HARDY DIAGNOSTICS - HISTORY

THE BEGINNING

"Hardy Media" was formed in October 1980 by Robert Shibata and Jay Hardy. The founders were both licensed Medical Laboratory Technologists, working at local hospitals in the Santa Barbara area, who saw a need for quality culture media in California. This media, which is packaged in plates, bottles and tubes, provides the nutrients necessary for culturing and identifying bacteria and fungi.

Starting with limited funds, they originally provided media to Santa Barbara Cottage Hospital, a large regional medical center. After news of the company's initial success spread, other laboratories in the area asked to be supplied by Hardy Media.

The owners eventually left their hospital jobs and made a commitment to promote the growth of the company on a full-time basis. During the first three years, the growth was confined within the Central Coast area of California. Hardy Media rapidly gained a significant market share in this area, before pursuing additional clinical lab customers along the West Coast.

As the company continued to grow (at the rate of about 30% each year), a need for more space was soon realized. The Central Coast area was searched for the appropriate city to meet the company's needs. Santa Maria was chosen for its relatively low cost of living, motivated labor force, and quality of life. Three acres of land just north of the Santa Maria airport was purchased and a 25,000 square foot facility was completed in October of 1991 to provide for the needs of this growing company. The new facility contained state-of-the-art air handling systems in clean rooms to ensure the production of a top quality product.

About the time of the move to Santa Maria, it was decided to change the name from "Hardy Media" to "Hardy Diagnostics" in order to emphasize the additional laboratory supply items that the company provides in addition to the culture media it manufactures.

RAPID GROWTH

In 1998, two new remote distribution centers were opened, one in Salt Lake City, Utah and one in Phoenix, Arizona. In 2003, another facility opened close to Tacoma, Washington. This completed the company's coverage of the Western United States and provided fast overnight service to customers in those areas. In 2004, a fourth distribution center was opened in Ohio in order to better serve the Northeastern and Midwestern customers; thus providing another step towards facilitating nationwide distribution.

In May of 2007, Hardy Diagnostics opened its sixth distribution center, in order to increase its "next day" service to Texas, Oklahoma, Arkansas, and Louisiana. The new warehouse is located in Irving, Texas, which is close to Dallas.

Seizing an opportunity to export Dehydrated Culture Media globally, the company began to blend powdered media in 1999. Hardy Diagnostics now utilizes its own "CRITERION™" powdered media for 95% of its prepared products, and exports the balance to over thirty distributors around the globe.

In June of 2005, the company completed a new building in Santa Maria on an adjacent lot that doubled the size of the previous facility to a total of 50,000 square feet.

Also in 2005, the company achieved certification as an ISO 13485 facility. This globally recognized quality standard for medical device manufacturers has opened many doors for expanded sales into pharmaceutical and foreign markets, and appeals to customers who demand the highest level of quality and service.

Hardy Diagnostics was the first company to introduce chromogenic culture media to the United States in 1996.

The development of chromogenic culture media has been a focus of the R&D effort for the last two years. Chromogenic media assists the microbiologist in rapidly identifying microorganisms based on the enzymes they produce, which create uniquely colored colonies as pictured below on the right. Hardy Diagnostics currently offers chromogenic media for the detection of E. coli, Staphylococcus aureus, MRSA, E. sakazakii, coliforms, Candida spp., and urinary pathogens.

In 2005, Hardy Diagnostics’ R&D lab released a very successful, unique product known as "Carrot Broth™" that produces a quick orange color change in the presence of Group B Strep, which is of concern in pregnant women.

Hardy Diagnostics has also produced a new line of products, known as "HardyVal™", which is designed for the hospital pharmacists in order help them with proficiency testing of their compounded sterile products. These products test the ability of hospital personnel to aseptically prepare sterile solutions.

A third building (25,000 sf) in Santa Maria was completed in 2008 to house additional offices, cleanrooms, labs, and warehouse space. Another milestone completed at this time was the initiation of online Certificates of Analysis so the company's customers can access their quality documents 24/7.

The October 2008 issue of Forbes Magazine featured Hardy Diagnostics for earning its certification from the American Heart Association for becoming a "Fit Friendly Workplace", thus honoring the company's commitment to promoting healthy lifestyles. The Fit Friendly program consists of walking trails, health incentives, free blood testing, healthy food choices in the vending machines, fresh fruit in the breakroom, discounts on gym memberships, daily Tai Chi classes, sports teams sponsorship and other recreational opportunities.

PRESENT STATUS

Hardy Diagnostics now manufactures over 2,800 culture media products for use in clinical, industrial, research, and academic laboratories.

The company is licensed by the FDA as an 'in vitro medical device manufacturer'. The quality control department performs growth, pH, gel strength, and sterility tests on each batch of media produced in compliance with the FDA's "Good Manufacturing Procedures" and the CLSI (Clinical and Laboratory Standards Institute) guidelines. In addition, since 2005, the company's quality management system is certified to ISO 13485 at the Santa Maria manufacturing and distribution facility.

Hardy Diagnostics offers unsurpassed technical services to its customers. A complimentary software program, "HUGO™" (Hardy User Group Observer), is provided to all media customers. HUGO™ is a complete microbiology technical manual which is comprised of over 4,500 pages of useful data. HUGO™ has a quick search function so that microbiologists can rapidly obtain the answers to their questions.

Updates to the HUGO™ software, which serves as a complete technical manual for all customers, are released periodically. The new version features close-up color photos of the microbial growth characteristics on the culture media, along with technical data and procedures for each product offering.

Culture media produced by Hardy Diagnostics accounts for 60% of the company's income. The other 40% is from the distribution of other laboratory supplies. Hardy Diagnostics is currently an authorized distributor for over 75 other laboratory supply manufacturers. These supply items include diagnostic kits, laboratory glassware, plastic disposables, disposable gloves, pipettes, loops, control microorganisms, stains, reagents, rapid test kits, etc. Over 12,000 laboratory products are offered to customers throughout the United States.

Hardy Diagnostics currently maintains over 6,000 active accounts, which include hospitals, clinics, doctor's offices, universities, veterinary clinics, food processors, biomedical research, pharmaceutical, environmental, water, and quality control laboratories. About 200 people are employed at Hardy Diagnostics, which includes a technical staff of microbiologists, Medical Technologists, and biochemists. There are twelve outside sales people that represent Hardy Diagnostics throughout the U.S. Many are experienced microbiologists and/or Medical Technologists who truly enjoy offering their assistance to their customers around the globe.

In 2003, Hardy Diagnostics became an Open Book Management (OBM) company, which encourages all employees to become involved in the financial management of the company's operations. A quarterly Profit Sharing program is an important part of this program, which creates business partners of all employees, resulting in a workforce that is highly motivated to satisfy their customers and helps to ensure the long-term success of the company.

Since the beginning, Hardy Diagnostics has always been an employee and community focused company. In addition to the OBM and profit sharing program, the company has always strived to pay competitive wages and benefits, and actively promotes the health and well-being of its workers. Hardy Diagnostics has a well developed 401k program with company matching, health and dental benefits, and an innovative workplace counseling program. Hardy Diagnostics believes in giving back to the community and is actively involved in promoting and supporting a variety of local community based charities and non-profit organizations.

CUSTOMER SERVICE

The marketing strategy has always been to provide a superior product with unexcelled service. In addition, Hardy Diagnostics’ customers enjoy the ability to receive other lab supply items along with their media orders from one source. Customers benefit by cost effective batching of orders, in addition to receiving fast (usually overnight) service. Hardy Diagnostics’ customers appreciate the fast turn-around time for just-in-time delivery. Another plus is the willingness of the company to manufacture custom products to the specifications of its customers.

OUR MISSION

We believe our uncompromising commitment to the highest standard of business ethics and our desire to exceed our customer's requirements are the key factors ensuring our continued success. Our mission continually guides our actions…

MISSION STATEMENT

"We are committed to producing and distributing the finest products for the detection of microorganisms, as we partner with our laboratory customers to prevent and diagnose disease"

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