Today's MedTech leaders shaping tomorrow's regulatory landscape
Advance industry priorities for regulatory and reimbursement by participating in a study ten years in the making.
Conducted by a leading university, this IRB exempt study aims to interview executive thought-leaders across medtech and digital health to examine trends, establish benchmarks, and inform future decision-making on regulatory and reimbursement.
MedTech & Digital Innovation study featured on DeviceTalks
Kwame Ulmer, study co-lead and former FDA deputy director and branch chief, sits down with Tom Salemi at DeviceTalks to share how this study aims to bring together the innovation ecosystem to be a part of breakthrough research to inform the advancement of regulatory and reimbursement.
What you need to do to participate in this study:
Schedule a live 30 minute interview with our research team
Choose one novel medical device or digital health technology that achieved US regulatory approval between 2010 and 2020.
Consult with your CEO / CFO or regulatory / clinical officer on key regulatory activities and costs
Participating companies will receive early access to the study report in Q3 2021
First 50 participants will receive a $50 honoraria
What questions will be explored?
How long does it really take innovations to get to market?
Do digital health and AI / ML have a clear path to market?
Is breakthrough designation breaking down regulatory barriers to access?
Is reimbursement the new barrier to innovation?
Is the U.S. keeping pace with Europe, Japan, and China?
What is next on the regulatory and reimbursement horizon?
What information is needed?
To participate in the study, please acquire information on:
required to achieve one of the following FDA pathways for a medtech product:
across the following milestones (where applicable):
For more information on what data is needed before starting your interview:
Which global regulatory markets will be examined?
European CE Mark
Results will be benchmarked across the following:
What happens after the study is completed?
Jennifer McCaney, PhD
Co-Executive Director, UCLA Biodesign
Assistant Professor at the UCLA Anderson School of Management and Geffen School of Medicine, former Director of Medtech Innovator.
Kwame Ulmer, MBA
Lecturer, UCLA Anderson
Venture Partner at Wavemaker Three-Sixty Health former medtech executive, former Deputy Director at the FDA, and founder of Medtech Color.
Christian Johnson, MBA
Fellow, UCLA Biodesign
Co-Founder and Board Member of Seed Consulting Group, former strategist and marketer at Edwards Lifesciences and various Healthtech startups.
Who is leading the research?
Want to learn more?
1001 Gayley Avenue, Suite 216
Los Angeles, CA 90095
About this study
This study is strictly an independent research study led by the University of California Los Angeles. The investigators have no conflicts of interest to disclose. Individual company data will not be released to any regulatory bodies or entities. Study results will be published in aggregate for the benefit of advancing innovation in medical technology and digital health. This research has been certified as exempt from IRB review per 45 CFR 46.104 category 2 (IRB#20-001604).