BRINGING IDEAS TO REALITY.
The Jacobs Institute’s Idea to Reality Center, or i2R, is at the cutting edge of medicine. The i2R is focused on developing novel, smart-engineered endovascular medical devices at a faster pace and in a more cost-effective way. The i2R creates devices designed by the physicians who use them. Physicians are on-site and available to i2R engineers so that the i2R can quickly prototype and validate potential devices. Our unique medical device development model streamlines the proof-of-concept process.
THE RIGHT PEOPLE IN THE RIGHT PLACE AT THE RIGHT TIME.
No one else can do what the Jacobs Institute’s i2R does, because we have a combination of experts all housed under one roof. By fostering collisions of physicians, engineers, researchers, and entrepreneurs, the JI is uniquely positioned to generate and transform ideas into reality.
Through our i2R process, we validate and test new ideas for endovascular devices that could change the way stroke and vascular disease are treated. There could be less devastating outcomes of stroke and other vascular disease, owed to a novel technology, for the people of Western New York and beyond.
Our medical device engineers and physicians are on-site, to work together and with the entrepreneur to prototype and test their device idea in the JI’s state-of-the-art laboratories.
We can help entrepreneurs usher their ideas down the pathway of their choosing–whether it’s starting their own company or hoping to be purchased by a larger device company.
The i2R Review Committee prescreens every idea submitted to determine its appropriateness for further evaluation. If accepted, the idea undergoes a rigorous assessment of its intellectual property status, followed by an in-depth evaluation of its market potential, an assessment of the clinical regulatory pathway to commercialization, and, finally, the potential for reimbursement by Medicare and other payers. Once an idea has passed these hurdles, the i2R works with the inventor to design and build a prototype. From there, the prototype undergoes computational testing, physical testing in vascular models, virtual testing in simulators and finally, in vivo testing in animals, alternating with device redesign until proof of concept is achieved. The i2R helps the inventor establish a path forward to commercialization, whether it involves the creation of a startup and associated fundraising initiatives or a partnership with a related industry partner.
Too often, inventors’ ideas for new medical devices are never realized, due to their lack of time, technical skills, trusted partners, and money. The JI created the i2R, or idea to Reality Center, as a medical device proof of concept center to address this issue. The i2R ensures that life-saving vascular device ideas are quickly designed, prototyped, and tested until clinical validation is achieved. It is the smartest, fastest, most cost-effective way to actualize an endovascular device idea. Upon reaching proof of concept, the de- vice can move out of the JI and on to the next stage in the commercialization contin- uum. The i2R device development process involves three iterative phases following initial device vetting as described below.
Phases of the i2R PROCESS
Phase 1 – Concept Evaluation
In the first phase of the i2R process, the idea is evaluated from a variety of perspectives in order to minimize product risk during product development and to prevent unexpected failures during design verification and validation testing. Evaluation activities include:
- Intellectual property searches to assess an idea’s patentability
- Market studies to assess market need
- Clinical regulatory studies to assess the pathway through the FDA
- Reimbursement evaluation thorough an economic value assessment
Phase 2 – Design Feasibility
In the second phase, user needs are collected and prioritized and then used to identify design inputs that capture all functional, performance, safety, and regulatory requirements. Once the design inputs are defined and prototypes are produced, core development begins during which device prototypes are tested:
- In silico. Computational testing assesses such things as sheer stress, structural integrity and material behavior under different scenarios.
- In vitro. Device testing equipment is used to test and analyze qualitative and quantitative feedback from hands-on user based assessments
- In vivo. Following appropriate protocol design and approval, the device can be evaluated in a suitable animal model. This test usually leads to design modifications and final development prior to design freeze.
Phase 3 – Design Verification & Validation
The third phase involves the preclinical and clinical stages of device development. In the preclinical part of this phase, the design of the device is frozen and validation of the device’s intended use is undertaken with end users (physicians) and in 3D printed vascular models and animals. Further testing in models and in animals under Good Laboratory Practice (GLP) standards and biocompatibility is achieved leading to our i2R exit stage which is Proof of Concept.
Exit – Commercialization Strategy (Reality) Once proof of concept is achieved, the JI will implement the commercialization exit strategy that was developed concurrently with the device development process. i2R projects will either transfer into a newco or license and/or sell the technology directly to a commercialization or industry partner.
For our i2R Brochure, download here.
How to Submit Your Idea to the i2R
At present, we are strategically bringing projects in to the i2R and will lay out the official idea submission process later this year. In the meantime, if you are interested in submitting an idea, please provide a non-confidential summary to Mike Springer.