SUMMARY OF MISSION:For technologies related to clinical and basic research in neuroscience, successful advances or innovations rely on the collaboration between multiple disciplines of expertise (i.e. medicine, engineering, law, business, etc). Therefore, creating an environment which facilitates collaboration between these multiple disciplines will enhance the development of novel neuro-technologies. This innovative environment and newly developed technologies have significant potential both academically and financially. The goal of developing the Center for Innovation in Neuroscience and Technology (CINT) is the following:
- Create a collaborative environment for the development of novel neuro-medical technologies and to facilitate their real world application.
- Create a multidisciplinary education for staff and students to better understand the process of idea generation, valuation, development, and application.
- Create a connection between academia and industry in a mutually beneficial relationship for developing neuro-medical technologies.
BYLAWS:1. Cross Disciplinary Sessions (CDS)a. Definition. These will consist of at least two separate 1-2 hour sessions consisting of 4-8 participants of which at least two will be physicians and two will be engineers (An “Inventive Team”). These sessions will consist of an exchange between physicians and engineers in which engineers will discuss their capabilities and emerging technologies while the clinicians discuss their practice and the problems and obstacles that they confront on a routine basis. The goal of the session will be to create new and innovative technical solutions to improve the practice of neurosurgical and neuro-interventional care of patients.
b. Frequency of meeting for CDS. A given Inventive Team will meet once a month. For a given Cross Disciplinary Session this will consist of at least two separate meetings spanning two months.
c. CDS Themes: The themes will be created based on interest. People interested in participating will submit list of clinical, research, and technical skills and interests. Group will be chosen based on complimentary and/or synergistic skill sets. (i.e. Spinal MD and mechanical engineer). These themes will be organized by the executive committee of the CINT. There will be numerous themes and inventive teams created. Participation in one team does not preclude participation in others.
d. CDS participation: Faculty from Departments including Neurological Surgery, Neurology, Neuro-radiology, the School of Engineering, and other Neuroscience relevant domains are invited to participate. Participation will be initiated by the faculty member expressing interest in participating and then submitting list of clinical and technical interests in conjunction with list of clinical/technical areas of expertise. The skill sets of the faculty member will then be matched with other faculty members who are deemed complimentary or synergistic. This matching will be done by the CINT executive committee. These faculty will then be assigned to a respective CDS group according to interest-derived themes. If a faculty member is interested, he or she may participate in more than one group.
e. CDS protocol: As stated above the CDS will consist of two meetings. Each meeting will serve slightly different roles:
i. Meeting #1: This meeting will have the following goals: 1) For clinical practitioners (e.g. neurosurgeons, neuroradiologists, etc) to describe details of their respective practice, current clinical obstacle, and wishes for future technical development. 2) Engineers describing relevant technical capabilities of their respective fields, 3) Brainstorming to create new possible technical solutions for surgical and technical management of patients. 4) At conclusion of meeting, cataloging ideas generated during meeting and triage ranking those ideas based on novelty and clinical impact. 5) Ascribing tasks for further investigation to aid in defining novelty and value of ideas.
ii. Interim: Over the next month participants will pursue questions raised about highly ranked ideas. These will include literature search, patent search to define level of novelty as well as further technical investigation into feasibility of concept. Additionally, preliminary sketches of concept will be created to further refine concept.
iii. Meeting #2: The meeting will have the following goals: 1) The triaged ideas will be reassessed in light of the research performed over the last month. Those ideas that have been found to be significantly novel, have high clinical/market impact, and are deemed feasible will be then allotted for consideration for further development. 2) Assignments for further participation will be made in regard to further development. This will include overseeing the drafting and design of the invention, creating the prototype, and interacting with a patent attorney for the development of the intellectual property.
f. CDS Duration: An established CDS will last for one year term. At the end of the year the CDS will be dissolved.
2. Idea Development:a. Executive Triage: The highly ranked ideas from the various CDS teams will be reviewed together. The priority of development will be determined based on patentability, clinical impact, and market value of the idea. These ideas will then be developed further in their respective order as resources and available manpower permits.
b. Disclosure: Those ideas that have been highly ranked by the Inventive teams and executive committee will then be disclosed to the Office of Technology Management (OTM). This will be in the form of a one page description. The disclosure will be written by one of the members of the inventive team.
c. Drafting: The preliminary draft of the highly ranked ideas will then be performed by one or more of the members of the inventive team in conjunction with a hired engineer to perform a professionally rendered design of the concept. Faculty participating in the drafting stage of development will be determined during Meeting 2 of a CDS. Creation of the drafted design will be an iterative process. Once completed, this drafted design will then be reviewed by the executive committee to determine most appropriate next stage of development.
d. Prototype Development: Once successful design created for given concept, next stage of development will involve the creation of a testable prototype. Nature of prototype creation in regard to time, cost, and interest of prospective licensee, will influence decision by Executive Committee in regards which method of prototype creation will be chosen. This could include prototype creation funded by investment group (e.g. Allied Minds) through sponsored research agreement, industry sponsor and external development, or as project of Innovation fellowship.
3. Allocation of Value to Inventors: a. Current Policy: The Intellectual Property Policy covers the distribution of net income from license agreements: 35 percent to inventor(s); 40 percent to inventor(s) school(s); and 25 percent to the Office of Research and Office of Technology Management. For further reference please see the OTM website (
http://otm.wustl.edu/forfaculty/intellectualproperty.asp)
b. Allocation of Inventor Share: The 35 percent that is allocated to the faculty participating in the CINT CDS will be subdivided according to a point system to optimize fairness in reward for effort put into an idea development. For a given idea there are several stages involved in its development. These include the following: 1) The two meetings for a standard CDS, 2) Drafting the Invention Disclosure, 3) Drafting a Design of Prototype, 4) Creation of Prototype and 5) Drafting A Patent. Each of these stages will involve a point allocation for a given milestone of accomplishment totaling 200 points. The point allocation is as follows: 1) Participating in the two meetings for the CDS – 40 points, 2) Drafting the Invention Disclosure – 10 points, 3) Aiding the successful completion of drafted design of a prototype – 50 points, 4) Aiding the successful completion of a workable prototype – 50 points, 5) Aiding in the drafting of the patent – 50 points. After a standard CDS all participating faculty will be given an equal share of the 50 points. The remaining points will be held in escrow for the remaining milestones. For each task beyond the CDS, one or more faculty can participate and thus share equally in the point allocation for a given milestone. As the tasks are accomplished the respective points will be assigned to the participating faculty. At the time of the license the given faculty members percentage of the 35 percent allocated to inventors will be determined by the their number of points divided by 200.
c. Deciding on and Tracking Ongoing Contribution. On the completion of the Stage 1 (CDS sessions) the group will internally triage their ideas and decide who wishes to participate in what aspects of the given ideas further development. An Idea Tracking Form (see appendix) will be signed to define the current contribution of the inventors and the planned future contribution. If there is disagreement how each member will contribute or participate in the future development, this will be arbitrated by the CINT executive committee and/or CINT director. At each subsequent stage the participating inventors will then return to this invention tracking form to again sign when a stage is complete and agree that the expected contribution matched with the actual contribution of the completed stage. At the completion of each stage the final allocated percentage will be decided by the contributing inventors and will be signed off on. If there should be a change and the inventors can not agree on allocated percentage this will then be arbitrated by the CINT executive committee and/or CINT director as deemed appropriate. The point scores for a given project will be maintained and followed by separate third party in the business office in the Department of Neurological Surgery.
4. Executive Triage: Once high ranked ideas per CDS are selected these ideas will then be reviewed together (across all CDS ideas) by the Executive committee. The executive committee will then rank order these in terms of priority of development based on the following criterion.
a. Triage Criteriai. Utility of idea
ii. Intellectual in origin?: Can the idea be sufficiently enabled via by at least one concrete example
iii. Closest technologies to current idea. Will this prohibit or promote the development of the idea
iv. Is the idea Inevitable/High Clinical Impact/Profitable in reasonable time frame? Assessed relative to the following
1. Is the idea or technology based on well established literature?
2. What level of change in human behavior is required?
3. What is the duration and path through regulatory approval for application?
4. Will idea require medical/technical breakthrough or discovery?
5. Will successful application require fundamental change in market or infrastructure?
v. Is the idea demonstrably better and/or likely to be perceived as better than existing technologies?
vi. Is the idea in a potentially friendly licensing industry?
5. Governance: a. The head of the CINT will be led by the Director. The Director will lead in conjunction with an Executive Committee. The Executive Committee will consist of eight positions. This will include the Director, the Chairman of Neurological Surgery and the Chairman of Biomedical Engineering. The remaining seats will be open to faculty members from the School of Engineering, Department of Neurological Surgery, Department of Neurology, Division of Neuroradiology, the Law School, and the Business School. This Chairman of the Committee is also the CINT Director. A meeting for the Committee will require at least the Director, and a representing member from the Engineering School and a clinical department. Recommendations of the committee will be decided by vote majority with final decision being made by the chairman if there is a voting tie.
6. Other Activities: a. Innovation Fellowship. In the highly-technically oriented fields such as neurosurgery, neurology, and neuro-interventional radiology, technical innovation and leadership in the academic mission are becoming synonymous. The tenets of leadership in academic neurosurgery revolve around providing cutting edge clinical care and training leaders who are capable of producing advances in the field. Successful innovations will increasingly depend on the collaboration between multiple disciplines of medicine, engineering, science, legal and business expertise. To engage these emerging trends and prepare future neurosurgeons and engineers, the CINT will sponsor several fellowship teams of training neurosurgeons and engineering students to work on innovative new translational projects.
1. Funding. The funding, which will be a combination of industry and university support, will fund summer internships involving faculty and residents from the Department of Neurological Surgery and faculty and students from the School of Engineering who together will design, and create innovative medical device prototypes that can potentially advance clinical neurosurgical practice.
2. Fellowship goals: The aims of the projects will be the following:
1. Understand process of idea generation and steps towards development and practical application
2. Enhance creativity in generation of new ideas and critical evaluation of current technologies
3. Develop cross-disciplinary medical and engineering thinking skills and interaction
4. Improve neurosurgical understanding of engineering principles involved in creation of new medical devices.
5. Improve engineering understanding of clinical principles involved in creation of new medical devices.
3. Implementation: The process for the funded summer internship will consist of the following process:
1. Prior to Internship: During the academic year neurosurgical staff (faculty and residents) and engineering faculty will meet on a monthly basis for Cross Disciplinary Sessions (CDR), as described above.
2. Idea Selection: Subsequent to the prior six to nine month period the top five candidate concepts will be identified by the CINT leadership. Input will also be taken from the industry sponsor as to which ideas have largest potential for licensing and further development.
3. Student Selection: Announcement for student application will be released in January. Top candidates will be selected for summer participation.
4. Announcement of Award. The participants in the top three to five concepts will be notified and the resident and student participants will be invited to be CINT Innovation Fellows for the summer
5. Summer Internship. The residents and students will then proceed to design, draft, and create the prototype of the original concept. This will involve three stages. The first stage (2 weeks) will involve establishing the clinical and medical specifications for the device. The second stage (6 weeks) will involve actual engineering design and draft of the device. The third stage (4 weeks) will involve creation of a prototype. Each stage will be overseen by a neurosurgical faculty and an engineering faculty. The internship team will consist of a neurosurgery resident and two engineering students who will be working together extensively throughout the internship. This team approach will give each of the members substantial l experience communicating with members from different technical and medical backgrounds.
6. Completion. At the completion of the fellowship the participants may be invited to present their results to the industry sponsor for industry evaluation and recommendation.
b. Seminar Series. The CINT will host a monthly lecture series on various aspects of neurotechnology and development. Examples of topics will include such topics as discussions on intellectual property, pertinent aspects of FDA regulations, conflict of interest.
c. Monthly Socials: The CINT will host monthly social events to enhance clinical and engineering interactions. The goals of these socials will be to highlight various aspects of clinical neuroscience (manners of treatment and current obstacles to care) and engineering (current and emerging technologies), and allow for unconstrained forum to identify possible research and technical synergies.
Appendix 1: Invention Tracking Form
Invention:
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Stages
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Points
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Inventors:
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Meetings
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40 – shared equally
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Planned
Contribution(%)
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Signatures
& Date
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Confirmed
Participation(%)
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Signatures
& Date
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Invention Disclo-sure
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10
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Drafting
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50
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Proto-typing
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50
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Patent Drafting
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50
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