Patient by Design is a concept by which patient input is necessary across all phases of the medical product life-cycle.
All phases of development and commercialization
All disease and therapeutic areas
all Medical Products
Design & Development Input
Patient experience is a critical and valuable input to the design and development of all medical products. Patients are experts in their own bodies and how they live with their conditions. Medical product sponsors will benefit from obtaining patient data during the design and development phase of product development.
There are several reasons to obtain relevant, clinically meaningful, and rigorous patient data in the design and development input phase. These efforts go beyond market research to obtain in-depth patient experience living with and be treated for their condition.
Understand natural history of disease
Determine patient priorities for treatment
Detail patients’ typical care pathway
Identify patients’ desired treatment outcomes
Document symptom and quality of life burden to patients and caregivers
Prioritize product pipeline with patient input
Clinical Trial Design and Implementation
Engagement with patients in the design and implementation of clinical trials is becoming increasingly important. Sponsors need to establish authentic partnerships with patients and patient groups to improve the conduct of clinical trials and ensure trials better meet the needs of patients and caregivers.
Engage with patients to identify clinical outcome priorities
Identify and mitigate barriers to patient enrollment, retention, and adherence
Understand patient perspectives on study burden to enhance patient trial experience
Establish relationships with patients and patient groups to support trial enrollment
Collect patient experience data and clinical outcome assessments
Provide education and support to patient groups while maintaining transparency
Regulatory Strategy & FDA SUbmissions
Assessing patient preference, patient risk tolerance, and patient experience can enhance the regulatory strategy for devices, drugs, and biologics. Engaging with patients to generate rigorous, scientific, and clinically meaningful data to support regulatory submissions is at the core of Patient x Design. Including patient input to influence regulatory decision-making is where patient-focused policy began at FDA, but it is not where it ends.
Conduct patient-centered benefit risk studies to assess patients’ tolerance for risks given potential benefits
Collect patient and care giver experience data to characterize symptom burden, and effect on patient quality of life
Identify and quantify patients’ treatment outcome priorities, importance of symptoms, and most desired quality of life improvements
Quantify preference heterogeneity to identify potential patient groups for expanded indications
Post-Market Studies, Surveillance, and Medical Affairs
Engagement with patients should not stop after a medical product is on the market. Patient x Design compels sponsors to continue to include the patient voice in the post-market phase of the product life-cycle. This includes ensuring the patient voices is being captured in post-market studies, surveillance, and design and development of observational or investigator-led studies of real-world product performance.
Understand patients’ experience and outcomes with treatment
Engage patients to support each other before, during, and after treatment
Empower patients to advocate for their care and treatment access
Encourage patients to tell their story and participate in ongoing patient research
