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Technical Brief

Augmenting a Clinical Study With Virtual Patient Models: Food and Drug Administration and Industry Collaboration1

[+] Author and Article Information
Adam Himes, Tarek Haddad

Medtronic plc,
Mounds View, MN 55112

Dawn Bardot

Medical Device Innovation Consortium (MDIC),
St Louis Park, MN 55416

2ANSYS: Marc Horner; BD: Anita Bestelmeyer and Val Parvu; Boston Scientific: Dan Cooke; FDA: Erin Cutts, Telba Irony, Rajesh Nair, Tina Morrison, Mitchell Shein, and Laura Thompson; MDIC: Dawn Bardot; Medtronic: Tarek Haddad, Adam Himes, and Mike Johnson; and St. Jude Medical: Russ Klehn and Lydia Telep.

DOI: 10.1115/1.4033870Manuscript received March 1, 2016; final manuscript received March 17, 2016; published online August 1, 2016. Editor: William Durfee.

J. Med. Devices 10(3), 030947 (Aug 01, 2016) (2 pages) Paper No: MED-16-1136; doi: 10.1115/1.4033870 History: Received March 01, 2016; Revised March 17, 2016

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References

Haddad, T. , Himes, A. , and Campbell, M. , 2014, “ Fracture Prediction of Cardiac Lead Medical Devices Using Bayesian Networks,” Reliab. Eng. Syst. Saf., 123, pp. 145–157. [CrossRef]
FDA, 2010, “ Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials,” accessed May 21, 2015, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071121.pdf
Center for Biologics Evaluation and Research (CBER), 2015, “ Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings With FDA Staff,” U.S. Food and Drug Administration, Rockville, MD, accessed Nov. 6, 2015, http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf

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Grahic Jump Location
Fig. 1

Simulated virtual patient cohorts

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