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Monday, December 11
 

1:00pm

Registration, networking
Monday December 11, 2017 1:00pm - 1:30pm
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626

1:30pm

Plenary Session: Speed equals innovation but how do I do my job faster?
The most innovative companies in the world are the ones who emphasize speed. But technologies have already sped up the process and the engineering is only one part of the process. When company leadership says “Do it faster” engineers may feel tapped out. They don’t necessarily have more tools or know how to put that directive into action. This panel aims to uncover the secrets of innovating quickly, both in product development and in processes to improve efficiencies. They’ll discuss real-world situations, as well as tools and tips to help meet innovation goals. 

Speakers
avatar for William Betten

William Betten

President, Betten Solutions
Bill is the president of Betten Systems Solutions, a product development realization consulting organization. Bill utilizes his years of experience in the medical industry to advance device product developments into the medical and life sciences industries. Bill most recently served... Read More →
avatar for Annie Cashman

Annie Cashman

Global Segment Manager - Medical, Proto Labs
Annie Cashman comes to Proto Labs with a depth of experience working at medical industry leaders Covidien (now Medtronic), St. Jude Medical, and most recently Nordson Medical. At these companies she worked closely with customers in various sales and marketing positions. Annie’s... Read More →
avatar for Scott Thielman

Scott Thielman

CTO and Co-Founder, Product Creation Studios
Scott Thielman is CTO and co-founder of Product Creation Studio. With expertise leading the development of consumer, medical and industrial products, Scott has participated in all aspects of development for clients including Philips, Johnson & Johnson, and Lilly. He holds a Ph.D... Read More →
avatar for Jeff Wyman

Jeff Wyman

Vice President, InVentures,, Smith and Nephew Advanced Surgical Device Division


Monday December 11, 2017 1:30pm - 2:30pm
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626

2:30pm

Managing Suppliers to improve speed to market
The funds have been approved. Key people have signed off on a new project and you have been given the green light to go ahead. Being part of a medical device commercialization team can be exhilarating but without the right planning, opportunity can quickly turn into disaster.


The clock is ticking. So how do you avoid those bumps in the road and keep your project running smoothly? A key part is doing your homework so that the suppliers you select to be part of your journey can help you race to the finish line instead of creating problems and obstacles along the way.
 
Although this might seem obvious, many medical device OEM and contract manufacturers can benefit from a reminder that a firm understanding of your project’s parameters, timeline and other key attributes is required upfront. Only then can you adequately match your needs with the supplier’s core competencies.
 
In this panel, experts from OEMs and MW Industries will discuss key areas of vendor evaluation with real life examples and discussion.

Speakers
DP

Dave Philbrick

Business Development Manager, MW Industries, Inc.


Monday December 11, 2017 2:30pm - 3:30pm
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626

2:30pm

The regulatory pathway of tomorrow: How do we gameplan for changes in Silver Springs, EMEA and more?
Changes at the FDA and its foreign counterparts could alter the way medical technology gets to market. After years of increasing predictability for device companies, what will create more uncertainty in the coming years? A panel of experts from across the industry discuss how best to game plan for changes in Silver Springs and beyond. 

Moderators
avatar for Theresa  Miles

Theresa Miles

Directory of Client Solutions, Regulatory and Quality Solutions (R&Q)

Speakers
avatar for Daniel Beard

Daniel Beard

Promenade Software
avatar for Theresa  Miles

Theresa Miles

Directory of Client Solutions, Regulatory and Quality Solutions (R&Q)
avatar for Frank Pokrop

Frank Pokrop

Director, Regulatory Affairs, Becton Dickinson
Frank is a Director of Regulatory Affairs at Becton Dickinson in San Diego – formerly CareFusion.  He is a member of ASQ, ISACA and RAPS and holds these certifications:   RAC, CSQE, CISA and CPGP.  Frank is also the president of the San Diego Regulatory Affairs Network (SDRAN... Read More →
avatar for Chip Zimliki

Chip Zimliki

Regulatory Affairs, Medtronic Diabetes
Charles Zimliki, Ph.D. is Sr. Director of Regulatory Affairs for the Intensive Insulin Management Business Unit within Medtronic Diabetes.  He is responsible for communicating with FDA on behalf of insulin pumps, continuous glucose monitors, and closed-loop device systems including... Read More →


Monday December 11, 2017 2:30pm - 3:30pm
TBA

3:30pm

Exhibition/Networking break
Monday December 11, 2017 3:30pm - 4:30pm
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626

4:00pm

Hot Topics: Financing, IP, and Products Liability Trends Impacting MedTech
·         Financing best practices from early stage to exit
·         IP protection is key to a successful exit
·         Avoiding and mitigating litigation risk 

Speakers
avatar for Roman Fayerberg

Roman Fayerberg

Shareholder & Patent Attorney, Greenberg Traurig, LLP
Roman Fayerberg is a registered patent attorney, who focuses his practice on the development and management of strategic patent portfolios and counseling clients on patent issues, primarily in technologies related to medical devices, drug delivery systems, biodegradable polymers and... Read More →
avatar for Eric Geismer

Eric Geismer

Principal, EPG Consulting
avatar for Paul Grand

Paul Grand

CEO, MedTech Innovator
avatar for Ginger Pigott

Ginger Pigott

Shareholder, Greenberg Traurig
Ginger Pigott focuses her practice on products liability litigation and commercial litigation. A particular focus of her practice lies in the defense of complex medical device and pharmaceutical products liability litigation, as well as counseling on pre-litigation issues that include... Read More →
avatar for Richard Yoon

Richard Yoon

Director of Intellectual Property, MicroVention, Inc.
Mr. Yoon is currently the Director of Intellectual Property at MicroVention, Inc, where he heads the IP function and the business development legal support for the company.  He has 20 years of patent law experience and 15 years of medical device company experience.  He has also... Read More →


Monday December 11, 2017 4:00pm - 5:30pm
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626

4:00pm

Creating the Connection: A Hands-On Approach to Creating Value in Connected Healthcare Ecosystems
From virtual care, to consumer wellness, adherence and compliance to patient experience; digitally-enabled health is disrupting our lives. This high energy, hands-on ThinkTank will have attendees break down an (assigned) problem and work to solve it. Participants will be taken through tried and true concept generation and evaluation processes aimed to shed light on areas where digital health technologies and their respective business models can be most disruptive providing value to all stakeholders.
 Key Take-Aways:

 - Techniques to sharpen your skills in being able to recognize key opportunities and unmet user needs as they assess potential solutions for investment

- Insight into an understanding of health economics and how to apply today’s equation: equivalence @ better cost > improving outcomes to generate your own profitable business model
- Best practices for collaborating and an understanding of the benefits of co-creation

Limited to 80 participants  
 *Hosted by Ximedica 

Speakers
avatar for Bill Evans

Bill Evans

SVP, Innovation, Ximedica
Bill founded Bridge Design, a San Francisco-based design consultancy specializing in medical products in 1992 that is now part of the Ximedica family of companies. He has grown as a designer alongside the medical industries’ gradual adoption of a user-centered design approach. His... Read More →


Monday December 11, 2017 4:00pm - 5:30pm
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626

5:30pm

Exhibition/Networking Reception
Monday December 11, 2017 5:30pm - 6:30pm
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626

6:30pm

Dinner and DeviceTalk: Featuring Stacy Pugh, ‎Vice President, Medtronic Neurovascular
Brian Johnson and Stacy Pugh sit down for a fireside chat about the state of the medtech industry and Ms. Pugh's career from trauma nurse to leading strategy for Medtronic's neurovascular business. 

Speakers
avatar for Brian  Johnson

Brian Johnson

Publisher, Co-Founder, DeviceTalks, MassDevice, Medical Design & Outsourcing
Brian grew up in the medical devices industry -- as a child, he and his older brother used the surgical staplers his father sold for U.S. Surgical Corp. as toy guns. One episode involving about $10,000 worth of surgical staples earned him an early lesson about medical technology and... Read More →
avatar for Stacy Pugh

Stacy Pugh

Vice President and General Manager, Medtronic Neurovascular
Stacey Pugh is Vice President and General Manager of Medtronic’s Neurovascular business area. She provides overall global strategic leadership, guides marketing and business development and is responsible for revenue growth. Prior to this role, Stacey was Vice President of Medtronic’s... Read More →


Monday December 11, 2017 6:30pm - 8:00pm
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626
 
Tuesday, December 12
 

8:00am

Exhibition/Networking Breakfast
Tuesday December 12, 2017 8:00am - 9:00am
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626

9:00am

Tools for Succeeding with Outsourced Product Development
Improving speed to market and optimizing resources are driving more medtech companies to consider virtual development partnerships. Knowing what to keep in house and what to outsource, finding the right partner and effectively managing requirements and expectations can be difficult. This panel will take a step by step look at what it takes to create a successful virtual product development partnership, from pre-engagement to commercialization.
*Sponsored by Minnetronix 

Speakers
avatar for Stuart Karten

Stuart Karten

President, Karten Design
Stuart Karten is President of the award-winning Los Angeles-based product design and innovation consultancy, Karten Design. For 30 years, he has partnered with medical and consumer product companies, ranging from start-ups to Fortune 500 corporations, to build their business through... Read More →
avatar for Jim Reed

Jim Reed

VP of Business Development and Marketing, Minnetronix
Jim Reed joined Minnetronix in 2014, bringing more than 20 years of experience in the medical device and healthcare industries. Jim has extensive sales and marketing experience in direct-to-physician devices, OEM devices, OEM components and subassemblies, and contract development... Read More →
avatar for Kim Bridges Rodriguez

Kim Bridges Rodriguez

President & CEO, Acessa Health Inc.
Ms. Bridges-Rodriguez joins the Acessa Health team with nearly 20 years of medical device experience. Prior to Acessa Health, she served at Spectranetics, a global medical technology leader focusing on cardiovascular solutions, as Senior Vice President of the Vascular Intervention... Read More →


Tuesday December 12, 2017 9:00am - 10:00am
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626

10:00am

Innovation story with Edwards Lifesciences's Stanton Rowe
In 1999, replacing a heart valve without opening up a patient's chest was a foreign concept that seemed destined for the dustbin of history. Cardiothoracic surgeons didn't think it would work and testing it on patients with aortic stenosis was as risky as it gets.

However, for Stanton Rowe, the son of a rocket engineer and medtech veteran, this was an opportunity to change the course of medicine.


Eighteen years later, transcatheter aortic valve replacement or TAVR, is one of the most exciting medical developments in the medical device industry and is saving lives as we speak. And so is Rowe, who now serves as the Chief Science Officer at Edwards Lifesciences, the Irvine, Calif.-based leader in this field.
MassDevice's Brad Perriello sits down with Rowe to discuss his career innovating everything from stents to TAVR. 

Speakers
avatar for Stanton Rowe

Stanton Rowe

Chief Scientific Officer, Edwards Lifesciences
Stanton J. Rowe has been chief scientific officer since 2008 and also serves as corporate vice president, advanced technology. He joined the company in 2004 when Edwards acquired Percutaneous Valve Technologies, a company he helped to found in 1999 and of which he served as president... Read More →


Tuesday December 12, 2017 10:00am - 10:30am
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626

10:45am

How Innovation transforms markets and Industries
Leaders from Integer, Nevro and Google's Verily discuss the best way to foster innovation inside organizations. 


*Sponsored by Integer 

Speakers
avatar for Jon Parker

Jon Parker

Sr. Director, Product Development, Nevro
Jon Parker is the Sr. Director of Product Development at Nevro Corp. and has been with the company since the early startup years in 2008. During this time he has had responsibility for Nevro’s Senza HF10 high-frequency Spinal Cord Stimulator and supporting equipment.  Previous... Read More →
avatar for Jordi Parramon

Jordi Parramon

Director of Medical Devices, Verily-Google Life Sciences
Jordi is the Director of Medical Devices at Verily-Google Life Sciences and is an engineering leader with 18+ years of industry experience developing class III neuromodulation devices.   He has authored or co-authored 50+ granted US patents and many pending patents in neuromod field... Read More →


Tuesday December 12, 2017 10:45am - 11:45am
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626

11:45am

Exhibition/Networking break
Tuesday December 12, 2017 11:45am - 12:15pm
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626

12:15pm

What's next in sensors?
Sensors are being used in a big way in medtech. We'll look at the next generation of miniature, disposable, and high tech sensors, and discuss what we should expect from them. We'll also look at how improvements in sensor technology are influencing the development of wearables and surgical robotics. Panelists will discuss the role sensors will play in big data and AI in medtech. In addition, the experts will offer some insight on the best ways to incorporate sensors into medtech design.



Speakers
avatar for Stuart Karten

Stuart Karten

President, Karten Design
Stuart Karten is President of the award-winning Los Angeles-based product design and innovation consultancy, Karten Design. For 30 years, he has partnered with medical and consumer product companies, ranging from start-ups to Fortune 500 corporations, to build their business through... Read More →
avatar for Andy Schimmoeller

Andy Schimmoeller

Senior Electrical Engineer, Battelle
Mr. Andy Schimmoeller is a Senior Electrical Engineer at Battelle located in Columbus, Ohio.   His experience in electrical system design for Medical Device and In-vitro Diagnostic products has made lasting impacts to the medical device market. In his 20 years at Battelle, Andy has... Read More →
avatar for Chris Thierfelder

Chris Thierfelder

Director, Research & Development, Halyard Health
Chris holds degrees from Marquette University, the University of Vermont, and MIT though did eventually get a real job. He began his career at GE Medical Systems, as a drafter and designer of nuclear imaging systems, and has spent over 20 years in the medical device industry in large... Read More →
avatar for Winnie Yu

Winnie Yu

Sr. Director, Medical Innovation, Flex
Winnie Yu is a technology, product development and manufacturing expert leading the Medical Innovation team in Health Solutions at Flex, the leading sketch-to-scale™ solutions company. With more than 200,000 professionals across 30 countries, the company provides innovative design... Read More →


Tuesday December 12, 2017 12:15pm - 1:15pm
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626

12:15pm

Untethering of innovation: The Wireless Revolution
This panel will take you inside how medical devices will communicate with each other today and in the future. 
  • How will the internet of things change the device design and development process?
  • What security measures must medical device companies consider? 
  • How will this revolution improve patient care
*Sponsored by DeviceLab

Speakers
avatar for Justin Barad

Justin Barad

Co-Founder, CEO, Osso VR
Justin Barad, MD is the co-founder and CEO of Osso VR, an award winning surgical training platform helping to increase patient safety and the adoption of cutting edge medical technology. Early in Dr. Barad’s career, he fully intended to become a game developer, but when a family... Read More →
avatar for Henry Bryson

Henry Bryson

Director Business Development, DeviceLab
A seasoned business development executive, Henry has worked with consulting services offerings in industries from Big 5 consulting to enterprise software and medical device engineering.  Maintaining the role as ‘voice of the customer’, he insures customer needs are addressed... Read More →
avatar for Harsh Dharwad

Harsh Dharwad

Vice President, Chief Technology Officer, Nihon Kohden Americas
Harsh Dharwad is an experienced global technology leader who is passionate about solving healthcare challenges with technological solutions that make a difference in the lives of patients and clinicians. He excels at simplifying complex problems, building high performing cultures... Read More →


Tuesday December 12, 2017 12:15pm - 1:15pm
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626

1:15pm

Exhibition/Luncheon
Tuesday December 12, 2017 1:15pm - 2:15pm
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626

2:15pm

Understanding value-based healthcare and its impact on medtech
Speakers
avatar for Debbie Donovan

Debbie Donovan

Senior Director, Corporate Marketing, EndosGastric Solutions, Inc
Debbie Donovan is a medical device digital marketer focused on developing revenue-generating digital marketing programs for medical technology companies that include the integration of social media strategy. Currently, Debbie is the Senior Director, Corporate Marketing at EndoGastric... Read More →
avatar for Reggie Groves

Reggie Groves

CEO, Reva Medical
Regina Groves joined REVA as Chief Executive Officer in September 2015. Her background encompasses more than 30 years’ experience in medical devices, executive leadership, and financial management. Prior to joining REVA, Ms. Groves served as Vice President and General Manager of... Read More →
avatar for Belinda Mohr

Belinda Mohr

Lead Health Economist, W. L. Gore & Associates, Inc.
Belinda A. Mohr currently serves as lead Health Economist on the Global Health Economics Team at W. L. Gore & Associates, Inc. She is committed to quantifying the value of Gore medical devices to multiple stakeholders by collaborating with internal associates and external researchers... Read More →
avatar for Matt Reifenberger

Matt Reifenberger

Health Economics and Reimbursement,, Edwards Lifesciences
Since Joining Edwards Lifesciences in 2015 Matt has been part of the Global Health Economics and Reimbursement (GHER) team working to remove economic barriers, develop value messages, reimbursement strategies, and improve patient access to surgical heart valve products. Most recently... Read More →
avatar for Suzanne Winter

Suzanne Winter

Vice President, Americas Region, Medtronic Diabetes
Suzanne Winter was named Vice President, Americas Region for Medtronic Diabetes in July 2015. Suzanne is responsible for partnering with region and business unit leaders to provide innovative, long-term business and market development strategies aimed at growing the Diabetes Group... Read More →


Tuesday December 12, 2017 2:15pm - 3:15pm
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626

3:15pm

Fireside Chat: Inside Bigfoot Biomedical with CEO & Founder Jeff Brewer
After founding two successful technology startups and dedicating his time to global philanthropy organizations, Jeffrey Brewer was facing the greatest challenge of his life – the diagnosis of his seven-year-old son Sean in 2002. Diabetes would become the new focus for his energy. Known as the “Father of the Artificial Pancreas,” the project he launched in his time as a volunteer, donor, and international Board Member for JDRF, Jeffrey Brewer is perhaps best known in the diabetes community for his time spent serving in the role of JDRF’s CEO from 2011 to 2014.
In the role of CEO of JDRF, Jeffrey forged financial partnerships with industry to drive research and development of insulin delivery and glucose monitoring technologies. He further spearheaded US regulatory reform in the area of automated insulin delivery, and elevated the organization’s strategic priorities to include health care policy, reimbursement, and access to technology for people with T1D. He joined in the founding of Bigfoot because he felt that industry could and should do more in each of these areas, marrying the best of our technologies to automate the management of diabetes, and making it available to the greatest number of people in need.

Moderators
avatar for Sarah Faulkner

Sarah Faulkner

Editor, Drug Delivery Business News

Speakers
avatar for Jeffrey Brewer

Jeffrey Brewer

President, CEO, BigFoot Biomedical
After founding two successful technology startups and dedicating his time to global philanthropy organizations, Jeffrey Brewer was facing the greatest challenge of his life – the diagnosis of his seven-year-old son Sean in 2002. Diabetes would become the new focus for his energy... Read More →
avatar for Sarah Faulkner

Sarah Faulkner

Editor, Drug Delivery Business News


Tuesday December 12, 2017 3:15pm - 4:00pm
Hilton Orange County/Costa Mesa 3050 Bristol Street, Costa Mesa, CA 92626