Designing a Patient Preference Study on Subcutaneous Medical Devices: Incorporating Health Authority Scientific...

Area of Science:

• Pharmacology
• Biomedical Engineering
• Patient-Reported Outcomes

Background:

• Subcutaneous (SC) drug delivery is evolving for high-volume (e.g., >2 mL) medications.
• Patient preferences are crucial for the adoption and usability of novel medical devices.
• Understanding patient needs informs the design of effective drug administration technologies.

Purpose of the Study:

• To describe the planning of a patient preference study.
• To evaluate device features for high-dose, large-volume SC drug delivery.
• To identify key attributes important to Multiple Sclerosis (MS) patients for SC administration devices.

Main Methods:

• Qualitative patient interviews were conducted.
• Patient partners were involved throughout the planning process.
• Advice was solicited from the US Food and Drug Administration (FDA).
• Study attributes and levels were refined based on multiple input sources.

Main Results:

• A robust protocol for a patient preference study was developed.
• Key device features important to MS patients for high-dose SC administration were identified.
• The study design incorporates patient-centricity and regulatory input.

Conclusions:

• The planned study will provide valuable insights into patient preferences for SC drug delivery devices.
• This research supports the development of user-centered medical devices for chronic disease management.
• Incorporating patient and regulatory feedback is essential for successful medical device development.