1.1 Patient-focused development
Modern medical product development succeeds when you deliver benefits that patients recognize as meaningful
Patient-focused development grounds every technical choice in the lived experience, priorities, and voice of the people who will use your product.
Using sDHTs in clinical trials fundamentally shifts measurement from episodic clinic visits to continuous real-world observation. Traditional assessments capture infrequent snapshots—brief moments that rely on recall or artificial clinic settings that don’t reflect how patients actually live. sDHTs enable frequent or continuous data collection during patients’ normal routines, delivering more authentic insights into function, symptoms, and survival outcomes.
For developers and adopters, this means building tools that generate richer, more ecologically valid data while reducing participant burden and study costs.
OVERVIEW
The real power of sDHTs
sDHTs deliver objective, real-world evidence that traditional methods can’t match. For someone with a chronic condition like Parkinson’s, a wearable sensor can track gait patterns throughout the day, revealing longitudinal patterns or fluctuations that a single clinic visit may not capture.
Adopters
You’re no longer piecing together puzzles from sparse data points or dealing with recall bias. Instead, you get a complete picture of disease progression and treatment effects between appointments.
Developers
This is where your tech shines—by providing unprecedented, reliable insights into patient’s daily lives.
Precision matters. High-resolution measurements from sDHTs can detect subtle changes that traditional, episodic assessments may miss, improving sensitivity to change and strengthening endpoint interpretability. When appropriately selected and implemented, these data can support more efficient trial designs, including reduced sample sizes or shorter study durations, helping teams generate evidence with fewer resources.
sDHTs also ease participant burden. Remote data collection minimizes the need for frequent site visits and supports decentralized or hybrid trial designs. This can expand access to participation for individuals who face barriers related to geography, mobility, work, or caregiving responsibilities, and can contribute to study samples that better reflect the populations affected by the condition under study.
By capturing objective data during participants’ everyday routines, sDHTs provide a complementary view of how people function, feel, and behave in real-world settings. Continuous or frequent measurement may reveal patterns or fluctuations that are not observable during infrequent clinic visits, strengthening understanding of disease progression and treatment effects.
Regulators and payers increasingly emphasize the importance of patient-focused evidence, including endpoints that reflect aspects of health patients identify as meaningful, such as daily functioning, symptom burden, or quality of life.
Frameworks like the FDA’s Patient-Focused Drug Development (PFDD) Guidance Series help teams systematically incorporate patient input and connect patient priorities to trial objectives, endpoint selection, and interpretation.
IN PRACTICE
Why patient-focused development matters
Patient-focused development systematically integrates patient perspectives across discovery, design, evidence generation, and decision-making for drugs, biologics, and medical devices. Doing so ensures the change a product produces aligns with what patients value most.
Adopters
Define clinical benefit by anchoring study objectives and endpoints to what patients consider meaningful. This alignment increases the probability that regulators accept your endpoint and that payors and clinicians recognize its relevance.
Developers
Ensure your sDHT measures a patient-relevant concept of interest (COI), and show how signals translate to that COI in ways that matter to patients and clinicians. Clear traceability from signal → feature → measure → endpoint strengthens scientific credibility and adoption.
Regulators increasingly expect evidence linking endpoints to direct patient input and experience. Endpoints that lack a clear patient-centered rationale face higher risk of delay or rejection. Early alignment with patient priorities reduces rework, streamlines validation, and improves operational efficiency for both adopters and developers. Human-centered design and usability testing further increase the likelihood of at-scale use, sustained engagement, and fit-for-purpose evidence.
Patient meaningfulness is of course not an isolated datapoint; it should be interpreted in the context of the trial’s scientific objectives and the expected treatment effect. Endpoints are most compelling when the aspect of health that matters to patients is clearly linked to how the medical product is intended to work and to the type of clinical benefit the trial is designed to demonstrate. Aligning patient priorities with the product’s value proposition strengthens interpretability, supports regulatory decision-making, and reduces ambiguity about what constitutes meaningful change.
sDHT-derived measures can be very informative when used alongside established assessment approaches. Patient-reported outcomes remain essential for capturing subjective experience, while clinician-reported and performance-based assessments provide important clinical context.
The appropriate measurement strategy depends on the concept of interest, patient population, and study setting, and in many cases a multi-method approach that combines digital and nondigital measures offers the most comprehensive and interpretable evidence.
The “triple win”
Prioritizing patient input and leveraging continuous, objective sDHT data benefits all clinical trial stakeholders:
Patients
Evidence reflects what matters most and reduces participation burden.
Adopters
Programs run more efficiently, generate decision-grade evidence, and differentiate on meaningful outcomes.
Developers
Technologies demonstrate clear clinical relevance and earn credibility with adopters and regulators, reducing costly redesigns and accelerating scale.
KEY TAKEAWAYS
When you incorporate patient perspectives, you improve trial relevance and align with regulatory expectations. sDHTs are now essential infrastructure for modern clinical trials, transforming clinical trials from episodic assessments to frequent or continuous, real-world evidence generation.
Patient-focused development serves as the spark that ignites better trials and better outcomes. It turns data into stories of real lives improved, setting you up for success as we move into Section 1.2: Your business case.
FDA SPOTLIGHT
“Digital health technologies … have expanded the types of trial-related data that can be obtained remotely from trial participants.
By enabling remote participation, DCTs may enhance convenience for trial participants, reduce the burden on caregivers, and facilitate research on rare diseases and diseases affecting populations with limited mobility or limited access to traditional clinical trial sites.
This may help improve trial participant engagement, recruitment, enrollment, and retention of a more representative trial participant population to improve the strength and generalizability of the evidence produced by the trial”
– Section II. Background, p. 2
FDA SPOTLIGHT
“The FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making.”
The Patient-Focused Drug Development (PFDD) Guidance Series “is intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can better inform medical product development and regulatory decision making.”
1.1 PATIENT-FOCUSED DEVELOPMENT
Library resources to guide you
The sDHT Adoption Library provides 200+ vetted resources with real-world examples to accelerate the adoption and implementation of sensor-based digital health technologies. Dive into the relevant spotlights below to apply the concepts in this section.
Features essential guidance, publications, and communications from regulatory bodies relevant to this section. Use these resources to inform your regulatory strategy and ensure compliance.
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.