Digital health has long been considered the silver-bullet of the healthcare industry, with medical professionals and device manufacturers alike lauding technologies like wearables and telemedicine for their disruptive potential. Despite rising popularity and growing mainstream adoption, the development of new digital health tools has been widely scrutinized due to uncertainty surrounding regulation policies.

…Until now.

Digital Health is About to Take Off

According to commissioner Scott Gottlieb, the FDA plans to streamline regulation for mobile technologies through its recently announced Digital Health Innovation Plan. Instead of intimidating entrepreneurial companies from developing new digital health technologies, the FDA intends to encourage safe and efficient innovation through new policies. The goals of the initiative include:

1. Clarifying the guidelines for digital health technologies to allow companies to manufacture confidently instead of seeking confirmation on a case-by-case basis.
2. Minimizing regulation of low-risk technologies to drive more digital health innovations to market.
3. Pairing with the National Evaluation System for health Technology (NEST) to collect post-market data and support further product innovations.
4. Employing a pre-certification program for software as a medical device (SaMD) to promote faster market entry.

The FDA’s Digital Health Innovation Plan aims to empower consumers, connect healthcare providers, and address public health crises through the integration of new digital health solutions. Ultimately, the goal pushes to improve patient outcomes and aligns with the industry’s trend towards delivering value-based healthcare.

Tech Giants will Take Advantage

Powerhouses like Apple and Google have demonstrated steady interest in entering healthcare, and the new FDA initiative has finally opened the floodgates for disruption.  For some time, Apple has been aiming to overtake a fragmented medical applications market by providing all-encompassing platforms like ResearchKit and CareKit. Apple has also been active in developing regulated products, including an app for diagnosing Parkinson’s disease and various cardiac monitors. Google, on the other hand, has been dedicated to transforming healthcare with DeepMind AI solutions. As patient outcomes grow increasingly dependent on early diagnosis, Google has researched into applications for computer screening in ophthalmology and digital pathology.

Technology companies like Apple and Google have a competitive advantage in developing and implementing engaging digital solutions, however, at this time, they still lack the medical expertise to go head-to-head with incumbent pharmaceutical companies.

Pharmaceutical Companies Must Continue to Adapt

The FDA’s new initiative pressures pharmaceutical companies to adopt new technologies and partner with digital health startups in order to keep pace with newcomers and each other. Insights into digital health trends suggest that pharmaceutical companies need to start thinking in terms of reach and brand building instead of simply pushing product as they have in the past. However, implementing something as nebulous and seldom defined as a digital strategy can be difficult. Designing a digital strategy requires a firm understanding of user channels and how to improve overall engagement.

Many pharmaceutical companies have realized that in order to create separation from competition, they need to assess the areas where they can improve user experience through the addition of the right digital health solutions. For example, in 2015, Otsuka Pharmaceuticals partnered with Proteus Digital Health to launch the first treatment with an ingestible sensor. Recently, Pfizer has continued to acquire mobile apps aimed to engage consumers directly, as opposed to the normal customer base of doctors and providers. Novartis has invested in Vivinda TV, a virtual conference platform for delivering medical content, in order to actively share more information with physicians.

As more pharmaceutical companies attempt to capitalize on digital business opportunities, they must consider shifts in the landscape and the evolving preferences of consumers.

How Pharmaceutical Companies can Navigate Digital Health

According to Clarkston’s Transforming Digital Strategy report, 4 trends will impact pharmaceutical companies developing digital health strategies:

1. Increased Decentralization – As channels of digital engagement continue to diversify and multiply, pharma will compete heavily for overall share of mind. Pharma will have to better identify digital patients along their journeys and insert informative, resonating messages at the right places and times.
2. Data-based Decision Making – Pharmaceutical companies must leverage owned datasets to maximize insights, drive product sales, and increase ROI. Constant analysis can help pharma uncover strategies to better engage consumers with digital health solutions.
3. Third Party Disruption – Lower barriers and lax regulations have allowed companies like Nike and UnderArmour to carve niches in the fitness space, forcing pharma companies to consider using “non-pharma” technology and partnership with third parties.
4. Volume to Value – increased personalization will cause consumers to demand treatments that go “beyond the pill.” Treatment  will be backed by data and evaluated constantly to gauge engagement rates and not just medical outcomes.

While steering a company through a tumultuous digital health revolution can be challenging, there is still time to acquire the correct insights and skills to develop a strategy. Aligning with digital health trends can help pharma create a competitive advantage, maximize efficiencies, and minimize costs. The result of employing a solid digital health strategy will be a revamped business model and improved patient experience.

Has your company implemented digital health in some capacity? What challenges have you faced shifting to a new model? How has your companies value proposition changed in lieu of recent socio-political developments? Please don’t hesitate to share your thoughts with me about anything on the topic of digital health and/or its effects on pharma, and feel free to reach out to me using the contact info at the top of the page.

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Co-author and contributions by Adam Kershner.