Connecting clinicians, engineers, and industry to accelerate
the development of next-generation life-saving vascular devices.

the idea to reality center (i2R)

The Idea to Reality Center (i2R) is a product development hub where medical device engineers, practicing physicians, regulatory experts, and industry veterans converge with a common goal: to create and accelerate the development of groundbreaking endovascular treatment technology. 

Whether a single testing session or start-to-finish co-development, we offer a unique vascular device testing experience, on-site prototyping capabilities, and a deep network of experts to help you succeed.

The JI has a brilliant vision to unite various experts in an innovative ecosystem under one roof and raise the what-if and why-not questions. This is bound to lead to extraordinary innovations that will address some of the most significant unmet challenges in medicine.
Fred Khosravi, Silicon Valley device entrepreneur

We can help you wherever you are in your journey

Evaluate your idea for success

  • On-site clinical needs-finding immersion programs
  • Rapid iteration of proof-of-concept prototyping and testing
  • Physician feedback to guide your design approach
  • Performance benchmarking
  • Regulatory strategy development
  • Preliminary data to support grant applications or fundraising
Next Phase
Refine Your Design Approach

  • Definition of user needs and key product requirements
  • Iterative development of fully-featured prototypes
  • Custom anatomical model design
  • Preliminary in-vitro, in vivo and ex vivo testing
  • Design History File initiation
  • Regulatory support of pre-submission process
Next Phase
Develop Your Device & Prepare for Design Freeze

  • Anatomical model justification report to support formal testing
  • Definition of:
    • Device design and manufacturing processes
    • Risk management documents
    • Useability and human factors protocols
    • Verification and validation protocols
    • Pre-clinical GLP testing plans
Next Phase
Demonstrate Device Functionality

  • Pre-clinical assessment of device safety profile
  • GLP in vivo studies to assess product safety
  • Qualification testing as defined in Design & Development phase
  • Regulatory and clinical support of First-in-Human study plan and IDE submission
Next Phase
Demonstrate Clinical Safety

  • CRO Coordination of on-site clinical studies:
    • IRB preparation and submission
    • Establish Data Safety Monitoring Board (DSMB)
    • Site initiation visit
    • Data management
    • Staff training
  • Ongoing regulatory support
  • Early Feasibility Studies
Next Phase
In a place with one of the highest rates of stroke and vascular disease in the country, this mission is personal.

IT’S ABOUT THE PATIENTS

We envision:

• Students armed with the knowledge to recognize and prevent vascular disease;
• Engineers trained with the skills to develop groundbreaking devices;
• Physicians confident with experience gained in realistic anatomical models;
• Patients saved by access to the newest vascular treatment technology first in the world.

A POWERHOUSE TEAM OF EXPERTS

Our Leaders
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Our Leaders

Founder & Chief Scientific Consultant

L. NELSON “NICK” HOPKINS

Chief Executive Officer & Chief Medical Officer

ADNAN H. SIDDIQUI

Chief Regulatory Officer / Chief Quality Officer

CARLOS PEÑA

Vice President, Programs

PAM MARCUCCI

Vice President, Engineering

Private: RICHARD DUCHARME

EMBEDDED IN AN ECOSYSTEM

Strategically located between a world-class university research center and a state-of-the-art vascular hospital, the i2R is uniquely positioned to support your cutting-edge product development in a clinical environment.

3d tour

COMMITMENT TO QUALITY

The Jacobs Institute is focused on accelerating the research, design, development and manufacture of innovative high-quality, clinically relevant engineering solutions and products to impact the treatment of vascular, neurological, and related diseases. 

We are registered to ISO 13495:2016 by SRI Quality System Registrar. Learn more about our quality management system