Science of Patient Input – Overview
Overview
Collaborating to advance the art and science of patient engagement in regulatory science, including advances in methodologies and tactical considerations for integrating the patient’s perspective and preferences in the design and clinical development of innovative medical technologies.
Our Mission
Drive increased adoption in MedTech industry of methods and tools that systematically integrate patient insights & perspectives in total product development lifecycle (TPL)
Science of Patient Input Programs
Adopting Patient Preference in Device Development
This project looks to broaden access and usage of patient preference research to promote the use and administration of Patient Preference Information (PPI) across industry and submission to regulators.
Modeling Patient Engagement Throughout TPL
This group seeks to promote the active voice of the patient from early design ideation to post-market stages of the Total Product Lifecyle (TPL).
Patient Centered Digital Health
As Digital Health innovations are designed, and built to scale, this project aims to provide an inclusive design framework to promote shared clinical decision making with Digital Health Technologies (DHTs).
Our Vision
To incorporate all patient’s values and preferences into medical device innovation and decision-making to improve their wellbeing and clinical outcomes
Using Patient Preference Information in the Design of Clinical Trials Framework
The Medical Device Innovation Consortium (MDIC) has released a patient-centered framework developed to help researchers interested in conducting rigorous patient preference studies for medical device design, development, evaluation, and regulatory submissions.
“Using Patient Preference Information in the Design of Clinical Trials” outlines a systematic approach for patient-focused clinical trial design to better meet patient needs and priorities.
Check out SPI's Annual Patient Summit 2023 Highlights
The Medical Device Innovation Consortium’s (MDIC) Science of Patient Input (SPI) program hosted the Annual Patient Summit in November of 2023.
The Summit led by Kert Gunasekaran, Director of SPI, MDIC, convened patients, patient advocates, industry leaders, and regulatory science professionals. Panelists and speakers discussed the opportunities and strategic priorities in patient engagement within the medical device industry.
Countdown to Annual Patient Summit 2024
Learn more about SPI's active Working Groups
Modeling Patient Engagement in Early Phases of Device Development
Provide framework and pathway for industry to incorporate PPI in the early stages of device development and through clinical stages.
Patient Engagement within Post Market Practices
Infuse the ”voice of the patient” into three areas of post-market activities. Helping the industry better meet patients’ needs for appropriate and meaningful information.
Patient Preferences in Device Product Lifecycle (PDL)
The Patient Preferences in Device Lifecycle (PDL) Working Group’s aim and purpose is meant to help industry perform studies to gauge patient preference and input of their respective devices.
Patient Centered Digital Health Technologies (PCDHT)
Provide tools and resources that foster greater engagement of patients, providers, and caregiver with Digital Health Technologies and their associated medical devices, with the ultimate goal of supporting improved shared clinical decision making.
SPI Key Leadership Team
Dan Stephens
Boston Scientific
SPI Steering Committee Co-Chair
Ali Massoud
Exact Sciences
SPI Steering Committee Co-Chair
Krishna Vemulapalli
Cook Medical
Early Phase Patient Engagement Working Group Lead
Kori Jew
Medtronic
Post Market Patient Engagement Working Group Lead
Alissa Hanna
Edwards
Patient Preferences in Device Lifecycle (PDL) Working Group Lead
Joris van Dam
Exact Sciences
Patient Centered Digital Health Technologies (PCDHT) Working Group Lead
Meet the SPI Team
Meet the MDIC Team
Kert Gunasekaran, MS
Program Director
Kert has worked for a number of years in the Medical Device Industry, he has spent over 15 years at Medtronic in a variety of roles and joined MDIC in 2022.
Jonah Golder, MS
Project Manager
Jonah joined MDIC in 2023 after completing his Master’s in Biotechnology from Georgetown University.