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10th December 2007

Balance between consumer and healthcare providers expected to shift as home medical testing expands

• Experts Examine Impact of Move from Physician-Directed Clinical Testing to Consumer Over-the-Counter (OTC) Home Diagnostics

The shift in the relationship between patients and medical providers will continue to change the healthcare landscape as the ease of use and reliability of consumer self-diagnostic products advance, according to a group of industry, research and academic leaders that convened at a recent day-long diagnostics workshop hosted by Cambridge Consultants (www.cambridgeconsultants.com). Yet, as the expansion of consumer diagnostics and monitoring products empower consumers to actively manage their own healthcare, new challenges and responsibilities for both consumers and the diagnostics technology industry are emerging.

A new report, based on this workshop of 20 industry experts, points to the growth of self-diagnostic technologies and lower-cost home testing products that range from new consumer screening tests for health condition tracking to disease screening. This may include conditions such as asthma, allergies and a range of genetic pre-dispositions. The current global market for consumer diagnostics and testing products is approximately $7 billion, but has been dominated to date by glucose and pregnancy testing. The convergence of an informed consumer with new enabling technologies could see this market rapidly expand as new tests become available and gain acceptance.

"As technology and device design make these products easier to use, more cost-effective, and results simpler to interpret, consumers are increasingly empowered to participate in and even, to a degree, manage their own healthcare," said Dr. Simon Burnell, head of Cambridge Consultants' diagnostics group. "Consumer-managed information creates new challenges for the diagnostics industry, namely to both educate consumers about these technologies and to consider how to provide the clinical and information infrastructure needed to support consumers. If consumers are to embrace new consumer diagnostic tests, there needs to be an actionable outcome for them."

"After years of targeting doctors and clinical labs, the diagnostics technology industry has little experience interfacing with consumers," said Professor Robert Christenson of the University of Maryland School of Medicine's Pathology Department, and a workshop participant. "Where test results were once discussed in a doctor's office, many consumers now use self-diagnostics pregnancy tests and even HIV screening tests because they want to discover their results in the privacy of their home. In providing new consumer testing products, the diagnostics industry must learn to use the internet and engage with online healthcare information groups to educate and support consumers."

This new consumer focus, according to the report, also means that the diagnostics technology industry may form new alliances with the pharmaceutical industry and retail and consumer products companies to reach this growing home healthcare market.

The report, based on the 20-person industry workshop, highlights some other issues and challenges facing the medical technology and diagnostics industries:

• Testing devices need to be easier to use and less prone to user error, given their use outside of a clinical setting.
• Results need to be presented in a manner easily understood and interpreted by the consumer and have an actionable outcome.
• Technology must help build consumer confidence by improving the reliability and reducing false results.
• The market for self-diagnostics products, while building momentum here in the U.S., is likely to grow faster in countries with state-run healthcare systems.
• Consumers need to be able to record, track and manage this information, much the way runners track their training performance with PDA's and online tools.
• The move toward self-diagnostics needs to be part of the larger consumer information and advocacy healthcare trend that ties into web-based and social media information.
• The industry must consider how consumer testing of sensitive medical information, for example genetic predisposition, impacts relationships with, and the rights of, family members or employers.
• Diagnostic companies will need to consider strategic partnerships with companies who have greater brand recognition and marketing firepower with consumers if the next generation of tests are to gain maximum acceptance.

"New technologies, such as novel sensing and imaging techniques, printable PCBs and optical detectors, micro fluidics and novel assay architectures, are making these consumer testing devices easier to use, and the results more reliable. This is key for building consumer confidence, improving consumer compliance and wide-scale acceptance of tests that are at the forefront of managing a host of healthcare issues facing our society," said Burnell.

A report on key findings from this workshop, "The Future of Diagnostics: Consumer Driven World," is available, please click here.

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