Patient-Centric Regulatory Affairs & Policy

Patient x Design

Putting Patients First


Patient x 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


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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