Digital health may become the biggest disruptor to business-as-usual since the genomics revolution. Beyond well-understood applications in patient communications and medical marketing, digital solutions are expanding into a variety of other areas that have value for pharmaceutical developers as well as patients and clinicians.
“Healthcare is ripe for innovation to improve costs, efficiency and convenience,” notes Naomi Fried, PhD, CEO of Health Innovation Strategies. “A lot of digital health innovation is occurring, and innovators are moving into uncharted territory, offering new services and creating new business models and sales channels. Digital health is disruptive, game-changing innovation.”
Naomi Fried, Health Innovation Strategies
The term “digital health” has many interpretations but, most broadly, “Digital health means care and information delivered to patients and clinicians using digital technology,” Dr. Fried explains. “That involves a range of technologies, including digital cameras, cell phones, sensors, computer hardware and software, mobile apps, games and social media.” These options are proving valuable in pain management and telemedicine as well as real-time monitoring of patient behavior to gather patient adherence data and manage clinical trials.
Digiceuticals have great upside
“To me, digiceuticals (which are digital therapies that directly treat conditions) are one of the most exciting areas,” Fried says. “It has the least activity but holds the greatest potential. For pharma companies, this is the most innovative, game-changing area of digital health because it means companies may offer not just drugs, but health solutions.”
In the near future, she predicts, pharmaceutical companies will deliver combinations of medications and digital applications, much like diagnostics and therapeutics, and therapeutics and medical devices, are paired today. “In individual diseases, for instance, patients may experience symptoms or side effects that aren’t addressed by their medications but that may be addressed digitally. Pain and depression are two examples.” In such situations, digiceuticals may deliver a better patient experience than medications.
Patient education and monitoring also are particularly well-suited for digital solutions. “A lot of education is needed for new and complicated therapies, particularly those with new mechanisms of action,” she points out. Consequently, patient education is likely to become a huge area of focus. Because of that value, Fried says, “Eventually, virtually no drug will be offered without digital support.”
Some leading multinational pharmaceutical companies already are investigating how digital health solutions can improve patient outcomes for specific therapeutics. “Developing a digital health strategy can be game-changing, helping companies advance quickly toward true personalized medicine,” Fried says.
Launch a solution, not a technology
When considering a digital strategy, she advises, “Start by defining a problem and work to solve it.” That should be obvious, but too many companies start with a technology and try to find a problem it can solve.
Don’t launch a digital platform just because mobile apps are popular and you want to be current. Instead, identify a problem that needs a better solution than you have now. If a digital strategy can solve that problem, then work with a tech company to develop a digital solution. Begin when a drug enters Phase II or III trials, she advises. “By then you’ll have a sense of patients’ unmet needs. This isn’t too early to think about partnering.”
External collaborations are particularly important in developing digital health strategies. “Don’t try to build an app internally.” While it may be tempting to develop a digital solution in-house with your own IT experts, Fried advises against it. For a digital solution to succeed, it needs the creativity that’s fostered in an innovative, fast-moving industry largely unconstrained by regulation. Internal pharma expertise is usually accustomed to constraints that limit use of the latest tools and have a mindset that prizes other values. Consequently, the developers who build the next killer app probably won’t come from a data center.
Instead, “look for digital partners,” Fried advises. “It’s often hard to build extremely innovative digital solutions from within, and there are excellent partnering opportunities with digital startups and high tech companies.”
Realizing this, a few multinational pharmaceutical companies are partnering with leading names in the technology industry to combine disruptive digital innovation and healthcare in ways that meet strict regulatory concerns as well as consumers’ expectations. “Most projects typically are initial pilots. It’s too early for long-term, robust partnerships to have formed,” Fried elaborates.
Taking a collaborative approach utilizes the strengths of each of the parties, enabling them to do what they do best. However, Fried cautions pharma to be aware that tech companies operate differently than biotech companies. “Tech companies’ time frames are shorter than biotechs’.” Consumer technology companies move to commercialize products quickly. “A solution can be built in a matter of months and validated soon afterward, so be prepared to move more quickly than usual.”
The downside to collaborating with consumer tech companies is that they aren’t accustomed to the level of regulatory scrutiny required for medical devices and drugs. Instead, they’re used to patching bugs long after the product is in use by customers. That detail can be worked out, though. And, she says, “the regulatory concerns for digital health solutions are simpler than for drug development.”
Despite these differences, consumer technology innovators are ideal partners to build the killer apps pharmaceutical companies need to engage users. Delivering digital solutions with the look and feel of the apps they use regularly helps ensure patients actually use the digital component of a digital health strategy.
Reimbursement isn’t settled
“Digital health solutions currently are divided into three categories: those with no risk,(like health and wellness apps); those with high risk (for example involving medication dosing); and those in the middle,” she says. Companies, therefore, need to carefully assess the risks of their digital strategies and have the appropriate conversations with regulators and payers to balance the opportunities of innovation with the demands for safety.
Some digital health developers are seeking FDA approval so their drug/digital combinations can be prescribed as a unit and reimbursed directly, like any other pharmaceutical. Some already have been approved by the FDA.
Third party payers, however, are waiting for the value of digiceuticals to be proven. “Payers are open to pilot studies. If digital health solutions improve patient outcomes, payers are willing to take a look. Once value is demonstrated, they will pay for it,” Fried predicts.
“Digital health is a wave that’s here now,” she says. “Pharma and biotech need to ride that wave or be left behind.”