Prize competition awardees and non-awardees

Form Approved

OMB No. XXXX-XXXX

Exp. Date XX/XX/20XX

KidneyX Evaluation

Attachment B

Post-Award Survey

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is XXXX-XXXX. The time required to complete this information collection is estimated to average 10 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, to review and complete the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: U.S. Department of Health & Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-E, Washington D.C. 20201, Attention: PRA Reports Clearance Officer.

To assess and improve the administration and impact of the KidneyX Initiative, the U.S. Department of Health and Human Services (HHS) has retained RTI International to conduct an external evaluation of the KidneyX prize competition, [name of challenge]. We request that you fill out this survey in conjunction with the submission for which you received a prize award from KidneyX. We estimate that this survey will take you 30 to 45 minutes to complete. Note that your identity will not be reported to HHS or any organization affiliated with KidneyX, and none of your answers here will be attributed to you. If you have questions about this survey or its contents, please contact Dr. Jeffrey Alexander, project manager for the External Evaluation of KidneyX, at 301-230-4656.

1. Please provide the following personal details: [TEXT BOXES]

   1. Last name/Family name

   2. First name(s)

   3. Names of co-applicants (if any)

2. To what extent do you agree or disagree with the following statements: [LIKERT SCALE]

   1. Communications provided by KidneyX about the judging process after the submission deadline were clear, and helpful.

      1. [NEUTRAL, DISAGREE, AND STRONGLY DISAGREE] Please briefly explain why you think the communication about the judging process has not been the be most appropriate. [TEXT BOX]

   2. Communications provided by KidneyX since the prize announcements have been clear and helpful.

      1. [NEUTRAL, DISAGREE, AND STRONGLY DISAGREE] Please briefly explain why you think the nature of communication has not been the most appropriate. [TEXT BOX]

   3. The total amount/volume of communication I have received from KidneyX since submitting my application has been appropriate.

      1. [NEUTRAL, DISAGREE, AND STRONGLY DISAGREE] Please briefly explain why you think the amount of communication has not been the most appropriate. [TEXT BOX]

   4. The judging process appears to have been conducted in a rigorous and fair way.

      1. [NEUTRAL, DISAGREE, AND STRONGLY DISAGREE] Please briefly explain any sources of doubt or lack of confidence in the judging or selection process. [TEXT BOX]

3. Are you still active in the field of kidney health? [Y/N]

   1. [IF YES] Are you still actively pursuing development of the project you proposed in your application to KidneyX? [Y/N]

      1. [IF NO] Are you pursuing a new kidney health project that is different than the one you proposed in your application [Y/N]

         1. [IF YES TO EITHER OF THE 2 IMMEDIATELY PRECEEDING QUESTIONS] Are you pursuing your project from within an existing company (not a startup)? [Y/N]

         2. [IF YES TO EITHER 3.1 OR 3.1.1] Please estimate the amount of money invested (internally) in your project by you, your partners, or your company since applying to KidneyX. [NUMERICAL BOX]

         3. [IF YES TO EITHER 3.1 OR 3.1.1] If you had chosen not to participate in KidneyX do you think this amount would be higher, about the same, or lower? [SINGLE SELECT]

            1. Higher

            2. About the same

            3. Lower

               1. [IF HIGHER OR LOWER] Please briefly explain. [TEXT BOX]

         4. [IF YES TO EITHER 3.1 OR 3.1.1] Please estimate the amount of time invested (internally) in your project by you, your partners, or your company since applying to KidneyX. [NUMERICAL BOX]

         5. [IF YES TO EITHER 3.1 OR 3.1.1] If you had chosen not to participate in KidneyX do you think this amount would be higher, about the same, or lower? [SINGLE SELECT]

            1. Higher

            2. About the same

            3. Lower

               1. [IF HIGHER OR LOWER] Please briefly explain. [TEXT BOX]

4. Since the submission of your application, have you participated in any of the following activities or had any of the following forms of contact with the types of organizations listed below?

   1. Webinars [Y/N]

   2. Conferences [Y/N]

   3. Meetings, networking, or other forms of contact with the following groups

      1. Healthcare payers (public or private) [Y/N]

      2. Regulatory agencies [Y/N]

      3. Patient or caregiver populations [Y/N]

      4. Funders or private investors [Y/N]

      5. Other innovators or entrepreneurs [Y/N]

      6. Strategic partners in industry [Y/N]

      7. Researchers [Y/N]

      8. Other [Y/N]

         1. [IF OTHER] Please specify [TEXT BOX]

5. [BASED ON THE SELECTION OF FORMS OF CONTACT] Was your participation, contact, or interaction facilitated by the U.S. Department of Health and Human Services or KidneyX in one or more instances? [Y/N]

6. [BASED ON THE SELECTION OF FORMS OF CONTACT] Were any of these interactions covered under NDAs? [Y/N]

7. [BASED ON THE SELECTION OF FORMS OF CONTACT] This contact or connection accelerated my project in some way. [LIKERT SCALE]

8. [BASED ON THE SELECTION OF FORMS OF CONTACT] In the absence of KidneyX, I would have eventually made these contacts and connections anyway. [LIKERT SCALE]

9. [IF SELECTED “PATIENT OR CAREGIVER POPULATIONS”] What is the role you envision for patients or caregivers in helping to advance your project? [MULTIPLE SELECT]

   1. Informing design requirements and specifications

   2. Testing prototypes and providing patient experience feedback or health outcome data

   3. Other

      1. [IF OTHER] Please specify. [TEXT BOX]

10. Please indicate whether you have gained useful information about any of the following that you would attribute, at least in part, to KidneyX. [MULTIPLE SELECT]

    1. Regulatory issues affecting my proposed project

    2. Navigating the regulatory system

    3. Strategies for dealing with reimbursement and payors

    4. Improved understanding of the market for my project

    5. Improved understanding of the technical, scientific, or engineering challenges of my project

    6. More or better input from patients or caregivers about my project

    7. Other

       1. [IF OTHER] Please specify [TEXT BOX]

11. [BASED ON THE SELECTION OF KNOWLEDGE BENEFITS] Where did you receive this information? [MULTIPLE SELECT]

    1. At a conference organized by KidneyX

    2. At a conference supported by KidneyX

    3. From webinars hosted by KidneyX

    4. Direct communication with program staff at KidneyX

    5. Publicity generated by my participation in the prize competition

    6. Other connections and networking opportunities that KidneyX enabled

       1. [IF YES] Please briefly describe the nature of the interaction(s) and how KidneyX enabled it. [TEXT BOX]

    7. Other

       1. [IF OTHER] Please specify [TEXT BOX]

12. [WINNERS ONLY] How important was the prize money with regards to:

    1. Acceleration and eventual success of your project?

       1. Unimportant

       2. Not very important

       3. Important

       4. Very important

       5. Critical

    2. The ultimate quality of your project?

       1. Unimportant

       2. Not very important

       3. Important

       4. Very important

       5. Critical

13. [WINNERS ONLY] How important was the recognition, credibility, and visibility that was attained as a result of being selected as a winner with regards to:

    1. Acceleration and eventual success of your project?

       1. Unimportant

       2. Not very important

       3. Important

       4. Very important

       5. Critical

    2. The ultimate quality of your project?

       1. Unimportant

       2. Not very important

       3. Important

       4. Very important

       5. Critical

14. [WINNERS ONLY] What (approximate) percentage of the prize money have you spent to-date on the following allocations? [NUMERICAL BOXES]

    1. Equipment

    2. Datasets or code

    3. Samples or specimens

    4. Experts or consultants

    5. Administrative personnel

    6. Compensation for team members (applicants listed on the project)

    7. Other

       1. [IF OTHER] Please specify [TEXT BOX]

    8. Not yet spent

15. Since applying to KidneyX, has your project achieved any of the following outcomes? [MULTIPLE SELECT]

    1. Published academic literature

       1. [IF YES] Please list the most important publications, including the title, the year, and the journal of the publication. [TEXT BOXES FOR TITLE AND JOURNAL AND DROPDOWN FOR YEAR; RESPONDENT CAN ADD ROWS FOR MULTIPLE PUBLICATIONS]

    2. Patent applications or awards

       1. [IF YES] Please list the patent application number(s) and the associated inventors named on each application. [TEXT BOXES FOR APPLICATION NUMBER AND INVENTORS; RESPONDENT CAN ADD ROWS FOR MULTIPLE APPLICATIONS]

    3. Formed a startup company

    4. Executed a licensing agreement

       1. [IF YES] Please select the type of company [SINGLE SELECT]

       2. Startup company (AUTM definition: START-UP COMPANIES refer only to those companies that were formed specifically to develop the technology being licensed. If a technology was licensed to an existing start-up company, that was formed to develop a different technology, this company should be counted as a SMALL COMPANY, not a START-UP COMPANY. A START-UP COMPANY may be formed well in advance of when the actual license is signed, while the founders research and write the company's business plan and explore the feasibility of securing investors or grants. A company should be reported as a START-UP COMPANY irrespective of whether the company was formed by the licensing institution OR by an entrepreneur, investor, the professor, a graduate student or a post- doctoral fellow. The key question is: "Was the company that licensed a technology formed specifically to license and develop the technology being licensed?”.)

       3. Small company (AUTM definition: Companies that had 500 or fewer employees at the time the license/option was signed, but, not including START-UP COMPANIES initiated in association with the technology.)

       4. Large company (AUTM definition: Companies that had more than 500 employees at the time the license/option was signed.)

    5. Executed an option agreement

       1. [IF YES] Please select the type of company [SINGLE SELECT]

          1. Startup company (START-UP COMPANIES refer only to those companies that were formed specifically to develop the technology being licensed. If a technology was licensed to an existing start-up company, that was formed to develop a different technology, this company should be counted as a SMALL COMPANY, not a START-UP COMPANY. A START-UP COMPANY may be formed well in advance of when the actual license is signed, while the founders research and write the company's business plan and explore the feasibility of securing investors or grants. A company should be reported as a START-UP COMPANY irrespective of whether the company was formed by the licensing institution OR by an entrepreneur, investor, the professor, a graduate student or a post- doctoral fellow. The key question is: "Was the company that licensed a technology formed specifically to license and develop the technology being licensed?”.)

          2. Small company (AUTM definition: Companies that had 500 or fewer employees at the time the license/option was signed, but, not including START-UP COMPANIES initiated in association with the technology.)

          3. Large company (AUTM definition: Companies that had more than 500 employees at the time the license/option was signed.)

    6. Attracted/raised additional funding

       1. [IF YES] Please indicate the source(s) and amount(s) of funding [MULTIPLE SELECT FOR SOURCE BESIDE A NUMERICAL TEXT BOX FOR AMOUNT]

          1. Foundations, associations, or non-profits organizations

          2. U.S. federal agencies

          3. State or local governments

          4. Universities

          5. Angel investors

          6. Venture capital

          7. Corporate/industry strategic partners

          8. Other

             1. [IF OTHER] Please specify [TEXT BOX BESIDE A NUMERICAL TEXT BOX FOR AMOUNT]

    7. [IF YES TO ‘PURSUING THE PROJECT FROM WITHIN AN EXISTING COMPANY (Q3.1.1.1.)] Created a new project division, subsidiary, or spin-off [Y/N]

    8. Registered a clinical trial [Y/N]

       1. [IF YES] Please list the name of the trial and year of registration. [TEXT BOX FOR NAME AND DROPDOWN FOR YEAR; RESPONDENT CAN ADD ROWS FOR MULTIPLE TRIALS]

    9. Awarded a regulatory approval for a new drug, device, or test [Y/N]

       1. [IF YES] Please list the name of the approved drug, device, or test and year of approval. [TEXT BOX FOR NAME AND DROPDOWN FOR YEAR; RESPONDENT CAN ADD ROWS FOR MULTIPLE APPROVALS]

    10. Launched a new product into the market [Y/N]

        1. [IF YES] Please list the name of the product, the approximate date it was launched, and the approximate revenue generated. [TEXT BOX FOR NAME, CALENDAR PICKER FOR DATE, NUMERICAL BOX FOR REVENUE; RESPONDENT CAN ADD ROWS FOR MULTIPLE PRODUCTS]

16. [BASED ON THE LIST OF OUTCOMES, I.E. FOR EACH OUTCOME SELECTED] This outcome would have materialized eventually in the absence of KidneyX. [LIKERT SCALE]

    1. [AGREE OR STRONGLY AGREE] This outcome would have likely taken longer to achieve in the absence of KidneyX. [LIKERT SCALE]

       1. [BASED ON THE LIST OF OUTCOMES AND EXCLUDE DISAGREE AND STRONGLY DISAGREE FROM PREVIOUS QUESTION] Which KidneyX activities, elements, features, or forms of support most contributed to the achievement of these outcomes? [MULTIPLE SELECT]

          1. [WINNERS ONLY] Prize money

          2. [WINNERS ONLY] Recognition, credibility, and visibility that was attained as a result of being selected as a winner

          3. Visibility that was attained as a result of participation in the prize competition

          4. Guidelines and structure provided by the KidneyX competition that helped shape my project

          5. Urgency created by the prize competition to formalize my project and introduce it publicly

          6. Conferences organized by KidneyX

          7. Conferences supported by KidneyX

          8. Webinars hosted by KidneyX

          9. Direct communication with program staff at KidneyX

          10. Other connections and networking opportunities that KidneyX enabled

              1. [IF YES] Please briefly describe the nature of the interaction(s) and how KidneyX enabled it. [TEXT BOX]

          11. Other

              1. [IF OTHER] Please specify. [TEXT BOX]

17. Please describe the most significant developments that have occurred for your project since submitting your application to KidneyX, and the role that KidneyX has played in those developments, if any. [TEXT BOX]

18. In retrospect, were there costs or risks of participating in KidneyX that you didn’t anticipate at the time you applied? [Y/N]

    1. [IF YES] Please explain the most significant cost and risks as well as any cost or risks that deviated from your expectations. [TEXT BOX]