Medical Devices Summit Midwest


September 6-7, 2012
TBA
Twin Cities, MN
United States

September 6-7, 2012

TBA

Twin Cities, MN

United States

Untitled Document

Conference Details

In response to an overwhelming amount of feedback from the industry, Opal Events is proud to announce that it will be taking it's Medical Devices Summit to Minnesota!

First 100 Medical Device Companies Register Free!

The Midwest is a hotbed for medical device innovation and development, and many companies are moving to the Midwest to be ahead of this curve. With so many new devices coming to market, it's absolutely vital for companies to arm themselves with the latest legal, regulatory and business strategies available. And Opal Events is striving to meet these needs!

Join us for insightful panel presentations, talks and workshops from foremost industry leaders as they build a roadmap for the industry's future. We will be bringing together industry professionals to discuss how medical devices will be impacted by the changing healthcare system in our country, how the current business model is changing and who the new players will be, how to be involved in the rapid globalization of the industry and how to foster innovation and plan for compliance!

Target Audience:

Medical Devices Manufacturing Companies - Manager/ Engineers/Director/ VP of:

Product Development and Design
Research and Development
Quality
Regulatory Affairs
Business Development
Compliance
Legal Affairs

Our Distinguished Speaking Faculty Includes:

Dan Dillon, Regulatory Scientist, MED Institute of Cook Medical
Dennis Hahn, Director of Regulatory Strategic Initiatives, Ethicon Endo-Surgery
Amra Rancic, Senior Regulatory Affairs Specialist, Bayer Healthcare
Dr. Steve Parente, Director, Medical Industry Leadership Institute, University of Minnesota
David M. Cronin, CEO, Cognition Corporation
Thomas Varricchione, Senior Vice President, RA & QA, Ximedica
Kenneth Sumner, Vice President of World Wide Scientific Affairs, Ethicon Endo-Surgery

Hotel Info:

TBD

Conference Registration Prices:

Early Bird Rate
(Expires 7/27/2012)

Standard Rate

Service Providers

$795

$995

Medical Device Companies, Academia, Government *

First 100 free*, after $495

Group Discounts:
Register 3 people and receive 10% off ***
Register 4 people and receive 15% off ***
Register 5 people or more and receive 20% off ***

If you'd like to be invoiced, please submit your contact details on the registration page and select "Please invoice me" at the bottom of the page.

If you are interested in sponsorship, exhibiting, or speaking opportunities, please call 212-532-9898 or email information@opalevents.org

* TERMS & CONDITIONS
Subject to approval. To qualify you must be currently employed by a non-vendor company.Eligibility will be verified by Opal. Opal reserves the right to allocate places and to refuse applications or to charge a normal attendance fee once the number of complimentary places has been exceeded.

* Excluding contract manufacturers and other service providers

Registration price reflects $100 online discount

Platinum Sponsor:

Gold Sponsor:

Silver Sponsor:

Round Table Sponsor:

Exhibitor Sponsor:

Media Partners:

Untitled Document

Conference Day 1: Thursday, September 6, 2012

8:00 am

Continental Breakfast & Registration

8:45 am

Chairs' Welcome

David M. Cronin, Director, Cognition Corporation

9:00 am

Keynote Address

Congressman Erik Paulsen, Minnesota's 3rd District, U.S. House of Representatives, (invited)

9:45 am

510k/Premarket Approval Step by Step Guide

Understand the importance of a comprehensive Premarket Approval Process: when to begin collecting materials, who to look to for guidance, what hiccups can you prepare for now
Learn how to interact most effectively with the FDA by having continuous dialog and providing feedback

Dan Dillon, Regulatory Scientist, MED Institute of Cook Medical
Dennis Hahn, Director of Regulatory Strategic Initiatives, Ethicon Endo-Surgery
Amra Rancic, Senior Regulatory Affairs Specialist, Bayer Healthcare

10:30 am

Interpreting Regulatory Intelligence and Redefining Due Diligence

The medical device space is more competitive than ever: and being aware of what is happening in the market is key to positioning yourself for success
Preparing for the mergers and acquisitions process by understanding what is looked at during the due diligence process
Partnering with your marketing team to understand what is happening in the competitive space

11:15 am

Morning Refreshment & Networking Break in Exhibition Space

Talk with your peers; enjoy some light refreshments all while learning about some new and exciting services and technologies from our exhibitors

11:45 am

Developing Profitable Partnerships: Case Studies in CRO Partnerships
(or topic TBD by sponsor)

12:30 pm

Luncheon Presentation

1:30 pm

Critical Thinking and Assessing Market Readiness

Hear how one group has been combining the expertise of the bench and the boardroom in assessing medical technology and it's viability in the market

Dr. Steve Parente, Director, Medical Industry Leadership Institute, University of Minnesota

2:15 pm

Afternoon Refreshment & Networking Break

Talk with your peers, enjoy some light refreshments all while learning about some new and exciting services and technologies from our exhibitors

Afternoon Workshop Presentation:
A Medical Device Start-Up's Roadmap to Success:
Navigating Corporate, Regulatory and Intellectual Property Challenges

Presented by:
FINNEGAN

2:30 pm

Fostering New Technology: Do You Have What Partnership Organizations Are Looking For?

Crossing the Valley of Death’- what has, should and will drive the development of new medical device technology?
More than ever it’s important to ‘incorporate the endgame’, and be up to date on reimbursement issues
How companies are evaluating how meaningful a product is in the lives of future patients

3:15 pm

Opening Remarks: The Relevance of These Three Main Themes in the Lives of Medical Device Start-Ups

3:25 pm

IP Discussion

Why IP is Important
How is IP viewed?
How does IP factor into acquisition and investment

4:00 pm

Corporate Presentation

Practical advice surrounding corporate issues and their importance

4:45 pm

The Regulatory Perspective

What are some of the issues involved with maintaining compliance and the potential implication of regulatory changes

5:30 pm

Closing Remarks and Q&A Session

5:45 pm

Day One Closing Remarks and Cocktail Reception (in the Exhibit Hall)

Conference Day 2: Friday, September 7, 2012

8:15 am

Continental Breakfast & Registration

9:00 am

Breakfast Workshops

Enjoy coffee and pastries with your fellow attendees during these intimate discussions on a wide variety of topics
Choose 2 half hour long workshops to attend, and join other industry leaders as they host in-depth discussions on a variety of topics
After 30 minutes, attendees will be given the opportunity to switch rooms and hear from a different industry leader on a whole new topic

Table 1 Sponsored by: Cognition Corporation

Table 2 Sponsored by: TUV Rheinland

10:15 am

Chairs' Welcome

David M. Cronin, CEO, Cognition Corporation

10:30 am

Getting to Know the Global Arena

With countries like China, Brazil and India quickly emerging as hotbeds for medical device technology, it is more important than ever for companies, (new and old), to be well versed in the regulations, customs and protocols of working abroad
Learn about the most pressing international standards and guidance impacting the medical device industry today, such as Country of Origin Rules
Going Beyond Premarket Clearance: Obtaining Reimbursement Coverage in OUS Markets

Moderator: Kenneth Sumner, Vice President of World Wide Scientific Affairs, Ethicon Endo-Surgery
Thomas Varricchione, Senior Vice President, RA & QA, Ximedica

11:15 am

Morning Refreshments & Networking Break in Exhibition Space

Talk with your peers; enjoy some light refreshments all while learning about some new and exciting services and technologies from our exhibitors

11:45 am

Reactions to the Global Shift: How Domestic Companies Can Best Leverage International Opportunities

Companies large and small are being impacted by the globalization of the medical device industry. Once your company decides to look outside of the US- what should the next step be?
What are the ‘push' and ‘pull' factors for companies looking to work internationally
Gain insight on navigating international regulatory bodies and how to become compliant on multiple fronts and where you should look for guidance

Moderator:
Kenneth Sumner, Vice President of World Wide Scientific Affairs, Ethicon Endo-Surgery

12:30 pm

Combination Products and the Unification of Multiple Industries
(Or topic TBD by Sponsor)

1:15 pm

Luncheon

2:15 pm

Patient Driven Design and the New Age of Medical Devices

Redefining innovation from design based to patient based by incorporating patient and provider experience into device design
Understanding human factors research and regulations

3:00 pm

Premarket Pitfalls: Skill Building for Start-Ups

Gain the skills for taking your company to the next level with insight on such issues as how to manage subcontractors or where to look for regulatory approval guidance
How do you identify possible partnership opportunities and develop sustainable partnerships?
Product commercialization: how to get ready to for the eventual FDA clearance while including not only sales and marketing, but clinical trials and regulatory departments as well

3:45 pm

The Reauthorization of User Fee Agreements

Unpacking the new draft agreements that are going before congress through a comprehensive look at goals and objectives for performance enhancement
Research and development in an age of instability: how can we preserve innovation
How will these changes reverberate throughout the industry, and when will you feel the effects

4:30 pm

Conference Adjourns

Speaker Biographies

David M. Cronin, CEO, Cognition Corporation

Mr. Cronin has worked in the product development world for over 20 years. He has a Bachelor of Science in Electrical Engineering and a High Tech MBA, both from Northeastern University in Boston, MA. Mr. Cronin has worked in both the engineering and marketing fields and is currently responsible for conducting applications and business development at Cognition Corporation. He assists companies who are implementing Systems Engineering, DFSS, lean, and other product development improvement initiatives and has experience in such industries as medical devices, automotive, defense/aerospace, consumer electronics, and services.

Amra Racic, MBA, Senior Regulatory Affairs Specialist, Bayer HealthCare

Amra Racic, MBA is a Senior Regulatory Affairs Specialist at Bayer HealthCare Interventional group in Coon Rapids, Minnesota. Her primary focus encompasses working with a variety of Thrombectomy, Atherectomy and Fluid Delivery devices and bringing those to the US market via 510(k) clearances and PMA and Supplement approvals.
Prior to joining Bayer, Amra retained a Regulatory role at Medtronic Inc. for five years. Her primary responsibilities were in the areas of Cardiovascular and In Vitro Diagnostic Devices. She was also an active member of the Medtronic Corporate 510(k) Subcommittee and Working Group discussing the FDA recommendations to the 510(k) Device Modification: Deciding When to Submit a 510(k) for a Change to an Existing Device, draft guidance.

She holds a Master’s Degree in Business Administration and in addition to English, speaks several other languages including German, Bosnian, Croatian and Serbian.

Current areas of focus include Regulatory, Clinical and Compliance matters in the U.S and International regions.

Dr. Steve Parente, Director, Medical Industry Leadership Institute, University of Minnesota

STEPHEN T. PARENTE, PhD, MPH, MS is the Minnesota Insurance Industry Chair of Health Finance in Carlson School of Management and the Director of the Medical Industry Leadership Institute at the University of Minnesota. As a Professor in the Finance Department, he specializes in health economics, health information technology, and health insurance. He has served has a consultant to several of the largest organizations in health care delivery including: UnitedHealth Group, Blue Cross Blue Shield, the Center for Medicare and federal and state governments as well as medical technology firms. Dr. Parente's peer-reviewed publications focus on the consumer directed health plans, health reform, medical technology assessment and consumer choices in health and wealth management. As the principal investigator for over $6 million in grants and contracts he has examined the national impact on health information technology on productivity and cost and has recently concluded several studies on topics including: innovations from health savings accounts and medical care fraud and abuse. In Washington DC, he in a governing board member of the Health Care Cost Institute, an Adjunct Scholar of the American Enterprise Institute and a health policy adviser to the American Action Forum. He has testified to the US Congress and state government on health reform legislation. Dr. Parente was a health policy advisor for the McCain 2008 Presidential Campaign and served as Legislative Fellow in the office of Senator John D. Rockefeller IV (DWV) during the Bush and Clinton Administrations' health reform initiatives. He has a doctorate from Johns Hopkins University and both a Masters of Public Health and a Masters of Public Policy Analysis for the University of Rochester.

Thomas Varricchione,Senior Vice President, RA & CA, Ximedica

Tom has managed clinical and regulatory affairs for 23 years at several medical product development companies engaged in developing first-of-a-kind products and has obtained more than 50 first-time product and clinical investigation approvals in the U.S., E.U., Japan and other markets.

Earlier, he worked in clinical, research and academic roles at Massachusetts General Hospital, Boston University Medical Center and Northeastern University.

Tom holds an M.B.A. from Boston University, a Post-Graduate Certificate in Respiratory Care from Northeastern University, and a B.A. with Honors from the University of Vermont. He is regularly invited to present at conferences, has coauthored several peer-reviewed medical papers and is a Registered Respiratory Therapist.

Service Providers Early Bird

Regular Price: $995.00
Price: $795.00

Qty:

Medical Device Companies, Academia, Government

First 100 Free

Regular Price: $495.00
Price: $0.00

Qty:

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