|Jeffrey Ballyns, Ph.D.|
Mammography Ultrasound and Imaging Software/Division of Radiological Health/CDRH
Multi-Reader Multi-Center Clinical Studies, Shearwave Elastography, Computer aided Detection software, Computer Aided Diagnosis software, and 3D Printing.
Proposed Research Project for FDA Commissioner's Fellow
Generate a comprehensive list and SOP of acceptable Clinical reader study designs and develop a flow chart to aid in determination for acceptable ground truth in reader studies. This project would also explore different statistical analysis methods and provide a list of recommended analysis tools and also list statistical evaluation techniques that should be avoided and the rational why. This project will utilize the FDA SSED database to gather information from previously approved devices as well as lean on the expertise of those in OSEL/DIDSR, OSB/DB, and OIR/DMQS. This two years project will start by consolidating existing studies for devices the FDA has approve for DBT and Breast CADe devices and then branch out to other diseases and imaging modalities. This should aid in providing a basis and future guide to handle new submissions in the future.
- Coursework in Biostatistics and medical diagnostic imaging
- Familiarity with multi-reader multi-center studies (ideally, but not required to have participated in conducting one)
- Experience with working on large teams and integrating information from multiple sources
- Good publication record
- Physics or engineering background
Selected Recent Publications
1. Ballyns JJ and Bonassar LJ. “The Effect of Dynamic Compression on Matrix Production and Mechanical Properties of Anatomically Shaped Tissue Engineered Menisci.” J Biomech. 2010; 3: 509-16.
2. Ballyns JJ, Doran RJ, Archer SD, and Bonassar LJ. “An Introduction to Tissue Engineering using Hydrogels.” Science Scope. 2011; 35: 50-6
3. Ballyns JJ, Shah JP, Hammond J, Gebreab T, Gerber LH, Sikdar S. “Objective Ultrasonic Measures for Characterizing Myofascial Trigger Points Associated with Cervical Pain.” J Ultrasound Med. 2011; 30: 1331-40.
4. Ballyns JJ, Turo D, Otto P, Shah JP, Hammond J, Gebreab T, Gerber LH, Sikdar S. “Office-based Elastography Technique for Quantifying Mechanical Properties of Skeletal Muscle.” J Ultrasound Med. 2012; 31: 1209-19.
5. Puetzer JL, Brown BN, Ballyns JJ, Bonassar LJ. “The Effect of IGF-I on Anatomically Shaped Tissue-Engineered Menisci.” Tissue Eng Part A. 2013; 19: 1443-50.