So, you've got a great idea for an optical point-of-care (POC) device. You've assembled smart engineers to produce it. But will it fly in a primary care practice?
To answer that question, remember that primary care practices are like small businesses. To incorporate POC devices into primary care workflow, Kent Lewandrowski, director of Clinical Laboratories at Massachusetts General Hospital, points out that each practice has to have capital, training, space, and specimen acquisition capacity.
Before entering the POC arena, a practice needs sufficient operating funds to purchase the device and to cover ongoing expenses associated with it, such as reagents and other consumables. Those funds may also have to cover the creation or purchase of software that stores and disseminates test results. Despite a federal mandate to move to electronic records, many practices have been slow to convert from paper. So, for some practices, electronic interfaces could be a stumbling block to POC acquisition.
And even if POC devices are user-friendly, office staff who operate them will need training to guarantee compliance with the Clinical Laboratory Improvement Amendments (CLIA). The CLIA program, coordinated by the Centers for Medicare & Medicaid Services, ensures quality laboratory testing.
Since most POC devices are small, space considerations within a practice shouldn't be too much of an impediment to use. Specimen acquisition requirements, on the other hand, could cause some practices to pause. A test that requires a fingerstick to draw blood is relatively easy to learn, but if a larger sample is needed, practices lacking phlebotomists may need to hire staff.
The silver lining in all of this is billing. If a practice can bill insurance companies for POC testing, it will likely recoup its initial investment and potentially create a revenue source.
As you wade into the POC arena, keep in mind that a device needs to demonstrate not only effectiveness, but also that it makes good business sense.