The rapid introduction of Lab-on-a-Chip (LOC) technology is accelerating the move to Point-of-Care Testing (POCT). However, many companies are finding that perfecting LOC technology is only part of building a viable business model. The need for a complete system approach is a prerequisite to broad and rapid market adoption. The options for building a complete system are complex, confusing, and sometimes conflicting. The remote and disconnected nature of POCT—whether at the bedside or in the field—requires a complete system solution that allows for mobile and cloud technologies that connect the point of care to the continuum of care.
Exacerbating the situation for LOC product companies is the unfortunate fact that these critical and essential technologies and systems are usually outside their core competencies. There are many companies focused on bringing microfluidics-based LOC products to market, but few products have been successfully introduced. Microfluidics technology companies have been around since 1983. The technical and clinical approaches to the devices vary broadly in materials, sample types, reagents, and signal detection, yet all are similar in general application in that they support more rapid results from POCT, and require smaller sample and reagent volumes.
In this article, the challenges from a systems perspective inherent in successfully launching LOC products into the POCT market are highlighted, including:
- Informing and aligning the science and testing innovations with practical real world needs
- Taking a holistic system view for integrating the various point problem solutions to achieve a coherent, fully functional product
- Seamless data connectivity to other systems, such as electronic medical records
POCT represents a Holy Grail within the diagnostic market—the potential to significantly improve overall diagnostic testing coverage while simultaneously lowering testing costs. Microfluidics fits perfectly within the profile of solution technologies and has long been shown to be effective and lower cost. But, more than effective testing is required to meet all the needs of the POCT market. The World Health Organization has identified a set of criteria for diagnostics in emerging markets called ASSURED—affordable, sensitive, specific, user-friendly, rapid, and robust—that can easily be applied to the U.S. and European markets as well.
This sounds simple, but a lot of technology is needed in order to satisfy the requirements of ASSURED. POCT products not only need to be effective from the diagnostics perspective, but they also need to be utilized within a fully integrated system. The product must have components that support the ability to track patients and results, while providing a repeatable construct for sample collection and necessary sample preparation. It must include an analyte-specific reaction, signal enhancement, and detection, along with result generation and collection. To be effective as a POCT device, it must work in a wide variety of contexts—from a medical technician at the bedside in a hospital to a self-administered application delivered at a local pharmacy to everyday use in remote areas of the world.
The integration of these various components into a reliable system requires a full understanding of the extent of the use contexts and potential technology available to address the specific needs of each. Unfortunately, the technologies and expertise required to create this fully integrated system is not usually within the core competency of most microfluidics organizations.
POCT devices have the potential to reach across a variety of different-use contexts. Controlling the protocols within a system flexible enough to reach and support these different users represents a core driver of the overall solution system. Recent technological developments that can directly support this include mobile devices and cloud-based systems that provide enormous potential in providing ease of use, low cast, and broad connectivity. Mobile devices have already been utilized as data collection and analysis solutions in various settings. Microsoft has developed a set of cloud services to directly address the medical market with support for application development, secure hosting of patient data, or interoperability with existing hospital and laboratory information systems. This tool can provide acceleration to developing required infrastructures. Several companies are developing cloud-based components, such as electronic health records, workflows, and interoperability modules, that provide building blocks for systems.
Using cloud and mobile technologies represents a faster, less costly route to developing the integrated system required to field POCT products. However, this approach is not without risk. It is imperative to start with a strong systems perspective, including a full understanding of users, contexts, the potential range of technical solutions available, and leverage provided by off-the-shelf components. Development of the components to meet custom or proprietary needs must be undertaken within a clearly defined system architecture to ensure seamless integration and reliable, secure operation.
The systems architecture must be developed to support the drivers of a new business model with a more dispersed customer base, variation in regulatory guidelines in different geographies, and the expectation that both technology and regulatory infrastructures will evolve over time. Use of formal systems architecture techniques will support this process, positively impacting the final product and save time and money.
The development of the complete software system to support fielding the POCT product requires that the engineering organization has sufficient large-scale systems development experience. Moving forward with programs outside an area of core competency will result in serious delays directly impacting revenue. A strong system perspective must be accompanied by a well-thought-out product roadmap showing major milestones, product evolutionary steps, and release points to enable planning of an efficient development path. A detailed software roadmap to accompany the product roadmap will support the creation of a more comprehensive systems architecture sufficient to meet both near- and long-term requirements, map out potential third-party components, and integration strategies.
Identifying the organizational core competencies and deficiencies prior to large-scale development programs will aid in finding complementary talent and partners. It is imperative to recognize that large-scale software systems development may not be a core competency. It is also important to keep in mind that building product development teams that are transitory is inherently expensive and laden with risks.
The transition from LOC technology to POCT device to complete system solution is complex and dependent upon the development of a large, distributed software system that is most often outside the comfort zone of the LOC organization. Addressing the POCT product from the systems perspective, using formal techniques, incorporating experienced partners, and leveraging emerging cloud and mobile technologies can lower the risk and improve the outcome associated with this effort.