Interview with Michael I. Ruxin, MD, CEO and Chairman of the Board for Global Med Technologies Inc

CLP: Wyndgate Technologies® is in the software business, but what type of software product does Wyndgate provide?

MICHAEL RUXIN: Wyndgate Technologies‚ a division of Global Med Technologies Inc, is a leading supplier of information management systems to blood centers and transfusion services. Wyndgate has developed two software products: SafeTrace‚ donor management system, and SafeTrace Tx‚ advanced transfusion management system. SafeTrace received 510(k) clearance from the FDA in 1997 and SafeTrace Tx received its 510(k) clearance in 1999. Together, SafeTrace and SafeTrace Tx provide vein-to-vein tracking from donor collection to patient transfusion.

CLP: Wyndgate Technologies has announced business partnerships or alliances with other companies. What is the strategy behind these partnerships and alliances?

MR: The partnerships and alliances that we form with other vendors are obviously mutually beneficial. In some cases, Wyndgate provides a product or service that the vendor does not have, but may require in order to complete its own product solution. In other cases, the other vendor has a product or service that Wyndgate needs to supplement its product offering.

CLP: With which types of companies do you form relationships?

MR: Our alliances with other companies include HIS and LIS vendors, companies that provide hardware and software that complement our products, and consulting firms.

CLP:Can you provide some examples of relationships with LIS vendors?

MR: Our relationships with LIS vendors comprise a very important group of alliances and partnerships. When these vendors offer their laboratory information system product to a hospital that requires a blood-bank module for its transfusion service, they offer our blood-bank software application, SafeTrace Tx. We have formal agreements with some and informal relationships with others. For example, we have formal business agreements with GE/Triple G Systems Group Inc, Siemens Medical Solutions Health Services Corp, and Sysmex InfoSystems America Inc. Wyndgate has strategic alliance agreements with Keane Healthcare Solutions and Computing Solutions Inc and informal relationships with Creative Computer Applications Inc and Orchard Software Corp.

On another level, Wyndgate recently entered into a business agreement with McKesson Information Solutions, enabling McKesson to privately label our product, SafeTrace Tx, as Horizon Blood Bank. Misys Healthcare Systems offers Wyndgate’s donor module, SafeTrace, when placing its LIS solution in larger facilities with donor collection programs.

CLP: Obviously, Wyndgate’s products provide a software component solution that these companies do not currently have. How do these relationships benefit Wyndgate?

MR: These companies market to hospitals of all sizes. Some specialize in smaller hospitals of 200 beds or less, while others market to large hospitals and multi-facility health care organizations. Our products are scalable and effective in facilities of all sizes. Therefore, through their sales and marketing efforts, our products are presented in sales opportunities where the blood-bank module is being purchased as part of the LIS. It is truly a win-win situation for both Wyndgate and our partnering companies.

CLP: Can you provide examples of other companies with which you have alliances?

MR: We have agreements with Data Innovations Inc, which provides an interface management solution for our donor management system, and Digi-Trax, which provides hardware and software to assist our clients with on-demand and stand-alone product label printing for the new blood component labeling standard, ISBT 128. Lattice Inc and Healthcare-ID provide software for handheld devices to help ensure positive patient identification at the bedside during blood transfusions.

Gambro BCT is a strategic partner with whom we have developed an interface with its Vista Information System to exchange information between SafeTrace and Gambro’s automated blood collection systems. Additionally, we have a relationship with Hemo-Net, an ASP for SafeTrace and SafeTrace Tx.

Wyndgate also has formal and informal alliances with several consulting companies, including RF Nozick and Associates Inc, Validation Partners Inc, and Rhodes Group Inc, which offer project management, validation assistance, data conversions from legacy systems, and other services.

These companies provide value-added products and services and are a valuable part of our current product offerings. Likewise, as a strategic alliance, Wyndgate can provide name recognition and leverage to those companies’ potential clients through their associations with us.

CLP: Are there plans to forge relationships with other companies?

MR: Wyndgate Technologies is continuously monitoring current trends in the blood-banking industry, including new products and services, technology advances, and regulatory changes. As we evaluate these trends, we will seek partnerships with companies where our product offerings can complement and add value to their product suites, and relationships with companies that can add the greatest value to our product and service offerings.

CLP: What are some recent innovations in the industry? How has Wyndgate met these new market demands?

MR: The blood-bank industry is continually changing and as these changes occur, Wyndgate Technologies must ensure that its software products accommodate new regulatory requirements and technology advances. For example, as new viral marker tests are developed to help ensure the safety of blood donations, Wyndgate must ensure that these tests can be implemented in its software products.

The blood-bank industry is in the process of adopting the new ISBT 128 blood-labeling standard. This new international standard enables critical data on the blood component label to be presented in a standardized bar code format that can be readily scanned into any computer system in the world. Wyndgate Technologies has been actively working with the advisory groups that developed this standard and we continue to keep up with changes to the standard as well as to customer needs during the implementation process.

Wyndgate’s user groups help drive the enhancement process by providing guidance in the development of requirements for the software modifications to meet both evolving regulatory changes and advances in technology. Our quality policy states, “Our organization stands for quality products and satisfied customers, through continuous improvement.” We put that policy to use in our everyday operations.

CLP: What are some of the challenges Wyndgate faces? How does the company resolve these issues?

MR: The most challenging issues that Wyndgate Technologies faces include the fact that the blood-bank industry is highly regulated and that the software products we develop and market are considered Class II medical devices by the FDA.

Donor collection facilities and transfusion services, as well as the software used to manage them, must meet requirements set forth in the FDA regulations and AABB standards, as well as those of other regulatory agencies. Wyndgate Technologies has regulatory and quality assurance policies to help ensure that our software products meet these regulations and standards.

Medical device classification requires a premarket 510(k) submission to the FDA. The documentation of the software development process and validation must be thoroughly reviewed by the FDA and a determination made that the product is substantially equivalent to another device on the market. Once the device has received 510(k) clearance, it can be marketed in the United States.

Medical devices require thorough documentation that established procedures have been followed in all aspects of manufacturing the software products, including software development, validation, distribution, and resolution of client-reported issues. Subsequent marketing and advertising of the software products must also follow established guidelines to avoid misbranding or overstating the intended use of the product.

Though these issues present challenges, it is rewarding to know that these requirements support the underlying proposition that the device has been developed to meet its intended use and that the software was developed correctly with very high quality standards. Wyndgate has been successful at meeting both of these challenges.

CLP: Where does the company expect to be within 5 years?

MR: Wyndgate Technologies has set a goal to become the leading supplier of blood-bank software for donor facilities and transfusion software for hospitals, both domestically and internationally.