Articles   Bookmarks   Books   Cases   Databases

Home   About   Tour   Contents   Help

Essays   Journals   Subjects   Tutors

Search   Libraries   Business School  UF

BusinessLibrary@UF

Exactech


Quick Links: Companies Guide | Company Tutor
Exactech Logo

Motto: A Great Day in the O.R.sm

"Back off, lawman -- Exactech's joints are medicinal. Hospitals, surgeons, and clinics worldwide use the company's knee and hip devices to replace joints weakened through injury or disease. Its Optetrak knee implant and various hip implant systems either partially or totally replace patients' damaged joints. It also makes Opteform, a bone allograft material developed at the University of Florida. Exactech markets its products through independent dealers in the US and through foreign distributors in some 20 other countries. International sales account for roughly a fifth of revenues. Chairman and CEO William Petty and his family own about 35% of Exactech." [Source: Hoover's Online.]
 

Key Websites & Links

 


Business Summary

"Exactech, Inc. engages in the development and marketing of orthopaedic implant devices, related surgical instruments, and biologic materials and services to hospitals and physicians. Its orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases, such as arthritis. The major product lines of the company include knee implants, hip implants, and tissue services. Its Optetrak® knee system is a modular system designed to improve patellar tracking, reduce articular contact stress that leads to implant failure, and provide a range of motion. The company's AcuMatch® hip system is designed to address the indications for total hip replacement, including primary and revision needs. The customers for the company's products are hospitals, surgeons, and other physicians and clinics. The company markets its orthopaedic implant products in the United States through 55 independent sales agencies and one domestic distributor; and internationally through 18 foreign distributors that distribute products in 23 countries in Europe, Asia, Australia, and Latin America. The company manufactures many of its orthopaedic devices at its Gainesville facility. Its competitors in the orthopaedic implant market include DePuy, a division of Johnson and Johnson, Inc.; Zimmer, Inc.; Stryker Howmedica Osteonics; Smith and Nephew plc; Sulzer Orthopaedics, Inc. and Biomet Orthopaedics."

[Source: "Exactech Inc. - Detailed Product Pipeline." By G. Harinatha. Life Science Analytics. August 4, 2003. In Investext.]


Investment Thesis

"Positive Industry Dynamics. Exactech is benefiting from several key ongoing trends in the orthopedic industry including favorable demographics, a healthy pricing environment, stable and established reimbursement, and the introduction of newer technology products. The convergence of these industry trends is driving growth across the overall orthopedic industry. The aging population is driving the market for reconstructive implants. The advent of newer technologies, including alternative bearing surfaces and advanced designs, has been contributing to steady pricing increases in this key segment.

"Geographic Expansion. Exactech products are available throughout most of the US and in approximately 20 countries in Europe, Asia, Australia and Latin America. The company is making strides at expanding its distribution network to reach a larger market as evidenced by the company's recent entrance into various distribution arrangements."

Risks & Caveats

"Highly Competitive Marketplace. EXAC is a relatively small company in an industry dominated by giants. The $15 billion global orthopedic market is led by six companies (almost 60% of the global market), each with more than $1 billion in annual sales. EXAC holds only a 1% share of the hip market and a 2% share of the knee market and doesn't currently offer products throughout the entire U.S.

"Potential Decline of Favorable Industry Pricing Environment. A slowdown or reversal of the positive pricing trends in the U.S. reconstructive market that have helped rejuvenate the industry over the last couple of years would likely reduce company share valuations. If this favorable pricing environment were to deteriorate, sales trends would likely be negatively impacted across the industry."

[Source: "Exactech Inc. By S.S. Wong, et al. Robert W. Baird & Co. July 25, 2003. In Investext.]


Exactech Expands

"David Petty is probably still counting the ways that a recently-completed expansion project at Exactech Inc. has improved the company's operations.

"'We've got more room for marketing, more room for engineering and more room for manufacturing,' said Petty, Exactech's executive vice president of sales and marketing. 'We have a new teleconferencing room and a bigger training area. We were really running out of space before this.'

"It's not surprising that Petty sounds relieved. Exactech, an orthopedic products manufacturer, had to double its space with a $4 million expansion in order to accommodate the company's rapid growth in recent years. Exactech grew steadily after it was formed in 1985, but the company found a worldwide market shortly after it moved to its current location on NW 66th Court in 1997. Sales in 2000 were $41.9 million, and that jumped to $46.6 million in 2001.

"Last year, Exactech pulled in $59.3 million in sales, due to strong domestic revenues but also an extensive international network that includes distribution agreements for Exactech's products in 20 foreign countries. Through the first half of 2003, the company has earned $35.8 million in sales, a 24 percent increase from $28.7 million through the first six months of 2002.

"The company's expansion project began last summer and with its completion this month has added 37,000 square feet to Exactech's 38,000-square-foot facility. The company's work force of 154 employees is expected to grow nearly 20 percent during each of the next five years, and it could bring Exactech's payroll to nearly 400 workers by the end of that period, said Jody Phillips, Exactech's chief financial officer.

"And with the extra manufacturing space and steady business, Exactech may add a second shift to meet the demand for its hip and knee replacement systems, the company's most popular products. Exactech also develops surgical instruments and biologic materials, such as bone paste, for orthopedic restoration.

"'Our needs are across the board, as far as hiring new workers,' Petty said, 'but our growth will likely come from manufacturing'"

[Source: "Exactech Elbowroom." By Joe Coombs. Gainesvillesun.com July 27, 2003]


Company History

"Exactech was founded by William Petty, M. D., an orthopaedic surgeon, Betty Petty, and Gary Miller, Ph.D., a bioengineer. Because of their positions on the University of Florida College of Medicine faculty, Drs. Miller and Petty had worked with several orthopaedic companies as consultants. Dr. Petty had increasing concerns about the cost pressure in medicine and the implications that might have for the products he used in his patients. He thought he saw some things the industry could do differently, and better, to assure superior quality products while responding to the need for medical cost containment. The Pettys invited Dr. Miller to join in forming Exactech with the intent of making a difference in the orthopaedic implant industry.

"Exactech was incorporated on November 11, 1985 under the laws of the state of Florida. In May of 1996 Exactech became a publicly traded company on the Nasdaq Stock Exchange. The founding philosophy is best expressed in the corporate purpose and values." [Source: Exactech Company History.]


Hawk Associates Profile

"Exactech develops and markets innovative orthopaedic implant devices and unique biologic materials to hospitals and physicians. The company's products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. the company's strategy is to provide mechanical and biological technologies that offer the best solutions for bone and joint restoration.

"Management estimates the current market for joint implants is $2.6 billion in the U.S., and exceeds $5.2 billion worldwide. The market for biologic materials is projected to approach this size in five years, according to industry analysts.

"The company's high quality FDA-cleared devices for hip and knee repair respond to the cost-conscious demands of the hospital and surgical community. Exactech's differentiated products provide true improvement over current healthcare offerings.

"The company has a strong growth record, with 2002 sales of $59.3 million, compared with $46.6 million in 2001. From 1997-2002 the company's CAGR was 28%.

"Exactech markets its products in the U.S. through experienced independent sales reps and has distributors in 25 countries in Europe, Asia, Australia and Latin America."

[Source: Hawk Associates.]


Wall Street Transcript Interview with Bill Petty (July 15, 2002)

"We incorporated Exactech in 1985. there were three Founders, myself, my wife, whose name is Betty, and Gary Miller a Bioengineer. All three of us still work at Exactech. We established the company to approach product development, for musculoskeletal treatments, by a method that we call solution based. We decided this, based on some of our observations in the industry. By solution based we mean we have a pretty good knowledge of the orthopedic medical field so we look at problems that patients are still having, surgeons are dealing with, and then see, with our own research, as well as reviewing the research of others, can we bring solutions or partial solutions to these problems? If we go back to 1985, it was a time in which cost and value were not high priorities in medical care. We recognized that as an opportunity as well. So we basically founded the company on the philosophy of the kind of product development I have described, as well as providing high value in what we do. From that point, we began to develop prostheses for replacing damaged hips and knees. That area still remains a major part of what we do, currently accounting for almost 90% of our revenues. We are also now involved in developing biologic means for restoring damaged bones and joints. We are represented in 45 states and we are also in 20 foreign countries. We did not begin marketing our products until about 1989, but since then we have grown to revenues just below $47 million. We hope we are able to continue a bit of substantial growth over the coming years."

[Source: "CEO Interview: William Petty - Exactech Inc." Wall Street Transcript 7/15/2002. Vol. 157 (3). In Investext.]


[Source: Quote.com.]


SECURITY OWNERSHIP

The following table sets forth, as of the Record Date, the number of shares of Common Stock of the Company which were owned beneficially by (i) each person who is known by the Company to own beneficially more than 5% of its Common Stock, (ii) each director and nominee for director, (iii) the Named Executive Officers (as defined in “Executive Compensation”) and (iv) all directors and executive officers of the Company as a group (after taking into account the Stock Split):

Name and Address

of Beneficial

Owner(1)

 

Amount and Nature of

Beneficial

Ownership(2)(3)

 

Percentage of

Outstanding

Shares Owned(2)

 

 

William Petty, M.D.

 

4,110,798

(4)

35.2

%

 

Betty Petty

 

4,110,798

(4)

35.2

%

 

Gary J. Miller, Ph.D.

 

619,962

(5)

5.3

%

 

David W. Petty

 

83,538

(6)

*

 

 

Joel C. Phillips, CPA

 

76,028

(7)

*

 

 

Albert H. Burstein, Ph.D.

 

6,000

(8)

*

 

 

R. Wynn Kearney, Jr., M.D.

 

454,860

(9)

3.9

%

 

Paul Metts, CPA

 

15,400

(10)

*

 

 

Prima Investments, Limited Partnership

 

3,876,998

 

33.2

%

 

Millerworks, Limited Partnership

 

473,562

 

4.1

%

 

FMR Corp.

 

1,027,600

(11)

9.7

%

 

All directors and executive officers as a group (8 persons)

 

5,366,586

(12)

45.9

%

 

________________________

      *     Less than 1%.

 [Source: Schedule 14A. Definitive Proxy Statement. March 21, 2003. EDGAR.]


Officers and Directors

William Petty, M.D. was a founder and has been Chairman of the Board and Chief Executive Officer of the Company since its inception. Dr. Petty also became President of the Company upon the departure of former president Timothy Seese on January 31, 2002. Dr. Petty was a Professor at the University of Florida College of Medicine from July 1975 to September 1998. Dr. Petty also served as Chairman of the Department of Orthopaedic Surgery at the University of Florida College of Medicine from July 1981 to January 1996. Dr. Petty has served as a member of the Hospital Board of Shands Hospital, Gainesville, Florida, as an examiner for the American Board of Orthopaedic Surgery, as a member of the Orthopaedic Residency Review Committee of the American Medical Association, on the Editorial Board of the Journal of Bone and Joint Surgery, and on the Executive Board of the American Academy of Orthopaedic Surgeons. He holds the Kappa Delta Award for Outstanding Research from the American Academy of Orthopaedic Surgeons. His book, Total Joint Replacement, was published in 1991. Dr. Petty received his B.S., M.S., and M.D. degrees from the University of Arkansas. He completed his residency in Orthopaedic Surgery at the Mayo Clinic in Rochester, Minnesota.

Gary J. Miller, Ph.D. was a founder and has been Executive Vice President, Research and Development of the Company since February 2000. He was Vice President, Research and Development from 1986 until 2000 and has been a Director since March 1989. Dr. Miller was Associate Professor of Orthopaedic Surgery and Director of Research and Biomechanics at the University of Florida College of Medicine from July 1986 until August 1996. Dr. Miller received his B.S. from the University of Florida, his M.S. (Biomechanics) from Massachusetts Institute of Technology, and his Ph.D. in Mechanical Engineering (Biomechanics) from the University of Florida. He has held an Adjunct Associate Professorship in the College of Veterinary Medicine’s Small Animal Surgical Sciences Division since 1982 and was appointed as an Adjunct Associate Professor in the Department of Aerospace, Mechanics and Engineering Sciences in 1995. He was a consultant to the United States Food and Drug Administration from 1989 to 1992 and has served as a consultant to such companies as Johnson & Johnson Orthopaedics, Dow-Corning Wright and Orthogenesis.

David W. Petty has been Executive Vice President, Sales and Marketing since February 2000. He has been employed by the Company in successive capacities in the areas of Operations and Sales and Marketing for the past thirteen years, serving as Vice President, Operations from April 1991 until April 1993 and Vice President, Marketing from 1993 until 2000. He also served as a Director from March of 1989 until March 1996. He was appointed to the Board of Directors on January 31, 2002 to fill the vacancy created by the resignation of Timothy Seese and was elected to the Board in May 2002. Mr. Petty received his B.A. from the University of Virginia in 1988 and completed The Executive Program at the Darden School in 1999. He is the son of Dr. and Ms. Petty.

Joel C. Phillips, CPA has been Chief Financial Officer of the Company since July 1998 and Treasurer since March 1996. Mr. Phillips was Manager, Accounting and Management Information Systems from April 1993 to June 1998. From January 1991 to April 1993, Mr. Phillips was employed by Arthur Andersen. Mr. Phillips received a B.S. and a Masters in Accounting from the University of Florida and is a certified public accountant.

Betty Petty was a founder and has been Vice President, Human Resources and Administration since February 2000. She has also been Secretary of the Corporation since its inception and served as Treasurer and a Director until March 1996. Ms. Petty served in the dual capacities of Human Resources Coordinator and Director of Marketing Communications from the founding of the Company until 2000. She received her B.A. from the University of Arkansas at Little Rock and her M.A. in English from Vanderbilt University. Ms. Petty is the wife of Dr. Petty.

Albert Burstein, Ph.D. has been a director of the Company since March 1996. From 1976 to 1996, Dr. Burstein was Senior Scientist, Department of Research and Associate Attending Orthopaedic Surgeon (Biomechanical Engineering) at the Hospital for Special Surgery, New York, New York and Adjunct Associate Professor of Mechanical Engineering at the Sibley School of Mechanical and Aerospace Engineering, Cornell University, Ithaca, New York. In addition, he was Professor of Applied Biomechanics (in surgery) at Cornell University Medical College, New York, New York from 1978 through 1996. From 1976 until 1992, he served as Director, Department of Biomechanics, Research Division, at the Hospital for Special Surgery. Since 1980, he has served as Deputy Editor for Research for The Journal of Bone and Joint Surgery . Dr. Burstein is an author of six textbooks on Orthopaedic Biomechanics. He holds the Shands Award of the Orthopaedic Research Society for outstanding career contributions to orthopaedic research and is a Past President of the American Society of Biomechanics. Dr. Burstein holds thirteen patents for orthopaedic devices.

R. Wynn Kearney, Jr., M.D. has been a director of the Company since September 1989. He is the senior partner of the Orthopaedic and Fracture Clinic, P.A., a medical group with locations in southern Minnesota. He has been a member of the group since 1972. He received his B.S. degree and M.D. degree through the Honors Program of Northwestern University Medical School in Chicago. He completed an orthopaedic surgery post-graduate residency at the Mayo Clinic in Rochester, Minnesota and was a member of the team that implanted the first total knee replacement in the United States in 1970. He is also an Assistant Clinical Professor of the University of Minnesota Medical School. Dr. Kearney has served as President of the Minnesota Orthopaedic Society, the Southern Minnesota Medical Association and the Orthopaedic Practice Society. He recently completed a term as President of the Foundation Board of Minnesota State University, Mankato. Dr. Kearney is a member of the board of directors of Hickory Tech Corporation and is a minority owner of the Minnesota Timberwolves NBA basketball team.

Paul Metts, CPA has been a director of the Company since April 1998. Mr. Metts was the Chief Executive Officer of Shands HealthCare at the University of Florida from 1987 to 1997. Shands HealthCare System is a 2000-bed, nine-hospital system with approximately 12,000 employees. Mr. Metts currently serves a member of the Robert Wood Johnson Foundation’s National Advisory Committee for Urgent Matters and has served as a board member of many local civic and business organizations including Barnett Bank, the University of Florida Foundation and University Medical Center in Jacksonville. Mr. Metts has also chaired or served as a member on state and national industry organizations such as the Florida Institute of Certified Public Accountants Healthcare Industry Committee, the Florida Hospital Association Board, the Association of Voluntary Hospitals of Florida Board, the University Health System Consortium Board, and several committees for the Association of American Medical Colleges. Mr. Metts, a Certified Public Accountant, received his undergraduate degree in Accounting from the University of South Florida and his Masters Degree in Health Care Administration from the University of Minnesota.

William B. Locander, Ph.D. has been Chairman of Marketing, Professor of Marketing and Quality, and Director of the USF Leadership Center at the University of South Florida in Tampa, Florida since 1992. He was previously Professor of Marketing at the University of Tennessee, Knoxville from 1983 until 1992. From 1973 through 1983 he was a faculty member at the University of Houston, serving as Associate Professor, Chairman of the Department of Marketing, and Associate Dean for Research and Administration at that institution. Dr. Locander has authored numerous articles in reference publications and has served on the editorial board of the Journal of Marketing and the Journal of Marketing Research. He was president of the National American Marketing Association in 1988 and 1999. He was an examiner for the Malcolm Baldridge National Quality Award in 1991 and 1992. Dr. Locander has spoken and consulted in the areas of marketing, total quality, strategic planning, and customer satisfaction, with companies such as IBM, General Electric, 3M, Proctor and Gamble, and Chevron. He received his B.S., M.S. and Ph.D. degrees from the University of Illinois in Champaign-Urbana.

 [Source: Schedule 14A. Definitive Proxy Statement. March 21, 2003. EDGAR.]


Orthopaedic Products Industry

"According to The Medical and Healthcare Marketplace Guide 2002-2003, published by Dorland Healthcare Information, the worldwide market for orthopaedic products was nearly $15 billion in 2001, which represented an increase of 13% from 2000. The three market segments in which the Company offers its products and services, reconstructive devices, biologics and other orthopaedic products, experienced 12%, 13% and 9% growth, respectively, during 2001 when compared to 2000. In 2001, the United States market for reconstructive products was $2.8 billion, and the international market was $2.6 billion. The market for biologics (which includes bone graft substitutes, allograft distribution and processing and other tissue based products and services) was $900 million in the United States and $300 million internationally in 2001. Other orthopaedic products, including power equipment, cement and cement delivery systems, experienced United States sales of $2.3 billion and international sales of $1.0 billion in 2001.

"Management believes that the industry will continue to grow due to the changing demographics of an aging population in much of the world. Increasing life spans impact the number of individuals with joints subject to failure, thereby increasing demand for joint replacement procedures. In 2001, more than 1.5 million joint replacement procedures were performed. Sixty percent of these were in persons over the age of 65. This age group is expected to grow at three times the rate of the overall population. Additionally, earlier generations of implanted joint replacement prostheses have begun to reach their maximum life and are beginning to fail, resulting in increasing demand for revision procedures."

[Source: Form 10-K. Exactech Inc. Filed on March 24, 2003. EDGAR.]


Competition

"The orthopaedic industry is highly competitive and dominated by a number of large companies with substantially greater financial and other resources than the Company. The largest competitors in the orthopaedic market are DePuy, Inc., a division of Johnson and Johnson, Zimmer, Inc., a subsidiary of Zimmer Holdings, Inc., Stryker Howmedica Osteonics, a subsidiary of Stryker Corp., Smith and Nephew plc, Sulzer Orthopaedics, Inc., a subsidiary of Centerpulse AG (formerly Sulzer Medica AG), and Biomet Orthopaedics, a subsidiary of Biomet, Inc. These six companies, according to The Medical and Healthcare Marketplace Guide 2002-2003, had an estimated aggregate market share of approximately 85% in 2001.

"Companies in the industry compete on the basis of product features and design, innovation, service, the ability to maintain new product flow, relationships with key orthopaedic surgeons and hospitals, the strength of their distribution network and price. While price is a key factor in the orthopaedic market, there are other significant factors, including: surgeon preference, ease of use, clinical results, and service provided by the company and its representatives. Due to health care reform, the rapid expansion of managed care at the expense of traditional private insurance and the advent of hospital buying groups, management believes that the price of the Company’s orthopaedic implant products will continue to become a more important competitive factor. Manufacturers of medical devices, including orthopaedic implants, are increasingly attempting to enter into contracts with hospital chains or hospitals pursuant to which the hospital chains or hospitals agree to purchase their products exclusively from such manufacturers, usually in exchange for discounted prices. If the Company’s competitors are successful in securing such contracts, the Company’s ability to compete may be materially adversely affected. Although to date generic products have not been a significant factor in the orthopaedic implant market, price may become even more important if suppliers of generic products enter the market on a larger scale."

[Source: Form 10-K. Exactech Inc. Filed on March 24, 2003. EDGAR.]


Research & Development

"During the years ended December 31, 2002, 2001 and 2000, the Company expended $2,803,000, $2,210,000 and $2,138,000, respectively, on research and development and anticipates that research and development expenses will continue to increase. The Company’s research and development efforts contributed to the successful integration of the AcuMatch ® hip systems, line extensions of the Optetrak ® knee system and design improvements targeted to improving internal manufacturing efficiency. The Company’s research and development efforts continue to focus on implant product line extensions, advanced biologic materials, extremity joint reconstruction and alternative bearing surfaces.

"As an important part of its research and development efforts, the Company has developed strategic partnerships through agreements with Genzyme Biosurgery and Diamicron Corporation to bring expertise in advanced materials to the Company’s products. The agreement with Genzyme is for the development of polymer-based synthetic biomaterials that when delivered with other biologic products support the growth of new bone. Through its agreement with Diamicron, the Company will apply Diamicron’s polycrystalline diamond compact (PDC) technology to its hip implants. This diamond technology holds the promise of improved mechanical and wear characteristics over currently available technology. This technology will likely require a number of years of development and regulatory clearance prior to the release of products for sale.

"The Company believes that the purchase of intellectual property and product line assets augmented by additional development provides a cost-effective and efficient way to bring products to market and expects to continue to do so in the future to complement its internal product development."

[Source: Form 10-K. Exactech Inc. Filed on March 24, 2003. EDGAR.]


How to Analyze a Medical Device Company

"The commercial success of a new medical device does not come easily. A manufacturer must invest heavily in research and development (R&D), obtain product approval from the U.S. Food and Drug Administration (FDA), get clearance for reimbursement by Medicare and private sector managed care payors, and achieve acceptance of the product in key hospital and physician markets. Leading companies also need global marketing capabilities and must compete effectively with foreign device manufacturers.

Researching The Business

"In analyzing a medical device company, first look at the business itself. Some questions to ask include the following:

  • What are the company’s principal products? Most leading companies offer both commodity-type medical products and proprietary items. Proprietary items, especially high-tech devices, offer high margins when they’re first introduced, since competition is relatively thin or, in some instances, nonexistent.

    Margins are characteristically lower on commodity-type products that have been on the market for a considerable length of time. However, cash flow from these products helps to support R&D. Indeed, investors and analysts generally don’t assign as much value to this important revenue stream as they should, since the cash flow from these product lines, while important to the aims of the organization, are not seen as growth areas. However, these revenue streams tend to have a very high level of consistency and help to fund working capital requirements.
     

  • What are the growth dynamics of the core business lines? Standard & Poor’s believes that the worldwide market for medical products and devices approximated $190 billion 2002, including more than $100 billion in the United States. Domestic market growth is currently running at about 12%, but the industry appears poised for some acceleration into the mid-teens in 2003, as new product launches in areas such as interventional cardiology, orthopedics, and cardiac rhythm management join with potentially significant benefits from foreign currency translations.

    For those participating in these dynamic growth markets, prospects for growth above the industry average are bright. The revenue benefits for these companies are likely to allow for increased spending to maintain research and development pipelines while building sales force capabilities.
     

  • How does the company rank within its principal markets? While size and critical mass are important to all businesses, their significance is heightened in the medical product areas. Large firms usually have the financial resources to support the R&D expenditures needed to move experimental devices through the discovery, testing, and regulatory filing stages. These companies also have the funds to maintain the large sales forces needed to market products in key domestic and foreign area once they have obtained regulatory approval. Hospital and physician clinic markets, as they consolidate, are increasingly attracted to vendors that can provide a full range of products and supplies. The larger participants can fill those needs, and can often do so on a volume-discounted basis.
     
  • How efficient is the manufacturing process? Being the low-cost producer in a competitive segment of the medical device industry often makes the difference between success and failure, and this is especially true in the cost-constrained U.S. healthcare industry. In an effort to lower manufacturing costs, these companies make many products overseas, especially in Latin America and the Far East. Tax credits provide an incentive to manufacture in developing areas such as Ireland and Puerto Rico.
     
  • Have R&D efforts been productive? Most leading technology-oriented medical device makers spend between 8% and 12% of their sales dollars on R&D programs. But their degrees of success in creating lucrative new medical products differ markedly. For example, among those with a favorable track record, Medtronic has maintained dominance in bradycardia pacemakers by investing heavily in new technologies that have spawned a steady stream of state-of-the-art products.

    Generally, the larger, well-funded firms have a decided advantage in developing new medical technologies. They can typically afford to hire top scientists and to conduct more of the costly clinical trials necessary to obtain FDA approval for their products.

    In a market dominated by managed care, a key determinant of success is a manufacturer’s ability to develop new devices that are both therapeutic breakthroughs and cost-effective. New products that provide essentially identical results to existing therapies aren’t as likely to achieve commercial success.
     

  • To what extent has the firm diversified abroad? The United States remains the most important market for U.S. medical device makers as well as for many foreign-based firms. Yet the U.S. industry generates about half of unit shipments from foreign markets. Without representation in key markets, such as Germany and Japan, as well as in developing nations, a company faces the risk of relying on an increasingly price-competitive U.S. market. However, for firms with international business, foreign exchange fluctuations have an impact on revenues and gross margins. They’re generally transitory in nature, but these fluctuations must be considered in near-term revenue and earnings projections.
     
  • How effective is the company in working with the FDA? All medical devices sold in the United States must first be cleared by the FDA. Therefore, it’s critical that a firm is able to work with the agency and understand its criteria. Here again, size and experience can help. While most large, well-established medical products manufacturers are adept at working with the FDA, smaller and newer firms are less proficient and often encounter major snags in seeking approval for their products.
     
  • Is management astute at making strategic acquisitions? Many companies seek to grow through acquisitions as part of a broader effort to fill out product lines and reposition themselves as “one-stop shops” for hospital supply buying collectives and other large purchasers of medical products. In a relatively mature industry, mergers and acquisitions are viewed as an important method of sustaining both revenue growth and margin expansion.
     
  • Have alliances been fruitful? Analysis of a major producer’s strategic alliances with smaller start-ups and development-stage device makers can also provide clues for future growth prospects.

    Leading companies like Johnson & Johnson, Medtronic, and Boston Scientific have benefited from acquisitions and alliances with development-stage companies. The smaller firms are typically eager to align themselves with big producers, which can provide them with funds to finance needed clinical trials and eventually to commercialize their products.

    Many companies also maintain relationships with scientists at leading medical colleges or other organizations, such as the federal government’s National Institutes of Health. These connections can be helpful in developing new products."
     

    [Source: "Healthcare: Products & Supplies." By Robert Gold. Industry Surveys. Standard & Poor's. September 11, 2003. In Standard & Poor’s Net Advantage.]


    Revised: September 22, 2003

Peter Z. McKay, Business Librarian. University of Florida.
This page uses Google Analytics (Google Privacy Policy)