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U.S. Department of Health and Human Services

Medical Devices

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FDA / NHLBI / NSF Workshop on Computer Methods for Medical Devices: Validation of Computer with Nonclinical Models, September 7-9, 2011

Date, Time and Location

The meeting was held on September 7-9, 2011 from 9:00 a.m. to 5:00 p.m. and an optional session (see agenda) was held on September 6, 2011 from 1:00 p.m. - 5:30 p.m. at the following location:

FDA / White Oak Campus (building 31, great room)
10903 New Hampshire Avenue
Silver Spring, MD 20993

More information about Public Meetings at the FDA White Oak Campus.

Agenda

Optional

September 6, 2011 – FDA Microstructure Modeling Session
1:00 – 1:20 Dinesh Patwardhan (FDA)
CHEMISTRY AND MATERIALS SCIENCE RESEARCH IN CDRH 
1:20 – 2:00 David Saylor (FDA)
TOWARD COMPUTER-AIDED DESIGN OF DRUG-ELUTING COATING MATERIALS 
2:00 – 2:40 Thomas Wanner (GMU)
TOPOLOGICAL QUANTIFICATION OF MICROSTRUCTURES 
2:40 – 3:00 Break
15:00 – 15:40 Christopher Forrey (FDA)
MOLECULAR DYNAMICS APPROACHES TO DETERMINING THERMODYNAMIC AND KINETIC PROPERTIES OF POLYMERIC DRUG-ELUTING COATINGS 
3:40 – 4:20 Robert Tryon (VEXTEC)
VIRTUAL SIMULATION OF MATERIAL DURABILITY 
   

Optional

September 6, 2011 – ASME V&V 40 Committee Meeting
1:00 – 7:00 Ryan Crane and Carl Popelar, Verification and Validation of Computational Modeling for Medical Devices
   

Day 1

September 7, 2012
9:00–9:15

Welcoming Remarks
Donna Lochner (Office of Science and Engineering Laboratories)
Michelle McMurry-Heath (Office of the Center Director)

Introduction of Keynote Speaker: Charles Taylor
9:15–9:55 Keynote Speaker – Peter Hunter (Auckland Bioengineering Institute)
THE DEVELOPMENT OF MODEL ENCODING STANDARDS AND MODEL REPOSITORIES 

With Q&A
9:55–10:55 State of the Art – Computational Modeling for Medical Devices
Kenneth Perry (EchoBio) – Cardiovascular Devices
Jeffrey Bischoff (Zimmer) – Orthopedic Devices

Two 20 min talks + Q&A at the end of the session
10:55–11:10 Break
11:10–12:30 Advancing Computational Models for Medical Devices
Computational Fluid Mechanics
Moderator: Charles Taylor
  1. Danny Bluestein – OPTIMIZING THE THROMBORESISTANCE OF MECHANICAL CIRCULATORY SUPPORT DEVICES– DEMONSTRATION IN A VENTRICULAR ASSIST DEVICE
  2. Mark Goodin – VALIDATION OF A COUPLED  ELECTROMAGNETCS/ COMPUTATIONAL FLUID DYNAMICS MODEL OF THE CLEVELAND CLINIC CONTINUOUS FLOW TOTAL ARTIFICIAL HEART
  3. Min Yun – SIMULATIONS OF PULSATILE FLOW THROUGH BILEAFLET MECHANICAL HEART VALVES TO ASSESS PLATELET DAMAGE
  4. Ashley Peterson – USE OF COMPUTATIONAL FLUID DYNAMICS IN A ROBUST DEVICE DESIGN CYCLE
  5. Stefano Morlacchi – MODELLING BIFURCATED CORONARY STENTING: STRUCTURAL AND FLUID DYNAMIC INVESTIGATION
  6. C. Alberto Figueroa – A COMPUTER FRAMEWORK TO EVALUATE ENDOGRAFT STABILITY: OPPORTUNITIES FOR CLINICAL VALIDATION
Six 10 min talks + Q&A at the end of the session
12:30–1:55 LUNCH
2:00–2:55 Advancing Computational Models for Medical Devices
Mathematical Models
Moderator: Christopher Forrey
  1. Daniel Burkhoff – A COMPUTER MODEL OF THE CARDIOVASCULAR SYSTEM IS USEFUL IN PREDICTING EFFECTS OF CERTAIN DEVICE AND SURGICAL THERAPIES FOR HEART FAILURE
  2. Rahul Mangharam – REAL-TIME HEART MODEL FOR IMPLANTABLE CARDIAC DEVICE VALIDATION AND VERIFICATION
  3. Robert Hester – USE OF AN INTEGRATIVE MODEL OF HUMAN PHYSIOLOGY TO UNDERSTAND PHYSIOLOGICAL RESPONSES TO CHRONIC ELECTRICAL ACTIVATION OF THE CAROTID BAROREFLEX
  4. Rami Tzafriri – STENT ELUTION RATE DETERMINES SIROLIMUS DEPOSITION AND BINDING
Four 10 min talks + Q&A at the end of the session
2:55–4:05 Advancing Computational Models for Medical Devices
Computational Solid Mechanics – Cardiovascular Devices
Moderator: Nandini Duraiswamy
  1. Francesco Migliavacca – WHICH IS THE EFFICACY OF IN VITRO TESTS IN REPRODUCING IN VIVO FATIGUE BEHAVIOUR OF NITINOL PERIPHERAL STENTS? A COMPUTATIONAL STUDY
  2. Cemil Gösku – QUANTIFICATION OF DEFORMATIONS DURING ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR USING FINITE ELEMENT SIMULATION
  3. Anamika Prasad – EFFECT OF ENDOGRAFT OVERSIZING ON LONG-TERM DEVICE STABILITY
  4. Matthieu De Beule – OPTIMIZED TREATMENT STRATEGIES FOR CORONARY BIFURCATION STENTING: INSIGHT FROM MICRO-CT VALIDATED COMPUTER MODELS
  5. Robert Tryon – INTEGRATED COMPUTATIONAL MATERIAL ENGINEERING FOR VIRTUAL LIFE MANAGEMENT
Five 10 min + Q&A at the end of the session
4:05–4:20 Break
4:20–5:20 Advancing Computational Models for Medical Devices
Computational Solid Mechanics – Orthopedic Devices
Moderator: M
  1. Tomaso Villa – FATIGUE RESISTANCE OF ORTHOPEDIC DEVICES: COMPARISON OF DIFFERENT EXPERIMENTAL CONFIGURATIONS SUGGESTED BY INTERNATIONAL STANDARDS
  2. Steven Rundell – DETERMINING THE BIOMECHANICAL ENVIRONMENT OF LUMBAR MOBILE TOTAL DISC REPLACEMENTS USING CASE-SPECIFIC FINITE ELEMENT MODELING RELATED TO RETRIEVED IMPLANTS
  3. Clare Fitzpatrick – PRE-CLINICAL EVALUATION OF KNEE REPLACEMENT DEVICES USING VALIDATED COMPUTATIONAL MODELING
  4. Marc Horner – USING PATIENT-BASED JOINT KINEMATICS TO PREDICT WEAR ON A HIP PROSTHESIS
Four 10 min + Q&A at the end of the session
5:20–6:00 Day 1 Recap & Discussion
   

Day 2

September 8, 2011

Introduction of Keynote Speaker: Laurence Grossman
9:00–9:40 Keynote Speaker – Arshad Alfoqaha (Medtronic Cardiac and Vascular Group)
EVALUATING FIXATION OF LEADLESS PACING SYSTEMS USING STATISTICAL METHODS AND PREDICTIVE ENGINEERING

With Q&A
9:40–10:40 State of the Art – Validation of Computational Studies
Carl Poplear (South West Research Institute) – Cardiovascular Devices
Melinda Harman (Clemson University) – Orthopedic Devices

Two 20 min talks + Q&A at the end of the session
10:40–10:55 Break
11:00–12:20 Best Validation Practices
Moderator: Laurence Grossman 
  1. Tim Fonte –  VALIDATION OF CFD TECHNOLOGY FOR DETERMINATION OF FRACTIONAL FLOW RESERVE: NON-INVASIVE DIAGNOSIS OF ISCHEMIA CAUSING CORONARY ARTERY DISEASE
  2. Amirhossein Arzani – IN VIVO VALIDATION OF COMPUTATIONAL QUANTIFICATION OF TURBULENCE INTENSITY IN AN AORTIC COARCTATION
  3. Samuel Hund – REDUCED ORDER MODELING OF BLOOD FLOW WITHOUT LOSS OF FIDELITY
  4. Katharine Fraser – DEVELOPMENT, VALIDATION AND APPLICATION OF A MODEL FOR HEMOLYSIS IN VENTRICULAR ASSIST DEVICES
  5. Jeffrey Holmes – COMPUTATIONAL DESIGN OF INFARCT REINFORCEMENT STRATEGIES
  6. Claudio Capelli – SYNERGIZING IN VITRO AND IN SILICO TESTS: CASE STUDY OF A NOVEL DEVICE FOR PERCUTANEOUS PULMONARY VALVE IMPLANTATION
Six 10 min + Q&A at the end of the session
12:20–1:45 LUNCH
1:50–3:00

Lessons Learned from Validation Studies
Moderator: Matthew Myers

  1. Chad Abunassar – Finite Element Analysis and Bench Testing: Clarifying Mechanical Behavior through an Integrated Approach
  2. Ramesh Marrey - DESIGN OF VASCULAR IMPLANTS FOR ACUTE STRUCTURAL INTEGRITY
  3. Samuel Hund  – EVALUATION OF SIMULATION RESULTS TO ENSURE BEST POSSIBLE OUTCOMES: A SUMMARY OF 15 YEARS EXPERIENCE
  4. Marc Horner – CARDIOVASCULAR FLOW MODELING – WE NEED TO BREAK SOME BAD HABITS
  5. Hui Jin – OPPORTUNITIES AND CHALLENGES UNCOVERED IN A PACEMAKER FEA MODEL VALIDATION
Five 10 min + Q&A at the end of the session
3:00–3:35

Updates from Standard Organizations & Consortium
Moderator: Tina Morrison

  1. ASME, V&V40 – Carl Poplear
  2. ASTM, Fatigue to Fracture – Kenneth Perry
  3. Nitinol Fatigue – John Draper
  4. ASTM, Hip Implant – John Goode
3:35–3:50 Break
3:50–5:10 FDA Session
Progress in Device Evaluation with Computational Modeling
Moderator:  Donna Lochner
FDA panel discussants: 
Maureen Dreher, Nandini Duraiswamy, Richard Gray, Nicole Ibrahim, Tina Morrison, Matthew Myers, Srinidhi Nagaraja, Jonathan Peck, Sandy Stewart, Erica Takai, Changfu Wu
5:10–5:45 Day 2 Recap & Discussion 
   

Day 3

September 9, 2011
9:00–12:00 Opening Remarks and Poster Presentations
Each non-podium author has 3 mins to present main idea of their research               
12:00–1:25 LUNCH
1:30–2:50 Data Resources and Computational Modeling Tools
Moderator: Tina Morrison
  1. Senthil Eswaran – BIORESORBABLE VASCULAR SCAFFOLD MATERIAL MODEL DEVELOPMENT: FROM IN VITRO TO IN SILICO
  2. Xiao-Yan Gong – COMPUTATIONAL CONSIDERATIONS FOR STENT NON-RADIAL FATIGUE
  3. Atul Gupta – USE OF PROBABILISTIC COMPUTER MODELING TECHNIQUES FOR ENDOVASCULAR STENT GRAFT DESIGN
  4. Songxiang Gu – DIGITAL HIGH-RESOLUTION HEART PHANTOMS
  5. Srinivasan Varahoor – COMPARISON OF THE MOTION AT THE ORIGIN OF THE LEFT SUBCLAVIAN BETWEEN PIGS AND HUMANS
  6. Alexander Nikanorov – STENT TESTING LOADING CONDITIONS IN THE FEMORAL ARTERY - CORRELATION BETWEEN CLINICAL AND IN VIVO PORCINE MODELS
  7. Brandis Keller – CFD ANALYSES OF STENTED CORONARY ARTERIES: WALL SHEAR STRESS AND NEOINTIMAL GROWTH
Four 10 min talks and Three 7 mins talks + Q&A at the end of the session
2:50–3:30 Day 3 Recap / Closing Remarks 
3:30–5:30 TOUR of the Office of Science and Engineering Laboratories 

Webcasts

Contacts

The workshop sponsors may be contacted at:

Donna R. Lochner
Acting Associate Director
Office of Science and Engineering Laboratories
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: (301) 796-6309
Fax: (301) 796-9959
e-mail: donna.lochner@fda.hhs.gov

Laurence W. Grossman, Ph.D.
Director
Division of Solid and Fluid Mechanics
Food and Drug Administration
10903 New Hampshire
Silver Spring, MD 20993
Phone: (301) 796-2502
Fax: (301)796-9934
e-mail: laurence.grossman@fda.hhs.gov

Tina M. Morrison, Ph.D.
Mechanical Engineer
Division of Cardiovascular Devices
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: (301) 796-6310
Fax: (301) 847-8114
e-mail: tina.morrison@fda.hhs.gov

J. Timothy Baldwin, Ph.D.
Program Director
Advanced Technologies & Surgery Branch
Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
Two Rockledge Centre, Room 8206
6701 Rockledge Drive
Bethesda, MD 20892-7940
Phone: (301) 435-0513
Fax: (301) 480-1335
e-mail: baldwint@nhlbi.nih.gov

Semahat S. Demir, Ph.D.
Program Director, Biomedical Engineering
Engineering Directorate
The National Science Foundation
4201 Wilson Boulevard Arlington, Virginia 22230, USA
Tel: (703) 292-5111, FIRS: (800) 877-8339 | TDD: (800) 281-8749
email: sdemir@nsf.gov

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