Wednesday, June 9, 2010

SDM certificate project evaluates in-vitro diagnostics market - SDM Pulse Summer 2010

By Vincent Balgos, SDM ’10

Vincent Balgos, SDM '10
Editor’s note: In this article, Vincent Balgos, SDM ’10, outlines the major points covered in the capstone project he completed to earn his Systems Design and Management Program (SDM) graduate certificate in systems and product development. The certificate program is frequently used as a jumping off point for the SDM master’s program, which Balgos has since joined.

The increasingly complex US health-care system poses several unique challenges for product developers; risks include disruptive technologies, emerging industry needs, and evolving regulations. Employing “systems thinking” can both manage the inherent complexities and interdependencies of the system and can accommodate future uncertainties—which is critical in the case of products that directly influence human health and welfare.
As suggested in Clayton Christensen’s book, The Innovator’s Prescription, an emerging trend toward decentralizing hospital care and testing could prove disruptive to the incumbent system of centralized lab testing. This is further supported by a 2007 study by the Point of Care: Journal of Near-Patient Testing & Technology, which indicated approximately 70 percent to 80 percent of the hospitals surveyed performed point-of-care (POC) testing, and showed continued growth in this market. Clearly, changes are under way that will affect the in-vitro diagnostics (IVD) market space.
My SDM certificate sponsor and employer, Instrumentation Laboratory (IL), develops and manufactures POC diagnostic analyzers for the dynamic IVD market. For my SDM certificate capstone project, I had the unique opportunity to help develop a new universal POC blood analyzer to address this market uncertainty. I found this exciting as I had the chance to apply my SDM skills to a project with real-world implications, aligned with my company’s goals. Together with other SDM certificate students (David Abichaker, Guy Criscenzo, Duc Vo, Sassan Zelkha) and IL, I formed a team to undertake this complex, yet engaging project.
Figure 1. In this systems engineering V model, the blue circle
indicates the areas of focus for Vincent Balgos’ capstone project.
We soon realized the project scope would be immense and decided to focus on the first three stages of the systems engineering “V model” (see Figure 1): defining customer attributes, establishing system requirements, and developing an initial systems architecture for the project.
Figure 2. This chart shows the flow of value among
stakeholders for the point-of-care analyzer.
Since Instrumentation Laboratory is a leader in the IVD market with POC analyzers, several in-house experts were surveyed to determine market trends, customer needs, and the future of POC analyzers. An external interview of a lead user at a well-known local hospital was also conducted to help refine the realistic POC needs. Next, the team performed a value flow analysis using the techniques taught by Professor Edward Crawley in SDM’s system architecture course. Our value map (see Figure 2), defined the priority needs from all stakeholders throughout the POC ecosystem, allowing the capstone team to recognize the variety of needs from different stakeholders and how they interact. The value map provided a holistic view of all values and their interdependencies so that we could prioritize the project needs.
We determined that the primary POC needs are:
•    Flexibility and adequacy of testing for all POC locations
o    Test menu flexibility and breadth
o    Portability for ease of transport
•    Affordable cost
•    Simple and easy-to-use interface
o    Safe and fully automated system with little user dependence
•    Efficacy and quality of results
o Precision and accuracy equivalent to central lab
•    Laboratory oversight and quality control
o Data and quality control management
o Integration ease with existing infrastructures
System requirements were derived from the value map and needs using quality functional deployment methods such as the “house of quality” diagram taught in SDM’s product design and development (PDD) course.  We particularly focused attention on requirements for the test menu system since it was a significant design driver. A wide variety of testing was needed for each department, so our central challenge was how to develop a single, universal system to address these disparate needs.
For example, while the respiratory therapy department needed testing for blood gas, electrolytes, and Co-Ox, the neonatal intensive care unit requires an additional specialty test for their patients. In the operating room, two different coagulation tests are mandatory, whereas the emergency room particularly requires cardiac markers and pregnancy diagnostic utilities.
Finding an innovative solution required several brainstorming sessions, during which we found it useful to employ many techniques from PDD, including visual illustrations, literature research, and reviewing feasible technologies, which ranged from optical to mechanical and electrochemistry technologies. After much research, we decided to treat these technologies as a “black box”—essentially an empty container to be filled in later—and to focus the project on the design of the whole system.
Several innovative concepts were generated, and by using the Pugh concept selection method from PDD, we were able to converge on a single design concept: modular system with multiple sample ports.
The modular concept incorporated several important features. First, the main system was designed as a common platform with all the user and external interfaces. It was also designed to accept up to three specialized analytical test modules. This platform would supply standard interface configurations so the system could accept various analytical test modules for data acquisition. These modules would incorporate the “black box” technology previously researched, which would ultimately depend on the company’s goals and resources. Furthermore, these analytical modules could be made flexible enough to allow future technologies to be incorporated.
Figure 3. This systems block diagram shows how
the point-of-care analyzer could be integrated into
the Emergency Department.
Finally, each specialized analytical test module would require its own specialized consumable cartridge to carry out the tests. These cartridges would hold the necessary reagents, sensor technology, and waste management to provide users with a single solution to their testing needs. The cartridge could be custom-built to fit the unique needs of a specific user. For example, as seen in our systems block diagram (see Figure 3), the Emergency Department requires the largest breadth of tests, and the capstone project allows that flexibility. However, if a respiratory therapy requires large volume of blood gas testing, the system would be able to adapt by using multiple blood gas analytical test modules and large volume blood gas cartridges.

In conclusion, the developed SDM capstone project provides several advantages in technological expandability, test menu versatility, and customizable solutions for the user. These flexibilities would allow the system to adapt to many different POC user needs and would mitigate some future market uncertainties. The systems thinking approach, coupled with the SDM certificate program tools, provided the holistic approach necessary to design a complementary system to fit the needs of many in a dynamic environment.

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