Gap Fund

• Austin, J. (2021). Customer discovery basics. Rock Center for Entrepreneurship, Harvard Business School.
• Blank, S. (2013). Customer discovery. In S. Blank, Four steps to the epiphany: Successful strategies for products that win (5th edition)(pp. 40-103). Wiley.
• Blank, S., & Dorf, B. (2012). Chapter 3: An introduction to customer discovery. In S. Blank & B. Dorf, The startup owner’s manual: The step-by-step guide for building a great company (pp. 53-68). K&S Ranch.
• Blank, S., & Dorf, B. (2012). Chapter 5: Customer discovery, phase two: “Get out of the building” to test the problem: “Do people care?”. In S. Blank & B. Dorf, The startup owner’s manual: The step-by-step guide for building a great company (pp. 189-226). K&S Ranch.
• Blank, S., & Dorf, B. (2012). Chapter 6: Customer discovery, phase three: “Get out of the building” to test the product solution. In S. Blank & B. Dorf, The startup owner’s manual: The step-by-step guide for building a great company (pp. 227-256). K&S Ranch.
• Mancini, D. & Horvath, D. (2024). Innovations vs. features: Tips for designing your product. Project MedTech Podcast. Ep. 196, 12:58-26:15.
• VentureWell. (2023, October 5). Customer discovery: Assumptions & Interviews [Video].
• Wilcox, J. (2017, January 4). How to interview your customers. Customer Development Labs.
• Wilcox, J. (2017, January 12). Customer discovery: What do you ask? [Video]. YouTube.

• Centers for Medicare and Medicaid Services. (2021). How to use the MPFS look-up tool. U.S. Department of Health and Human Services.
• Centers for Medicare and Medicaid Services. (2023). List of CPT/HCPCS Codes. U.S. Department of Health and Human Services.
• Technological Leadership Institute, University of Minnesota. (2018, March 29). Technically speaking: Lowering risk in early-stage technology commercialization[Video]. YouTube. 
• Ulwick, A. W. (2014). What is Outcome-Driven Innovation (ODI)? [Whitepaper].  
• Ulwick, A. W., & Bettencourt, L. A. (2008). Giving customers a fair hearing. MIT Sloan Management Review, 49(3), 62-68.  

• A Complete Guide to Bringing a Medical Device to Market [Blog]
• Greenlight Guru. (n.d.). The entrepreneur’s guide to the medical device industry [Video]. Greenlight Guru Academy.
• The Device Development Process
• What Are the Four Different Types of Medical Device Risk Analysis? [Video] 
• How to determine if your product is a medical device
• Classification of products as drugs and devices and additional product classification issues: Guidance for industry and FDA staff
• Guide to understanding health technology assessment (pdf)
• Medical technology assessment guidelines for Blue Cross Blue Shield of Massachusetts (pdf)

• FDA Center for Devices and Radiological Health and Center for Biologics Evaluation and Research. (2023). Requests for feedback and meetings for medical device submissions: The Q-Submission program – Guidance for industry and Food and Drug Administration staff. U.S. Food and Drug Administration.
• Five Tips for a Competitive Regulatory Strategy [Blog]
• Greenlight Guru. (2020, July 13). How to prepare and conduct pre-submission meetings [Video]. YouTube.
• Medical Device Regulations/FDA Approval [Video]
• Planning Your Medical Device Global Market Regulatory Strategy [Blog]
• What actually happens in a Pre-Submission meeting with FDA? Part I [Blog]
• What actually happens in a Pre-Submission meeting with FDA? Part II [Blog]

The Gap Fund is an integrated component of OTM’s workflow to move promising technologies from the laboratory to commercial use. The objective of the Gap Fund is to strategically deploy capital to help OTM accomplish its mission of transferring technologies created from the research conducted at WashU to the marketplace so that they can be used to benefit society.

In operating the Gap Fund, OTM has made a conscious decision to move away from the open competition model to make better use of its limited resources. The new model enables OTM to provide much better support to those technologies that are funded as well as technologies that are not yet ready for gap fund assistance. In the end, the new model holds promise to enable more WashU technologies to be successfully commercialized than the previous funding programs.

No, the Gap Fund does not provide funding to university start-up companies. The funding that the Gap Fund provides is directed to the laboratories of WashU researchers, who use the established WashU processes and procedures for contracting services and making purchases. As such, WashU owns any additional intellectual property (whether patentable or non-patentable) that is developed from gap funded projects.

Any WashU researcher in good standing who has properly assigned their intellectual property rights for inventions and creations to the university is eligible to receive Gap Fund support.

A person may submit multiple technologies for consideration. Because the WashU Gap Fund has very limited resources to support the maturation and de-risking of all non-therapeutic technologies across the entire university, an individual is generally limited to serving as principal investigator (PI) for only one active Gap Fund award at any given time. However, an individual may be allowed to serve as PI on more than one active Gap Fund award if there is compelling justification. When deciding whether to provide multiple simultaneous awards to a single PI, the status of the PI’s current active Gap Fund awards will also be taken into consideration.  There is no limit to how many projects on which a person may be a non-PI team member.

Applications and nominations for the Gap Fund are accepted at any time.

The limit for a single Gap Fund award is $55,000 under current guidelines. Proposed projects with budgets significantly greater than this will be broken down into sequential sub-projects with budgets up to the $55,000 limit per award. A stage-gate approach will be used but the Gap Fund will only commit to providing $55,000 in funding at a time. Subsequent awards may be given if the results of the prior sub-projects warrant it.

The financial support provided by the WashU Gap Fund can only be used for direct Project costs. Funds are intended to cover costs directly related to achieving the objectives of the Project scope of work (SOW) including, but not limited to, the following:

· Services from contract research organizations (CROs)

· Consulting or professional service fees

· Materials and supplies

· Specialized equipment not capable of being obtained through partnerships, renting, or leasing

· Testing services

Funds cannot be used for university overhead or new venture start-up costs including, but not limited to, the following:

· Facilities and administration (i.e., overhead) costs

· Employee salaries and fringe benefits (except in rare instances on a case-by-case basis)

· Student tuition remission, fellowships, and grants

· Consulting or professional service fees for preparing organizational registrations documents

· Organization registration filing fees (e.g., incorporation filing fees, attorney’s fees)

· Fees associated with licensing intellectual property

· Office expenses

· Marketing and advertising expenses

Because of intellectual property rights issues, undergraduate students cannot work on a Gap Fund project without prior notice to and agreement by OTM.

There are several types of students that fall under the term “graduate student”.  The only graduate students who can work on Gap Fund projects are those who are subject to the requirements and obligations specified in the WashU Intellectual Property Policy or those who are being compensated for their work on the project and agree to assign their intellectual property rights to WashU as part of the compensation agreement.

Decisions about which projects receive Gap Fund awards are made by an evaluation committee with input from external domain experts. Several factors are considered such as:

· Satisfaction of eligibility criteria

· Primary innovator contribution to commercialization and out-licensing efforts

· Project leader commercialization aptitude

· Primary innovator or project leader relationship with OTM

· Anticipated increase in technology maturity level

· Anticipated increase in the value of the technology

· Anticipated strength of intellectual property protection

· Alignment of the research and development plan with the market need

· Anticipated impact of the technology if it is commercialized

· Breadth of value creation

· Estimated size and growth of the target market

Other guidelines of which investigators should be aware include the following:

· WashU must be the lead institution if the technology has collaborators from other institutions

· The maturity level of the technology must be at least the equivalent of TRL-3 but no higher than the equivalent of TRL-6 on the NASA technology readiness level (TRL) scale

· There must not be any unresolved compliance issues with the technology

· The technology must not yet be licensed or otherwise encumbered

· There must be no apparent conflicts of interest that appear unmanageable or unresolvable

· The investigator must be in “good standing” with WashU

· There must be no serious unresolved issues with the investigator’s laboratory

· Technologies previously denied funding but not determined to be unviable may be reconsidered during a later selection cycle after sufficient actions have been taken to address deficiencies

The technology readiness level (TRL) scale is an ordinal scale that was developed by the National Aeronautics and Space Administration (NASA). It is used to characterize and describe the maturity level of a technology. The NASA TRL scale ranges from 1 (least mature) to 9 (most mature). OTM uses an adaption of the NASA TRL scale which ranges from 0 (least mature) to 9 (most mature).