Gold Sponsors

NDH
Teleflex

Supporting Organizations

Austin

Austin Chamber of Commerce

Bio Austin

Helix

MedtoMarket

MedtoMarket

Texas

Texas Medical

Texas Healthcare and Bioscience

Silver Sponsors

AGR

Braun

Cadence

CYIENT

Eldon James

Fischer Connectors

Forefront Medical

GW Plastics

IQMS

KP

MedBio

Natvar

Neotech

Novobi

Pexco

Qosina

Sigmatron

SMC

Steri-Tek

Surgical Technologies, Inc./McLean Medical and Scientific, Inc

Syncro

Tegra

Temple

Bronze Sponsors

Bonifacio

Covington Associates

Dynatec Labs

PMCF

Oratech

PMCF

Polymer

Silicon

 

Wednesday, October 5
Location: Ballroom, Austin Hilton
7:00-8:30 a.m. Registration & Continental Breakfast
8:30-8:40 a.m. Welcome Address
Speakers:
Howard Revitch, MPO/ODT Publisher
Sean Fenske, MPO/ODT Editor
8:40-9:00 a.m. A Texas Life Science Perspective
An overview of the industry in Texas with a focus on the medical device sector.
Speaker: Thomas R. Kowalski, President and CEO, Texas Healthcare and Bioscience Institute
9:00-10:00 a.m. State of the Industry Panel
Panel will discuss a number of vital medtech industry topics, including the upcoming presidential election, future expectations of the device tax suspension, FDA review times, and CMO consolidation.
Panelists:
Mark Bonifacio, President, Bonifacio Consulting Services LLC
Perry DeFazio, Vice President, Covington Associates
Bill Ellerkamp, Operating Partner, Inverness Graham Investments
Clayton Hall, Vice President, Government Affairs, Medical Device Manufacturers Association (MDMA)
Moderator:
Sean Fenske, MPO/ODT Editor
10:00-10:45 a.m. Managing Products Liability Risk in the Supply Chain
Supply chains can be a source of products liability lawsuits, yet sometimes manufacturers fail to recognize the potentially costly risks inherent in their supplier relationships. This presentation will discuss how products liability can arise through the supply chain and will provide best practices for minimizing the risk. Using case studies and actual data on defective products and the injuries they cause, this session will enhance your understanding of products liability law as well as the importance of implementing a products liability risk mitigation strategy when managing your supply chain.
Speaker: Sara Dyson, Assistant Vice President—Loss Control, Medmarc Insurance Group
10:45-11:30 a.m. Networking Break
Sponsored by
Dynatec Labs
11:30 a.m.-12:30 p.m. The Supplier/OEM Relationship: An Executive Panel
This session will explore key dynamics of the supplier and OEM relationship. Topics of focus will include assessing value from suppliers (difference between “price” and “cost”), buy (outsourcing) vs. build (in-house), the transformation of a supplier into a true development partner, and maximizing the supply chain.
Panelists:
Dan Croteau, CEO, Vention Medical
Todd McCaslin, Global Sourcing Director, 
Boston Scientific
Dennis L. McWilliams, Founder, President, and Chief Commercial Officer, Apollo Endosurgery
Andrew J. Miclot, President & CEO, Micro Machine Co.
Moderator:
Howard Revitch, MPO/ODT Publisher
12:30-2:00 p.m. Networking Luncheon
2:00-2:45 p.m. Leveraging Big Data in Post-Market Surveillance
There is an explosion today in the quantity of information being created by smart medical devices. This new data can be mined for insight into the safety and efficacy of these devices in ways never before possible, opening the door for certain classes of high-tech, low-risk devices to enter the market with less pre-market data. Savvy medtech manufacturers that can establish a strategy for applying post-market data effectively stand to win in such a venture.
Speaker: Mickey Garcia, Director—Medical Device Industry Solutions, MasterControl
2:45-3:30 p.m. How to Keep Up with an Evolving FDA
As new technologies come into the medical device space, the FDA is constantly evolving to keep up with these advances. As such, regulations and guidelines are being issued that may impact the development of a device manufacturer’s project. What are the best methods for keeping up with these changes and potential challenges to a successful regulatory review and product launch? This session will offer strategies medical device manufacturers can utilize to best keep abreast of potentially project derailing regulatory changes.
Speaker: Dawn Lissy, President & Founder, Empirical
3:30-4:15 p.m. Networking Break
Sponsored by
BMP Medical
4:15-5:00 p.m. FDA—Do They Really Have the Public’s Best Interest in Mind?
While the FDA’s intention is to ensure the safety of all new medical devices, that objective seems to, at times, conflict with the advancement of innovation in the space as well as perhaps not serving the best interests of taxpayers monies. Does the FDA impede innovation in today’s medtech industry or is it simply a matter of understanding the requirements of compliance? This session will look at the challenges faced by today’s medical device manufacturer in the face of a cumbersome regulatory landscape, and offer a future vision of an improved compliance environment.
Speaker: Dana A. Oliver, Senior Director of Research & Development, Medtronic’s Surgical Technologies ENT/NT division
5:00-7:00 p.m. Reception
Join attendees, speakers, and exhibitors for drinks and hors d’oeuvres during an evening reception at the Hilton. Take advantage of the setting for networking and conversation with peers within the medtech manufacturing industry.
* All session times, speakers, and content are subject to change.
Thursday, October 6
Location: Ballroom, Austin Hilton
7:30-8:30 a.m. Registration & Continental Breakfast
8:30-8:45 a.m. A Glimpse at Austin’s Medtech Scene
Speaker: Kevin Johns, Economic Development Director, City of Austin
8:45-9:30 a.m. Day 2 Keynote: Innovation and Emerging Medtech
What developments lie in university labs and research facilities for the medical device space? What device technologies will be in use in five to ten years from now? Where is 3D printing headed in healthcare and what will be its impact in the future? Will wearables still be popular or will we transition to implantables or consumables? This session will serve up a vision of what medical technology will look like in the future, from five years out to 50 years from now. Hear about advances that are just starting to be explored that will change the face of tomorrow’s healthcare.
Speaker: Maninder “Mini” Kahlon, Ph.D., Vice Dean for Strategy & Partnerships, Dell Medical School, The University of Texas at Austin
9:30-10:15 a.m. Bringing Point-of-Care Medtech to the Home
As patients transition from spending less time in hospitals or even visiting their doctors in the office, diagnostic testing devices will need to be developed to accommodate that change. Point-of-care and consumer-based diagnostic technologies will become more of the norm. With these advances come development challenges such as proving clinical accuracy, ensuring ease of use, and communicating results to a physician to oversee. This session will look at this enormous growth area for medical device manufacturers and address many of the obstacles that could stand in the way of success.
Speaker: Steve Maylish, Chief Commercial Officer, Fusion Biotec
10:15-11:00 a.m. Networking Break
11:00 a.m.-12:00 p.m. The Outsiders’ Effect—How Tech Leaders Are Impacting Medical Device Innovation
What do advances from non-medtech companies who are getting into the medical device space mean for the industry? Technology leaders such as Google, Apple, and IBM are pushing the limits of innovation and even partnering with medical device companies to help bring these new ideas to market. Does this mark a significant transition in the medtech space or will the unfamiliar regulatory environment slow them down? What role will these companies play on the big picture in terms of advancing technology and device capabilities? This session will offer insights on the impact of these “outsider” companies, with a discussion on their experience in the sector, the unique challenges they face, and how they are changing the perception of innovation in the medical technology space.
Panelists:
Kim Cobb, IoT Industry Solutions Executive, IBM Watson
Kristin S. Crosland, Chief Operating Officer, Experien Group LLC
Susan Mucha, President, Powell-Mucha Consulting Inc.
Moderator:
Sean Fenske, MPO/ODT Editor
12:00 p.m. End of Conference
On-site Wifi and Twitter sponsor: BMP Medical