Partnerships
The Center collaborates with industry and academic partners to jointly develop regulatory science resources that are shared in the public domain. Examples of such collaborations are highlighted below.
SYSTEM OF HOSPITALS FOR INNOVATIONS IN PEDIATRICS-MEDICAL DEVICES
The System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) aims to transform the pediatric medical device ecosystem by accelerating developmental processes to stimulating investment and innovation in pediatric devices.
Pediatrics Medical Device Public-Private Partnership
The Harvard-MIT Center for Regulatory Science, in partnership with the Foundation for the National Institute of Health (FNIH) and other stakeholders, are using the SHIP-MD framework to develop a pediatrics medical device private-public partnership (PMD-PPP). The project currently exists in a design phase, where goals are being established goals and infrastructure is being set up. This design phase aims to assemble a governance structure, discuss relevant aspects of the innovation ecosystem through six integrated workstreams, and ultimately produce a white paper with a detailed plan to build and launch a multi-year public-private partnership. This will be achieved by developing a sustainable infrastructure integrating existing frameworks, expertise, and resources into a strategic and actionable plan. The launch of the PMD-PPP will consolidate a national ecosystem to optimize the translation of technological advances in pediatrics medical device design, evaluation, and approval, thereby de-risking and streamlining translation of medical advances from bench-to-bedside. For a more in-depth review of the state of the PMD-PPP visit the FNIH page here.
Pediatric Medical Device Design Phase
Visit this FNIH page for a more in-depth review of the state of the PMD-PPP.
SHIP-MD Phase I
The beginning of the SHIP-MD project was born out of an assessment of current issues with device development, and the challenges associated with bringing these devices to market. This assessment determined a lack of participation and innovation in pediatric medical devices due to poor return on investment for a litany of problems associated with high-cost and high-risk. The core objective of SHIP-MD is creating a program and network that will provide low-risk access to evidence generation networks, synergistic financing, patient pools, and more.
This video provides a high-level overview of SHIP-MD and its goals in Phase I:
Digital Health Regulatory Pathways
CRS contributed to an exciting industry collaboration led by the Digital Medicine Society (DiMe) to develop free resources to help digital product developers and founders optimize their regulatory strategy to drive the development of high-quality, trustworthy digital health products that best meet their commercial goals and the needs of patients. The resources – including U.S. RegPath, the world’s first tool for navigating U.S. regulatory pathways for digital health products – were developed as part of a DiMe collaborative project, Digital Health Regulatory Pathways.
“Digital health solutions offer enormous promise to address some of the most pressing and persistent challenges in healthcare but to fully realize the benefits of novel digital offerings, concomitant innovation in regulatory science and education for a new group of health technology leaders is necessary. Dr. Ariel Stern and CRS played an integral role in the development of these new, action-oriented resources,” said Smit Patel, Associate Director for DiMe.
A survey of digital medicine stakeholders in 2022 found that 25% of medical product developers didn’t know whether their digital health products should be regulated. Of those surveyed who did know their product should be regulated, 75% reported not knowing the optimal regulatory pathway.
A fit-for-purpose regulatory strategy that includes a bespoke timeline and approach to if, when, and whether to seek regulatory oversight offers end users, patients, and clinicians confidence about the tools and products they are using. It can also improve market access, support payment strategies, and optimize the impact on patient care and outcomes. Finding ways to help innovators navigate regulations and incorporate a robust regulatory strategy into their business plans is critical to addressing some of the most pressing and persistent challenges in healthcare.
The new resources became available March 1, 2023 and can be accessed for free on the DiMe website here.