When the first pilot of a digital therapeutic I advised showed strong clinical outcomes, I expected celebration. Instead, I watched procurement committees stall and clinicians raise practical objections. The trial data meant the product worked in ideal conditions, but it did not answer the daily questions that determine whether a tool becomes routine care. That gap between evidence and everyday use is what I call the reputation gap.

Digital therapeutics sit at the intersection of software, clinical care and regulation. They are software with a medical claim, and that combination creates practical questions that no randomized controlled trial can answer on its own. How will this tool fit into a busy clinic workflow? Who takes responsibility when an algorithm flags a patient? What happens to patient data when the app interoperates with hospital systems? Regulators, clinicians and patients ask different questions, and each group needs tailored signals to trust a product beyond a pilot.

The reputation gap explained

Evidence proves potential. Reputation proves readiness. The reputation gap is the distance from statistical significance to trusted use. Evidence can be technical and narrow. Reputation is relational and operational. Closing the gap means building signals that answer not only "Does this work" but also "Will this work safely, fairly and reliably when it matters."

Regulators want governance, clinicians want integration and patients want clear, usable benefits. A single submission dossier may demonstrate safety and efficacy, but it rarely shows monitoring plans, escalation routes and revalidation schedules. Those operational details matter more than press statements to people making purchase and adoption decisions.

Why this matters for scale

A DTx that sits on a shelf is a sunk investment for founders and a missed benefit for patients. Investors want scale, payers want outcomes and healthcare systems want predictable workflows. When adoption lags, innovation stalls and trust in the entire category can suffer. Worse, poor implementation can create patient safety incidents that hurt the whole field.

Reputation is not spin. Reputation is a pattern of consistent, credible signals. Those signals include clinical translation by respected practitioners, transparent monitoring plans, patient-facing explanations and a governance record that shows a product will behave reliably outside a lab.

Four strategic levers to close the gap

These levers are practical and complementary. Use them together rather than sequentially.

1. Design evidence for real world use
   Randomized controlled trials remain essential. Complement them with pragmatic implementation studies that mirror clinic schedules, staffing constraints and patient diversity. Use endpoints clinicians care about, such as time to clinical decision or reduction in referral rates. When evidence addresses everyday realities, procurement and clinicians listen.
2. Mobilise clinician translators, not just endorsers
   Engage a small set of respected clinicians early and ask them to test integration into care pathways, to co-design clinical playbooks and to co-author guidance documents. These clinician translators show peers how the product fits within existing responsibilities, who is accountable for alerts and how escalations should work. Their visible participation reassures procurement committees and hospital boards.
3. Humanise outcomes with patient narratives and consent clarity
   Patients rarely buy efficacy curves. They respond to clear language about how the tool will change their care, how their data will be used and what happens if something goes wrong. Co-create short videos, plain language consent summaries and FAQs with real users. Bring patient advocates into pilot governance so that lived experience shapes product design from the start.
4. Show governance and operational readiness
   Publish monitoring plans, revalidation schedules and escalation protocols. Regulators and buyers want operational plans, not promises. Be explicit about data flows, third party dependencies and re-certification timelines. Transparency about how you will measure, monitor and remediate builds confidence.

Where communications fits in

Communications for DTx is not a launch checklist. It is a strategic asset that runs alongside evidence generation. Early external communications should not overpromise. Start with technical rationale and operational readiness aimed at clinician, payer and regulator audiences. As pilots deliver real-world outcomes, shift to patient stories and implementation case studies that show the tool working at scale.

Timing and tone matter. Avoid novelty-first messaging that frames DTx as a disruptive gadget. Speak in the language of patient safety, clinical workflows and governance. Prepare spokes to answer the practical questions clinicians will ask in meetings: Who owns monitoring? How do we handle false positives? What training is required? What are the data governance arrangements?

Measure what matters

Move beyond downloads and vanity metrics. Track clinician adoption rates, time-to-first-use after prescription, escalation incidents, and patient reported experience measures. Correlate reputation signals with adoption metrics. For example, measure whether KOL-led implementation pilots increase clinician uptake or whether a published monitoring plan shortens procurement timelines. Those linkages show how reputation investment drives scale.

Bring medical affairs into strategy

Medical affairs must sit at the strategy table, not the periphery. When medical affairs leaders help define evidence generation and stakeholder engagement, translation from trial to practice is smoother. Medical affairs translate science into the language clinicians use and ensure patient safety considerations are embedded in rollout plans. Their presence at the strategy table protects patients and speeds adoption.

A final thought

Digital therapeutics will not scale solely because they work in a trial. They will scale when evidence is designed for the messy reality of care and when reputation work translates that evidence into trusted practice. That requires early investment in clinician translation, patient partnership, governance transparency and adoption planning. Communications leaders who prioritise these areas do more than tell a story. They help build the operational trust that turns pilots into practice.

If you are a communications or medical affairs leader advising DTx teams, start with this question: what operational signal will convince the regulator, clinician and patient that your product will work where it matters? Design your evidence and your communications to answer that single question. Do that and pilots will not only prove, they will become care.