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Articles from 1996 In December


WASHINGTON WRAP-UP

Medical Device & Diagnostic Industry Magazine | MDDI Article Index

Originally published December 1996

James G. Dickinson

Even as it escaped reform legislation that would have removed some of its fingers from the medical device regulation pie, FDA in September seemed headed for public disgrace on two device issues: over-the-counter substance-abuse test kits and ophthalmic excimer laser approvals.

Barely two months before the November elections, both issues made fine campaign fodder. The first set the federal bureaucracy against parents of teenagers everywhere; the second, in the words of an Investors' Business Daily headline, portrayed the bumbling "national nanny" as the witless tool of "senatorial privilege."

The adjourning Republican Congress was quick to take note. It staged a highly publicized hearing on the test kits issue and expanded its investigation of "lasergate" to include the alleged influence of Summit Technology, Inc. (Waltham, MA), on the approval process. Summit had made numerous and sizable donations to Senator Edward M. Kennedy's (D­MA) reelection campaign in 1992. Previously, Congressman Joe Barton's (R­TX) oversight and investigations subcommittee had been interested only in whether FDA had leaked laser documents from competitor Visx (Santa Clara, CA) to Summit last October.

The test kits issue centered around an FDA warning letter sent to Sunny Cloud, head of Atlanta-based Parent's Alert. The letter accused the group of distributing a misbranded and adulterated Class III medical device--to wit, a plastic cup, jar, and mailing label to a licensed lab. Parent's Alert had sold the kits, at a price of $40 each, to about 1000 customers, presumably parents wanting to know whether their teenagers had been abusing il-legal drugs.

When she was visited by the FDA investigator, Cloud recalls, she was at first flattered that her organization's good work seemed to be receiving federal recognition. The warning letter's arrival a month later quickly shattered that illusion. Cloud turned to the maker of Alcoscreen, a home test for alcohol, for help. The company, which had also received a warning letter and was in deep regula-tory trouble with FDA, referred Cloud to well-known device attorney Larry R. Pilot of McKenna and Cuneo (Washington, DC). Pilot not only wrote FDA a formal response to the warning letter, but also made several unreturned calls to Center for Devices and Radiological Health (CDRH) director Bruce Burlington on Cloud's behalf.

FDA had classified Cloud's kits as medical devices on the basis of their use in detecting "other conditions" besides diseases. But as former director of compliance in CDRH's predecessor, the Bureau of Medical Devices, Pilot had actually been present when FDA inserted the phrase "other conditions" into the 1976 Medical Device Amendments. It appears in the second statutory definition of a regulated medical device, in the phrase "intended for use in the diagnosis of disease or other conditions."

According to Pilot, the "other conditions" that the amendments' framers intended to address were only medical conditions, such as pregnancy. In fact, he says, the phrase "other conditions" was added specifically to embrace over-the-counter pregnancy test kits, which were controversial at the time. Unfortunately, neither the amendment nor its accompanying committee reports actually spelled out this important limitation. Of course, bureaucracies tend to expand definitions not completely spelled out when doing so can increase their power.

Since at least the mid-1980s, FDA has been expanding the definition of "other conditions." FDA closed down a Virginia diagnostics manufacturer that was selling home test kits for drug detection on the grounds that the products were medical devices lacking assurance of effectiveness. In 1987, FDA prepared a "points-to-consider" document for home-use in vitro diagnostic kits that declared that the center would evaluate such products' benefits and impact on society as well as patients. FDA's attempts to evaluate the societal impact of products may have caused much of the current dissatisfaction with the agency's performance.

This was certainly true of Commerce Committee chairman Thomas Bliley (R­VA). At a congressional hearing on September 26 on the issue of drugs-of-abuse home test kits, Bliley raged at the agency's behavior regarding a dispute with Psychemedics Corp. (Boston), a supplier of such tests. During that dispute, FDA had said its jurisdiction extended to "family discord" caused by a test's use.

CDRH director of compliance Lillian Gill faxed a letter to Pilot on the morning of the hearing confirming that the agency deemed Cloud's "device" to be adulterated and misbranded. This letter caused a sensation when Pilot faxed it to the still-sitting subcommittee that afternoon.

FDA's position at the hearing, held by Barton's subcommittee, was particularly inexplicable given that five months earlier it had been forced to back out of the Psychemedics lawsuit. Burlington had acknowledged at the time that FDA's position would lead to certain defeat in the suit.

In comments made at a press conference the day after the September 26 hearing, Bliley said, "I am so angry I can barely contain myself."

Bliley said that FDA showed "a gross display of contempt for American parents." For example, Bliley said, "One witness, the FDA's Dr. Steven Gutman, went so far as to suggest that American parents are not competent to draw a urine sample from their own children, put it in a jar, mail it off to a lab, and then deal in a responsible manner with the results. 'I can deal with the results with my own child,' Dr. Gutman told us, 'but after all, I'm a doctor. I've got the benefit of two volumes of federal regulations on drug testing.' In 15 years in Congress, I don't believe I've ever heard the audience break into spontaneous boos and laughter at government witnesses."

Bliley continued, "Yesterday, they had to be warned five times to stop. They were right to laugh. They were right to boo. I'm right to be angry. And every American ought to know the story, and see that hearing. An arrogant, insulting policy based on a contemptible view of the American people. Washington know-it-alls who think we're not smart enough to handle and discipline our own children."

Bliley demanded a list of all those in the Clinton administration who had had any part in FDA's testimony. Congressman Christopher Cox (R­CA) went further, demanding the resignation of Commissioner David A. Kessler. Democrats also joined in the criticism of FDA.

That same day, September 27, Burlington sent a two-page written apology to the subcommittee. In the letter, he reaffirmed his testimony that "the agency will expeditiously review our policy governing these products, including convening a public advisory committee meeting to reexamine the factors that are appropriate as a basis for marketing home test kits for drug abuse. Moreover, the agency has decided that it will defer any further regulatory action against Parent's Alert pursuant to the warning letter dated June 15, 1995, until the policy review we are undertaking has been completed."

Then came lasergate's latest episode, in the form of a report on the first page of Investor's Business Daily, September 30, with the headline, "Senatorial Privilege at the FDA? Kennedy Campaign Donor Gets Speedy Approval." Just when FDA's crisis-management team was hoping the laser approvals issue had died down, it was back in mainstream media headlines, and the congressional investigation into the document leaks to Summit had widened to include the Kennedy angle.

The newspaper's coverage included most of what had already been reported in trade publications and other media. The coverage also added more detail about the number and scope of Summit Technology contributions made to both the Kennedy reelection campaign and the Democratic National Committee during the FDA review of Summit's excimer laser. The newspaper reported that in addition to 17 donations in 1994 and 24 in 1995, when the device finally received approval, eight top Summit officials attended a postapproval Kennedy fund-raiser and "wrote checks to Kennedy's reelection campaign for 1994 to help retire the campaign's debt." Former Summit CEO David Muller reportedly "pitched in an extra $1000 toward Kennedy's year 2000 campaign."

The report echoed the implication made in a nationwide satellite television broadcast on September 5 by conservative National Endowment Television (NET) investigative reporters. The NET reporters had implied that FDA's approval of the Summit device was corrupted by Kennedy's political influence and the improper relationship between FDA and Summit.

CDRH's Burlington labeled the charges "utter fantasy." He said that "the idea that Senator Kennedy did anything that affected the approval is just stunning. I can't believe that that happened."

This assertion has been repeated even more fervently by higher FDA officials, who do not wish to be quoted for fear of giving the charges even a hint of credibility. But the ongoing FBI investigation on the leakage by FDA of Visx laser documents to Summit and the widening of Barton's investigation into alleged political influence strongly suggest that the charges cannot be dismissed so easily.

We're sure to hear more.

James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.

IMPROVING BIOCOMPATIBILITY STANDARDS FOR THE GLOBAL MARKET

Medical Device & Diagnostic Industry Magazine | MDDI Article Index

Originally published December 1996

Standards for medical device biocompatibility testing have become much more clear and useful in recent years. There are now documented procedures for several common biological tests, as well as matrices to help determine which kinds of tests to use. Despite this tremendous progress, however, the standards contradict one another on some important aspects of biocompatibility testing. Some aspects are not covered at all by the existing standards. With such confusing information, it can be difficult to be sure that a medical device meets all necessary requirements for biological safety.

The requirements for biocompatibility testing of biomaterials were adapted from classical toxicology standards. The potential adverse biological effects of biomaterials are, in most cases, the same as those caused by chemicals or drugs: irritation, sensitization, organ and tissue toxicity, mutagenicity, tumors, and reproductive problems.

The standards that have guided biocompatibility testing are the Tripartite Guidance; the International Organization for Standardization (ISO) 10993 standards, which are known as the Biological Evaluation of Medical Devices and remain under development internationally; and the FDA blue book memorandum, #G95-1, which is currently used only in the United States.

The Tripartite Guidance provides useful background information, a brief discussion of the principles that need attention in testing for biocompatibility, and a matrix relating intended use of a device to the categories of biological changes that may be caused by chemicals extractable from biomaterials. It does not describe testing methods. The ISO 10993 standards are being developed in multiple sections that contain all the Tripartite-like information, but also give as much detail as available on suitable test methods for ensuring the absence of undesirable biological effects that may be caused by the chemicals extractable from biomaterials. The relatively new FDA blue book memorandum, a variation on the ISO 10993-1 standard, addresses only the selection of tests.

These three bodies of standards identify 12 principal categories of possible biological effects. The FDA blue book memorandum and ISO 10993-1, "Guidance on Selection of Tests," also offer a matrix that makes it relatively easy to select the categories of biological effects that are of concern for the materials in a particular medical device.

But in several areas of biocompatibility testing, there is a lack of direction in the existing standards. For example, there is in some cases not enough, and in other cases conflicting, information on test methods. The existing standards also do not offer clear guidance on how to prepare the test samples properly or even to characterize the materials for testing.

CHARACTERIZING TEST MATERIALS

Biocompatibility testing is nearly without value unless the test and control articles under study have first been characterized in appropriate ways to permit repeating the studies and to ensure that the clinical devices of concern will be made from materials representative of the tested ones. In a section on general principles, ISO 10993-1 says that in the selection of materials, "the first consideration should be fitness for purpose having regard to the characteristics and properties of the material, which include chemical, toxicological, physical, electrical, morphological, and mechanical properties." According to this standard, the device characteristics that are relevant to biocompatibility testing are "the materials of manufacture, intended additives, process contaminants and residues, leachable substances, degradation products, other components, and their interactions in the final product, and the properties and characteristics of the final product."

Materials characterization as it relates to biocompatibility is likely to receive considerable attention in the years ahead, largely because, for such an important issue, it has received little attention in the past.

It is not enough to subject an uncharacterized material (e.g., one identified only as a "blue PVC tubing") to a biocompatibility test, because such a test would not be repeatable. Lack of characterization would also mean that there would be little or no basis for analytical evaluation of "problem" lots of materials when they are encountered.

Because characterization is so essential, the next revision of ISO 10993-1 circulated for approval this year will contain a flowchart, similar to the one contained in FDA's blue book memorandum, in which the first box will instruct the user to characterize the material before proceeding to biological testing.

Characterization can be accomplished with many methods, depending on the criticality of the materials. It may mean determining physical properties or confirming major components with infrared analysis or other fingerprinting techniques. It may include physicochemical tests to determine the weight of nonvolatile residues present in an aqueous or alcoholic extract prepared under controlled conditions or tests to identify specific extractables and their relative quantities.

The phrase materials characterization is actually used in two related but distinctly different contexts. In the first context, it refers to knowing the qualities and components of a material, so that biological test results can be associated with a particular formulation for future reference.

In the second context, the phrase refers to a step in the risk-assessment process. This type of characterization is described in a 48-page draft released in December 1995 by FDA's Center for Devices and Radiological Health entitled "Guidance for the Biological Evaluation of Materials." According to the "new paradigm" described in this document, materials are first characterized by identifying and quantifying their principal available chemicals. The industry literature is then searched to determine the relative toxicity of those components. Judgments are made about the safety of medical devices based on the toxicity of the chemicals they contain and the amounts of those chemicals that are available to patients. If only minimal quantities of extractables are present, no further testing is required.

In principle, this is a very logical approach. It avoids unnecessary, often duplicative testing by using the results of existing toxicity studies. It replaces, whenever possible, empirical in vitro or in vivo testing with systematic, scientific calculations.

However, this approach is years away from being useful, except in isolated situations, because there are insufficient toxicity data for the range of chemical species recoverable from material formulations used in medical devices. Also, although there is much information on systemic responses, not enough data are available to predict local tissue responses.

SAMPLE PREPARATION

To achieve true standardization of test methods, it is essential to control and standardize the preparation of the test and control articles. This is particularly true in the case of biomaterials, which must often be subjected to extraction with specific fluids under specified conditions to prepare suitable dosage forms. ISO 10993-12, "Sample Preparation and Reference Materials," deals with sample preparation and eventually should be the only standard in the series that does so. For now, many of the other ISO 10993 standards also address sample preparation, sometimes in confusing and potentially contradictory ways. It is likely that this will be corrected in the ongoing revision process.

TEST METHODS

Once the materials are characterized and the samples prepared for testing, the next step, selecting specific test methods, can be difficult, depending on the categories of biological effects for which a device is to be tested. Some test methods have been in use for many years, are generally accepted in the industry, and are described in great detail in the various ISO 10993 standards. Thus, if cytotoxicity testing is required (as it is for the materials in every device category), ISO 10993-5, "Tests for Cytotoxicity: In Vitro Methods," provides protocol-like directions for the use of several alternative laboratory methods (elution and overlay are the ones most commonly used). The standard describes sample preparation; appropriate cell lines; culture media; and methods of handling, incubating, and scoring cells. It requires that triplicate flasks be used for each sample (more replicates than laboratories have typically used) and lists the information that must be included in the test report.

For other categories of biological effects, the amount of detail included in test methods or protocols described in the respective ISO standards varies according to the availability of accepted methods that either have been validated or have simply become widely used and accepted by the medical device industry. In general, the more familiar the tests are by virtue of their years of use, the more detail is presented in the standards. Thus, ISO 10993-10, "Tests for Irritation and Sensitization," describes the intracutaneous injection test, the primary skin irritation test, and the maximization sensitization test in protocol-like detail. All three of these tests are based on evaluations that have been widely used in the pharmaceutical, cosmetic, and medical device industries for more than 20 years. This standard also includes a listing of additional irritation tests (e.g., oral, vaginal, penile, and rectal models) that have been used somewhat less extensively.

Like the requirement for triplicate flasks in the cytotoxicity standard, there are unique aspects even of the traditional tests as interpreted by the authors of ISO 10993-10. For example, the ISO intracutaneous test method is not the same as the one described in most pharmacopoeial texts. For example, the ISO version requires that three rather than two animals be used for each test article and describes a scoring scheme that is a hybrid of the one used for the intracutaneous test and the one used for the primary skin irritation test. In the case of the Magnusson-Kligman sensitization method, the ISO version contains numerous small variations from the test originally described by its developers in 1969.

The standard also varies from common practice in some small details. For example, ISO requires that the fur on guinea pigs be clipped the day before they are treated with the test or control article. In practice, however, clipping the fur on the day of treatment has become standard in many laboratories and is considered preferred, especially by technicians who conduct the tests.

For systemic toxicity, ISO standard 10993-11, "Tests for Systemic Toxicity," is of little value to the industry because it contains no details applicable to biomaterials testing, instead referring to methods that were written specifically for chemicals and drugs. The standard references U.S. and European pharmacopoeias as well as the standards and methods of FDA, the Environmental Protection Agency, the American Society for Testing and Materials (ASTM), and the Organization for Economic Cooperation and Development (OECD) guidelines for testing chemicals. These various reference sources are simply listed in the ISO standard without any experimental details in sections on subjects such as acute systemic toxicity, acute oral application, subchronic dermal application, chronic toxicity, and carcinogenicity. Though the principles behind chemical and drug tests are generally sound, they can be applied to the study of medical devices only after modification. Some subjects covered in the standard, such as acute application by inhalation, are virtually never used in testing medical devices.

ISO 10993-3, "Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity," also contains no experimental detail and refers to the OECD guidelines. However, the standard does provide some general advice about the extent of testing required for devices that may have problematic biological effects. For example, in the case of genotoxicity, the standard says that "a series of in vitro tests shall be used. This series shall include at least three assays. At least two of these should preferably use mammalian cells as the target. The tests should preferably cover the three levels of genotoxic effects: DNA effects, gene mutations, and chromosomal aberrations."

Thus, although in the past FDA has considered the Ames bacterial reverse mutation test sufficient to ensure the absence of genotoxic effects, two additional in vitro tests with mammalian cells must be included to satisfy international requirements. The ISO standard also describes materials that require carcinogenicity testing: materials that produce a positive in vitro genetic toxicity effect on mammalian cells, resorbable materials, and materials that will remain in the body for 30 days or longer. Carcinogenicity test methods are based on modified OECD guidelines designed for implantation of the maximum implantable dose and some fraction of that dose in separate groups of animals. Intrauterine devices, energy-depositing devices, and resorbable materials are identified as candidates for reproductive toxicity tests, also based on information from the OECD guidelines. In practice, genotoxicity tests are commonly performed to qualify materials, but carcinogenicity and reproductive effects studies are seldom considered necessary based on the history of the materials and their chemical composition. Very few of the many biomaterials in use today have been subjected to rigorous carcinogenicity or reproductive effects studies.

ISO 10993-6, "Tests for Local Effects after Implantation," recognizes the potential for implantation of materials in a wide variety of alternative animal species including mice, rats, guinea pigs, rabbits, dogs, sheep, goats, and pigs. The two-rabbit muscle implant method has its origins in the United States Pharmacopeia implant test for plastic pharmaceutical containers and is still widely used. However, ISO variations on the USP test may now include the use of more animals, different species, longer implant intervals, additional implant sites, and microscopic examination of tissue reactions. The choice of species is based on implant size and test duration in relation to the expected life span of the animals. Multiple test periods are generally specified "to ascertain that a steady state has been reached with respect to biological response." Thus, for short-term implantation in rabbits, 1-, 4-, and 12-week test periods are prescribed; for long-term implantation, 12, 26, 52, and 78 weeks.

Some materials produce adverse effects only in the immediate postimplantation period, presumably because of the effects of surface chemicals that are rapidly dissipated in the body. Other materials produce few or no acute effects, but as they undergo biodegradation, their breakdown products eventually cause irritation. The authors of ISO 10993-6 intended for local effects to be evaluated by comparing the tissue response caused by a test article to that caused by materials used in medical devices whose clinical acceptability has been established.

Because there is a lack of standardized testing models for studying the effects of biomaterials on blood, ISO 10993-4, "Selection of Tests for Interaction with Blood," deals largely in generalities. The standard provides information on the classification of products that require biological testing and the categories of hematologic effects that may be caused by biomaterials, and offers lists of commercially available assays for various hematological effects, informative annexes with general information on devices and laboratory tests, and an extensive bibliography. In the sense that it does not give procedures or how-to information, the standard is not yet a standard at all; it is more of a review article.

However, the document does contain a useful list of five test categories that need to be considered for various kinds of blood-contact devices, and it appears that as validated methods become available, they could logically be added to the standard under one of these categories, such as the effects on thrombosis, coagulation, platelets, hematology, and immunology.

In the past, FDA has generally accepted hemolysis testing and sometimes thromboresistance testing as sufficient evidence for hemocompatibility. But, as the lack of detail in the ISO 10993-4 standard indicates, there is not yet enough information in this area. The ASTM hemolysis test (which was recently modified and is undergoing reapproval) is an excellent test for hemolytic activity. Several methods now exist for studying effects on complement activation, which is an immunologic effect. Methods are under development for studying effects on the coagulation proteins in decalcified plasma and on the formed elements of blood in vitro and in vivo. Numerous models exist for studying the thrombogenic properties of materials, but most are relatively unsatisfactory because they are difficult to perform, are subject to experimental variables that are difficult to control, and require samples in special forms that may be unavailable. These are perplexing difficulties, particularly because most materials used in medical devices are thrombogenic and most blood-contact materials are used clinically only for patients who have received anticoagulant drugs.

OUTLOOK FOR THE FUTURE

Methods for biocompatibility assessment of medical devices are evolving. The ISO 10993 standards, the FDA blue book memorandum, and the "Japanese Guidelines for Basic Biological Tests of Medical Materials and Devices," issued in 1995, are all steps toward providing specific methods that can be used by device manufacturers and recognized by regulatory systems worldwide. But, because there is disagreement among those in charge of regulations, there is not yet clear direction on all the issues. For example, there is confusion on characterizing materials for testing, preparing the samples, and testing methods. There is also need for detailed standardization on the selection of tests according to the end use of a device, methods of sample preparation, number and kinds of tests to be performed once test categories have been selected, and definition of a positive and a negative test result. In addition, those who assess safety data for regulatory review have yet to agree on when specific testing must be performed, especially costly, time-consuming testing, to what extent existing data and literature can be used in support of device safety, and by what degree specific testing protocols may vary from standards and still be considered acceptable. So the search continues for the most practical, affordable, and valid ways to ensure the biological safety of medical devices.

Richard F. Wallin, DVM, PhD, is the president of NAmSA (Northwood, OH).

DIRECTORY OF ORGANIZATIONS AND ASSOCIATIONS

Academy of Dental Materials
3302 Gaston Ave., Dallas, TX 75246; 214/828-8378, fax 214/874-4503
Objectives are to provide a forum for the expression of opinions related to the physical and chemical properties, biological interaction, clinical applications, and techniques of utilization of materials in the field of dentistry and to encourage research in the development of materials applicable to the art and science of dentistry.

Adhesive and Sealant Council, Inc.
1627 K St. N.W., Ste. 1000, Washington, DC 20006; 202/452-1500, fax 202/452-1501
A nonprofit, international trade association incorporated in 1958 for the purpose of providing opportunities for dialogue, education, advancement, and improvement of all aspects of the adhesive and sealant industry. Offers semiannual conventions, technical short courses, government relations, statistics, and publications.

American Association for Clinical Chemistry
2101 L St. N.W., Washington, DC 20037-1526; 202/857-0717, 800/892-1400, fax 202/887-5093
A nonprofit, international educational organization of more than 11,000 members with a common interest in clinical laboratory science. Members specialize in fields such as clinical chemistry, biochemistry and immunology, molecular pathology, medical technology, clinical pathology, toxicology, and laboratory management. The association publishes books, a news magazine, and a journal; holds a national meeting; offers educational programs; and is involved in government and regulatory affairs.

American Dental Trade Association
4222 King St. W., Alexandria, VA 22302-1597; 703/379-7755, fax 703/931-9429
The oldest and largest trade group representing the dental industry in the United States, with international ties. Members include distributors, laboratories, and manufacturers of supplies and equipment used in dental offices, laboratories, and schools.

American Electronics Association
1225 Eye St. N.W., Ste. 950, Washington, DC 20005; 202/682-9110, fax 202/682-9111
Dedicated to strengthening the U.S. electronics and information technology industry's global competitiveness. The trade group, which represents some 3000 companies, offers members opportunities such as financial conferences, management programs, compensation surveys, group advantage member services, an industry statistics program, local council networking, and government relations programs. Its public affairs staff represents the association and industry in such areas as taxation, trade, education, government procurements, and the environment.

American Institute for Medical and Biological Engineering
1901 Pennsylvania Ave. N.W., Ste. 401, Washington, DC 20006; 202/496-9660, fax 202/466-8489
AIMBE was formed in 1991 with the sponsorship of the National Science Foundation to assist various constituencies of the medical and biological engineering community on issues of mutual interest. The institute offers a forum for catalyzing broad involvement of engineers, representation of medical and biological engineering on issues of national interest, and research on policy issues related to the development and evaluation of the appropriate use of technology in medicine and biology. The organization also offers workshops and courses designed to educate the professional community and the public at large. Fifteen scientific societies representing the full spectrum of bioengineering research and education in the United States are full members of AIMBE.

American National Standards Institute
11 W. 42nd St., New York, NY 10036; 212/642-4900, fax 212/398-0023
A private nonprofit membership organization that coordinates the U.S. voluntary standards system, bringing together interests from the private and public sectors to develop voluntary standards for a wide array of U.S. industries. The institute's membership includes approximately 1300 national and international companies, 32 government agencies, 24 institutions, and 261 professional, technical, trade, labor, and consumer organizations. ANSI is the official U.S. member body to the world's leading standards bodies--the International Organization for Standardization and the International Electrotechnical Commission--via the U.S. National Committee.

American Society for Clinical Laboratory Science
7910 Woodmont Ave., Ste. 530, Bethesda, MD 20814; 301/657-2768, fax 301/657-2909
A large nonregistry professional association for nonphysician clinical laboratory professionals. Its 20,000 members include hematologists, phlebotomists, immunologists, immunohematologists, clinical chemists, microbiologists, managers, and educators.

American Society for Testing and Materials
100 Barr Harbor Dr., West Conshohocken, PA 19428-2959; 610/832-9500, fax 610/832-9555
A primary source of voluntary standards for materials, products, systems, and services. The society's 32,000 members contribute their time and expertise to the development and maintenance of standards and related technical information. More than 10,000 standards are published in the 71-volume Annual Book of ASTM Standards.

American Vacuum Society
120 Wall St., 32nd Fl., New York, NY 10005; 212/248-0200, fax 212/248-0245
An interdisciplinary organization of professionals in basic research, applied research, development, manufacturing, and sales. Its technical divisions are: applied surface science, electronic materials and processing, nanometer science and technology, plasma science and technology, thin film, vacuum metallurgy, and vacuum technology. The society sponsors more than 70 short courses in addition to publishing three technical journals.

AOAC International
481 N. Frederick Ave., Ste. 500, Gaithersburg, MD 20877-2417; 301/924-7077, fax 301/924-7089
An independent association of scientists and organizations in the public and private sectors devoted to promoting methods validation and quality measurements in the analytical sciences.

ASQC (American Society for Quality Control)
P.O. Box 3005, Milwaukee, WI 53201-3005; 800/248-1946, fax 414/272-1734
Founded in 1946, the ASQC is a quality source for information on the development, promotion, and application of quality strategies and techniques. The professional, not-for-profit association serves more than 140,000 individuals and 1100 sustaining members.

The Association for Electric Motors, Their Control and Application (SMMA)
P.O. Box 378, Sherborn, MA 01770-0378; 508/655-4409, fax 508/651-3920
SMMA is the North American association, with a global focus, for electric motors, their control, and application. It serves as the principal voice of the industry and provides a forum to develop, collect, and disseminate technical and management knowledge. Current membership is 180 companies including manufacturers of motors, controls, materials, and components; media; universities; and consultants. In addition to a spring management meeting and a fall technical meeting, SMMA offers motor design courses through the SMMA Motor College.

Association for the Advancement of Medical Instrumentation
3330 Washington Blvd., Ste. 400, Arlington, VA 22201-4598; 703/525-4890, fax 703/276-0793
An alliance of engineering, medicine, nursing, industry, and government professionals united by the common goal of increasing the understanding and beneficial use of medical instrumentation. AAMI fulfills its mission through continuing education conferences, certification of health-care technical specialists, and the publication of technical documents and periodicals.

Association of Medical Diagnostics Manufacturers
Columbia Square, 555 13th St. N.W., Ste. 700W, Washington, DC 20004-1108; 202/637-6837, fax 202/637-5910
Established in 1973, AMDM is a nonprofit trade association that serves as a resource for education and information on compliance issues for member companies, and as an interface between member companies and FDA. Originally, membership was limited to manufacturers and distributors of prepared microbiological media. Today membership includes companies of all sizes that manufacture and distribute in vitro diagnostic products, including cell cultures and cell culture media, immunology and immune status test products, antigen and microbial detection products, and toxicology products.

Biomedical Marketing Association
3905 Vincennes Rd., Ste. 304, Indianapolis, IN 46268; 317/228-8067, fax 317/872-7133
A nonprofit professional organization of nearly 700 marketing and management professionals involved in marketing diagnostics and other medical products or services. The association offers seminars, an annual conference, a marketing educational conference, and presents marketing excellence awards.

California Healthcare Institute
1020 Prospect St., Ste. 310, La Jolla, CA 92037; 619/551-6677, fax 619/551-6688
A statewide public policy research and advocacy organization for California's health-care technology industry. CHI's members include medical device, biotechnology, and pharmaceutical companies, as well as public and private research institutions in California. The organization combines the strengths of these industries to advocate state and federal policies that promote scientific discovery and biomedical innovation. CHI's legislative priorities include: FDA reform, broadening state R&D tax incentives to reflect the special needs of medical device innovators, ensuring Medicare reimbursement for procedures involving investigational medical devices, and tort reform that ensures the availability of biomaterials to medical device manufacturers.

Contact Lens Manufacturers Association
4400 E. West Hwy., Ste. 33, Bethesda, MD 20814; 301/654-2229, fax 301/654-1611
Organized in 1961, CLMA is made up of contact lens laboratories and material, solution, and equipment manufacturers both in the United States and abroad. The mission of CLMA is to increase awareness and use of custom-manufactured contact lenses.

Controlled Release Society
1020 Milwaukee Ave., Ste. 235, Deerfield, IL 60015; 847/808-7071, fax 847/808-7073
European Office: c/o University of Geneva School of Pharmacy, 30 quai E.-Ansermet, CH-1211 Geneva 4, Switzerland; (41) 22 7026339; fax (41) 22 7026339
An international organization with the mission of advancing the science and technology of chemical and biological delivery systems. The society sponsors annual symposia, workshops, and short courses; publishes a newsletter; and promotes education and student and local chapters.

Council on Packaging in the Environment
1255 23rd St. N.W., Ste. 850, Washington, DC 20037; 202/331-0099, fax 202/833-3636
A national coalition of consumer product companies, packaging producers, material suppliers, retailers, trade associations, and recyclers. The council was formed in recognition of the fact that in recent years packaging, as part of larger environmental issues, is of increasing concern. The council acknowledges this concern and wishes to do its part in helping to resolve environmental packaging issues in the most efficient and responsible manner possible.

ECRI
5200 Butler Pike, Plymouth Meeting, PA 19462-1298; 610/825-6000, fax 610/834-1275
ECRI, a nonprofit health services research agency and a collaborating center of the World Health Organization, provides information to the health-care community to support safe and cost-effective patient care. ECRI is world's largest independent evaluator of medical devices and maintains numerous databases on medical technologies. ECRI publishes the Health Devices Sourcebook, an annual directory of medical device manufacturers and equipment, and the Healthcare Product Comparison System on CD-ROM, an international database of capital medical equipment, including brand-name product specifications and overviews of various technologies.

Edison Welding Institute
1250 Arthur E. Adams Dr., Columbus, OH 43221; 614/688-5000, fax 614/688-5001
EWI is a leading engineering organization with over 160 engineering, technical, and support staff members with expertise in virtually every welding and joining technology available today for joining metals, ceramics, and plastics. EWI operates as a nonprofit industrial consortium, working with over 340 member companies to provide applied research, consultancy, training, and general technical support. Medical manufacturers have used EWI's expertise to assess the weldability of nitinol; develop processes for refractory metals such as platinum, platinum-iridium, tungsten, and molybdenum; join dissimilar materials such as ceramics to stainless steel; or assess the seal integrity of plastic materials.

Electromagnetic Energy Association
1255 23rd St. N.W., Ste. 850, Washington, DC 20037; 202/452-1070, fax 202/833-3636
A nonprofit association of manufacturers and users of electrical and electronic systems. The association develops educational programs, sponsors research, and advocates rational, science-based exposure standards on the production and use of nonionizing electromagnetic energy.

Electronic Industries Association
2500 Wilson Blvd., Arlington, VA 22201; 703/907-7500, fax 703/907-7501
A national trade organization representing U.S. electronic manufacturers. Committed to the competitiveness of the American producer, EIA represents the entire spectrum of companies involved in the manufacture of electronic components, parts systems, and equipment for communications, industrial, government, and consumer uses.

Electrostatic Discharge Association
7902 Turin Rd., Ste. 4, Rome, NY 13440-2069; 315/339-6937, fax 315/339-6793
A professional voluntary association dedicated to advancing the theory and practice of electrostatic discharge (ESD) avoidance. From an initial emphasis on the effects of ESD on electronic components, the association is broadening its scope to include other areas such as textiles and fully assembled electronic products. The association sponsors educational activities, including symposia and regional tutorials to support research and education in ESD.

Ethylene Oxide Sterilization Association
1815 H St. N.W., Ste. 500, Washington, DC 20006-3604; 202/296-6300, fax 202/775-5929
EOSA is a trade organization for parties interested in ethylene oxide and its diverse uses. Membership is open to any interested party, but EOSA's primary focus is to service medical and pharmaceutical companies, contract ethylene oxide sterilizers, gas sterilant suppliers, related users and suppliers, and consultants to the industry. The association was formed to promote the benefits of using ethylene oxide for sterilization purposes and to represent other common interests of its members. Some of the objectives include information sharing, monitoring regulatory activities, undertaking advocacy positions, addressing proposed government regulations, and fostering reasonable regulations and truthful communications regarding ethylene oxide.

FDLI
1000 Vermont Ave. N.W., Ste. 200, Washington, DC 20005; 202/371-1420, fax 202/371-0649
Composed of more than 480 manufacturers, suppliers, law firms, consultants, and other organizations, FDLI is a nonprofit educational organization that provides a neutral forum for the exchange of views. Its mission is to promote an understanding of the laws, regulations, and policies affecting the public health aspects of foods, drugs, cosmetics, medical devices, biological products, and veterinary medical products. This is done through seminars, publications, scholarships, and the support of food and drug law courses. The organization, once known as the Food and Drug Law Institute, now uses FDLI as its complete name.

Flexible Packaging Association
1090 Vermont Ave. N.W., Ste. 500, Washington, DC 20005; 202/842-3880, fax 202/842-3841
Represents companies that convert or supply flexible packaging made of paper, plastic film, aluminum foil, or any combination of those materials. The association produces statistics on industry growth, imports and exports, operating ratios and compensation; develops standards and guides on technical specification, sterilization packaging, and bar code scanning; issues legislative and regulatory alerts and reports, curriculum guides for public schools, and a newsletter with pertinent industry developments; and sponsors an annual awards competition for the best flexible packaging.

Georgia Biomedical Partnership, Inc.
2800 Nations Bank Plaza, 600 Peachtree St., P.O. Box 54151, Atlanta, GA 30308-4151; 404/817-5917, fax 404/817-4345
A nonprofit membership organization devoted to the advancement of biomedical technology and healthcare-related economic development, technology transfer, and strengthening of the state's biomedical infrastructure. Membership is composed of biomedical companies, research institutions, corporate service providers, and individuals committed to the promotion, support, and development of the biomedical technology industry in Georgia.

Health Care Industries Association
P.O. Box 89, Niagara Square Station, Buffalo, NY 14201-0089; 716/856-8111, fax 716/856-1744
A not-for-profit membership organization composed of many of western New York's health-related companies and organizations. HCIA brings together manufacturers, distributors, providers, suppliers, and members from universities and hospitals. It is dedicated to promoting this sector and its economic growth by facilitating networking, providing support services, and marketing the region nationally and internationally.

Health Industry Business Communications Council
5110 N. 40th St., Ste. 250, Phoenix, AZ 85018; 602/381-1091, fax 602/381-1093
An industry-sponsored and -supported nonprofit organization, the council's primary function is to facilitate electronic communications by developing appropriate standards for information exchange among all health-care trading partners.

The Health Industry Council of the Dallas­Fort Worth Region
1460 Post & Paddock, Grand Prairie, TX 75050; 972/606-0510, fax 972/641-5719
A nonprofit association founded to encourage health industry growth in the Dallas­Fort Worth region. The council gathers health industry data about the area, promotes industry conferences and conventions, and facilitates interaction among members of the health-care community.

Health Industry Distributors Association
66 Canal Center Plaza, Ste. 520, Alexandria, VA 22314-1538; 703/549-4432, fax 703/549-6495
National business trade association representing medical product distributors and home-health-care providers. The association's wholesale and retail members serve the nation's home-care, hospital, long-term-care, and physician/alternate-care markets.

Health Industry Manufacturers Association
1200 G St., Ste. 400, Washington, DC 20005; 202/783-8700, fax 202/783-8750
HIMA is a Washington, DC­based trade association and the largest medical technology association in the world, representing more than 700 manufacturers of medical devices, diagnostic products, and medical information systems. HIMA's members manufacture nearly 90% of the more than $51 billion of health-care technology products purchased annually in the United States, and nearly 60% of the $120 billion purchased annually around the world.

Health Industry Representatives Association
6535 S. Dayton St., Ste. 3000, Englewood, CO 80111-6135; 303/649-1622, 800/777-4474, fax 303/799-0678
A trade association of independent contractor sales representatives in the health-care industry.

Independent Medical Distributors Association
5818 Reeds Rd., Mission, KS 66202-2740; 913/262-4510, 800/398-5632, fax 913/262-0174
An association of specialized medical distributors who are engaged primarily in the sale and distribution of specialized high-technology medical supplies and equipment.

Independent Reagent Manufacturers Association
845 Ave. G E., Arlington, TX 76011; 817/640-0965, 800/433-7224, fax 817/649-2461
IRMA is a coalition of in vitro diagnostic manufacturers working together with regulatory agencies, legislators, and other trade associations to address relevant issues that affect the device industry. There are no dues associated with membership.

Indiana Medical Device Manufacturers Council, Inc.
1908 E. 64th St., South Drive, Indianapolis, IN 46220; 317/257-8558, fax 317/259-4191
Formed in 1991 as a trade association of companies and individuals involved in the manufacture of medical devices in Indiana. Composed of 41 corporate and 23 associate members, IMDMC focuses on training and education, legislative and regulatory issues, networking, and technology transfer. Meetings include four international business briefings, four regulatory/legislative roundtables, and four presentations on industry topics each year. IMDMC produces two seminars per year and a quarterly newsletter.

The Institute of Electrical and Electronics Engineers, Inc.
445 Hoes Ln., P.O. Box 1331, Piscataway, NJ 08855-1331; 908/981-0060, fax 908/981-1855
IEEE is the world's largest technical professional society. Serving the computing, electrical engineering, and electronics professions, IEEE engages in technical, educational, and professional activities that advance the theory and practice of electrotechnology, contribute to the lifelong professional and personal development of its members, and advance the profession. As scientific and technological advances are made, IEEE members transform such new knowledge into practical, safe products and procedures that enhance the quality of life. IEEE provides services and standards to serve members, the profession, and the public.

Institute of Environmental Sciences
940 E. Northwest Hwy., Mt. Prospect, IL 60056; 847/255-1561, fax 847/255-1699
An international professional organization dedicated to enhancing process and product quality through the advancement of controlled environment technologies. The institute establishes and maintains standards, recommended practices, educational programs, and communication forums. Members contribute to environmental sciences in the areas of contamination control in electronics manufacturing and pharmaceutical processes; design, testing, and evaluation of commercial and military equipment; product reliability issues associated with commercial and military systems; and computer applications in all areas of environmental science.

Institute of Packaging Professionals
481 Carlisle Dr., Herndon, VA 20170; 703/318-8970, fax 703/318-0310
IoPP is the leading individual membership organization in the packaging industry. The institute offers a full program of membership services, including technical and news publications, professional development conferences, local chapter activities, an annual packaging design competition, and the only professional certification program in the packaging field.

International Society for Optical Engineering (SPIE)
P.O. Box 10, Bellingham, WA 98227-0100; 360/676-3290, fax 360/647-1445
An international technical society dedicated to advancing engineering, scientific, and commercial applications of optical, photonic, imaging, electronic, and optoelectronic technologies. Its members are engineers, scientists, and users interested in the development and reduction to practice of these technologies. SPIE provides the means for communicating new developments and applications information to the engineering, scientific, and user communities through its publications, symposia, education programs, and on-line electronic information services.

ISHM, The International Society for Hybrid Microelectronics
1850 Centennial Park Dr., Ste. 105, Reston, VA 20191-1517; 703/758-1060, fax 703/758-1066
ISHM, the International Society of Hybrid Microelectronics, will merge in January 1997 with the International Electronics Packaging Society to form the new International Microelectronic and Packaging Society, which will have more than 5500 members worldwide. Member benefits include a free comprehensive guide to industry products and services, discounts on attendance at symposia and lectures, membership in a local chapter, and a free subscription to our quarterly publication, the International Journal of Microcircuits & Electronic Packaging, and bimonthly publication, Advancing Microelectronics.

Joint Council of Immunohistochemical Manufacturers
P.O. Box 260051, Crestwood, MO 63126; 317/576-3854, fax 317/845-2324
An association that advocates collectively the interests of its members in regulatory, clinical, and scientific matters concerning antibodies and molecular biology reagents and related products. JCIM includes manufacturers of IVD devices employing related technology, relevant contract research organizations, and others.

Medical Alley
Travelers Express Tower, Ste. 725, 1550 Utica Ave. S., St. Louis Park, MN 55416-5307; 612/542-3077, fax 612/542-3088
A 230-member trade group whose membership includes high- and low-technology medical device and product manufacturers; those involved in health-care delivery, such as hospitals, clinics, health professionals, third-party payers, health plans, integrated service networks, research facilities, public sector representatives, and pharmaceutical companies; and companies and organizations that share in the industry's goals and concerns. Medical Alley is a collaborative forum that promotes an environment to enhance innovation in health care. The association serves as a forum for the diverse sectors of the industry to meet on common ground and offers an opportunity to connect with other industry leaders. Main areas of activity include educational/informational seminars; peer group discussions of regulatory, clinical, and reimbursement issues; legislative advocacy; and increasing international activity of members.

Medical Device Manufacturers Association
1900 K St. N.W., Ste. 300, Washington, DC 20006; 202/496-7150, fax 202/496-7756
A national trade association that represents nearly 110 independent manufacturers of medical devices, diagnostic products, and health-care information systems. MDMA seeks to improve the quality of patient care by encouraging the development of new medical technology and fostering the availability of beneficial, innovative products. To achieve these goals, MDMA represents its members' interests with regard to the laws and regulations administered by FDA and Congress and any interpretation or application of those laws and regulations. MDMA is a founding member of the National Medical Device Coalition.

Medical Devices Canada (MEDEC)
401 The West Mall, Ste. 510, Etobicoke, Ont., Canada M9C 5J5; 416/620-1915, fax 416/620-1595
Established in 1972, the association has about 100 members representing manufacturers and distributors of medical devices in Canada. MEDEC has three action groups focused on regulatory, marketing, and professional development issues.

Medical Marketing Association
74 New Montgomery, Ste. 230, San Francisco, CA 94105; 415/764-4807, 800/551-2173, fax 415/764-1023 Provides personal, professional, and educational growth opportunities for people interested in marketing medical products and services. The association encourages the exchange of ideas, promotes standards, and provides education and training to enhance the quality of medical marketing and business success. Its 1200 members are from pharmaceutical, diagnostics, and device companies, and agencies and suppliers serving them. There are 13 chapters nationwide that provide monthly educational activities.

Michigan Medical Device Manufacturers and Suppliers Association
P.O. Box 130500, Ann Arbor, MI 48113; 313/930-9787, 800/930-5698, fax 313/930-0145
MMDM&SA was formed in 1993 with the mission to promote and strengthen the medical device industry in Michigan. It sponsors training seminars and a luncheon speaker series; is active in the areas of government relations, networking, and business development; and acts as an information clearing house for matters of interest to members. It also sponsors the only statewide industry trade show every October, publishes a bimonthly association newsletter, has launched a home page on the Internet, is developing a membership directory, and works with other associations in the region to enhance the visibility of its members.

National Association for Medical Equipment Services (NAMES)
625 Slaters Ln., Ste. 200, Alexandria, VA 22314-1171; 703/836-6263, fax 703/836-6730

Site Selection DirectoryPart 1

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

A MD&DI December 1996 Column

Contact information for US agencies and organizations that can help companies relocate. Part 2 lists overseas offices.

Regions Bank
Mobile, 334/690-1594, fax 334/690-1448

The industrial development department provides general advice and counsel for prospect assistance and program development, and offers financing advice. General site information and research data on Alabama and Mobile are available, including training and educational facilities linkage programs.

Peoria Economic Development Group
Peoria, 602/486-2011, fax 602/486-2009

Peoria, as part of the Phoenix metro area, has access to a large educated labor base anchored by Arizona State University. Its demographics of a large retired population and an emerging young population are excellent for research-related projects. Sun Health Research Institute, described as a world leader in Alzheimer's and Parkinson's diseases, provides leadership. Has assisted several medical delivery, care, and research facilities located in the community.

California Central Valley Economic Development Council
Fresno, 800/676-SITE, fax 916/322-3524

The 17-million-acre region from Stockton to Bakersfield combines low cost with access to California's enormous markets. A dedicated team can provide companies with comprehensive assistance, including site location and employee training. Assistance is free and confidential.

City of Brea
Brea, 714/671-4421, fax 714/671-4480

The city of Brea's commitment to business customer service includes a streamlined permit process, elimination of overlapping fees, special staff training, customized business incentive packages, and the establishment of a business liaison in city hall. The Redevelopment Services Department has a color brochure available.

City of Sunnyvale
Sunnyvale, 408/730-7607, fax 408/730-7696

The city of Sunnyvale is committed to supporting business through the incentives of low taxes, a specially trained biotechnology staff team, low office lease rates, low crime, and a highly educated workforce. The city actively works to retain businesses with its plan called "the Sunnyvale Advantage," which includes a stable cost environment, high quality of life, and a quick permit process. The city's zoning provides for biotech facilities and has assisted medical device manufacturers in finding sites for manufacturing, laboratory, and research facilities and corporate headquarters.

Economic Development Corp. of Shasta County
Redding, 916/225-5300 or 800/207-4278, fax 916/225-5303

Shasta County is a business-friendly California alternative for companies seeking market presence, lower cost, and high quality of life. Advantages for medical device manufacturers include local job credit incentive programs, state tax credits, a large enterprise zone, and medical technician training programs. Has assisted medical device companies in finding sites for manufacturing, laboratory, and research facilities.

Northern California Industrial Development Executives Association (NorCal IDEA)
Sacramento, 800/726-IDEA, fax 916/322-3524

Northern California is a region of opportunity for suppliers to the medical services industry. The opportunity is illustrated by low-cost improved industrial land and buildings, a dedicated workforce, and aggressive communities--armed with tax, financing, and training incentives--that understand the needs of the medical products industry. The region is home to three state universities that specialize in technology transfer. Has assisted manufacturers of laser equipment, dental equipment, dental chairs, ultrasound equipment, and other medical devices.

Colorado Office of Business Development
Denver, 303/892-3840, fax 303/892-3848

Colorado Institute for Research in Biotechnology offers seed grants for faculty projects with commercial value; matching funds for student internships in biotechnology companies; and support for graduate students. Other resources include the Colorado Bioprocessing Center at Colorado State University, which offers process development assistance, facilities, and operator training for biotechnology companies; the Colorado Biomedical Venture Center, a business incubator for biomedical and biotechnology companies; enterprise zones throughout the state; and local economic development programs.

Greater Colorado Springs Economic Development Corp.
Colorado Springs, 719/471-8183, fax 719/471-9733

Since 1990, more than 110 companies have relocated to or established new or expanded facilities in Colorado Springs, creating more than 14,500 new jobs. The area offers a trained and available labor force, low operating costs, reasonable tax policies, financial incentives, below-average cost of living, and affordable housing.

Connecticut Innovations, Inc.
Rocky Hill, 203/563-5851, fax 203/563-4877

Connecticut Innovations, Inc., is the state of Connecticut's high-technology investment agency. For the medical products and instrumentation industry, it provides capital to emerging companies for invention and innovation. It also sponsors research grant programs for small businesses and universities and works to increase the state's share of federal science and technology grants.

Newtown Economic Development Commission
Newtown, 203/270-4271, fax 203/270-4205

Located in northeastern Fairfield County along the I-84 corridor, Newtown has a business climate that is attractive to medical and technological companies seeking a quality community. The commission has a professional staff that will assist companies in establishing a Newtown location.

Southwestern Area Commerce & Industry Association
Stamford, 203/359-3220, fax 203/967-8294

Southwestern Connecticut is located 45 minutes away from New York and New Haven. Medical firms in the area include U.S. Surgical, Circon ACMI, Miles, Boehringer Ingelheim, and Bristol-Myers Squibb. A large population of affluent investors and 40 venture firms are in the region. Innovative state financing and technology programs are offered.

Delaware Economic Development Office
Dover, 302/739-4271, fax 302/739-5749

DEDO has created a public and private Delaware Innovation Fund, which provides funding to assist high-technology businesses in obtaining patent protection, as well as in marketing and further developing the technologies for the consumer. Located in the heart of the East Coast's biotechnology corridor, Delaware is strategically situated near Washington, DC, New York, and Philadelphia. Delaware also has one of the most rapidly growing labor forces in the country.

City of Sunrise
Sunrise, 954/741-2580, fax 954/746-3439

The Office of Economic Development allows medical device manufacturers to focus on industry concerns rather than on new facility issues such as complying with permitting procedures, zoning, and ordinances.

Gainesville Council for Economic Outreach
Gainesville, 904/378-7300, fax 904/378-7703

The University of Florida Health Science Center has gained international recognition in medical research that involves more than 900 faculty members in six colleges. Technology transfer is facilitated through a biotechnology incubator and one of only three Technology Innovation Centers in Florida. The council assisted a manufacturer of a blood treatment device in locating laboratory and research facilities.

St. Petersburg/Clearwater Economic Development Council
Largo, 813/541-8080, fax 813/541-8585

Pinellas County's officially designated economic development office, the council is capable of handling all relocation or expansion needs. The organization has facts on labor, infrastructure, international trade, foreign trade zone and enterprise zone benefits, incentives, financing, and available real estate for sale or lease. More than 100 medical and pharmaceutical companies have relocated to the area.

Sarasota County Chamber of Commerce Committee of 100
Sarasota, 941/955-2508, fax 941/951-7837

The Sarasota County Committee of 100 is the professional economic development entity for Sarasota county. Its purpose is to attract and retain quality jobs, solicit new business, promote the county's business image, assist expansion of existing companies, and enhance the quality of life. Medical device manufacturing is a valued industry in Sarasota County. The committee can provide assistance in accessing NASA-supported technology transfer programs, programs sponsored by the University of South Florida's Small Business Development Center, and a listing of potential sources of investment capital.

Southeastern Realty Group, Inc.
Orlando, 407/629-6660, fax 407/645-2035

The group offers confidential up-front site location research. It has
Contacts with government agencies--local, regional, or state--that have incentive programs for new and expanding industry. Valencia Community College and University of Central Florida (home of the Center for Research in Electro-Optics and Lasers and the Institute for Simulation and Training) are located in central Florida.

Athens Area Chamber of Commerce
Athens, 706/549-6800, fax 706/549-5636

The University of Georgia's program in Biomedical Resources and Biotechnology involves 100 faculty members in research at the molecular level as well as broad-based studies of microorganisms, plants, animals, and whole ecosystems. The program includes education and training, interdisciplinary research centers, central research support facilities, industrial interface, and technology transfer. Has helped locate manufacturers of pharmaceuticals, in vitro clinical diagnostic products, and biotechnology firms.

Clayton County Chamber of Commerce
Jonesboro, 770/478-6549, fax 770/478-0226

The area offers the Georgia QuickStart training program at Clayton State College, the Georgia Research Alliance in Atlanta, a jobs tax credit program, foreign trade zone, low taxes, low cost of living, property available for development and redevelopment, close proximity to Atlanta International Airport, a local airport, and many business parks.

Georgia Department of Industry, Trade, and Tourism
Atlanta, 404/656-7795, fax 404/657-4309

Georgia offers biomedical research centers, a large and growing pool of talents and specialized support services, low taxes and operating costs, free state assistance in start-up recruiting and training, and sources of financing. The Clifton Corridor Council offers one-stop shopping for companies considering a move to Georgia. Has assisted numerous medical device companies in expanding or relocating manufacturing and warehouse facilities and corporate headquarters.

Lockwood Greene
Atlanta, 404/525-0500, fax 404/818-8100

Lockwood Greene describes itself as one of the world's leading business location and site- selection consultants. One of its major focus industries is manufacturing of health-care products, including medical devices, pharmaceuticals, vaccines, and other materials. The firm has helped manufacturers of medical devices and in vitro diagnostics find manufacturing, warehouse, laboratory, and research facilities.

Macon Economic Development Commission
Macon, 912/750-9900, fax 912/741-8021

Mercer University School of Engineering offers undergraduate and graduate degrees in biomedical engineering. Since 1991, students and faculty have participated in the National Science Foundation's Bioengineering and Research to Aid the Disabled program. The Mercer University School of Medicine has affiliations with 14 hospitals and health centers. Work is under way to expand the medical school's research facilities; the growing research program includes numerous nationally funded research projects.

MEAG Power
Atlanta, 800/WIN-IN-GA, fax 770/563-0004

The Municipal Electric Authority of Georgia provides electricity to 48 participant cities and complete site selection services for companies seeking to locate in those cities as well as in other cities in Georgia. The Georgia Resource Center offers interactive tours of all sites available in the state. MEAG Power also offers lower taxes, reasonable land prices, and reasonable energy costs through special rate structures that include additional credits for jobs created. Georgia is a right-to-work state with aggressive tax credits and business incentives, and it is the ninth-ranked state in the U.S. in numbers of institutions of higher learning.

Fairfield Area Development Commission
Fairfield, 618/842-4802, fax 618/842-5654

The Fairfield area offers tax increment financing benefits, Illinois enterprise zone benefits including sales tax exemptions on materials used in construction, and property tax abatement for taxes on increases in assessed value. The city also offers low-interest loans, job training assistance, sites up to 600 acres, low utility rates, and an available workforce.

Lake County Economic Development Commission
Waukegan, 847/360-6350, fax 847/360-6734

Lake County is home to Abbott Laboratories and Baxter Healthcare. As a result of their presence, many medical device manufacturers and other health-product-related companies continue to locate or expand facilities in Lake County. Lake County is home to more than 35 medical device manufacturers and more than 30 medical supply distributors.

Richland County Development Corp.
Olney, 618/392-2305, fax 618/392-2405

The Richland County Development Corp. provides free and confidential plant site services to expanding companies (including medical firms). Available incentives include new building leases, low-interest loans, limited venture capital, customized workforce training and internship programs, and access to regional hospital/clinic resources.

Anderson Corp. for Economic Development
Anderson, 317/642-1860, fax 317/642-0266

The organization has two business parks. It also has access to local investors who have financed three office buildings and three industrial buildings. A city revolving loan fund and access to other state programs are useful to the medical industry.

The Greater Fort Wayne Chamber of Commerce
Fort Wayne, 219/424-1435, fax 219/426-7232

The Fort Wayne Medical Society and the Greater Fort Wayne Chamber of Commerce have formed a partnership called the Medical Economic Development Council. The council's primary objective is the recruitment of medical device, medical component, and biotechnology companies. The partnership provides free reports on demographics, available land and buildings, analysis of current labor costs, skills and training programs, estimates for electrical and natural gas and energy costs, and confidential site and community tours of Fort Wayne and northeast Indiana.

PSI Energy, A Cinergy Co.
Plainfield, 317/838-2000 or 800/688-0688, fax 317/838-1950

As Indiana's largest electric utility, PSI is now part of Cinergy, an energy services company. Encouraging economic growth in Indiana, PSI offers an independently researched medical device industry report that provides business data such as costs of property, investment, utility, labor, and freight. Taxes and transportation access are also covered.

IES Utilities
Cedar Rapids, 319/398-4542, fax 319/398-4567

IES is a progressive, diversified utility company dedicated to the growth and economic development of its customers and Iowa communities. Development specialists provide professional, confidential consulting services to assist clients in their search for a new location in the Midwest. Iowa has the fifth-lowest workers' compensation rates in the nation, no corporate income tax on profits from sales outside of Iowa, and no property, sales, and use taxes on industrial machinery, equipment, and computers. It also has the lowest new employer unemployment insurance rate in the nation and low property taxes, and is a right-to-work state.

Greater Louisville Economic Development Partnership
Louisville, 502/625-0200, fax 502/625-0211

Louisville, which has a high concentration of health-care professionals, is located near two research universities: the University of Louisville and the University of Kentucky. Offering quick turnaround, UPS International Air Hub repairs diagnostic equipment and other time-sensitive medical devices.

The Greater Baton Rouge Economic Partnership, Inc.
Baton Rouge, 504/381-7125, fax 504/336-4306

The Greater Baton Rouge Economic Partnership is working to recruit companies in the medical device industry to any of Baton Rouge's selected area research facilities, such as the Center for Advanced Microstructures and Devices, Pennington Biomedical Research Center, and other corporate R&D facilities. Several sources of venture capital, such as the LSU Board of Regents Funds, Premiere Venture Capital, and Louisiana State Business Technology Center, are available. Major tax incentive programs are offered to companies locating in one of the above-listed research parks.

MetroVision Economic Development Partnership
New Orleans, 504/527-6943, fax 504/527-6970

MetroVision markets and coordinates the use of public and private resources for medical industry development. General and industry-specific tax incentives for R&D and manufacturing are available. Cost-free employee training is offered and assistance with the acquisition of state-based and national venture capital is available. Allied health education is offered through community colleges.

Department of Economic and Community Development, Office of Business Development
Augusta, 207/287-3153, fax 207/287-5701

Maine offers a wide variety of financing programs, loan guarantees, investment tax credits, and worker training programs for business. Of interest to medical device manufacturers is the manufacturing machinery and equipment tax credit that can be claimed for 1% of federal tax basis up to $25,000 per year for five years, and the jobs and investment tax credit (10%) on personal property investments exceeding $5 million and where at least 100 jobs are created. A program reimburses taxpayers for local property taxes paid on business machinery and equipment placed in service after April 1995 for up to 12 years. The Maine Quality Centers provide workers who are trained to a company's individual specifications at no cost. A new financing program pays expanding and relocating businesses between 30 and 50% of employees' state income tax withholdings for 10 years.

Harford County Economic Development
Bel-Air, 888/I95-SITE, fax 410/879-8043

The Office of Economic Development supports a collaborative environment among business, education, and federal and local government for technology advancement. The opening of the Higher Education and Applied Technology (HEAT) Center in Aberdeen combines over 17 advanced academic and technical training programs with the opportunity for businesses to locate in a campus-like setting at I-95 midway between Baltimore and Philadelphia.

University of Maryland Baltimore County
Baltimore, 410/455-3222, fax 410/455-1050

The campus has a business incubator, the University of Maryland Baltimore County (UMBC) Technology Enterprise Center, for technology-based companies. The center offers companies at the R&D stage inexpensive space, shared facilities and equipment, and access to university resources (library, computing facilities, labs, faculty, and students). A 41-acre research park is being planned and will be under construction by summer 1997.

City of Cambridge

Cambridge, 617/349-4600, fax 617/349-4669

Home to 83 of the Cambridge-Boston region's 117 biomedical firms, Cambridge offers resources including the MIT and Harvard research facilities and faculties, the Whitehead Institute, and proximity to the region's world-class teaching hospitals. Programs designed to make Cambridge a congenial host for the biomedical industry include a biomedical careers training program; a financing program for the fit-out of laboratory space; ready-to-go zoning designed to accommodate a range of uses, from R&D to manufacturing and company headquarters; customized site searches; and job shadowing and mentoring programs.

Midland County Economic Growth and Development Corp.
Midland, 517/839-0340, fax 517/839-7372

Midland County, home of the Dow Chemical Co. and the Dow Corning Corp., is an ideal base for high-technology companies. Companies in Midland are involved in technology transfer and high-technology medical devices and diagnostic enhancers. Tax abatement, training grants, scientific grants, as well as venture capital companies and the Mid-Michigan Venture Capital Forum, are available to provide start-up services and funding.

City of Maple Grove
Maple Grove, 612/494-6041, fax 612/494-6420

The city offers many benefits to manufacturers, including hundreds of acres of available land, freeway frontage for development, financing programs, a skilled labor force, high-quality business parks, and proximity to Minneapolis/St. Paul. The University of Minnesota and technical and community colleges are nearby. The city has assisted manufacturers with locating sites for manufacturing, corporate headquarters, laboratory and research facilities, and warehouse facilities.

Minnesota Power
Duluth, 800/228-4966, fax 218/723-3983

As upper Minnesota's chief source of electric power, the company has firsthand knowledge of facilities and workforce capability. Its staff is also familiar with the state's regulatory environment and the area's academic and medical research centers, and can help arrange cooperative research ventures. Through connections with venture capital and financial institutions, the company can help acquire needed support.

Northern States Power Co.
Minneapolis, 612/330-6746 or 800/367-7414, fax 612/330-5878

Contact: Economic Development
The company offers free professional business development assistance including site and facility searches, business cost comparisons, energy- efficiency and conservation incentives, facility design consultation, project financing recommendations, and business source referrals. The company has assisted medical device and in vitro diagnostic companies find sites for manufacturing, corporate headquarters, and laboratory, research, and warehouse facilities.

The Northspan Group, Inc., Arrowhead Business Connection Program
Duluth, 218/722-5545, fax 218/722-2335

The Northspan Group, Inc., is a private nonprofit corporation whose mission is economic and community development. Its Arrowhead Business Connection Program is the northeastern Minnesota regional
Contact point for all of the region's incentive programs. These include community and utility-sponsored incentives, and
Contact with the University of Minnesota and investment capital firms in northeastern Minnesota.

St. Cloud Area Economic Development Partnership
St. Cloud, 320/252-2177, fax 320/251-0081

The St. Cloud Area Economic Development Partnership represents the three-county St. Cloud Metropolitan Statistical Area, which has a rapidly growing population of about 200,000. The partnership offers site location assistance, access to a variety of public and private finance options, training, and technology assistance.

Southern Minnesota Municipal Power Agency
Rochester, 507/285-0478, fax 507/287-9506

Located in Minnesota are more than 500 medical- related companies and institutions that are involved in research and development, manufacturing, and distribution. The agency can provide information on marketing opportunities as well as information on lowering manufacturing costs.

University of Minnesota, Office of Research and Technology Transfer
Minneapolis, 612/624-9398, fax 612/624-4843

Research faculty each year disclose about 70 new medical and diagnostic technologies to the Office of Research and Technology Transfer. The office currently has license agreements with more than 80 medical companies. Services offered by the office include assisting start-ups based on medical technologies, providing technology development funding, and working with public and private economic developers to locate sites in Minnesota's "Medical Alley" of more than 300 companies.

Harrison County Development Commission
Mississippi Coast, 601/863-3807, fax 601/863-4555

Benefits of locating in Harrison County include competitive wage rates in manufacturing, good labor-management relations, proximity to various raw material sources, moderate land costs for industrial and land development, favorable levels of labor productivity, central location to Gulf Coast markets, adequate energy capacity at competitive rates, and availability of large tracts of fully served industrial land.

Jackson County Department of Economic Development
Independence, 800/881-4105, fax 816/881-4511

The Jackson County Department of Economic Development serves as a central source of information on the 19 communities that comprise this metropolitan Kansas City market. The department provides population, education, workforce, business, tax, incentive, building and site, cost of living, and community information essential to businesses considering expansion.

St. Louis Regional Commerce & Growth Association
St. Louis, 314/231-5555, fax 314/444-1122

St. Louis is a major center of the biotechnology industry with prominent medical schools at Washington University and St. Louis University, Monsanto's headquarters and Life Science Research Center, and Mallinckrodt's headquarters. The Biomedical Technopolis Foundation will create a biomedical enterprise center and an urban research park and provide technology transfer support.

Nebraska Public Power District
Columbus, 800/282-6773, fax 402/563-5090

Nebraska Public Power District offers free and confidential plant location assistance. Information can be provided on communities in Nebraska, available industrial sites and buildings, energy costs, and financing. Free copies of a study on opportunities for medical and surgical product manufacturers are available.

RELIABILITY : Innovations in Impedance Testing

Medical Device & Diagnostic Industry Magazine | MDDI Article Index

Originally published December 1996

Jim Richards

Unlike many types of electronic products, medical equipment such as defibrillators and pacemakers must meet unusually high standards for performance; their failure can cause injury or death. Pacemakers typically remain dormant for extended periods, waiting for a signal, so failure is often not detected until too late for a routine response. Defibrillators must deliver high-voltage pulses on demand, often in harsh evironments. Hearing aids, while not crucial for maintaining life, must also function reliably, and their extremely dense construction and diminutive size require that component tolerances be tighter than those of many other products.

A key factor in the safety of these devices is impedance, the opposition to ac current flow offered by a device or circuit. A complex value made up of resistance, inductance, and capacitance, impedance can help determine whether a device or circuit will function to specifications. Unfortunately, its role in device reliability is often overlooked; in fact, industry standards do not even specify necessary impedance values. Yet impedance should not be ignored as a safety factor.

With their special safety requirements, medical electronics can benefit substantially from impedance measurement.

Many medical equipment manufacturers routinely perform impedance tests on their components at one or more stages in production, as early as incoming inspection and as late as final testing (see Table I). However, it is likely that just as many manufacturers rarely if ever perform these tests.

One reason for this is undoubtedly that many design engineers think impedance measurements are difficult to conduct and require a toolroom full of instruments and a tangle of cables, banana plugs, and baby Neill Concelman connectors. While that was certainly true a decade ago, today, thanks largely to advances in digital signal processing and semiconductor technology, there are instruments available that make impedance measurement clean and simple. They can display the resistance, inductance, and capacitance parameters of an impedance measurement as well as calculate and display many other related parameters, such as impedance, yielding admittance, reactance, conductance, susceptance, and dissipation.

INSTRUMENT ADVANCES

In the past, the instruments used to perform impedance tests were either meter types, which measured voltage or current and left it to the operator to calibrate the impedance quantities, or bridge (null) types, which required an adjustment and indicated impedance on a scale or dial associated with a variable component of some kind. Meters were faster and easier to use, but bridges were more accurate.

Today's instruments have the best characteristics of both types of instruments, with few of their eccentricities. Digital in design, these new machines provide the typical array of features of this type of equipment, such as Institute of Electrical and Electronics Engineers (IEEE) bus control, nonvolatile memory for instrument setups, broad configurability, ease of use, and the ability to be upgraded in place.

Because impedance measurement requires rapid and accurate ratio calculations, microcomputers are well suited for this testing and are the basic component of all modern impedance equipment. While these new instruments perform the functions of a bridge, they lack a null function, instead successively measuring the voltage across the unknown resistor and the voltage across a standard resistor carrying the same current, and then dividing the results.

Four helpful features available in today's instruments include swept parameter measurement capability, menu programming, test data collection, and setup storage. Swept parameter measurement provides values over a user-specified frequency range and delivers the information in graphical or tabular format via the display or printer. Menu programming allows operators to access test conditions with the touch of a button. Test data collection allows test results to be stored automatically on an internal diskette drive or transferred to a PC for further analysis. Setup storage allows operators to store commonly used test routines.

TIPS ON HANDLING AND MEASUREMENT

Thanks to these new instruments, making impedance measurements today is relatively simple. However, care must still be exercised to ensure reliable results.

Especially important for surface-mount manufacturing is the need for careful handling of small parts. The size of these devices often makes it difficult to obtain good electrical contact. One of the most useful tools is the Kelvin clip cable, which allows four-terminal connections to be made to passive components. It is especially useful for testing low impedances encountered with components such as electrolytic capacitors and inductors.

A set of chip component tweezers that plug directly into the instrument is also helpful. The tweezers allow the devices to be picked up, measured, and placed in the proper bin in one operation.

The same results can be obtained with a component test fixture. Chip component fixtures ensure that tiny devices are nestled securely so measurements can be made easily and quickly. The same level of electrical contact obtained with Kelvin clip cables can be obtained with a test fixture.

Remote high-voltage test fixtures are necessary when high voltages are required to make the measurement. A safety interlock allows the person making the measurement to place a component in a fixture, make the measurement, and remove the component without risk.

CHOOSING THE NUMBER OF CONNECTIONS

Impedance measurements can be made using 2, 3, 4, or 5 terminals. Two-terminal measurements are easiest and typically are used in the impedance range of 100 ohms to 10 k ohms. Three-terminal measurements (made with two terminals and a guard) are useful for high-impedance measurements when the effects of stray capacitance can introduce errors as well as when guarded, in-circuit measurements are necessary.

Four-terminal measurements (with two current and two potential terminals) are required to obtain accurate impedance measurements below 100 ohms. The method eliminates series impedances and contact-resistance errors. Five-terminal measurements are made when results over a wide impedance range are desired.

When low impedances are measured, a two-terminal connection introduces errors caused by the addition of the series impedance of the connecting leads. As a result, instruments now use the four-terminal method to perform low-impedance measurements.

The terminals carrying the current are called the current terminals and those used to make the voltage measurement are called the potential terminals. The proper method for a given application is determined by the measured impedance value and the accuracy required.

OTHER TEST CONSIDERATIONS

The basic measurement parameters such as voltage, frequency, and equivalent circuit are determined by national and international standards and manufacturer specifications. Generally, low impedances such as large-value capacitors and low-value resistors and inductors are measured using a lower frequency, such as 100 Hz or 1 kHz, in the series configuration. For small inductance, higher measurement frequencies are required.

Because many instruments allow the user to select measurement speed, it is tempting to attempt the measurement in the shortest possible time. However, the higher the measurement speed, the lower the accuracy. Instruments that offer autoranging will automatically find the proper range for a given measurement, but locating the proper range can add time to the measurement.

CONCLUSION

Medical devices such as defibrillators and pacemakers must perform unfailingly, often without periodic testing. Thus, manufacturers must perform an exhaustive battery of tests as they are developing and producing these types of devices. Incorporating impedance measurements in these test routines is an important part of ensuring a high level of performance, and thanks to advances in measurement equipment, the impedance tests can now be performed easily.

Jim Richards is the marketing engineer at QuadTech, Inc. (Marlborough, MA).