Prize competition awardees

Form Approved

OMB No. 0990-XXXX

Exp. Date XX/XX/20XX

KidneyX Evaluation

Attachment E

KidneyX Interview Guide: Awardee

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Thank you for participating in this discussion. My name is [Interviewer Name]. I work for RTI, a research organization contracted by HHS to evaluate the Kidney Innovation Accelerator (KidneyX). The evaluation will assess the effects of KidneyX in terms of spurring innovative solutions to address kidney disease and improve outcomes for patients. The evaluation assesses participation in the prize competitions and potential longer-term outcomes related to commercialization of innovations.

The purpose of this interview is to get your perspectives as a [name of challenge] awardee.

Before we begin, I’d like to review a few key points about today’s discussion:

• Your participation is voluntary, and you can decide not to respond to a question or to stop participating in the discussion at any time.

• This conversation is one of several we will have to help inform the KidneyX evaluation.

• The RTI IRB did not need to approve this study because our conversations will inform the program and there is little to no risk for participants.

• You were selected as a key informant because you received an award for the [name of challenge] and we’d like to understand more about your experience.

• We have reserved 45 minutes for today’s discussion. So, I may have to interject at times to help us stay on topic, or to introduce a new topic. This will help us get through all the questions within the allotted time. We are happy to follow up with you on a later date if there are any topics we don’t get to today.

• [Note taker], also from RTI, is on the line and will be taking high level notes. We would like to record the session so that we can have a full record of our conversation and accurate transcript. The recording and transcript will be stored on RTI’s secure project drive.

Do we have your permission to record?

• Yes; If there is any point during the discussion that anyone would like for us to pause the recording, please just let us know.

• No

Do you have any questions before we begin?

INTRODUCTIONS

1. To start, can you please tell me a little bit about the nature of your involvement in the field of kidney health?

   • How long have you been involved in this field?

   • What are some of you or your organization’s contributions in this field?

MAIN QUESTIONS

Now I’d like to hear about your experiences around the KidneyX challenge application process.

2. What led you to decide to submit an application to this round of KidneyX?

• What information about KidneyX was important in your decision to submit an application?

• What did you anticipate would be the benefits of engaging with KidneyX?]

3. To what extent were you satisfied with the application process?

   • What aspects of the process worked well/ not as well?

• Information provided (e.g. clarity, completeness, timeliness)

• Application process

• Judging and feedback

4. What (if any) challenges did you encounter in the application process?

   • In what ways could the process be improved?

5. At the time you submitted your application, what did you consider your probability of winning the prize? What factors did you think would make you more/or less likely to win?

6. What factors made you hesitant to submit your application, if any?

7. What is your next step in pursuing your submitted idea?

8. Are you inclined to submit an application to a future KidneyX competition? Why or why not?

   • Would you recommend that other innovators interested in the kidney health domain participate in KidneyX? Why or why not?

9. Thinking about the reasons you decided to submit an application, to what extent would you say your expectations have been met?

Now I’d like to ask about how your experiences following your KidneyX award.

10. Since receiving prize funding, to what extent have you been satisfied with the guidance, consulting, support, and connections provided by KidneyX?

• What has been most valuable?

• What additional guidance, consulting, and support would you like?

11. In what ways are you making progress towards the successful development and implementation of your idea?

    • In what ways did your participation in KidneyX help you to be more successful or otherwise enhance your efforts?

12. To what extent has KidneyX accelerated innovation in your [firm/organization]? In what ways?

13. In addition to the prize money, what has been most valuable (technical & scientific guidance, business planning guidance; regulatory guidance; access to funding networks; connections with patient advocacy groups; connections with other researchers, entrepreneurs, and other) in accelerating your innovation?

14. What have been the barriers to the success of your innovation?

    • In what ways (if any) did KidneyX help to address these barriers?

15. What else could KidneyX do to accelerate innovation in your company?

Now I’d like to hear your thoughts on exploring issues related to innovation in the kidney health domain.

16. What are some examples of things that you learned about the kidney health domain in the process of preparing your submission? From whom did you learn them?

    • Any examples of regulatory issues?

    • Any examples of issues related to medical treatment reimbursement or healthcare financing?

    • Any examples related to patient preferences and needs?

17. To what extent do you feel you understand the potential barriers to commercializing your submitted idea?

    • To what degree is that due to your own research, or information provided by KidneyX or others involved in the prize competition?

    • What do you believe are the key barriers?

Now I’d like to hear about your experiences seeking funding for your innovation.

18. Have you previously sought financial support for your submitted idea?

    • Were you successful? In your view, why or why not?

    • How long have you been pursuing funding for your idea?

19. Since winning the prize, have you pursued additional financing for your submitted idea?

    • If so, what is the status of that effort?

20. Did any potential investors approach you after your award was announced?

    • If so, what was the outcome of such conversations?

Now I’d like to hear your thoughts on engagement of patients and care-partners in KidneyX.

21. In what ways have you seen patients and care-partners engaged in KidneyX?

• What roles have you seen patients and care-partners play?

22. What have you seen as the benefits of engaging patients and care-partners? Drawbacks?

23. Where has KidneyX been successful in engaging patients and care-partners?

• How has KidneyX facilitated engagement of patients and care-partners?

• How could patients and care-partners engagement have been strengthened?

24. In what ways did you engage patients or patient advocacy groups in the process of developing your application?

• When in the process of your application did you engage patient / care-partner groups?

• What did that engagement involve (i.e. single or multiple discussions, etc.)?

• What were the benefits of engaging patient groups? What were the challenges or drawbacks?

• Prior to KidneyX did your organization have experience engaging patient groups in this way?

1. In what ways have you developed or adapted your approach to reflect patient and care-partners preferences, priorities and quality of life concerns?

• What specific preferences or priorities were you working to accommodate?

• What led you to take these actions (i.e. where did you learn that these were patient or care-partner preferences or priorities?

1. How have you consulted with patients or patient advocacy groups since you received your KidneyX prize, if at all?

• In what ways has that consultation been useful or helpful?

• Do you expect to continue such consultations in the future?

SUMMARY AND WRAP UP

27. Do you have any closing thoughts to share about the topics we discussed?

28. Do you have any recommendations for KidneyX based on your experiences?

Thank you for your time and valuable feedback. Your input will help to inform the KidneyX evaluation.