DTC devices and tests can complement the professional market.
Direct-to-consumer medical devices are what the market is demanding today. Educated, motivated, health-conscious and busy consumers are attracted to almost anything online, including home blood pressure equipment, glucose meters, in vitro tests and diagnostic wearables. But distributors should view the DTC market as complementary to – not opposed to – the professional market in which they operate, according to those with whom Repertoire spoke.
Direct-to-consumer digital health is a growing industry that can address unmet patient needs by directly engaging patients, according to the authors of “Direct-to-consumer digital health,” which appeared in The Lancet Digital Health in 2020. “The direct-to-consumer approach might be particularly helpful for those without consistent access to care because of financial, social, cultural, or geographical barriers.” DTC is attractive to medical technology companies as well, because it offers them a large customer base and few regulatory barriers to entry, they said.
“We believe that the availability of DTC medical devices will promote more active participation by patients in their own healthcare,” says Anna Ivashko, manager, sales and marketing lead – life sciences, at Clarkston Consulting. “As a result, patients leveraging DTC medical devices will be more engaged and likely to visit doctors’ offices more frequently, prepared to have more informed discussions. This should drive the utilization of monitoring devices in the physician’s office rather than reducing current utilization and sales.”
Jonathan Overbey, head of corporate alliances and channel management, Sekisui Diagnostics, believes that educated consumers will drive more traffic to the physicians’ office. “As we have seen in the cases of pregnancy testing and glucose testing, most professionals test again as the patient presents in their practice to confirm their OTC results. In my opinion, the DTC market complements the professional one and, in some cases, drives more efficiencies in testing and patient management.”
Opportunities for distributors
Distributors should consider the short-term and long-term opportunities of interacting with the DTC medical device market, says Ivashko. Short-term opportunities include presenting educational seminars, while long-term opportunities include supporting data-sharing capabilities with physicians in the rise of telemedicine.
“Under controlled conditions, manufacturer sales reps for prescription devices currently sponsor educational seminars for prospective patients of certain medical devices such as insulin pumps and continuous glucose monitors. Offering similar educational seminars to patients using equivalent DTC devices under the physician’s care can promote disease management in that patient population and will be a value-add to the physician. This would differentiate the distributor as a partner to the professional practice.
“The seminars would need to focus on disease state education, for example, why a DTC glucose meter is beneficial to the patient along with routine physician visits to better manage the disease,” she continues. “These offerings may make the professional more likely to purchase equipment from a sales representative who can help with the education of their patients on specific diseases. Any such educational offerings would need to be reviewed for promotional considerations to ensure regulatory standards are not violated as part of ongoing management controls.”
Looking long-term, the rise of telemedicine will reduce office visits and therefore the utilization and sales of medical devices to the professional market, says Ivashko. In that case, “distributors may look to expand their portfolio to include equipment that lowers the barriers to information-sharing between patient and physician practice. These type of capabilities (typically considered a SaMD, i.e., software as medical device) enable seamless sharing of monitoring data between physician and patient to support in-office appointments. Enabling this functionality would hinge on the ability to capture consent from the patient.”
Red flags
As attractive as they are to consumers, DTC products bypass the typical filters and safeguards of healthcare systems, write the authors of the Lancet article. “The risk is that low value, or even harmful, products will inundate the commercial healthcare market.” Think Theranos, they say. “Even companies with good intentions are challenged to balance the rapid and iterative nature of technological development with the deliberative and cautious nature of medicine. As the direct-to-consumer digital-health industry grows, these risks must be carefully assessed.”
By ensuring companies explicitly state the product’s purpose and limitations, the US FDA will help to differentiate high-quality products from low-quality products, they add. “Just as nutrition labelling led to a healthy food revolution in the USA, a label of digital health facts could drive consumer demand towards products that are able to support explicit health claims and motivate companies to compete on quality and value.”
Sidebar 1:
DTC and the FDA
Over-the-counter (OTC) medical devices are those that may be offered for sale directly to the consumer. They do not require a prescription for sale. But they do require oversight. According to the FDA, consumers may have different physical, sensory (vision, hearing, tactile), cognitive, and emotional abilities than healthcare professionals, as well as different literacy levels and ability to process information. These capabilities and others may be relevant considerations in the design of an OTC device.
In general, labeling for OTC medical devices should be simple, visible, concise, and easily understood by the lay person, with narratives or pictures where appropriate, says the FDA. Labeling should include contraindications and clear warnings of all hazards. In addition, the labeling should be accessible to users even when the device may become separated from the labeling, perhaps through a website or through calling the manufacturer.
Direct-to-consumer tests for non-medical, general wellness, or low-risk medical purposes are not generally reviewed by the FDA before they are offered. DTC tests for moderate to high-risk medical purposes, however, are reviewed to determine the validity of test claims.
When reviewing tests, the FDA assesses:
- Whether a test can accurately and reliably measure what it claims to measure (analytical validity).
- Whether the measurement is predictive of a certain state of health (clinical validity).
- What a company says about its test and how well it works (claims).
The FDA also looks at whether the test offers accurate descriptive information that can be easily understood by a consumer without the involvement of a healthcare provider.
Sidebar 2:
High-growth DTC categories
It is true that direct-to-consumer medical devices have made it less attractive for physician offices to carry the same devices, says Meghna Eichelberger, partner and associate director and global leader of medtech marketing for Boston Consulting Group. That said, BCG foresees strong growth in a number of DTC areas, including:
- OTC hearing aids.
- Eye care.
- Cardiac monitors / wearables / patch devices.
- Continuous glucose/ketone monitors.
- Imaging screener tools / AI detection.
- Stool collection/gut biome.
- Saliva tests.
- Sleep detection/diagnostics.