Following in Pharma’s Footsteps, MedTech Companies are Increasingly Marketing to Consumers (The MedTech Download)

Key Takeaways

• Medical device companies are taking a page out of pharma’s book by increasingly marketing their products directly to consumers.

• Due to the Delta surge, non-emergency surgeries are once again getting delayed.

• The FDA has announced the formation of the Office of Digital Transformation (ODT) to help the agency bring its use of technology and data “in line with modern practices and to cut duplicative processes.”

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MedTechs are Boosting DTC Investment, but Industry Still Years Behind Pharma

Imagine a television commercial that begins with a woman forlorn, gazing out a picture window at a tree lined street. Something is holding her back, preventing her from living her best life. She visits her doctor, who gives her the drug that she was looking for. Suddenly, life is brighter, and she’s back to her true self, health woes forgotten.

Direct-to-consumer pharmaceutical advertising has been commonplace for years, so much so that it has sparked many conversations in the process. However, medical device companies have been slower to embrace the tactic, until now. A MedTech dive article explains that the increased investment in DTC ads for MedTech “follows a broader healthcare industry trend where companies focus on the complete patient experience and not just clinical outcomes.” The article goes on to say that “the rise in high-deductible insurance is increasing patient decision making discretion as the plans put them on the hook for more of the bill.”

Surgeries are Getting Delayed Again

Last year, when the pandemic began to take hold and society began to implement mitigation strategies, much of the healthcare industry was turned upside down. Those outside of the industry struggled to understand how healthcare facilities were losing money when beds were at a premium. But the fact that non-emergency surgeries are critical to the health of the ecosystem became clear. If COVID was raging, that sector of healthcare was shut down, and a revenue downturn followed.

But as infections waned earlier this year, many procedures were put back on the books. Now, with Delta on the rise, surgeries are getting delayed – again. This is putting the squeeze back on associated MedTech and healthcare facilities. But, although Stryker CEO Kevin Lobo told investors “the effects have been more negative than we imagined,” many see the dip in revenue as only temporary.

CMS Wants to Pull Trump-Era Pathway that Speeds up Medicare Coverage of Breakthrough Medical Devices

In 2016, the FDA unveiled the Breakthrough Devices designation, which was meant to “fast track devices that meet an urgent need where patients lack an equally good alternative.” Many applauded this effort, especially those experiencing chronic conditions that were dangerous or burdensome to manage. Since then, there has been a debate related to the use of Breakthrough Devices for those on Medicare due to the average Medicare recipient’s age and likelihood of them living with a disability. For weeks, CMS delayed a rule from going into effect that would cover these devices for these patients.

But now, it appears that delays are over. In what is being seen as a win for the insurance industry, CMS recently issued a proposed rule “that would withdraw the rule that creates a new pathway that mandates Medicare coverage as soon as a breakthrough medical device is authorized by the Food and Drug Administration. CMS said the pathway could lead Medicare to cover unnecessary products.” CMS’s concerns revolve around the absence of clinical data from patients within the Medicare population.

FDA Creates New Office to Drive Forward Digital Transformation Strategy

When it comes to addressing and integrating modern technology, the healthcare industry has a bit of catching up to do. A robust integration of healthcare, medical devices, and technology has become commonplace. As a result, healthcare systems, physicians, and other stakeholders are confronting a variety of considerations, from cybersecurity to modernizing care. Included in the list of players is the FDA, as the agency grapples with creating scalable systems and oversight measures that address the latest technology.

Recently the FDA announced that it reorganized its IT, data management and cybersecurity groups into the Office of Digital Transformation (ODT). The new office will report directly to the commissioner and allow the agency to “streamline and advance” its operations by reducing “duplicative processes, implementing technological efficiencies … and promoting shared services within agency offices and centers.” The hope is that the formation of the new office will “bring its use of technology and data in line with modern practices.”

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