1. Fragmented Regulatory Environment
The Challenge: Getting a DTx approved is challenging, not least because the regulatory framework is patchy, with often unclear or differing approaches within the same market. Even though requirements to approve a new pharmaceutical medicine or drug differ across markets, there is at least some consistency.
The Opportunity: The situation is gradually becoming more structured, think the DiGA framework in Germany, the NICE digital health framework, the FDA digital health software pre-cert program, and various other country-specific frameworks.
2. Reimbursement
The Challenge: Once the approval hurdle is cleared, there is still no guarantee of making any money. The complexity here warrants a separate post (or thesis), but the key barrier is the fragmented payer environment in most markets.
The Opportunity: There are opportunities for digital therapeutic companies including choosing public markets (UK NHS or US Medicaid), partnering with hospital systems, pharmacy chains or insurance companies. Other popular approaches include partnering with large employers to tap into their captive audience of employees, or partnering with pharma companies and leveraging their expertise in health economics and market access.
3. Differentiating DTx
The Challenge: Even with a great DTx there is a lot of noise out there, particularly unvalidated digital health apps. Over 350,000 health apps are available. The number of these that are regularly used and clinically validated is a tiny fraction.
The Opportunity: The framing of these DTx products as Prescription Digital Therapeutics (PDT) by companies, e.g., Pear Therapeutics was a smart move. It is important to focus on the clinical evidence base and even more vital to express what that means for patient outcomes. Ensure that healthcare professionals (HCPs) and payers don’t think ‘it’s just another app’.
4. Patient Literacy
The Challenge: Health literacy is a gap in most markets, in the US only 12% of adults have proficient health literacy. This is often a major barrier to initiating or continuing treatment where the goal is simply to get the patient to take a pill every day. When you add tech literacy into the mix and need to onboard and engage the patient with an app, expecting them to enter data and respond to prompts, the complexity can become exponential.
The Opportunity: Seamless onboarding is key, maybe the app is intuitive enough for the patient to download via a QR code and be guided through the initiation process. Maybe a chat bot could resolve the patient’s doubts. But in many cases an actual human is needed, a doctor, nurse, pharmacist, or someone from the support team to walk the patient through.
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5. Patient Experience
The Challenge: No matter how much data a DTx product has or how good patient onboarding and ongoing support is, if the experience for the patient is poor, then the product will fail.
The Opportunity: ‘Frictionless’ is a frequent buzz word when designing a patient experience, but digital therapeutic solutions can sometimes be anything but. Where possible the DTx should passively collect patient data that has a purpose. Mild friction can be a good thing, where the patient engages with the DTx and enters data, but there needs to be instant gratification, e.g., a reward providing valuable insights.
6. HCP Experience
The Challenge: The HCP experience is often overlooked; if a solution is great for the patient but not aligned with a HCP’s workflow, then don’t expect it to get prescribed.
The Opportunity: Aligning the DTx to fit into a physician’s workflow is the minimum bar to be reached. A better goal is to positively disrupt the HCP workflow and make their job easier.
7. Compliance
The Challenge: In addition to ensuring all product claims are true and accurate, DTx have the additional dimension of complying with cybersecurity and data privacy regulations.
The Opportunity: Even though these are mandatory requirements, it represents an opportunity to further differentiate DTx from the plethora of unregulated health apps, which often have unvalidated claims or data privacy issues. Although these requirements can vary by market, the expectations for a DTx have become a lot clearer.
8. Gathering Evidence
The Challenge: When you consider a pharma drug can spend 8-10 years in development gathering data, and DTx are relatively new, it is no surprise that sometimes the evidence base for DTx are lacking.
The Opportunity: One of the splendid benefits of DTx is they can simultaneously offer a medical intervention and collect data. Consider a patient support app, collecting data from a wearable that gives a patient valuable insights. This data collected from multiple patients can form a pool of Real-World Evidence (RWE) that can further support efficacy claims or direct product enhancements.
9. Targeting
The Challenge: To encourage DTx adoption, it usually is not enough to say, 'we will target all COPD patients in the US'. More precision is often needed, i.e., we will initially target all those with moderate disease, between 60-70 years, with access to technology, affiliated to a provider network where we have reimbursement and who have a defined persona.
The Opportunity: This is not new. ‘Traditional’ pharma drug marketing has used this approach for years. A DTx has other layers of complexity around tech access and literacy, but doing this marketing step well can ensure rapid adoption of your DTx product.
These 9 challenges infused with opportunity certainly give me hope that DTx will flourish. If these approaches are effectively followed, then it is a matter of time before we move from small scale adoption to a world of DTx blockbuster products.
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About the author
Digital health thought leader, writer, and speaker.
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