the resulting information in planning policies for use of devices in the home environment. The action was prompted by the results of a public meeting held in September 2002.

Copyright ©2003 Medical Device & Diagnostic Industry

Controlling the Motion of Magnetic Fields

Originally Published MDDI January 2003


Studies of the biological motors that enable intracellular transport could provide the basis for a new generation of diagnostic tools. An international group of researchers from the University of Michigan (Ann Arbor, MI) and Japan's Institute of Physical and Chemical Research (RIKEN; Tokyo) are exploring the use of a new class of microdevices to control magnetic flux quanta in superconductors.

The researchers explain that as integrated circuits become smaller, it becomes more challenging to create the many guiding channels that act like wires to move and position electrons on circuit components. The difficulty in wiring nanocircuits must be overcome to develop useful applications based on nanotechnology. The researchers explain that a similar problem exists in the development of better magnetic imaging tools for medical diagnostics. Essentially, the motion of magnetic field lines within the superconducting material must be controlled so that their motion does not produce noise that degrades the performance of the diagnostic device.

In an article published last November, researchers Franco Nori, PhD, of the University of Michigan and RIKEN, and Sergey Savel'ev, PhD, of RIKEN, described a number of new concepts for addressing such problems by controlling the motion of flux quanta.

The researchers explain that magnetic fields penetrate superconducting materials via lattices of quantized magnetic flux, called vortices, because electrons whirl around them without dissipating energy. Electrical currents, externally applied to superconducting devices, induce the motion of these magnetic flux quanta. This vortex motion produces noise that degrades the device performance in practical applications, such as the sensitive measuring of the magnetic fields produced by the brain. Therefore, say the researchers, the precise control of the motion of these vortices is of central importance for applications involving superconducting materials.

Controlling the motion of quanta inside superconducting materials enables the design of micromachines such as pumps, diodes, and lenses. The magnetic flux quanta can create specific magnetic profiles within a given sample or device, according to Nori and Savel'ev. This would give designers the ability to remove unwanted flux trapped inside superconducting devices. Researchers would also have the ability to increase the magnetic field in designated target regions inside materials, which would magnetically focus nearby magnetic particles, they add.

Nori explains how these "radically new proposals" could aid in the development of new medical devices: "First, several medical imaging devices use superconducting magnets. These are needed to achieve sufficiently large magnetic fields. Second, controlling the motion of these magnetic field lines is important. Third, some other devices have trapped flux inside that must be removed. Controlling the motion of these magnetic flux lines would allow the removal of undesired magnetic flux. And fourth, for other systems, a local increase in magnetic fields is important to achieve higher magnetic fields at specific locations. These proposals provide several new specific ways to reach this goal."

Copyright ©2003 Medical Device & Diagnostic Industry

A Risk Management Approach to HIPAA Remediation

Originally Published MX January/February 2003

Business Planning & Technology Development

With a series of orderly steps, medical technology organizations can accomplish the tasks needed to bring them into HIPAA compliance on time.

by Patrick Quirk

Like other components of the healthcare sector, many medical technology companies recognize that their operations are being affected by implementation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). However, acknowledgement of the importance of HIPAA has emerged among companies only gradually, and few medtech executives are comfortable that they fully understand what changes will be required for their organizations to comply with this regulation.1 

If they have not already done so, now is the time for medtech executives to get a handle on the ways that HIPAA and its regulations affect their organizations, and on what measures they must undertake to bring their organizations into compliance. 

State Grant Supports Biosensor Research

Originally Published MDDI January 2003


A New York state research agency has awarded $750,000 to a Cornell University (Ithaca, NY) engineer and physicist to develop a chip-based analytical system for rapid analysis of chemical and biological compounds. The research could lead ultimately to development of medical devices capable of performing rapid diagnostic tests.

The grant was made in November through the New York State Office of Science, Technology, and Academic Research (NYSTAR) Faculty Development Program, which is intended to help universities recruit leading research faculty. The researcher, Harold Craighead, is the C. W. Lake Jr. Professor of Engineering and professor of applied and engineering physics at Cornell.

The NYSTAR grant will support Craighead's research involving the application of nanotechnology to chip-based chemical and biochemical analysis systems. His research group has been involved in developing highly selective biological sensors capable of detecting small quantities of biological microorganisms or biochemicals. Craighead plans to create a new class of devices that will use microfluidic systems incorporating engineered nanostructures for high-speed analysis of chemical mixtures. The planned microfluidic systems use methods that are described as being similar to those used to produce electronic integrated circuits.

Copyright ©2003 Medical Device & Diagnostic Industry

The Terminology of Statistical Analysis

Untitled Document

Originally Published MX January/February 2003


Return to Article:
When Earnings

Multiple regression is a method of explaining the linear relationship between several independent, or predictor, variables and a dependent, or criterion, variable. Multiple regression enables a researcher to seek a trustworthy answer to the question, What is the best predictor of ______? The statistical analytical technique determines the linear relationship between the values that change, and then finds an equation that satisfies such a relationship.

R-square is an indicator of how well the model fits the data, and is a value expressed as a decimal term between 0 and 1. An R-square of 0.4 means that 40% of the original variability has been explained, and the re-maining 60% cannot be explained by these variables in the equation.

Coefficients are the multipliers in front of the independent variables in the equation. The higher their value, the more impact on the dependent variable they are trying to predict (in the case presented here, market capitalization). Those with especially high values are referred to as

FDA Aims to Eliminate the "Pre-1976" Stigma

Originally Published MDDI January 2003


A new CDRH office will be the showcase for director David Feigal's concept of the total product life cycle.

James G. Dickinson

Risk Management Comes to Devices | User Fee Implementation Delayed | Head of Bioresearch Monitoring Leaves FDA

One of the oddities of U.S. medical device law is that most new products are cleared for marketing by being deemed equivalent to devices marketed before 1976. Short of going to Congress to revise the law, how can FDA avoid the perception that it is stuck with a backward regulatory system? Device center director David Feigal answered this question in November by opening the Office of In Vitro Diagnostic Device Evaluation and Safety. The center's newest office will serve as a pilot of Feigal's total product life cycle (TPLC) concept, which he has been describing at every opportunity for the past two years. The director of the new office, Steven Gutman, hopes it will free U.S. devices from the pre-1976 perceptional straitjacket.

Gutman told a Regulatory Affairs Professionals Society in vitro diagnostics conference in San Francisco in November that the TPLC concept is the "entire fuel" of the new office. TPLC, he said, will be shown to "maximize efficiency" by providing "seamless oversight" and a "cradle-to-grave" approach to regulation.

While CDRH has long been familiar with TPLC, the new office will demonstrate it to the world. Inside the center, Gutman said, "the mantra is that this stuff is everybody's business. Everybody is supposed to be working off the same page."

Gutman noted that, to someone "who has spent 10 years in premarket science," the idea of TPLC "has tremendous intellectual appeal." The 1976 and subsequent laws governing premarket review, he said, are "starting to show their age." Though treating products as equivalent to those marketed in 1976 was tenable in 1986, he said, "in 2002, as a regulatory scientist, it's not a comfortable place to be."

The problem is most pronounced in the international scientific circles where device standards are discussed, Gutman said. Other countries' delegates, he said, look at U.S. representatives "as if we're aliens from another planet when we talk about seeing new products as equivalent to 1976."

Everyone recognizes, he said, that products "behave differently" after they have been introduced into real-world use. The TPLC approach not only gets away from the stigma of equivalence to 1976 standards, but recognizes this "different behavior."

It's no secret, Gutman said, that the "snapshot" of premarket data that reviewers see doesn't always reflect the actual performance of the product after it has been "stressed" by "dozens or thousands of labs and perhaps tens of thousands of users."

CDRH chose IVDs to pilot the pan-regulatory TPLC approach because these devices have "very stereotyped review issues," Gutman said. "Whether it's premarket, postmarket, compliance, or adverse reporting, the questions are always the same. How accurate is the device? How precise is the device? What is the sensitivity of the device? What is the specificity of the device? Always, these are the same four core questions. And across the center there is a cadre of like-minded scientists who are interested in diagnostic outcomes as opposed to therapeutic outcomes."

Gutman told his RAPS audience that "in spite of the flat economy, we have an amazing emerging technology positioned to enter the marketplace with really wonderful new tests to profoundly impact public health. And in our [in vitro diagnostics] area, we are uniquely multitasked. We already do both FDA and CLIA [Clinical Laboratory Improvement Amendments] programming, and I think that we have the technical savvy to globalize our perspective."

Risk Management Comes to Devices

As it has in other FDA-regulated areas, risk management for medical devices is becoming a major focus of the agency. In the world of devices, however, the term has a handicap: it isn't defined in FDA's 1997 quality system regulation. Instead, the agency must extrapolate it from the restrictive term that is found in the regulation: risk analysis.

In a November presentation to the Regulatory Affairs Professionals Society in San Francisco, FDA's Kimberly Trautman said, "Risk analysis is not a proper term. We adopted this term due to international harmonization . . . ." However, the medical device quality systems expert added, the term as used in Europe has much more to do with risk management than plain risk analysis. When it was adopted in the U.S. device design control requirements, she said, "we were not as sophisticated as we should have been."

Risk management in its broadest sense is critical to all aspects of regulatory compliance, including medical device design validation, Trautman said. "Under risk management, we do risk identification as well as risk analysis and risk reduction," she said. "If FDA finds that you have identified an unacceptable risk but you have taken no action to reduce it, we will cite that as a deficiency."

Trautman reminded her audience that the preamble to FDA's quality system regulation emphasizes that manufacturers must take scientifically documented actions that are commensurate to the risk of their products. In addition, she said, ISO Standard 14971 on risk management is becoming increasingly important to FDA.

"Without a formal risk management program, you cannot comply with the intent of the regulations," Trautman warned. "You will be hearing a lot more about this," she said, adding that the agency will increasingly look at how a risk management program is integrated into a company's quality management system.

Trautman's presentation ranged over FDA's experience with design controls, and she repeatedly emphasized the importance of correct terminology. "Too many times," she said, "I hear people talk about 'product validation.' There is no such thing as product validation. You're either validating the design, which is the complete device—labeling, any accessories, etc.—or you are doing process validation to ensure that you are consistently meeting a predetermined set of specifications or requirements."

Trautman also stressed the importance of controlling design changes "through the life of the product." The longer you wait to do so, she said, the more expensive it becomes, especially when it results in product recalls.

Asked whether FDA has hard evidence that effective design controls reduce recalls, Trautman answered tentatively. Although inadequacies in FDA's databases have prevented analysis, she said, the agency does have anecdotal evidence from individual companies: "They have been able to show . . . an almost linear decrease in the amount of recalls."

When FDA analyzes recall data, Trautman said, "the really sad part of it is that there is still a high percentage of recalls that are due to errors that are simply things that you would think would be common sense. I can't tell you how many recalls we still get that are due to mislabeling—the wrong product in the wrong box." It's "mind-boggling," she said, that many recalls still involve "silly, sloppy mistakes."

All design changes, including labeling changes and manufacturing changes, must go through design validation. Only rarely will verification alone be sufficient. Design changes are the focus of 21% of FDA-483 citations during inspections of design control systems. One of the top design control deficiencies is having an inadequate design plan.

"You do not have to have a design plan for every single design change," Trautman advised. It is sufficient, she said, to establish "an appropriate design control procedure that lays out how you're going to evaluate that change and what type of different steps it may kick into. The design change control procedure should allow for multiple different ways, depending on the complexity. . . . The procedure itself, if it's written properly, can act as the design plan for design changes."

The requirement for design transfer in 21 CFR 820.30(h) is poorly understood, Trautman said. "Design transfer does not happen at one particular time—it happens throughout the design process."

There is also some confusion about the difference between design verification (making the product right) and design validation (making the right product), Trautman said. Acceptance criteria must be established up front, before starting any verification or validation activity. Too often, she said, manufacturers perform validation studies without first establishing their goals and criteria. In effect, they launch elaborate studies, then try to make the results fit what they want to hear. FDA investigators "are always looking for traceability and documentation that the firm's verification confirms that design output meets the design input requirements, to see in the validation studies how the firm has gone beyond the verification testing," she said.

Trautman's presentation kept harking back to the role of risk management. "It's very important that you are able to show us how you have integrated the risk management system," she said. "We're going to be looking at that not only in the design control section but throughout, with respect to decisions on purchasing controls, acceptance activities, and any type of failure investigations or [corrective and preventive action] activities."

User Fee Implementation Delayed

Although FDA device user fees for PMAs, PMA supplements, and 510(k)s came into legal effect on October 1, FDA is not collecting payments until separate legislation authorizes it to do so. CDRH said last November that companies should not send in any payments until a Federal Register notice is published explaining the process.

Businesses with sales under $30 million seeking a reduced fee must submit their federal income tax return showing that their sales and receipts do not exceed the threshold. Firms must qualify as a small business at least 60 days before their first submission in any fiscal year, CDRH says.

For more information on device user fees, visit

Head of Bioresearch Monitoring Leaves FDA

Well-known CDRH director of bioresearch monitoring Charma Konnor retired from the agency on January 3 after 25 years of service. She will join the consulting firm of Phoenix Regulatory Associates (Sterling, VA) as senior manager/consultant for devices and drugs. Former FDAers Adam Trujillo (from the Office of Regional Operations) and Frank Fazzari (from Case Management/New Drug Stategy) already work for the consultancy.

In addition to her device work, Konnor served in FDA's Center for Drug Evaluation and Research, the Commissioner's Office, and in the field (as Florida District acting director). She has been recognized for her leadership in improving FDA premarket and postmarket programs, and in representing FDA in regulatory, legislative, and educational matters.

At CDRH Konnor was most recently responsible for the conduct of preclinical and human trials for investigational medical devices, implementation of CDRH's Application Integrity Policy, and enforcement of promotion and advertising regulations for investigational medical devices. Under her direction, CDRH's Division of Bioresearch Monitoring was transformed into a performance-based division known for its skillful management of compliance issues, its improved interactions with the Office of Device Evaluation, and its educational outreach to the clinical research community.

Copyright ©2003 Medical Device & Diagnostic Industry

Keeping Secrets

Originally Published MX November/December 2003


Recent court rulings about employee confidentiality make noncompetition agreements more important than ever.

Joel D. Covelman

If a trusted employee leaves a company to take a similar position with a competing firm, can the first company bring a lawsuit to stop it? The answer

 depends upon several factors. However, a recent California appellate court decision narrows the scope of remedies available to the former employer when the departing employee has a confidentiality agreement, but not a noncompetition agreement, with that employer.

HACCP: Resolving Product Safety and Liability Nightmares

Originally Published MDDI January 2003


In today's business environment, the benefits of implementing HACCP into a product development and manufacturing process are well worth the effort.

Lorena L. Williams
The Chubb Group of Insurance Companies

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Late in 2001, a Minnesota man died from tainted tissue implanted during reconstructive knee surgery. After his death—and numerous serious infections among other patients—FDA ordered CryoLife Inc. (Kennesaw, GA) to recall and halt sales of the implantable human tissue that accounted for a large share of its revenues.

The agency alleged CryoLife could not ensure that the implantable tissue was free from fungal and bacterial contaminants. Costs associated with the recall turned a projected $2.8 million profit for the second quarter of 2002 into a $5.5 million loss. CryoLife stock slid, the firm laid off workers, and its bank warned it might call in loans.1

Even as CryoLife expresses optimism about its prospects for full financial and regulatory recovery, its problems continue to serve as a striking reminder that medical device companies whose products can cause death or serious injury should be looking at ways to make those products safer. This means taking an honest look at vulnerabilities that can compromise a product's safety and taking action to prevent them from occurring.

Companies would go a long way toward resolving product safety and liability nightmares if they implemented Hazard Analysis and Critical Control Points (HACCP), a scientific and systematic approach to minimizing the impact of manufacturing processes on product safety and performance. Unlike current safety systems, which focus on finding defects during manufacturing through spot checks and by testing the end product, HACCP focuses on three key areas: identifying critical safety hazards in advance, establishing preventive measures to control hazards reasonably likely to occur, and monitoring each critical control point for the hazards identified. HACCP would best suit the medical device industry if it could be adapted to encompass the entire product life cycle.

A Space-Age Solution

HACCP was developed three decades ago by Pillsbury Co., the National Aeronautics and Space Administration, and the U.S. Army Laboratories at Natick. The collaboration sought a way to meet the space program's need for nutritious food that would not spoil and did not need preparation. The program focused on preventing hazards that could cause food-borne illnesses by applying science- based controls, from raw material acquisition through production of the finished item.

Since then, HACCP has become accepted worldwide as an effective way to ensure food safety. Not long ago, momentum was building at FDA to incorporate HACCP into its safety program for medical devices, but the effort stalled because of a lackluster response by the industry.

Proponents of HACCP—academics and industry experts who have studied it and teach companies how to use it—don't believe FDA regulation should be the primary reason that medical device manufacturers embrace HACCP. Companies should adopt the approach because it can protect patients and save companies money. A company that can minimize, during the manufacturing process, errors that compromise safety can save the expense of a potential recall and product liability costs. And because using HACCP can identify problems long before the end product testing stage, companies can save the cost of rework and product that must be scrapped.

HACCP Principles

HACCP consists of seven steps: Conducting hazard analyses, determining the critical control points, establishing the critical limits for each control point, establishing procedures to monitor each critical control point, establishing corrective actions, establishing verification procedures, and establishing recordkeeping and documentation procedures.

Conducting Hazard Analyses. Companies conduct an analysis of each manufacturing process to identify potential product safety hazards and develop preventive measures to control them. The hazards might be biological, chemical, or physical. Hazards are ranked in order, from most to least significant, and controls are ranked from most to least effective.

Determining Critical Control Points. Critical control points are those points in the manufacturing process where product safety can be compromised if a problem occurs. They are also points at which potential hazards can be controlled or eliminated. There may be many possible control points, but it is important to focus on those that are considered critical and for which preventive measures can eliminate the hazard or reduce it to an acceptable level.

Establishing Critical Limits for Each Control Point. Critical limits are parameters, such as maximum or minimum values, used to ensure that a process is working properly or that the product meets a safety specification.

Establishing Procedures to Monitor Each Critical Control Point. Continuous or frequent monitoring of critical control points is essential to ensure that processing systems are working properly and that critical limits are not breached.

Establishing Corrective Actions. Corrective actions must be defined in advance and must be taken when monitoring reveals that a critical limit has been compromised. This may involve removing defective materials from production to get the control point back within the critical limit.

Establishing Verification Procedures. There must be procedures, in addition to monitoring, to verify that the HACCP system is working correctly. They often take the form of an audit.

Establishing Recordkeeping and Documentation Procedures. The company must keep records of hazards and their control methods, monitoring data for critical control points, actions taken to correct potential problems, and verification activities and results.


FDA first considered making HAACP a mandatory requirement as part of the evaluation of new products in the 1970s. "That didn't go over well [with industry], and it died a quick death," said Philip Frappaolo, acting director of compliance for CDRH. Then, in the late 1990s, as part of FDA's reengineering initiative, CDRH developed a pilot project to measure the effectiveness of HACCP.

According to Frappaolo, FDA did not intend to make HACCP mandatory; the agency expected hundreds of companies to jump on the HACCP bandwagon because of the potential for saving money on waste and rework while controlling risks in the manufacturing process. Companies participated in developing the training manuals and FDA's HACCP team trained about 1200 people, representing hundreds of companies. But when it came time to sign the feasibility agreement protocol they helped write, few companies stepped forward.

Some HACCP proponents reasoned that once it became clear FDA would not make HACCP mandatory, industry lost interest. There is also another factor that may have contributed to the loss of momentum: the agency's new quality system inspection technique (QSIT) was developing on a parallel course with HACCP. Even though many at CDRH believed that HACCP and QSIT worked well hand in hand, Frappaolo said, others viewed the systems as being competing inspection programs.

Even firms that may have been using HACCP appeared unwilling to submit data to FDA. Some firms feared that if they submitted a HACCP plan with their premarket approval application, approval might be delayed because of the study. It's just as likely that firms feared that HACCP would reveal a problem with their product and that the product would not be approved until the problem was corrected.

Why Use HACCP?

It's true that HACCP exposes a company's product safety vulnerabilities; many companies may be reluctant to run the risk that FDA would force them to make expensive corrections to problems that the process unveiled. While that position is understandable, it is not defensible. Indeed, HACCP brings vulnerabilities to light for that precise purpose: so manufacturers can address them before they cause harm.

That is not to say that HACCP is perfect; it's not. Nothing can guarantee safety, and to serve the medical device industry well, HACCP should be broadened to address hazards and controls during the design stage of the product. Companies also must address those residual risks that are not considered critical. Even with these weaknesses, though, prudent medical device manufacturers can look to the principles of HACCP as the foundation of a robust, enterprisewide risk management program.

There are a number of reasons—aside from obvious concern over patient safety—that the time is right for medical device manufacturers to embrace and adopt HACCP.

Corporate Responsibility. In the post-Enron, post-Worldcom business environment, there is a growing focus on corporate responsibility. With increasing skepticism of business, regulators, investors, and other stakeholders will be paying closer attention to best practices and will be punishing those companies that put their assets at risk by cutting corners.

The Information Age. If a company experiences a product crisis, news about it—whether fair and accurate or not—will spread like wildfire, reaching more people more rapidly than ever possible because of the Internet and the proliferation of round-the-clock news channels. The more steps a company can take to avoid or mitigate such crises, the better able it will be to defend itself in the court of public opinion.

Litigation and Insurance. An aggressive plaintiffs' bar has had great success targeting companies that manufacture medical products. Medical device companies must necessarily be concerned about their vulnerability to product liability lawsuits. In the 1990s, the average verdict in medical product liability lawsuits was almost $2.8 million, with 47% of verdicts over $1 million, according to Jury Verdict Research (Horsham, PA).

A company that has implemented a HACCP plan has a better chance of successfully defending itself in court. Why? Because the HACCP process requires that a company be vigilant about safety and document the steps it takes to ensure it. The courts recognize that companies cannot prevent injuries 100% of the time; the fact that a company has complemented its quality program with a formal, rigorous hazard analysis and risk management process will demonstrate just how vigilant it is.

At a time when many insurers are raising prices, tightening underwriting, and restricting coverage, implementation of an HACCP program might also save money on insurance premiums. Some insurance companies have specialty programs that address the unique needs of the medical device industry. As part of the underwriting process, these insurers may offer better prices and better coverage to companies that implement product safety controls that exceed minimum standards.

HACCP and Quality Controls

HACCP does not replace substantive quality control measures, such as those called for by FDA's quality system regulation (QSR). Rather, it is a set of protocols that enable medical device manufacturers to minimize process errors. The QSR focuses attention on the design process, during which medical device companies are required to conduct a hazard analysis and implement controls into the design of their products. At times, however, those controls are lost as the designs move into the production stage. The QSR does not require that companies have a formal process for documenting and communicating all the hazards and controls that were identified in the design phase to the people who take control as the device moves into production.

One of the weaknesses of HACCP is that the program has been focused solely on the manufacturing phase. But a company that considers HACCP principles during the design stage and implements them in manufacturing—as well as during distribution and use in the field—may reduce the risk of fatal errors throughout the product life cycle.


One common criticism of HACCP is that it applies more to process industries than to discrete manufacturing. This is a misconception. With HACCP, a company must identify hazards up front and control them during manufacturing and use. The complexity of the device has nothing to do with whether HACCP can be used. For complex products, the manufacturing process is subdivided and separate HACCP plans may be developed for each process step.

Given FDA's tight funding, it is unlikely that it will engage in promoting HACCP or promulgating HACCP principles. That is why it is essential that industry take the lead and look for ways to take this risk management system, which is so widely accepted for food safety, and adapt it to work just as effectively for medical device manufacturers. And should FDA revisit the idea of HACCP and revive its feasibility study, it is incumbent upon prudent medical device manufacturers to step forward and volunteer.


1. "CryoLife Announces Filing and Certification of 10-Q; Revises Previously Announced 2002 Second Quarter Results due to FDA Order," CryoLife Inc. news release, September 4, 2002.

2. OV Oparah, Implementation of Hazard Analysis and Critical Control Points (HACCP) Plan as a Continual Improvement Initiative in the Manufacturing Process of Medical Devices (master's thesis, Massachusetts College of Pharmacy and Health Sciences, Boston, 2001).

3. S Maschino and W Duffell Jr., "Can Inspection Time Be Reduced?: Developing a HACCP Plan," Medical Device & Diagnostic Industry 20, no. 10 (1998): 64.

The author will be responding to questions and comments about this article in MD&DI's Author Forums during the week beginning February 10, 2003. Visit and select the Author Forums link.

Copyright ©2003 Medical Device & Diagnostic Industry

For and Against

Untitled Document

Originally Published MX January/February 2003


Return to Article:
Keeping Secrets

The inevitable disclosure doctrine is a legal fiction that has been employed to prevent employees of one company from working subsequently for a competing company. The doctrine assumes the possibility of the employee breaching a confidentiality agreement and sharing trade secrets of the previous employer with the new one to be a fact, whether or not such disclosure has occurred or can be proven. The presumption in favor of injury to the former employer is not universal however; several state and federal district courts have recently sided with the employee in such cases.
The following court decisions have rejected the inevitable disclosure doctrine:

o Government Technology Services Inc. v. Intellisys Technology Corp. (VA Cir. Ct., October 20, 1999) no. 160265, WL 1499548.
o Bayer Corp. v. Roche Molecular Systems Inc. (N.D. Cal. 1999) 72 F. Supp. 2d 1111, 1120.
o Globespan Inc. v. O'Neill (C.D. Cal. 2001) 151 F. Supp. 2d 1229, 1235.
o Del Monte Fresh Produce Co. v. Dole Food Co., Inc. (S.D. Fla. 2001) 148 F. Supp. 2d 1326, 1337.

The Medical HACCP Alliance

Originally Published MDDI January 2003


is a consortium of industry representatives, academics, and regulators dedicated to promoting the application and implementation of the HACCP principles to medical device manufacturing.

The Alliance works to increase public awareness of HACCP, providing training and technical support for medical device companies that wish to implement HACCP plans. Another of its major activities is the development of a voluntary standard.

"The self-appointed job of the alliance is to convince people that HACCP is a good thing," says Alliance vice chairman William Hyman, professor and interim head of the biomedical engineering department at Texas A&M. "It is systematic, it captures the critical control points, and ultimately you make better products more cheaply and more reliably by redirecting your effort to the parts that really count."

For more information on the Medical HACCP Alliance, visit

Copyright ©2003 Medical Device & Diagnostic Industry