By Lori Sichtermann

An interview with Gregory R. Vail, Cofounder, President, and CEO

Founded in 1989, Data Innovations Inc has grown to become the world’s largest clinical lab data-management, or middleware, company. Based in South Burlington, Vt, the organization has regional offices in Brussels, Hong Kong, and Sao Paulo. Together with its strong network of business partners, the company has installed nearly 4,000 systems globally.

Clinical Lab Products recently spoke with Gregory R. Vail, cofounder, president, and CEO of Data Innovations Inc regarding the state of the global laboratory, and what Data Innovations Inc is doing to enable its growth.

CLP: What needs does Data Innovations satisfy within the clinical diagnostic market?

Gregory R. Vail: Laboratories today are facing staffing, budget, and turnaround-time issues. They have a need to increase productivity while lowering costs and maintaining a high standard of quality. Our product, Instrument Manager™, equips labs with an inexpensive tool that helps them increase their efficiencies to meet this need.

CLP: What kinds of products and services does the company offer the industry?

Vail: Data Innovations Inc is the worldwide leader in middleware systems. Middleware typically resides between laboratory instrumentation and/or automation and a variety of software systems, such as one or more laboratory information systems (LIS) and outreach applications. It is fast becoming the main tool laboratory technologists use to assist them in workflow management, allowing them to produce fast, quality results, even with the pressures of reduced staffing. Our Instrument Manager licensing is organized in a manner that allows labs to buy only the functionality they need at the time. With the easy addition of optional modules, labs can create a system that grows with, and is individually customized to, their unique needs. Instrument Manager is a feature-rich, flexible software application that is easily installed and supported, thereby offering the lab a complete solution.

One of the unique services we offer the industry is our Business Partner program. In this offering, we place a great deal of emphasis on being not just a solution provider, but a true partner. This program includes services such as product customization and private labeling, customized support and training, and custom turnkey system builds.

CLP: What new products and services will soon be released by the company?

Vail: Instrument Manager version 8.05 will feature a dramatically enhanced specimen-management area, allowing the user a greater deal of flexibility in configuring—on the fly—the presentation, sorting, and filtering of their data. We will greatly expand our user-notification capabilities, allowing users to define their own notification events and write rules to trigger them. We will also add new functionality, such as the ability to query our database via SQL and a maintenance scheduling and tracking module.

We have recently added an Implementation Consulting Services group to help labs derive greater value from, and enhance satisfaction and return on investment in our software. Our recently revamped on- and off-site training programs will also continue to expand.

CLP: Where do you see the industry heading?

Vail: Due to factors such as the focus of information systems vendors on total clinical information aystems and the changing landscape of the lab, we are seeing the decline of the classic LIS. Labs today are faced with the complexities of managing outreach programs, shrinking information-technology budgets, and automation. This has led to the emergence of middleware systems to serve as the hub of the new lab, interfacing to instruments and automation, classic LISs, outreach applications, electronic medical records, and more. Especially when combined with implementation consulting services, a middleware solution can address the immediate needs of the lab quickly and cost-effectively.

CLP: What is Data Innovations Inc doing to continue the growth of the industry?

Vail: The additions and enhancements we make to Instrument Manager are 100% customer driven. As labs are faced with new challenges, requests for help in meeting them flow into Data Innovations Inc, where we compile them and use them to define new or improved features within Instrument Manager. As we produce specifications for these additions and enhancements, we actively involve our business partners and end-users to ensure what we produce will meet their needs. In this way, we are allowing the industry to grow in the directions dictated by real-world business models.

CLP: Where do you see the company in 5 years?

Vail: Data Innovations Inc will continue to be the industry leader in the transition from the classic LIS and lab-operating model to the newer systems and work flows of the lab. We will do this with an ever-evolving product and continual addition of requested services.

CLP: With regard to the industry, what are some issues the company has faced?

Vail: There has been a great deal of confusion in the industry regarding regulations, particularly FDA clearances, as they pertain to middleware. Among other things, this has caused hesitancy in the adoption and comprehensive use of middleware in many labs.

CLP: What has the company done to overcome these issues?

Vail: Although Data Innovations Inc has been registered with the US Food and Drug Administration (FDA) and has followed good manufacturing practices for quite some time, we have taken the next step and prepared an FDA submission. Once we obtain FDA 510(k) clearance, any regulatory doubts that a lab has about using Instrument Manager should be alleviated. We feel the FDA will increase their activity in this area of the lab in the not-too-distant future.

CLP: What would you like CLP readers to learn about Data Innovations Inc?

Vail: Data Innovations Inc generates most of its sales through our business partners, where Instrument Manager is usually bundled with their offerings to create unique solutions for the laboratory. Instrument Manager, however, is the middleware system available in the United States that is independent of both specific instruments and the LIS in use. This independence allows the lab to standardize on one system throughout their operation, gaining cross-training and maintenance efficiencies. By complementing both the existing instrumentation and the existing LIS, Instrument Manager allows labs to get more out of both. This can often extend the life of these investments, especially that of the LIS.

CLP: What distinguishing feature(s) sets you apart from your competitors?

Vail: Data Innovations Inc is the only company in the clinical data management area that is truly a worldwide player. With our offices around the world, we can offer installation, support, and training in local time zones and languages.

In addition, Instrument Manager is the most comprehensive data-management solution on the market, covering lab processes from order entry through automation and auto verification, all the way to specimen storage and retrieval.

Perhaps the most distinguishing difference lies in our rules engines. Through innovative design, we allow users to write rules using intuitive screens with drop-down choices of the data elements, operators, and actions at their disposal. These rules can be as simple or complex as the user wishes to make them, and they can be created and tested by non-programmers. The rules engines are used in many different modules, such as determining specimen routing, results processing, and collecting data for analysis like cost per reportable result tracking. Full audit trails and testing facilities are included to assist the lab in complying with regulations.

Lori Sichtermann is a contributing writer for Clinical Lab Products.