Pharmaceutical companies have an opportunity to invest in digital health

Recent changes made by the FDA have made it easier for digital health products to be cleared and approved, offering life sciences companies—and pharmaceutical companies in particular—the opportunity to accelerate approvals and improve provider and patient satisfaction.

(For more on these changes, please see HRI’s recent report, Acceleration by Regulation.)

Overall, these changes—though individually small—are resulting in a significant change that will allow many high-value digital health products supporting pharmaceutical approvals and products to come to market more easily.

Are companies ready to invest?

In In a 2018 survey of pharmaceutical executives by HRI, just 42% said they were actively developing digital therapeutics or connected devices. Of those executives whose companies were not actively developing these products, 42% said they planned to begin doing so in the next one to two years, and 58% said they planned to do so in the next three to six years.

Implications for pharmaceutical companies

The FDA’s new and emerging regulatory changes may make it easier for these products to get to market, especially if companies have invested in analytical capabilities.

There are challenges ahead. Pharmaceutical companies have cultures of manufacturing quality, but relatively little experience developing digital health products or apps, both of which are traditionally the purview of medical device and technology companies. Creating a culture of coding quality and software quality will therefore require a new investment.

Beyond culture, creating competencies in analytics, machine learning, user design, usability engineering, risk management, cybersecurity and user experience will also be needed to excel in digital health and create tools that are useful for both the end user and physicians.

Companies’ focus should be on the quality of their applications and use cases rather than quantity. Providers and patients don’t necessarily want a digital health product or application that does the bare minimum, but instead are seeking ones that will make an impact on patient care.

For more implications and insights, please read our full report, Acceleration by Regulation: Pharma stands to benefit from the FDA’s digital health approach.

For more of HRI’s insights and content, visit our Regulatory Center and report library.