Conference

View all available Conference files below:


Date Session Title Start Time End Time
2018-02-06

Have You Made the Leap? Implementing ISO 13485

Date: 2018-02-06
Time: 09:15:00-05:00 - 11:00:00-05:00


General Session Files:

Speaker - Garth Conrad, Vice President, Quality, CR Bard (now part of BD)
09:15:00-05:00 11:00:00-05:00
2018-02-06

Challenges & Best Practices in Deploying IIoT

Date: 2018-02-06
Time: 09:30:00-05:00 - 10:00:00-05:00


Speaker - David Iyoha, Director of Software Solutions, Fortech LLC
09:30:00-05:00 10:00:00-05:00
2018-02-06

Challenges in Design with Biomaterials

Date: 2018-02-06
Time: 10:15:00-05:00 - 11:00:00-05:00


Speaker - Ekaterina Tkatchouk, PhD, Principal Chemist, Edwards Lifesciences
10:15:00-05:00 11:00:00-05:00
2018-02-06

Do You Really Know If Your Medical Device PCBs Comply With Required Qualification Standards?

Date: 2018-02-06
Time: 10:30:00-05:00 - 11:15:00-05:00


Speaker - Alfred Macha, Managing Director, AMT Integrated Systems Inc
10:30:00-05:00 11:15:00-05:00
2018-02-06

Becoming a Future-Proof Employee

Date: 2018-02-06
Time: 11:00:00-05:00 - 12:00:00-05:00


Speaker - Stacy Feiner, PsyD, Business Psychologist & Coach, BDO USA
11:00:00-05:00 12:00:00-05:00
2018-02-06

Fiber Optic Sensors Enable New MRI Applications

Date: 2018-02-06
Time: 11:00:00-05:00 - 11:45:00-05:00


General Session Files:
11:00:00-05:00 11:45:00-05:00
2018-02-06

Ensuring Accurate Data for Good Decisions

Date: 2018-02-06
Time: 11:15:00-05:00 - 11:45:00-05:00


Speaker - David Iyoha, Director of Software Solutions, Fortech LLC
11:15:00-05:00 11:45:00-05:00
2018-02-06

Metal Printing for the Masses

Date: 2018-02-06
Time: 11:15:00-05:00 - 11:45:00-05:00


Speaker - Erick Wolf, Co-Founder & CEO, Airwolf 3D
11:15:00-05:00 11:45:00-05:00
2018-02-06

Are you ready for ISO 13485:2016?

Date: 2018-02-06
Time: 11:30:00-05:00 - 12:15:00-05:00


Speaker - Grant Palmer, Quality, Regulatory and Pilot Production, Sparton
11:30:00-05:00 12:15:00-05:00
2018-02-06

Design for Demand: The Creation of NovaDerm® Skin Substitute

Date: 2018-02-06
Time: 13:15:00-05:00 - 13:45:00-05:00


Speaker - Kelly Hickel, Chief Marketing Officer, PureMedFarma
13:15:00-05:00 13:45:00-05:00
2018-02-06

New Collar Job Training for the Digital Age

Date: 2018-02-06
Time: 13:15:00-05:00 - 14:00:00-05:00


Speaker - Sarah Boisvert, Founder, Fab Lab Hub
13:15:00-05:00 14:00:00-05:00
2018-02-06

ISO 9001 & ISO 13485: Managing & Advancing Your Risk Control Program

Date: 2018-02-06
Time: 13:15:00-05:00 - 15:00:00-05:00


Speaker - Tom Bento, Senior VP of Quality and Regulatory Assurance, Nihon Khoden America
13:15:00-05:00 15:00:00-05:00
2018-02-06

Cedars-Sinai Hospital Adopts Virtual Reality, But Is It Moving the Needle for Device Manufacturers?

Date: 2018-02-06
Time: 13:15:00-05:00 - 14:00:00-05:00


Speaker - Vartan Tashjian, MD, Internist, Cedars-Sinai Medical Center
13:15:00-05:00 14:00:00-05:00
2018-02-06

Panel: Criteria for Choosing the Right Material for Your Device

Date: 2018-02-06
Time: 13:15:00-05:00 - 15:00:00-05:00


Panelist - Steve Jepson, Senior Engineer, Baxter

Panelist - James Semler, PhD, Technology Manager, Research & Development, BD Medical
13:15:00-05:00 15:00:00-05:00
2018-02-06

Solving the OT-IT Conflict

Date: 2018-02-06
Time: 13:15:00-05:00 - 14:15:00-05:00


General Session Files:
13:15:00-05:00 14:15:00-05:00
2018-02-06

Evaluating New Technologies Using a Balanced Score-Card Approach

Date: 2018-02-06
Time: 14:00:00-05:00 - 15:00:00-05:00


General Session Files:
14:00:00-05:00 15:00:00-05:00
2018-02-06

You Can't Ignore Security in IIoT

Date: 2018-02-06
Time: 14:15:00-05:00 - 15:00:00-05:00


Speaker - Ashok Banerjee, CTO for Enterprise Security Products, Symantec
14:15:00-05:00 15:00:00-05:00
2018-02-06

Panel: FDA Case for Quality Update

Date: 2018-02-06
Time: 15:15:00-05:00 - 16:45:00-05:00


General Session Files:

Panelist - Stephanie Christopher, Program Director, Medical Device Innovation Consortium
15:15:00-05:00 16:45:00-05:00
2018-02-06

Source Reduction Concepts to Help You Realize Corporate Sustainability Objectives

Date: 2018-02-06
Time: 15:30:00-05:00 - 16:15:00-05:00


Speaker - Kyle Mick, Product Manager, Bemis Healthcare Packaging
15:30:00-05:00 16:15:00-05:00
2018-02-06

Shedding Light on Your Shadow Customers

Date: 2018-02-06
Time: 16:00:00-05:00 - 16:45:00-05:00


Speaker - Ashlea Mittelstaedt, Vice President, Marketing, Autonomic Technologies
16:00:00-05:00 16:45:00-05:00
2018-02-06

What You Need to Know About Designing Medical Electronics

Date: 2018-02-06
Time: 16:00:00-05:00 - 17:30:00-05:00


Speaker - Jerry Twomey, Founder, Effective Electrons
16:00:00-05:00 17:30:00-05:00
2018-02-06

New Developments in Micro-Miniature Torque Sensors for Robotic Surgery

Date: 2018-02-06
Time: 16:00:00-05:00 - 16:45:00-05:00


Speaker - Joon Park, Project Manger, Futek
16:00:00-05:00 16:45:00-05:00
2018-02-06

The 3D Printing Revolution: Design, Education, & Entrepreneurship

Date: 2018-02-06
Time: 16:15:00-05:00 - 17:00:00-05:00


Speaker - Forrest Leighton, VP of Marketing, MakerBot
16:15:00-05:00 17:00:00-05:00
2018-02-06

Building a Culture of Risk Assessment

Date: 2018-02-06
Time: 16:45:00-05:00 - 17:30:00-05:00


Speaker - Tom Bento, Senior VP of Quality and Regulatory Assurance, Nihon Khoden America
16:45:00-05:00 17:30:00-05:00
2018-02-07

Developing the Right Commercialization Strategy for Medical Devices

Date: 2018-02-07
Time: 08:30:00-05:00 - 09:15:00-05:00


Speaker - Marwane Berrada, Senior Director, Product Development , Cleveland Clinic
08:30:00-05:00 09:15:00-05:00
2018-02-07

Panel: EU MDR & IVDR Implications for Manufacturers & Suppliers

Date: 2018-02-07
Time: 08:30:00-05:00 - 10:00:00-05:00


General Session Files:
- EUMDR_IVDR_Machen.pdf (611KB)  


Panelist - Kim Walker, Vice President of Regulatory, Quality, and Clinical Affairs, Hycor Biomedical

Panelist - Vinay Goyal, Project Engineer, Johnson and Johnson Enterprise Product Stewardship
08:30:00-05:00 10:00:00-05:00
2018-02-07

Beyond Prototyping: The New Landscape of Industry & Production

Date: 2018-02-07
Time: 08:30:00-05:00 - 09:15:00-05:00


General Session Files:
08:30:00-05:00 09:15:00-05:00
2018-02-07

Desktop 3D Printing: Bringing Accessibility & Efficiency to Design & Manufacturing

Date: 2018-02-07
Time: 09:15:00-05:00 - 10:00:00-05:00


Speaker - John Kawola, President, Ultimaker North America
09:15:00-05:00 10:00:00-05:00
2018-02-07

Panel: New Product Iteration: Is Your Process Better, Faster, & Cheaper?

Date: 2018-02-07
Time: 09:15:00-05:00 - 11:00:00-05:00


General Session Files:

Speaker - Eric Steuben, Vice President, Operations, PROCEPT BioRobotics

Speaker - Anupam Phukan, Senior Program Manager, mHealth-Data and Informatics Innovation, Medtronic
09:15:00-05:00 11:00:00-05:00
2018-02-07

A Lot Is at Stake When Writing Stakeholder Requirements

Date: 2018-02-07
Time: 09:15:00-05:00 - 10:00:00-05:00


Speaker - Tom Ulrich, Chief Scientist, Tandem Diabetes Care
09:15:00-05:00 10:00:00-05:00
2018-02-07

Getting the Best ROI from Your Collaborative Robot

Date: 2018-02-07
Time: 09:15:00-05:00 - 10:00:00-05:00


Speaker - Craig Tomita, Area Sales Manager, Universal Robots
09:15:00-05:00 10:00:00-05:00
2018-02-07

Innovations in Additive 3D Printing of Silicone Rubber Components

Date: 2018-02-07
Time: 10:15:00-05:00 - 11:00:00-05:00


Speaker - Rick Ziebell, VP of Technology, R.D. Abbott Company
10:15:00-05:00 11:00:00-05:00
2018-02-07

Designing the Perfect Surgical Instrument

Date: 2018-02-07
Time: 10:15:00-05:00 - 11:00:00-05:00


Speaker - Bryce Rutter, Founder and CEO, Metaphase Design Group, Inc.
10:15:00-05:00 11:00:00-05:00
2018-02-07

Implementation: Notified Body Expectations & Readiness

Date: 2018-02-07
Time: 10:15:00-05:00 - 11:45:00-05:00


Speaker - Ibim Tariah, PhD, Technical Director, BSI Medical Devices
10:15:00-05:00 11:45:00-05:00
2018-02-07

Case Study: Best Practices for Modeling Using Finite Element Analysis for Combination Products

Date: 2018-02-07
Time: 13:15:00-05:00 - 14:00:00-05:00


Speaker - Seungyil Yoon, Associate Director, Allergan
13:15:00-05:00 14:00:00-05:00
2018-02-07

Shoring up the Statistical Underpinnings of Human Factors Engineering

Date: 2018-02-07
Time: 13:15:00-05:00 - 14:00:00-05:00


Speaker - Jacques Ginestet, Head of Wearables, Proteus Digital Health
13:15:00-05:00 14:00:00-05:00
2018-02-07

Safety Considerations When Working with Collaborative Robots

Date: 2018-02-07
Time: 13:15:00-05:00 - 14:00:00-05:00


Speaker - George Schuster, TÜV Functional Safety Expert (FSExp) & Business Development Manager, Rockwell Automation
13:15:00-05:00 14:00:00-05:00
2018-02-07

GMP, GLP or ISO 17025: How Do These Apply to Outsourced Analytical Testing?

Date: 2018-02-07
Time: 13:30:00-05:00 - 14:15:00-05:00


Speaker - Joe Grappin, Account Executive, EAG Laboratories
13:30:00-05:00 14:15:00-05:00
2018-02-07

Using Novel Materials & 3D Printing Technologies for Industry Growth

Date: 2018-02-07
Time: 13:45:00-05:00 - 14:30:00-05:00


General Session Files:
13:45:00-05:00 14:30:00-05:00
2018-02-07

ISO18562_2017: Biological Evaluation of Breathing Gas Pathways of Medical Devices, A New ISO Standard

Date: 2018-02-07
Time: 14:30:00-05:00 - 15:15:00-05:00


Speaker - James Lyons, Senior Toxicologist, Eurofins Medical Device Testing
14:30:00-05:00 15:15:00-05:00
2018-02-07

3 Ways to Make Your Factory Smarter with IIoT

Date: 2018-02-07
Time: 15:15:00-05:00 - 16:00:00-05:00


Speaker - Christoph Wimmer, Director for Electronic Vertical and Customer Experience, Omron Microscan
15:15:00-05:00 16:00:00-05:00
2018-02-07

Platform Strategies for Line-Extension Offerings

Date: 2018-02-07
Time: 15:15:00-05:00 - 16:30:00-05:00


General Session Files:
15:15:00-05:00 16:30:00-05:00
2018-02-07

What the 21st Century Cures Act Means for Medtech

Date: 2018-02-07
Time: 16:00:00-05:00 - 17:30:00-05:00


Speaker - Michael Hoffman, Deputy Director, Division of Neurological and Physical Medicine Devices, FDA
16:00:00-05:00 17:30:00-05:00
2018-02-08

What's New & How to Get the Best Battery Solution for Your Products

Date: 2018-02-08
Time: 08:30:00-05:00 - 09:15:00-05:00


Speaker - Michael Xie, PhD, CEO, Founder, PHD Energy Inc.
08:30:00-05:00 09:15:00-05:00
2018-02-08

Understanding FDA Regulatory Expectations: Keys to Successful 510(k) Regulatory Submissions

Date: 2018-02-08
Time: 08:30:00-05:00 - 09:15:00-05:00


Speaker - Allison Komiyama, PhD, Principal Consultant, AcKnowledge RS, LLC
08:30:00-05:00 09:15:00-05:00
2018-02-08

The FDA's Role in 3D Printing

Date: 2018-02-08
Time: 09:15:00-05:00 - 10:00:00-05:00


Speaker - Yarmela Pavlovic, Esq., Partner, Hogan Lovells
09:15:00-05:00 10:00:00-05:00
2018-02-08

Sterility Assurance for Sensitive Combination Products: Defining a Regulatory Path

Date: 2018-02-08
Time: 09:15:00-05:00 - 10:00:00-05:00


Speaker - Byron Lambert, Senior Associate Fellow, Sterilization Science, Abbott Vascular
09:15:00-05:00 10:00:00-05:00
2018-02-08

IDEO Workshop: Empathy, Insights & Innovation

Date: 2018-02-08
Time: 10:00:00-05:00 - 12:00:00-05:00


General Session Files:
10:00:00-05:00 12:00:00-05:00
2018-02-08

Panel: Machine Learning & AI - Examining the Key Differences & Similarities

Date: 2018-02-08
Time: 10:15:00-05:00 - 11:15:00-05:00


General Session Files:
10:15:00-05:00 11:15:00-05:00
2018-02-08

When the De Novo Pathway is the Simplest Way to Market

Date: 2018-02-08
Time: 10:15:00-05:00 - 11:45:00-05:00


General Session Files:
10:15:00-05:00 11:45:00-05:00
2018-02-08

Understanding California's Rigid Plastic Container Law

Date: 2018-02-08
Time: 10:30:00-05:00 - 11:15:00-05:00


Speaker - Natalie Rainer, Associate, Keller and Heckman LLP
10:30:00-05:00 11:15:00-05:00
2018-02-08

Commercializing a Single-Use Electronic Patch

Date: 2018-02-08
Time: 11:00:00-05:00 - 11:45:00-05:00


Speaker - Mark Troutman, Vice President, Design Engineering, Benchmark Electronics
11:00:00-05:00 11:45:00-05:00
2018-02-08

Using 3D Printed Anatomical Models for Surgical Training, Planning & Medical Device Testing

Date: 2018-02-08
Time: 11:15:00-05:00 - 12:00:00-05:00


Speaker - Michael Gaisford, Director of Marketing, Stratasys Healthcare Solutions
11:15:00-05:00 12:00:00-05:00
2018-02-08

Value-Based Selling: Moving from Features and Benefits to Value

Date: 2018-02-08
Time: 11:30:00-05:00 - 12:15:00-05:00


PR Contact - Ernesto Nogueira, Founder and Managing Director, ValueConnected
11:30:00-05:00 12:15:00-05:00
2018-02-08

PTFE Coatings in the Catheter Market: Where We Have Been and Where We Need to Go

Date: 2018-02-08
Time: 12:30:00-05:00 - 13:15:00-05:00


Speaker - Charles Fields, Global Business Manager-Medical Device Coatings, Whitford Worldwide
12:30:00-05:00 13:15:00-05:00
2018-02-08

IDEO Workshop: Prototyping Our Way to Success

Date: 2018-02-08
Time: 13:00:00-05:00 - 15:00:00-05:00


General Session Files:
13:00:00-05:00 15:00:00-05:00
2018-02-08

What FDA Looks for During Inspection

Date: 2018-02-08
Time: 13:15:00-05:00 - 14:30:00-05:00


Speaker - Marcelo Trevino, Senior Vice President of Regulatory Affairs and Quality, Applied Medical
13:15:00-05:00 14:30:00-05:00
2018-02-08

AI Strategies & Applications: Cosmetic Defects

Date: 2018-02-08
Time: 13:15:00-05:00 - 14:00:00-05:00


General Session Files:
13:15:00-05:00 14:00:00-05:00
2018-02-08

Case Study: A Device with Multiple Technical Areas: Acute Care Covering for Severely Injured Limbs (ACCSIL)

Date: 2018-02-08
Time: 13:15:00-05:00 - 14:00:00-05:00


Speaker - Erik Edwards, Senior Research Scientist, Battelle
13:15:00-05:00 14:00:00-05:00
2018-02-08

Quality Measurement Tools for Additive Manufacturing Applications

Date: 2018-02-08
Time: 13:30:00-05:00 - 14:15:00-05:00


Speaker - David Wick, Manager of Product Management, ZEISS Industrial Metrology
13:30:00-05:00 14:15:00-05:00
2018-02-08

California's Proposition 65: Understanding the Impact on Food Packaging

Date: 2018-02-08
Time: 13:30:00-05:00 - 14:15:00-05:00


Speaker - Mitzi Clark, Partner, Keller and Heckman LLP
13:30:00-05:00 14:15:00-05:00
2018-02-08

How's Your Relationship? Working with FDA for Successful Product Launch

Date: 2018-02-08
Time: 14:30:00-05:00 - 15:45:00-05:00


General Session Files:
14:30:00-05:00 15:45:00-05:00
2018-02-08

Preventing Contamination from Entering Your Critical Space (A Process Improvement)

Date: 2018-02-08
Time: 14:30:00-05:00 - 15:15:00-05:00


Speaker - Shanelle Reeve, Contamination Control Specialist, Dycem
14:30:00-05:00 15:15:00-05:00
2018-02-08

Is Your Medical Device at Risk for Particulates in Coatings?

Date: 2018-02-08
Time: 15:15:00-05:00 - 16:30:00-05:00


Speaker - Sean Stucke, Director of Commercial Development, Surmodics, Inc.
15:15:00-05:00 16:30:00-05:00
2018-02-08

Panel: Driving Innovation: Getting Innovative Products Through FDA

Date: 2018-02-08
Time: 15:45:00-05:00 - 16:30:00-05:00


Panelist - Grant Bennett, Chief Executive Officer, Brandwood Biomedical

Speaker - Michael Hoffman, Deputy Director, Division of Neurological and Physical Medicine Devices, FDA
15:45:00-05:00 16:30:00-05:00