Prestigious FDA award allocated to group that developed the V&V 40 standard

This award is given to groups of internal and external stakeholders that exemplify one or more of the following characteristics:

1. Superior achievement of the Agency’s mission through teamwork, partnership, shared responsibility, or fostering collaboration and coalition to achieve FDA goals.
2. Excellence in improving communication and information sharing throughout the FDA, Department, or the Federal Government.
3. Special effort or contribution resulting in significant benefits to the programs or constituents of FDA and fulfillment of FDA’s mission and the Departmental goals.

The language of the award stated that the awardees were being recognized “for exemplary performance in developing and establishing the first international standard for verification and validation of biomedical computational models for medical products”.

More specifically, the award acknowledged the successful partnership between the US FDA’s Center for Devices and Radiological Health (CDRH) and multiple stakeholders across the medical device industry to develop the ASME V&V 40-2018 Standard.

This standard outlines a risk-informed credibility assessment framework that helps an organization or team determine the level of rigor required to support using computational modeling and simulation for decision-making. The ASME V&V 40 standard has been adopted by stakeholders in the medical devices and pharmaceutical industries, both nationally and internationally.

The ASME V&V 40 standard is the first consensus standard for evaluating the predictive capability of computational models for medical devices and represents a landmark moment for the medical device modeling community and is officially recognized by the US FDA.

Among the full list of awardees that follows, we are proud to count Avicenna Alliance WG members (identified by an asterisk).

Tina Morrison, US FDA
Prasanna Hariharan, US FDA
Leonardo Angelone, NIH
Kenneth Aycock, US FDA
Andrew Bauman, US FDA
Brent Craven, US FDA
James Coburn, US FDA
Finn Donaldson, US FDA
Maureen Dreher, US FDA
Nicole Ibrahim, US FDA
Matthew Myers, US FDA
Bahram Parvinian, Lighthouse Regulatory Consulting
Prasanna Pathmanathan, US FDA
Christopher Scully, US FDA
Jason Weaver, US FDA
Charlie Yongpravat, US FDA
Zane Wyatt, US FDA
Marc Horner, ANSYS, Inc.*
Jeffrey Bischoff, Zimmer Biomet, Inc.*
Ryan Crane, ASME *
Carl Popelar, Southwest Research Institute
Brian Choules, Embry-Riddle Aeronautical University
Jeff Bodner, Medtronic, Inc.