Device Development from A to D: Getting on the same page to improve efficiency

A unique educational event centered on obligatory attendee participation

Proposed Goals:

  1. To describe the process of general device development from design to post-market assessment
  2. To better understand the clinical and engineering challenges with device development
  3. To identify clinical, engineering and regulatory needs required for device development
8:00 AM Registration Opens
Continental Breakfast
8:30 AM Introduction
Matthew Eagleton, MD
Dorothy Abel
8:40 AM

Update on progress from Greenberg Stent Summit 2017
Kelly Emerton, PhD and Eric Roselli, MD


Update on FDA Biocompatibility
Robert Allen, PhD

9:00- 11:25 AM Session 1: Design (General Device Development)
9:00 AM Device Design: How it gets started, feasibility, budget, timeline, resources and initial design
Jarin Kratzberg, PhD
9:10 AM Business and IP Considerations    
Robert Whirley, PhD           
9:20 AM Clinical lessons learned on getting an idea to reality
Gary Ansel, MD
9:30 AM Risk management during device development: Industry perspective
Marc Ramer
9:45 AM Risk management during device development: Regulatory perspective
Jose Pablo Morales, MD
9:55 AM Discussion
Tim Chuter, MD
Daniel Clair, MD
Patrick Kelly, MD
10:10 AM Break
10:25 AM Case Studies Part 1: General Device Development
10:25 AM Case Study 1 (Breakthrough Technology)
Clinical Proposal
Jean Bismuth, MD

Industry Viewpoint
Austin Byrne

10:55 AM

Case Study 2 (Iterative Technology)
Clinical Proposal
Matthew Sweet, MD

Industry Viewpoint
Scott Rush, PhD


11:25 AM-2:15 PM Session 2: Preclinical Testing

Value and need for non-clinical testing perspective

11:25 AM

Regulatory Perspective: Device evaluation strategy through product development      
Stacy Monza

Regulatory Perspective: Test to failure
Jason Weaver, PhD

11:35 AM Industry Perspective: Feasibility, verification/validation, failure analysis, testing to address clinical observations (ie. Off-label use)
Kevin McCann
11:45 AM Physician Perspective: Modified devices/off-label use – using a device without having bench testing
Ben Starnes, MD
11:55 AM Discussion
Zak Arthurs, MD
Chris Cheng, PhD
Will Jordan, MD

12:15- 1:15 PM

1:15 PM Case Studies Part 2: Preclinical Testing
1:15 PM

Case Study 1 (Breakthrough Technology)
Industry Viewpoint
Tim Bertini

Clinician Viewpoint
Tom Maldonado, MD

Regulatory Viewpoint
Terry Woods, PhD


1:45 PM

Case Study 2 (Iteration)
Industry Viewpoint
Dale Ehnes

Clinician Viewpoint        
Jason Lee, MD

Regulatory Viewpoint
Rohini Retarekar, PhD


2:15-3:00 PM Session 3: IDE and Clinical Feasibility
2:15 PM IDE Perspective: IDE regulations, SI- v. Manufacture-sponsored, Types/Stages of clinical evaluation and when
Anna Schumaker, PhD
2:25 PM

Industry Perspective: How to draft/submit/execute
Megan Indeglia 

2:35 PM

Clinician Perspective:
Participation in IDE drafting and execution
Yuki Kuramochi, RN, BSN

What’s it like being asked to participate in an IDE?                  
Matthew Eagleton, MD

2:45 PM Discussion

Marc Schermerhorn, MD 

Carlos Timaran, MD
Andres Schanzer, MD

3:00 PM


3:15 PM Small Group Exercise Part 1 – each group led by a clinician and an engineer
5:00 PM

Day 1 Wrap Up

5:30 PM  


6:30 PM                

Dinner at the Harvard Club (Downtown Boston)