MDIC CM&S 5-Year Strategic Planning: Landscape Study

The Medical Device Innovation Consortium (MDIC) is the first public-private partnership created to advance the medical device regulatory process for patient benefit. MDIC was formed in 2012 to bring the FDA and industry together to share vital knowledge that can help bring safe, affordable, and effective devices to patients and providers more quickly.

The purpose of the survey is to gather input on a revised 5-year strategic roadmap for the MDIC Computational Modeling and Simulation (CM&S) Program which is built on a foundation of validation requirements demonstrating regulatory grade simulation results. This roadmap will chart the course of milestones to realize the MDIC CM&S vision of quick and predictable access for patients to innovative, yet, safe and effective technologies enabled by CM&S evidence.

In addition, MDIC is partnering with FDA, in pursuit of our common goal to establish Top 10 Considerations for Good Simulation Practices (GSP). Through this survey hope to gather stakeholder feedback to narrow down simple best practices to guide the use of modeling and simulation in health technologies.

Please provide as much commentary as needed to identify your needs. Participation in this survey is anonymous. The survey has 27 questions and will take approximately 20 minutes. Questions that have an asterisk(*) at the beginning require an answer before the survey can be submitted.

Please provide details about the organization you represent.

Question Title

* 1. Please identify your organization type.

Industry, pre-revenue

Industry, global revenue less than $1 Billion

Industry, global revenue greater than $1 Billion

Academic Institution

Non-profit

Government - Research

Government - Regulatory

Other

Comments

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* 2. What is your primary field of academic/professional training?

Computer science

Engineering

Formal sciences (e.g. mathematics, statistics)

Healthcare

Life sciences (e.g. biology)

Physical sciences (e.g. chemistry, physics)

Social sciences (e.g psychology, sociology)

Other (please specify)

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* 3. Is your organization an MDIC member? If you are unsure, please refer to our list of members.

Yes

The following are general questions about your experience with Computational Modeling and Simulation (CM&S):

Question Title

* 4. How familiar are you with computational modeling and simulation?

Not familiar at all

Familiar with no hands-on experience with CM&S

Less than 5 years of hands-on experience in developing and/or using CM&S

Between 5 and 10 years of hands-on experience in developing and/or using CM&S

More than 10 years of hands-on experience in developing and/or using CM&S

Familiar with and use modeling and simulation data for decision-making, but currently not developing/or using CM&S

Question Title

* 5. Where does your organization use CM&S today (select all that apply)?

New Product Discovery

Clinical Trial Development and Conditions

Manufacturing

Field Surveillance and Root Cause Analysis

Reimbursement (e.g. supporting data)

Other, please comment

Comments

Question Title

* 6. How does your organization use CM&S (select all that apply)?

To develop/optimize the device

To evaluate device performance

As an embedded component for the device

As the medical device

As a surrogate test environment used to test the physical device

To identify clinically relevant uses cases for bench testing inputs / configuration / conditions

To product sustainment / failure analysis / design change

Other, please comment

Comments

Question Title

* 7. How do you leverage CM&S resources (experts, software, methods, etc.)?

Available within my organization

Utilize consultants regularly

Rely on expertise of software companies

Personally apply CM&S regularly

Personally utilize when specifically required

Other (please specify)

Question Title

* 8. What is the primary reason for your interaction with modeling and simulation (M&S) data in health technologies?

To support clinical research

To support scientific research

To support product development

To support regulatory approval

To support medical training

To support clinical decision making

Not using nor interested in M&S

Other (please specify)

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* 9. What type of business case does your organization use for CM&S (select all that apply)?

Productivity

Performance

Quality

Other, please comment

Comments

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* 10. Please describe your organization’s CM&S strategy.

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* 11. Which the following do you feel are obstacles in using CM&S? (select all that apply)

Expertise required for creating and running CM&S

Cost required for creating and running CM&S

Uncertainty in what is expected by regulatory affairs personnel inside my organization when using CM&S

Uncertainty in what is expected by regulatory bodies when using CM&S

Science associated with CM&S in my field is not mature enough

Business case not well defined

Other, please comment

Comments

Question Title

* 12. Within the next five years, what do you feel are the most immediate applications for CM&S in FDA submissions that would have the most positive impact?

Bench Testing (e.g. determine worst case for bench testing, define improved bench testing, replace an outdated bench test)

In-Vivo testing: reduce/replace/refine animal testing

In-Vivo testing: reduce/replace/refine clinical trial testing

Expanding indications for use

Down-classifying devices

Supporting CAPAs

Manufacturability and distribution

Other, please comment (e.g. areas such as pediatric devices)

Comments

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* 13. Where can CM&S be most beneficial?

Early Feasibility Studies

510k Submission

PMA Submission

Device Development

Device Discovery

Device manufacturing

Post-market assessments

Other, please comment

Comments

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* 14. What is your most pressing problem that CM&S should address?

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* 15. How important are the following simple rules for credible practice of CM&S in health technologies?

We recognize the importance of all the rules presented below. However, our goal is to identify relative importance levels, in particular, the MOST important simple rules of credible practice. As a result, please be sure to evenly distribute your responses, e.g., no more than 7 of your responses should have a score of 5 (Extremely Important). You may want to review the entire list first before providing your input.

	Least Important	Less Importance	Moderately Important	Very Important	Extremely Important	N/A
Inputs to the computational model are traceable.	Inputs to the computational model are traceable. Least Important	Inputs to the computational model are traceable. Less Importance	Inputs to the computational model are traceable. Moderately Important	Inputs to the computational model are traceable. Very Important	Inputs to the computational model are traceable. Extremely Important	Inputs to the computational model are traceable. N/A
Use simulation software with established reliability.	Use simulation software with established reliability. Least Important	Use simulation software with established reliability. Less Importance	Use simulation software with established reliability. Moderately Important	Use simulation software with established reliability. Very Important	Use simulation software with established reliability. Extremely Important	Use simulation software with established reliability. N/A
Provide clear descriptions of limitations.	Provide clear descriptions of limitations. Least Important	Provide clear descriptions of limitations. Less Importance	Provide clear descriptions of limitations. Moderately Important	Provide clear descriptions of limitations. Very Important	Provide clear descriptions of limitations. Extremely Important	Provide clear descriptions of limitations. N/A
Disseminate whenever and whatever is possible, e.g., source code, test suite, data.	Disseminate whenever and whatever is possible, e.g., source code, test suite, data. Least Important	Disseminate whenever and whatever is possible, e.g., source code, test suite, data. Less Importance	Disseminate whenever and whatever is possible, e.g., source code, test suite, data. Moderately Important	Disseminate whenever and whatever is possible, e.g., source code, test suite, data. Very Important	Disseminate whenever and whatever is possible, e.g., source code, test suite, data. Extremely Important	Disseminate whenever and whatever is possible, e.g., source code, test suite, data. N/A
Validate the M&S activity within the context of use.	Validate the M&S activity within the context of use. Least Important	Validate the M&S activity within the context of use. Less Importance	Validate the M&S activity within the context of use. Moderately Important	Validate the M&S activity within the context of use. Very Important	Validate the M&S activity within the context of use. Extremely Important	Validate the M&S activity within the context of use. N/A
Explicitly identify experimental scenarios that illustrate when, why, and how the M&S is false or not applicable.	Explicitly identify experimental scenarios that illustrate when, why, and how the M&S is false or not applicable. Least Important	Explicitly identify experimental scenarios that illustrate when, why, and how the M&S is false or not applicable. Less Importance	Explicitly identify experimental scenarios that illustrate when, why, and how the M&S is false or not applicable. Moderately Important	Explicitly identify experimental scenarios that illustrate when, why, and how the M&S is false or not applicable. Very Important	Explicitly identify experimental scenarios that illustrate when, why, and how the M&S is false or not applicable. Extremely Important	Explicitly identify experimental scenarios that illustrate when, why, and how the M&S is false or not applicable. N/A
Define the context in which the M&S is intended to be used.	Define the context in which the M&S is intended to be used. Least Important	Define the context in which the M&S is intended to be used. Less Importance	Define the context in which the M&S is intended to be used. Moderately Important	Define the context in which the M&S is intended to be used. Very Important	Define the context in which the M&S is intended to be used. Extremely Important	Define the context in which the M&S is intended to be used. N/A
Make it easy for anyone to repeat and/or falsify your results.	Make it easy for anyone to repeat and/or falsify your results. Least Important	Make it easy for anyone to repeat and/or falsify your results. Less Importance	Make it easy for anyone to repeat and/or falsify your results. Moderately Important	Make it easy for anyone to repeat and/or falsify your results. Very Important	Make it easy for anyone to repeat and/or falsify your results. Extremely Important	Make it easy for anyone to repeat and/or falsify your results. N/A
Verify the M&S processes within context of use.	Verify the M&S processes within context of use. Least Important	Verify the M&S processes within context of use. Less Importance	Verify the M&S processes within context of use. Moderately Important	Verify the M&S processes within context of use. Very Important	Verify the M&S processes within context of use. Extremely Important	Verify the M&S processes within context of use. N/A
Document the development and use of M&S appropriately.	Document the development and use of M&S appropriately. Least Important	Document the development and use of M&S appropriately. Less Importance	Document the development and use of M&S appropriately. Moderately Important	Document the development and use of M&S appropriately. Very Important	Document the development and use of M&S appropriately. Extremely Important	Document the development and use of M&S appropriately. N/A
Engage potential end-user base.	Engage potential end-user base. Least Important	Engage potential end-user base. Less Importance	Engage potential end-user base. Moderately Important	Engage potential end-user base. Very Important	Engage potential end-user base. Extremely Important	Engage potential end-user base. N/A
Use appropriate data, e.g., for input, validation, verification.	Use appropriate data, e.g., for input, validation, verification. Least Important	Use appropriate data, e.g., for input, validation, verification. Less Importance	Use appropriate data, e.g., for input, validation, verification. Moderately Important	Use appropriate data, e.g., for input, validation, verification. Very Important	Use appropriate data, e.g., for input, validation, verification. Extremely Important	Use appropriate data, e.g., for input, validation, verification. N/A
Define the M&S evaluation metrics in advance.	Define the M&S evaluation metrics in advance. Least Important	Define the M&S evaluation metrics in advance. Less Importance	Define the M&S evaluation metrics in advance. Moderately Important	Define the M&S evaluation metrics in advance. Very Important	Define the M&S evaluation metrics in advance. Extremely Important	Define the M&S evaluation metrics in advance. N/A
Document your code.	Document your code. Least Important	Document your code. Less Importance	Document your code. Moderately Important	Document your code. Very Important	Document your code. Extremely Important	Document your code. N/A
Make the M&S results reproducible.	Make the M&S results reproducible. Least Important	Make the M&S results reproducible. Less Importance	Make the M&S results reproducible. Moderately Important	Make the M&S results reproducible. Very Important	Make the M&S results reproducible. Extremely Important	Make the M&S results reproducible. N/A
Use version control, i.e., to track different revisions of the model.	Use version control, i.e., to track different revisions of the model. Least Important	Use version control, i.e., to track different revisions of the model. Less Importance	Use version control, i.e., to track different revisions of the model. Moderately Important	Use version control, i.e., to track different revisions of the model. Very Important	Use version control, i.e., to track different revisions of the model. Extremely Important	Use version control, i.e., to track different revisions of the model. N/A
Adopt and promote standard operating procedures.	Adopt and promote standard operating procedures. Least Important	Adopt and promote standard operating procedures. Less Importance	Adopt and promote standard operating procedures. Moderately Important	Adopt and promote standard operating procedures. Very Important	Adopt and promote standard operating procedures. Extremely Important	Adopt and promote standard operating procedures. N/A
Report appropriately (i.e., to enable reproducibility), to assess reliability, and to establish accountability.	Report appropriately (i.e., to enable reproducibility), to assess reliability, and to establish accountability. Least Important	Report appropriately (i.e., to enable reproducibility), to assess reliability, and to establish accountability. Less Importance	Report appropriately (i.e., to enable reproducibility), to assess reliability, and to establish accountability. Moderately Important	Report appropriately (i.e., to enable reproducibility), to assess reliability, and to establish accountability. Very Important	Report appropriately (i.e., to enable reproducibility), to assess reliability, and to establish accountability. Extremely Important	Report appropriately (i.e., to enable reproducibility), to assess reliability, and to establish accountability. N/A
Perform numerical error estimation/quantification within context of use.	Perform numerical error estimation/quantification within context of use. Least Important	Perform numerical error estimation/quantification within context of use. Less Importance	Perform numerical error estimation/quantification within context of use. Moderately Important	Perform numerical error estimation/quantification within context of use. Very Important	Perform numerical error estimation/quantification within context of use. Extremely Important	Perform numerical error estimation/quantification within context of use. N/A
Perform uncertainty estimation/quantification within context of use.	Perform uncertainty estimation/quantification within context of use. Least Important	Perform uncertainty estimation/quantification within context of use. Less Importance	Perform uncertainty estimation/quantification within context of use. Moderately Important	Perform uncertainty estimation/quantification within context of use. Very Important	Perform uncertainty estimation/quantification within context of use. Extremely Important	Perform uncertainty estimation/quantification within context of use. N/A
Follow discipline-specific guidelines and standards whenever possible.	Follow discipline-specific guidelines and standards whenever possible. Least Important	Follow discipline-specific guidelines and standards whenever possible. Less Importance	Follow discipline-specific guidelines and standards whenever possible. Moderately Important	Follow discipline-specific guidelines and standards whenever possible. Very Important	Follow discipline-specific guidelines and standards whenever possible. Extremely Important	Follow discipline-specific guidelines and standards whenever possible. N/A
Develop the M&S with the end-user in mind.	Develop the M&S with the end-user in mind. Least Important	Develop the M&S with the end-user in mind. Less Importance	Develop the M&S with the end-user in mind. Moderately Important	Develop the M&S with the end-user in mind. Very Important	Develop the M&S with the end-user in mind. Extremely Important	Develop the M&S with the end-user in mind. N/A
Conform to discipline-specific standards.	Conform to discipline-specific standards. Least Important	Conform to discipline-specific standards. Less Importance	Conform to discipline-specific standards. Moderately Important	Conform to discipline-specific standards. Very Important	Conform to discipline-specific standards. Extremely Important	Conform to discipline-specific standards. N/A
Use consistent terminology or define your terminology.	Use consistent terminology or define your terminology. Least Important	Use consistent terminology or define your terminology. Less Importance	Use consistent terminology or define your terminology. Moderately Important	Use consistent terminology or define your terminology. Very Important	Use consistent terminology or define your terminology. Extremely Important	Use consistent terminology or define your terminology. N/A
Perform sensitivity analysis within the context of use.	Perform sensitivity analysis within the context of use. Least Important	Perform sensitivity analysis within the context of use. Less Importance	Perform sensitivity analysis within the context of use. Moderately Important	Perform sensitivity analysis within the context of use. Very Important	Perform sensitivity analysis within the context of use. Extremely Important	Perform sensitivity analysis within the context of use. N/A
Disclose conflict of interests.	Disclose conflict of interests. Least Important	Disclose conflict of interests. Less Importance	Disclose conflict of interests. Moderately Important	Disclose conflict of interests. Very Important	Disclose conflict of interests. Extremely Important	Disclose conflict of interests. N/A
Explicitly list limitations of the M&S.	Explicitly list limitations of the M&S. Least Important	Explicitly list limitations of the M&S. Less Importance	Explicitly list limitations of the M&S. Moderately Important	Explicitly list limitations of the M&S. Very Important	Explicitly list limitations of the M&S. Extremely Important	Explicitly list limitations of the M&S. N/A
Be a discipline-specific example of good practice.	Be a discipline-specific example of good practice. Least Important	Be a discipline-specific example of good practice. Less Importance	Be a discipline-specific example of good practice. Moderately Important	Be a discipline-specific example of good practice. Very Important	Be a discipline-specific example of good practice. Extremely Important	Be a discipline-specific example of good practice. N/A
Use credible, e.g. verified, solvers (code, software, applications).	Use credible, e.g. verified, solvers (code, software, applications). Least Important	Use credible, e.g. verified, solvers (code, software, applications). Less Importance	Use credible, e.g. verified, solvers (code, software, applications). Moderately Important	Use credible, e.g. verified, solvers (code, software, applications). Very Important	Use credible, e.g. verified, solvers (code, software, applications). Extremely Important	Use credible, e.g. verified, solvers (code, software, applications). N/A
Provide examples of M&S use.	Provide examples of M&S use. Least Important	Provide examples of M&S use. Less Importance	Provide examples of M&S use. Moderately Important	Provide examples of M&S use. Very Important	Provide examples of M&S use. Extremely Important	Provide examples of M&S use. N/A
Learn from specialized and broadly applicable guidelines for good practice.	Learn from specialized and broadly applicable guidelines for good practice. Least Important	Learn from specialized and broadly applicable guidelines for good practice. Less Importance	Learn from specialized and broadly applicable guidelines for good practice. Moderately Important	Learn from specialized and broadly applicable guidelines for good practice. Very Important	Learn from specialized and broadly applicable guidelines for good practice. Extremely Important	Learn from specialized and broadly applicable guidelines for good practice. N/A
Provide user instructions whenever possible and applicable.	Provide user instructions whenever possible and applicable. Least Important	Provide user instructions whenever possible and applicable. Less Importance	Provide user instructions whenever possible and applicable. Moderately Important	Provide user instructions whenever possible and applicable. Very Important	Provide user instructions whenever possible and applicable. Extremely Important	Provide user instructions whenever possible and applicable. N/A
Use data that can be traced back to the origin of source.	Use data that can be traced back to the origin of source. Least Important	Use data that can be traced back to the origin of source. Less Importance	Use data that can be traced back to the origin of source. Moderately Important	Use data that can be traced back to the origin of source. Very Important	Use data that can be traced back to the origin of source. Extremely Important	Use data that can be traced back to the origin of source. N/A
Make the M&S code readable.	Make the M&S code readable. Least Important	Make the M&S code readable. Less Importance	Make the M&S code readable. Moderately Important	Make the M&S code readable. Very Important	Make the M&S code readable. Extremely Important	Make the M&S code readable. N/A
Get the M&S reviewed by independent users, developers, and members of the intended stakeholder community.	Get the M&S reviewed by independent users, developers, and members of the intended stakeholder community. Least Important	Get the M&S reviewed by independent users, developers, and members of the intended stakeholder community. Less Importance	Get the M&S reviewed by independent users, developers, and members of the intended stakeholder community. Moderately Important	Get the M&S reviewed by independent users, developers, and members of the intended stakeholder community. Very Important	Get the M&S reviewed by independent users, developers, and members of the intended stakeholder community. Extremely Important	Get the M&S reviewed by independent users, developers, and members of the intended stakeholder community. N/A

Question Title

* 16. Please provide your level of agreement with the following statements.

	Strongly Disagree	Disagree	Agree	Strongly agree	No basis to judge
Modeling and simulation can reduce the time to market for my product.	Modeling and simulation can reduce the time to market for my product. Strongly Disagree	Modeling and simulation can reduce the time to market for my product. Disagree	Modeling and simulation can reduce the time to market for my product. Agree	Modeling and simulation can reduce the time to market for my product. Strongly agree	Modeling and simulation can reduce the time to market for my product. No basis to judge
Modeling and simulation can reduce the risk of post market complications.	Modeling and simulation can reduce the risk of post market complications. Strongly Disagree	Modeling and simulation can reduce the risk of post market complications. Disagree	Modeling and simulation can reduce the risk of post market complications. Agree	Modeling and simulation can reduce the risk of post market complications. Strongly agree	Modeling and simulation can reduce the risk of post market complications. No basis to judge
FDA supports the use of modeling and simulation in the regulatory evaluation of health technologies.	FDA supports the use of modeling and simulation in the regulatory evaluation of health technologies. Strongly Disagree	FDA supports the use of modeling and simulation in the regulatory evaluation of health technologies. Disagree	FDA supports the use of modeling and simulation in the regulatory evaluation of health technologies. Agree	FDA supports the use of modeling and simulation in the regulatory evaluation of health technologies. Strongly agree	FDA supports the use of modeling and simulation in the regulatory evaluation of health technologies. No basis to judge
FDA accepts data from modeling and simulation to support regulatory decision-making.	FDA accepts data from modeling and simulation to support regulatory decision-making. Strongly Disagree	FDA accepts data from modeling and simulation to support regulatory decision-making. Disagree	FDA accepts data from modeling and simulation to support regulatory decision-making. Agree	FDA accepts data from modeling and simulation to support regulatory decision-making. Strongly agree	FDA accepts data from modeling and simulation to support regulatory decision-making. No basis to judge
Our organization is using modeling and simulation technologies to enhance our business processes.	Our organization is using modeling and simulation technologies to enhance our business processes. Strongly Disagree	Our organization is using modeling and simulation technologies to enhance our business processes. Disagree	Our organization is using modeling and simulation technologies to enhance our business processes. Agree	Our organization is using modeling and simulation technologies to enhance our business processes. Strongly agree	Our organization is using modeling and simulation technologies to enhance our business processes. No basis to judge
We are using modeling and simulation internal to our organization but are not submitting it our regulatory applications to the FDA.	We are using modeling and simulation internal to our organization but are not submitting it our regulatory applications to the FDA. Strongly Disagree	We are using modeling and simulation internal to our organization but are not submitting it our regulatory applications to the FDA. Disagree	We are using modeling and simulation internal to our organization but are not submitting it our regulatory applications to the FDA. Agree	We are using modeling and simulation internal to our organization but are not submitting it our regulatory applications to the FDA. Strongly agree	We are using modeling and simulation internal to our organization but are not submitting it our regulatory applications to the FDA. No basis to judge
In the future, data used to support health technologies will come more from computational modeling and simulation than from other data sources (e.g., animal studies, bench top studies)	In the future, data used to support health technologies will come more from computational modeling and simulation than from other data sources (e.g., animal studies, bench top studies) Strongly Disagree	In the future, data used to support health technologies will come more from computational modeling and simulation than from other data sources (e.g., animal studies, bench top studies) Disagree	In the future, data used to support health technologies will come more from computational modeling and simulation than from other data sources (e.g., animal studies, bench top studies) Agree	In the future, data used to support health technologies will come more from computational modeling and simulation than from other data sources (e.g., animal studies, bench top studies) Strongly agree	In the future, data used to support health technologies will come more from computational modeling and simulation than from other data sources (e.g., animal studies, bench top studies) No basis to judge
Our organization knows what is expected to use modeling and simulation data in regulatory submissions.	Our organization knows what is expected to use modeling and simulation data in regulatory submissions. Strongly Disagree	Our organization knows what is expected to use modeling and simulation data in regulatory submissions. Disagree	Our organization knows what is expected to use modeling and simulation data in regulatory submissions. Agree	Our organization knows what is expected to use modeling and simulation data in regulatory submissions. Strongly agree	Our organization knows what is expected to use modeling and simulation data in regulatory submissions. No basis to judge
FDA will provide useful guidance on expectations for modeling and simulation plans provided and reviewed during the presubmission process.	FDA will provide useful guidance on expectations for modeling and simulation plans provided and reviewed during the presubmission process. Strongly Disagree	FDA will provide useful guidance on expectations for modeling and simulation plans provided and reviewed during the presubmission process. Disagree	FDA will provide useful guidance on expectations for modeling and simulation plans provided and reviewed during the presubmission process. Agree	FDA will provide useful guidance on expectations for modeling and simulation plans provided and reviewed during the presubmission process. Strongly agree	FDA will provide useful guidance on expectations for modeling and simulation plans provided and reviewed during the presubmission process. No basis to judge

Other (please include any comments you have on options disagreed with above):

Question Title

* 17. What would be most useful to you when evaluating the success of CM&S over the next five years?

I do not feel that a specific metric is needed to evaluate CM&S success. Having periodic meetings and regular conference calls to facilitate communications would be enough for me.

I would measure success based how my interactions with FDA fare over the next three years with our IDE, PMA, and 510(K) submissions. If my company is able to use CM&S to support these interactions, I would feel that CM&S would be deemed a successful project and I would continue to support it .

I would like more objective measurements that show that there is a tangible improvement in the time to gain approval or clearance of IDE, PMA, and 510(k) applications, based on the removal of mutually identified barriers and enhanced effort leading to collection and submission of high quality data.

I would measure success by assessing the quality of the products brought to market, reduction in post-market product issues, and other stakeholder feedback

Other, please comment

Comments

Question Title

* 18. Please provide any additional comments, practices, or thoughts you would like us to consider as we work toward establishing common guidelines for implementation of CM&S in health technologies.

The following relates to the concept of a Mock Submission.
MDIC can facilitate mock submissions to demonstrate the thought process, evidence, and documentation needed for a model to be used as regulatory grade evidence

Question Title

* 19. Identify potential devices types and how modeling would serve a significant role in a mock submission (510k, IDE, PMA)

In order to support faster, more efficient development and regulatory evaluation of medical devices, FDA issued draft guidance in 2013 entitled: “Medical Device Development Tools” which outlines a proposed voluntary process for evaluating (qualifying) clinical and nonclinical tools for measuring device function, biomarkers and clinical outcomes – Medical Device Development Tools (MDDT). Examples of potential MDDT which might be eligible for qualification include patient reported outcome rating scales, such as those for pain or improved mobility, clearly defined clinical outcomes used as a measure of benefit, such as heart-failure related hospitalization, and nonclinical tools such as material phantoms and simulations to evaluate imaging devices. Transparency about such tools which FDA qualifies and expects can be relied upon in assessing safety and effectiveness of medical devices, could enable faster development and availability of medical devices.

The following questions are about your opinion on FDA qualification of medical device development tools:

Question Title

* 20. Would products in your company’s portfolio benefit from FDA-qualified MDDTs which FDA/CDRH viewers should accept for the qualified context of use without the need to reconfirm the suitability and utility of the MDDT when used in a CDRH regulatory submission?

Yes, my company would benefit from this.

No, my company would not benefit from this.

Question Title

* 21. If yes to 17, which of the following describes your current views on FDA qualification of such tools:

I would consider participating in consortia efforts to develop suitable evidence or consensus opinion to support MDDT qualification by FDA.

I would support other parties (such as professional societies or disease groups) supporting efforts to develop evidence or consensus opinion to support MDDT qualification by FDA.

Other, please provide comments below.

Question Title

* 22. If no to 17, please provide a comment about regulatory science tool(s) that will be valuable to streamline device development and regulatory evaluation of novel or innovative technologies.

The following is related to the concept of a Library or Repository for Models, Inputs, and Validation Data:

Question Title

* 23. Do you currently have data that your organization would be willing to share to an open database to improve CM&S and validation?

Yes

Question Title

* 24. Do you currently have models that your company would be willing to share to an open database to improve CM&S and validation?

Yes

Please provide a short description of the models or reasons you would share

Please answer the following questions as they relate directly to MDIC's CM&S program.

Question Title

* 25. How familiar are you with MDIC and its mission?

Very familiar

Familiar

Somewhat familiar

Not familiar

Comments

Question Title

* 26. Please rank your top three priorities for MDIC’s CM&S project.

	First Choice	Second Choice	Third Choice
Creating collaborations across the MDIC community and academia to advance the use of CM&S in Regulatory Science	Creating collaborations across the MDIC community and academia to advance the use of CM&S in Regulatory Science First Choice	Creating collaborations across the MDIC community and academia to advance the use of CM&S in Regulatory Science Second Choice	Creating collaborations across the MDIC community and academia to advance the use of CM&S in Regulatory Science Third Choice
Holding workshops and meetings to highlight, educate, and discuss the use of CM&S in Regulatory Science	Holding workshops and meetings to highlight, educate, and discuss the use of CM&S in Regulatory Science First Choice	Holding workshops and meetings to highlight, educate, and discuss the use of CM&S in Regulatory Science Second Choice	Holding workshops and meetings to highlight, educate, and discuss the use of CM&S in Regulatory Science Third Choice
In partnership with standards determining organizations, leveraging the breadth of the MDIC membership to identify CM&S best practices	In partnership with standards determining organizations, leveraging the breadth of the MDIC membership to identify CM&S best practices First Choice	In partnership with standards determining organizations, leveraging the breadth of the MDIC membership to identify CM&S best practices Second Choice	In partnership with standards determining organizations, leveraging the breadth of the MDIC membership to identify CM&S best practices Third Choice
Demonstrating the use of CM&S Validation Requirements	Demonstrating the use of CM&S Validation Requirements First Choice	Demonstrating the use of CM&S Validation Requirements Second Choice	Demonstrating the use of CM&S Validation Requirements Third Choice
Identifying areas for research and research funding	Identifying areas for research and research funding First Choice	Identifying areas for research and research funding Second Choice	Identifying areas for research and research funding Third Choice
Planning and creating a library/repository for CM&S inputs, models, and validation experiment results	Planning and creating a library/repository for CM&S inputs, models, and validation experiment results First Choice	Planning and creating a library/repository for CM&S inputs, models, and validation experiment results Second Choice	Planning and creating a library/repository for CM&S inputs, models, and validation experiment results Third Choice
Envisioning methods to qualify CM&S as a medical device development tool (MDDT)	Envisioning methods to qualify CM&S as a medical device development tool (MDDT) First Choice	Envisioning methods to qualify CM&S as a medical device development tool (MDDT) Second Choice	Envisioning methods to qualify CM&S as a medical device development tool (MDDT) Third Choice
Creating whitepapers to inform the industry and FDA on CM&S and its applicability in specific fields of application	Creating whitepapers to inform the industry and FDA on CM&S and its applicability in specific fields of application First Choice	Creating whitepapers to inform the industry and FDA on CM&S and its applicability in specific fields of application Second Choice	Creating whitepapers to inform the industry and FDA on CM&S and its applicability in specific fields of application Third Choice
Facilitating round robins to demonstrate and improve repeatability and reproducibility of CM&S	Facilitating round robins to demonstrate and improve repeatability and reproducibility of CM&S First Choice	Facilitating round robins to demonstrate and improve repeatability and reproducibility of CM&S Second Choice	Facilitating round robins to demonstrate and improve repeatability and reproducibility of CM&S Third Choice
Other, please comment	Other, please comment First Choice	Other, please comment Second Choice	Other, please comment Third Choice

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Question Title

* 27. MDIC is planning to hold an event to debrief the survey findings and continue its strategic plans in the CM&S. To help us identify which break-out session topics are most relevant, please identify the topics you would like to have as break-out session themes (select your top three)

	First Choice	Second Choice	Third Choice
Cardiology: Leads, human hearts, valves etc	Cardiology: Leads, human hearts, valves etc First Choice	Cardiology: Leads, human hearts, valves etc Second Choice	Cardiology: Leads, human hearts, valves etc Third Choice
Orthopedics	Orthopedics First Choice	Orthopedics Second Choice	Orthopedics Third Choice
Additive manufacturing for medical devices	Additive manufacturing for medical devices First Choice	Additive manufacturing for medical devices Second Choice	Additive manufacturing for medical devices Third Choice
Image segmentation, analysis, and reconstruction	Image segmentation, analysis, and reconstruction First Choice	Image segmentation, analysis, and reconstruction Second Choice	Image segmentation, analysis, and reconstruction Third Choice
Repository for models, inputs, validation data, model qualification	Repository for models, inputs, validation data, model qualification First Choice	Repository for models, inputs, validation data, model qualification Second Choice	Repository for models, inputs, validation data, model qualification Third Choice
Biomaterials and/or tissue manufacturing	Biomaterials and/or tissue manufacturing First Choice	Biomaterials and/or tissue manufacturing Second Choice	Biomaterials and/or tissue manufacturing Third Choice
MR heating	MR heating First Choice	MR heating Second Choice	MR heating Third Choice
Blood damage modeling	Blood damage modeling First Choice	Blood damage modeling Second Choice	Blood damage modeling Third Choice
Combining bench and simulation to impact/inform/limit clinical trials	Combining bench and simulation to impact/inform/limit clinical trials First Choice	Combining bench and simulation to impact/inform/limit clinical trials Second Choice	Combining bench and simulation to impact/inform/limit clinical trials Third Choice
Business use case for CM&S and metrics	Business use case for CM&S and metrics First Choice	Business use case for CM&S and metrics Second Choice	Business use case for CM&S and metrics Third Choice
Tissue Characterization	Tissue Characterization First Choice	Tissue Characterization Second Choice	Tissue Characterization Third Choice
Diagnostics	Diagnostics First Choice	Diagnostics Second Choice	Diagnostics Third Choice
Virtual prototyping: 3D data display/interaction/manipulation and open data standards to facilitate this	Virtual prototyping: 3D data display/interaction/manipulation and open data standards to facilitate this First Choice	Virtual prototyping: 3D data display/interaction/manipulation and open data standards to facilitate this Second Choice	Virtual prototyping: 3D data display/interaction/manipulation and open data standards to facilitate this Third Choice
Uncertainty quantification (UQ) in CM&S	Uncertainty quantification (UQ) in CM&S First Choice	Uncertainty quantification (UQ) in CM&S Second Choice	Uncertainty quantification (UQ) in CM&S Third Choice
Neuromodulation	Neuromodulation First Choice	Neuromodulation Second Choice	Neuromodulation Third Choice
Harmonized good simulation practices (GSP)	Harmonized good simulation practices (GSP) First Choice	Harmonized good simulation practices (GSP) Second Choice	Harmonized good simulation practices (GSP) Third Choice
Other, please comment	Other, please comment First Choice	Other, please comment Second Choice	Other, please comment Third Choice

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