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. 

Learn more about the Science of Patient Input (SPI) through this informational overview

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

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Featured Resource

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.

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Video Resource

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.

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Countdown to Annual Patient Summit 2024

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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.

SPI Resources

Patient Engagement in Clinical Trials: Patient, Industry, and Clinical Investigator Perspectives

Patient Preference Information in Clinical Trial Design

Use of Patient Preference Information in Heart Failure: Executive Summary

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