News & Events
Check out upcoming events and News below. To receive periodic updates on the FCVC Innovation Program, innovation resources, and events, sign up for our email list here.
Upcoming Events
Check back for upcoming events in the future!
Upcoming FCVC Innovation Webinars
The Frankel Cardiovascular Center (FCVC) and Fast Forward Medical Innovation (FFMI) are excited to announce the launch of the 2024 FCVC Innovation Webinar Series. This webinar series aims to educate our community on topics of interest regarding cardiovascular innovation, encourage innovative thinking, and connect the community with resources to help further the advancement of ideas.
FDA Regulation of Cardiovascular Medical Devices
Victor Mondine, PhD, Biomedical Engineer/Lead Reviewer at U.S. Food and Drug Administration (FDA)
Jeanne Wright, RN, RAC, Clinical Research Program Director, Regulatory, University of Michigan
Wednesday, November 6, 2024, from 12:00 – 1:00 PM (EST)
Victor Mondine, MSE, studied Biomedical Engineering at the University of Michigan earning both a B.S.E. and M.SE. Before joining the FDA, Victor interned at Pall Corporation running extractable/leachable reports for single-use drug filters. He also has experience at multiple startups in the orthopedic and biological assay fields. He joined the FDA in 2019 working as a TPLC Reviewer in the Occluders and Hemostasis Devices team. His work focuses on PFO occluders, interatrial shunts, vascular closure devices, and left atrial appendage occluders.
His talk will delve into a brief history of the FDA and how we define medical devices. There will be a focus on the devices regulated by the Occluders and Hemostasis Devices team along with the most common FDA pathways. Finally, we will discuss the IDE submission and clinical trial design for PMA devices.
Jeanne Wright is a Registered Nurse with a B.S. in both Nursing and Medical Technology with over 20 years of research experience with drugs and devices, including Phase 1 Clinical Research trials at Pfizer Global Research and Development, a Research Compliance Specialist position at the U-M IRBMED, and over 15 years working with the Michigan Institute for Clinical & Health Research IND/IDE Investigator Assistance Team (MIAP). She has been the Program Director of MIAP since 2018. She will give an overview of U-M's MICHR IND/IDE Investigator Assistance Program (MIAP).
MIAP provides consultation on research involving investigational agents (drugs, devices, and biologics) that includes:
Determination of FDA regulatory pathway and need for an IND (Investigational New Drug) or exemption, IDE (Investigational Device Exemption), orphan disease designation, or humanitarian use device (HUD).
Protocol and informed consent review and assistance.
Assistance with FDA meeting requests, preparation, and support.
Expertise and guidance on navigating investigational agent regulation and compliance.
Value Assessment at Michigan Medicine: What every company needs to know when crafting their value proposition
Carmen Carmichael, Senior Procurement Agent at Michigan Medicine
Pete Bryant, RN, Value Analysis Manager at Michigan Medicine
Nicole Black, PhD, Program Director, MedTech Innovator
Wednesday, November 13, 2024, from 12:00 – 1:00 PM (EST)
Carmen Carmichael has 20 years of progressive procurement and contract management experience in an academic medical center. She has significant experience in high-level negotiations and a thorough knowledge of contract law. She has a proven track record in identifying and implementing cost-saving initiatives and standardization to accomplish system-wide goals and strategic missions. She is skilled in sourcing, project management, enterprise-wide negotiations, and cross-team collaborations.
Carmen will present on the procurement process for cardiovascular products at Michigan Medicine, such as; regental delegation of authority, Bid/RFP process (including price analysis and benchmarking), and supplier relationships.
Pete Bryant will present on Value Analysis at Michigan Medicine, such as standardization initiatives, MedSurg Commit updates, the new product request process (NIIT Tool), and the Emergency Product Request Process (PDF Form).
Nicole Black, PhD, is the Program Director for MedTech Innovator. Nicole grew up in Michigan before attending Boston University to study Biomedical Engineering as a Trustee Scholar. In 2020, Nicole completed her PhD at Harvard University, working on interdisciplinary medtech projects between the Wyss Institute for Biologically Inspired Engineering and Mass Eye and Ear Hospital. After graduating, Nicole launched a startup company, Beacon Bio, based on her PhD work as a Gliklich Healthcare Innovation Scholar. Following Beacon Bio’s acquisition by Desktop Metal, Nicole served as the Vice President of Biomaterials and Innovation in their Desktop Health division. Nicole’s accolades include the Collegiate Inventors Competition Graduate Winner (2018), the Baxter Young Investigator Award (2020), the Lemelson-MIT Student Prize (2021), and the MIT Technology Review Innovators Under 35 (2023).
MedTech Innovator is the world’s largest and most successful accelerator and ecosystem for the most promising medical device, digital health and diagnostic companies. Graduates have brought 350 products to market, raised over $8B in follow-on funding, and transformed millions of lives. MedTech Innovator seeks early to mid-stage start-ups in the medical device, diagnostic, or digital health/health IT spaces. Applications for our 2025 cohort will open in Fall 2024 and close on January 31, 2025.
Dr. Nicole Black will present on MedTech Innovator and the importance of a MedTech startup considering value.
Q&A with Broadview Ventures
David Prim, PhD, Principal at Broadview Ventures
Moderator: Sarah Jameson-Valencia, MBA, Associate Director of Ventures, Life Sciences at the University of Michigan
Wednesday, December 11, 2024, from 12:00 – 1:00 PM (EST)
Broadview Ventures is a mission-driven investment organization. Their goal is to improve human health in cardiovascular disease and stroke. They define success as improving human health by bringing innovative technologies to patients.
David Prim, PhD, shares responsibility for the day-to-day investment activities at Broadview Ventures, including identification and screening of new opportunities, due diligence, negotiation of deal structure, and portfolio company board involvement.
Before joining Broadview, David was a Senior Associate at Locust Walk. At this global life sciences transaction firm, he led engagements for biopharma and medtech clients guiding corporate development strategy and supporting sell-side, buy-side, and financing deal execution. Previously, David was a consultant at ClearView Healthcare Partners, a premier life science strategy consulting firm, where he supported the completion of high-impact strategy projects for a broad range of industry clients across all aspects of the product lifecycle, including new product planning, R&D, commercial, medical affairs, market access, and lifecycle management.
David earned a PhD in Biomedical Engineering from the University of South Carolina, where his research focused on vascular grafting. His research projects covered a wide range of vascular mechanics, hemodynamics, and tissue engineering, with a specific focus on understanding and improving the remodeling of coronary artery bypass grafts. David also holds a BS in Biomedical Engineering from the University of South Carolina with honors from the South Carolina Honors College.
David serves on the Board of Directors for CorFlow Therapeutics and is a Board Observer to Puzzle Medical Devices and Vascular Graft Solutions.
Sarah Jameson-Valencia, MBA, oversees the creation of new life science startups based on technologies invented and developed at U-M. In this role, she manages resources to build, launch, and grow new ventures, including U-M’s mentor-in-residence program, the MTRAC and Kickstart Life Science Innovation grant hubs, and the Accelerate Blue Fund.
Before joining Innovation Partnerships, Sarah spent 3.5 years as a Senior Associate on the investment team at Arboretum Ventures, an Ann Arbor-based healthcare venture capital firm. Prior to Arboretum, Sarah spent 8 years as a field clinical specialist and field clinical engineer supporting cardiac medical devices at Boston Scientific, Sorin, and Biosense Webster (J&J).
Sarah holds a BS in Cellular and Molecular Biology and an MSE in Biomedical Engineering from the University of Michigan, as well as an MBA from the Ross School of Business at the University of Michigan.
Past FCVC Innovation Webinars
The Future of Cardiovascular Medicine
David McManus, MD, Professor and Chair of Medicine at the University of Massachusetts Medical School
Jag Singh, MD, PhD, Professor of Medicine at Harvard Medical School
Friday, January 5, 2024, from 9:00 - 10:00 AM (EST)
Digital Medicine for Management in Atrial Fibrillation
Hamid Ghanbari, MD, PhD, Co-Chair of Innovation, FCVC Innovation Program and Assistant Professor, Cardiac Electrophysiologist at the University of Michigan
Wednesday, January 17, 2024, from 12:00 – 1:00 PM (EST)
Using Digital Health Technologies in Cardiovascular Innovation
Jessica Golbus, MD, Clinical Instructor, Cardiovascular Medicine at the University of Michigan
Wednesday, February 7, 2024, from 12:00 – 1:00 PM (EST)
Mobile health technologies have been increasingly used in healthcare for the diagnosis and management of cardiovascular diseases. This session will highlight recent studies that used mHealth technology for prognostication, diagnosis, and treatment in patients with cardiovascular diseases. A particular emphasis of this talk will be on the use of mobile health technologies to deliver just-in-time adaptive interventions (JITAIs), a novel intervention design that uses contextual information from mobile devices to provide at the moment to support to users. The session will provide two examples of recently deployed JITAIs targeting two cardiovascular disease populations including the VALENTINE Study, a JITAI delivered to participants enrolled in cardiac rehabilitation, and the myBPmyLife study, a JITAI delivered to participants with hypertension.
Advancing Healthcare Delivery System Redesign Through Team Innovation and Implementation Science
Catherine Lau, MD, Professor of Medicine and Director of the Caring Wisely Program at UCSF Health
Wednesday, February 14, 2024, 12:00 – 1:00 PM (EST)
Improving the value of healthcare is an imperative goal for health systems across the country. Successful interventions to catalyze healthcare system redesign are more likely to be successful if front-line providers are engaged in the problem-solving process. For over a decade, the Caring Wisely program at UCSF Health has done just that, partnering with inter-professional front-line healthcare providers and providing them with the coaching and resources needed to design, innovate, implement, measure, and sustain changes to improve quality outcomes and reduce costs for the health system. This talk will provide an overview of Caring Wisely, specifically highlighting how implementation science, Lean, and human-centered design experts collaborate to bring innovation to life and provide examples of recent Caring Wisely projects and their impact on patients, healthcare teams, and costs.
Organ Preservation, More Than Just a Phase
Paul Tang, MD, PhD, Vice Chair for Research in Cardiovascular Research and Associate Professor of Surgery at the Mayo Clinic
Tuesday, February 20, 2024, 12:00 - 1:00 PM (EST)
Dr. Tang will discuss the phenomenon of liquid-liquid phase separation on augmenting harmful processes mediated molecular signaling during organ preservation. Furthermore, strategies to mitigate this process will be explored.
Investment Trends in Cardiovascular Medicine
Kenneth Nelson, Partner at MedTech Advantage Fund
Wednesday, March 20, 2024, 12:00 - 1:00 PM (EST)
FDA Regulation of Cardiovascular Medical Devices
Aneesh Deoras, MS, Assistant Director for Cardiac Ablation, Mapping, and Imaging Devices at the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health, Office of Cardiovascular Devices, Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
Dinesh Puppala, MS, RAC, Regulatory Affairs Lead at Google
Wednesday, April 24, 2024, 12:00 - 1:00 PM (EST)