The development and adoption of point of care systems continues to increase due in part to expanding test menus, lower cost and advances in data management infrastructure.

To provide a forum on the needs and requirements for the lab of the future, we invited industry leaders and clinicians to join a live discussion on these important topics:

• How market forces and new technologies are shaping the role of point of care testing in the lab of the future
• Ways the point of care ecosystem could be impacted by new paradigms of customer needs, including where testing is performed and verified
• How the IVD industry can contribute to the dialogue of the Lab of the Future and serve as a stakeholder in its development

The discussion was hosted by the American Association of Clinical Chemistry (AACC) and featured presentations by:

• Krista Thompson, Vice President of Global TEG & Diagnostics at Haemonetics, providing insights on the rising need for reliable, simple tests that can be administered in hospitals and at the point of care that can enable rapid and accurate therapy decisions;
• Robert Bujarski, Senior Vice President, Business Development and General Counsel for Quidel Corporation, identified key product development considerations for Point of Care systems including performance, ease of use, turnaround time, cost-effectiveness and information connectivity; and
• Dr. Valerie Ng, Chair of Laboratory Medicine and Pathology, Director of Clinical Laboratory, and Director of Transfusion Service at Alameda Health Systems Highland Hospital in Oakland, California, who provided the practical clinician’s view of real-life implementation of point of care testing in the healthcare system of today and for the future.

Below is a recap of the main points that were discussed. Click here to watch the webinar recording in its entirety.

Haemonetics provides solutions for hemostasis monitoring and assessment, and they consider the future of testing needs to develop a product strategy based on customer feedback about future needs. Krista Thompson explains the process of planning for new products: “We’re thinking about where we would have to go to reach the patients who need us, and who’s treating those patients, and what kind of solutions they need.”

The company is preparing to launch the TEG 6, a device that is small enough to be used at the bedside and is connected to the central lab so both practitioner and laboratorian can access crucial data from the test. “Our job is not to dictate where you run this system in your facility, it’s to offer that flexibility, so that whoever wants to run it and whoever needs to see the data has that opportunity to do that,” she says.

Robert Bujarski discussed similar goals in terms of point of care system flexibility. He pointed to Quidel’s new molecular Strep A test, where they’ve eliminated the need for culture backup and can provide a rapid and reliable result with a single test. “We need to provide something that’s going to be very cost-effective and that’s going to be much faster than culture testing today.” As he points out, it’s not about creating instrument systems at the point of treatment—it’s about coming up with new, creative solutions that help the patient and provide more effective access to the testing and the results.

Access to information and Point of Care system connectivity were a common theme among the webinar panel, and each emphasized the importance of decreasing time to results and providing access for viewing data both in the lab and at the point of care.

Quidel’s new focus, according to Bujarski, is making sure they can get and deliver information where it needs to go. In looking forward, he considers a variety of issues and challenges related to LIS systems, wireless systems, and cellular solutions. “We carefully approach issues on the side of security and privacy,” he says, stressing the importance of integrating information in both the developing and developed worlds.

Dr. Ng, who provides oversight for a complex information system consisting of various POC data streams, lab systems and servers, acknowledges that every health system will have different needs. But a unifying requirement for all is connectivity: “I need [data] to get to the current medical record. I need the data not to be intercepted. I need it not to interfere with transmission from other devices, especially in my ICU, I can’t have a critical care pump shutdown because a point of care device is trying to connect. I need the ecosystem of point of care systems and central laboratory testing to be immune to cyber-attacks and viruses.”

Haemonetics considers connectivity as a core consideration for any new product. It’s crucial that their systems connect with labs and integrate with other patient data. Data security, as Thompson explains, should be a consideration even before product development—manufacturers should think about the ecosystem they have to plug into, as well as keep up with constant change to those systems.

In thinking about providing direction for point of care product development, the panel emphasized usability as a key factor to success. Dr. Ng points out several scenarios in which POC products worked more consistently in theory than in practice, making these recommendations to manufacturers:

• Minimize the number of parts and steps to obtain a result
• Avoid confusing product design, like color-coded swabs, that can affect accuracy
• Eliminate manual specimen application with a metered dose
• Make results easy to interpret
• Make tests that withstand use, like cleaning with bleach or dropping

From the panelists’ conversation, it seems that some manufacturers are well on their way to taking Ng’s advice. Both Thompson and Bujarski mention ease of use as a driving force in their product development.

Designing Point of Care systems for emerging markets, presents even more stringent requirements for product development as healthcare practitioners face a unique set of challenges, including unreliable technology and connectivity, poor sanitation, greater risk of infectious disease, and the need for much more economical solutions on the ground.

Bujarski talks about a product currently in development, a fully integrated sample-to-answer solution with a low cost of goods and low instruments system cost. Quidel plans to position this instrument for quickly identifying blood borne illness in developing countries at an affordable cost.

In emerging markets, usability is especially important. Dr. Ng points out that no matter what procedures and quality systems are put in place, making sure that personnel performing a test accurately can be challenging. Durability and simplicity of products can improve effectiveness in markets where products must travel across a long supply chain and are used in facilities with very different requirements than in a lab or local hospital.

One of the most important considerations for product developers who are thinking about challenges for Point of Care solutions is developing a strong collaboration between industry, clinicians, laboratorians and patients. Including all the stakeholders in the development of new product requirements—ease of use, access, test menu, instrument features and performance, connectivity—can ensure that the changing ecosystem of point of care is incorporated effectively.