Funding Process for Facilitating Clinical and Engineering Collaboration

GOALS & PURPOSE OF DOCUMENT

A goal of the Center for Medical Innovation (CMI) is to provide an organizational structure and process to link faculty, clinicians, and students to foster the creation of innovative biomedical technologies applied to medical problems. To accomplish this goal, CMI will work with the Clinical Departments within the Schools of the Health Sciences (SoHS) and the Swanson School of Engineering (SSoE) to facilitate innovation to solve unmet clinical needs. This will include:

• Reaching out to clinicians who recognize unmet needs in patient care and have ideas for potential solutions.
• Reviewing and vetting those ideas for technical and clinical feasibility.
• Linking appropriate engineering faculty with interested clinicians to develop a plan to move the solutions forward.

The purpose of this document is to outline a multi-step process to accomplish the above goals.

OVERVIEW OF PROCESS

The process will involve up to four steps: First, a short questionnaire addressing specifics about the clinical problem and potential solutions will be written by the clinician. The questionnaire will consist of up to two pages, following the outline provided in the enclosed "Clinical Concept Questionnaire." Second, a review of the questionnaire will be conducted by the CMI for feasibility and for identification of the required technical (engineering) expertise. Third, for ideas that are deemed feasible and for which there is local engineering expertise available, the clinician will be matched with an engineering faculty member(s) to form a team to develop a short pilot grant proposal after a CMI organized brain-storming session as described below. In the final step, these pilot proposals will then be reviewed by CMI periodically, and funding will be made on an as-available basis.

PROCESS OUTLINE

1. Concept Questionnaire Submission: CMI will solicit concept questionnaires from clinicians within clinical departments (two page limit) describing the clinical problem and any pre-existing ideas of engineering approaches for solution. We foresee that the questionnaires will fall into either of the following categories:
   1. Unsolved problems or unmet clinical needs that can benefit from engineering input, concept refinement, and fresh thinking about solutions.
   2. Fully-formed concepts and innovative product ideas that could benefit from engineering review, proof of concept demonstration, and initial prototype design and development.
   The questionnaire should also include information that will help the CMI identify key aspects that are amenable to engineering design. For example, the clinician may know of technologies that have been employed in alternative solutions to the identified problem. This will provide some guidance to the CMI about potential improvements employing state-of-the-art engineering.
   
   
2. Initial Review Process: The CMI will initiate a review of the submitted questionnaire, which may include:
   1. Requesting the University of Pittsburgh's Office of Technology Management (OTM) to perform an initial evaluation of the commercial and intellectual property (IP) potential of the concepts developed therein.
   2. Confidential consultation with a multidisciplinary, expert panel as necessary.
   3. Preparing a summary of the CMI review, including comments pertaining to the following important aspects:
      1. Clinical Impact
      2. Commercial Viability
      3. Potential Engineering Directions
   4. Selecting those projects for further action. (Those not chosen will be given feedback to as to the CMI's findings and what additional work, if any, the CMI feels would be necessary to move the project forward in the future.)
3. Brainstorming, Research Partnership Formation, and Pilot Proposal Development: For those projects selected for further action, the CMI will schedule a brainstorming meeting with the clinician and potential engineering faculty partner(s) to identify a range of technical solutions. The output of the brainstorming session may lead to the formation of a research partnership between a clinician and an engineer, and to a diverse set of concepts that will be evaluated on several criteria for technical and commercial viability. The Clinician-Engineer team that has reached this stage will be asked to prepare a short (5-page maximum) proposal to develop an R&D plan to move the project forward.
   
   
4. Proposal Review: The proposal submitted by the Clinician-Engineer team will be reviewed by CMI at periodic deadlines and, if approved, a funding plan will be developed. Funding could come from CMI on an as-available basis, or sought from other sources.

INTELLECTUAL PROPERTY ISSUES

The CMI wants to ensure that all intellectual property issues are handled appropriately from the outset to protect the investigators. Therefore, the OTM will be involved in the review of both the questionnaire and the pilot proposals. For example, OTM will advise the investigators when an invention disclosure should be filed. Any inventions that subsequently result from the project team will be subject to detailed assessment by the OTM to determine patentability and commercial potential. The Office of Enterprise Development (OED) will then advance the commercialization of the IP as appropriate.

PROJECT MONITORING AND FOLLOW-UP

CMI will monitor the progress of the projects and continue to function as an advisory group for the projects that make significant progress toward commercialization. This will include, but not be limited to, recommendations for follow-on funding sources (e.g., federal funding, Coulter Program funding, investor funding), interfacing project teams with additional resources as needed (e.g., prototyping, other engineering expertise), etc.