6.3 Business case refinement
Goal: Quantitatively validate the investment
Earlier in the roadmap, you estimated the potential value of adopting an sDHT using assumptions and benchmarks. This step closes that loop by replacing those assumptions with observed trial performance to confirm or modify the original business case.
Finalize the financial and scientific justification for the sDHT investment by revisiting the business case developed in Section 1.2: Your business case and recalculating the Return on Investment (ROI) and Expected Net Present Value (eNPV) using actual trial metrics, securing the executive buy-in necessary to scale the digital strategy across the development portfolio.
OVERVIEW
Validate the business case for scale
You have proved the technology works; now you must prove the business case. This step replaces initial financial projections with validated performance metrics, confirming where your digital strategy is an entrenched value driver rather than just an experimental pilot.
For adopters: This step is crucial for proving the value of your efforts and securing the internal budget necessary to scale the strategy across the portfolio. In one analysis, sponsors that embedded digital endpoints demonstrated a 4-to 6-fold ROI in Stage III and $27–40 million incremental expected net present value (eNPV) per indication.
For developers: You codify quantifiable evidence of your product’s value (e.g., demonstrating how the tech accelerated enrollment or improved retention), which is essential for forging long-term partnerships and enabling your adoption partners to justify the investment internally.
in practice
Step-by-step actions
1. Update the quantitative ROI
Recalculate your investment model by inputting real-world data (e.g., actual enrollment speed, retention rates, monitoring costs)into the DiMe ROI Calculator originally used in Section 1.2: Your business case to estimate pre-trial value. This approach updates your Net Present Value (NPV) estimates.This approach updates your Net Present Value (NPV) estimates.
Analyze gains: Compare the achieved performance (e.g., cycle reductions, sample size savings) against the initial projections from Section 1.2: Your business case. Document the true value delivered, such as achieving cycle times that are 3–5 months shorter per stage.
Get specific: Tailor the results to highlight specific financial levers: the developer focuses on validation efficiencies, while the adopter focuses on decentralized elements that reduce overall trial cost.
2. Refine the qualitative value story
Combine the hard numbers with qualitative wins. For example:
Patient access: Did the sDHT allow a broader demographic to participate?
Clinical relevance: Did you capture meaningful endpoints that standard visits missed?
Efficiency: Did site staff report lower administrative burden?
example
Based on a comprehensive analysis of digital endpoints used in clinical trials across therapeutic areas (including cardiovascular, CNS, and diabetes), modeling studies using observed trial performance metrics demonstrated a 4–6× return on investment in Phase III trials.
Incorporating digital endpoints was associated with reductions in trial duration of approximately 4–5 months and enrollment reductions of ~12%, resulting in incremental eNPV gains of $27–40 million per indication through faster cycle times and lower development costs.
These findings are being used to update business models, support executive decision-making, and inform the scaling of digital strategies across development portfolios.
Key deliverable
Quantify impact with your decision memo
Draft a compelling decision memo that pairs the quantitative outputs with this qualitative value story. Use industry benchmarks to reference the demonstrated financial upside, such as the 4–6x ROI in Phase III trials.
Ensure alignment
Present this final, evidence-backed narrative to finance and executive leadership to secure the buy-in necessary to scale, repeat, or pivot the initiative.
6.3 Business case refinement
Library resources to guide you
The sDHT roadmap library gathers 200+ external resources to support the adoption of sensor-based digital health technologies. To help you apply the concepts in this section, we’ve curated specific spotlights that provide direct access to critical guidance and real-world examples, helping you move from strategy to implementation.
Gathers real-world examples, case studies, best practices, and lessons learned from peers and leaders in the field relevant to this section. Use these insights to accelerate your work and avoid common pitfalls.