Sage advice from Psyche Systems

Medical Laboratory Observer, Dec, 2004

MLO: Since arriving on the scene in 1976, Psyche Systems has achieved many firsts, from LIS on a standard operating system to graphic interface milestones, and now secure LIS hosting. Which of these do you think has had the greatest impact on the medical lab?

Bob Sage: Psyche introduced the first anatomic pathology information system featuring a graphical user interface (GUI) in 1988. We introduced the system on a Macintosh because the Windows operating system could not support a GUI at that time. To our knowledge, ours was the first commercially available system with a GUI in the healthcare information market. Competitors in the anatomic pathology information system market began developing products with GUIs following our introduction, but did not release them until three years after our WindoPath system came to market. Today, all newer systems have a GUI. I believe without the competitive challenge that Psyche posed, the GUI would not have become as ubiquitous as quickly as it has. I believe Psyche's relatively recent introduction of hosted laboratory systems (in 1998) will be similar to the GUI scenario. Time will tell whether hosted systems will replace turnkey systems.

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MLO: Web-based technologies have opened great opportunities for Psyche Systems' product development, as with its hosted application provider systems. Where do you see the next big advance in Web technology for healthcare applications?

Sage: The next step is the incorporation of Web technology directly into the applications. Currently, Web outreach tends to be an add-on to clinical systems. Microsoft's .NET framework has made it possible to build Web access directly into the product. To take full advantage of these capabilities, the software must be designed to run on .NET--not merely modified from an older technology. New applications built from the ground up with the Web in mind will be the norm in coming years.

MLO: What will Psyche's next significant achievement be, and how will it benefit medical laboratories?

Sage: Raising awareness of the many advantages of a hosted system is our current goal. Having a server in the laboratory is no longer necessary. Natural inertia, however, will keep turnkey systems viable for many years. The market for hosted laboratory systems will remain niche until its competitive advantages overwhelm the natural resistance to change. Our focus today is to carry the flag for hosting and eventually bring its benefits to a broader market.

Psyche, however, never stands still; we are constantly innovating. Our latest product, launched this fall, is called e.lixa--from the word 'elixir', as in "elixir of life." By using e.lixa, the lab can extend the reach and, essentially, the life of a legacy LIS. This product uses the Internet to deliver tools to enhance the functionality of an existing LIS with features like graphical analysis, Web-based outreach, and advanced ad hoc search capabilities for an unlimited variety of management and patient reports with just a click of the mouse. Upgrading can be expensive and time-consuming. For a fraction of the cost in money and time, e.lixa gives laboratorians the best new features as an extension of their existing system.

MLO: Where does Psyche Systems stand in the security vs. patientsafety controversy among users, vendors, manufacturers, and the Food and Drug Administration (FDA) about the administration of program patches to regulated patient-care systems? What is your solution?

Sage: We spent many years testing our blood-bank system during our submission to the FDA for 510(k) approval. We were among the few companies that achieved acceptance on the first pass. We learned through that rigorous approval process that, although the cost of quality is high, such precautions are critical in an area like blood banking; this experience helped us strengthen our system. As a result, we have only had two bugs since our acceptance over three years ago--both of which were very minor. Fortunately, because of our choice of technology platform, our system is not subject to the frequent security vulnerabilities that require regular patching.

In a field like blood banking, where the stakes for taking risks are actually life and death, high-quality software is imperative, and mandatory safeguards are necessary in order to protect patient safety. The downside of the 510(k) approval process, however, is that we cannot continuously improve and enhance our blood-bank system the way we do our other products without resubmitting, which is cost prohibitive. In this way, regulatory approval for safety standards can actually stifle innovation that may save lives in another way.

It seems a great deal of the controversy stems from a misunderstanding between the FDA and vendors, and vendors and their customers, as to what is permissible and what is not concerning security patches. Perhaps clearer communication among all parties and a more streamlined regulatory submission process may help strike a better balance between patient safety on the one hand, and security and innovation on the other.