|
Name, Affiliation |
Friday AM Sessions |
Notes, Quotable Moment |
| Ellen Zane, president and CEO Tufts Medical Center, Boston MA | Bringing it All Together: Clinical Practice, Industry, Research & Education | Providers brand increases cost Insurers need to be value-driven Employers’ fair share Consumers need to become cost conscious and take responsibility Government pay fairly |
| Lisa Greenwald-Swire, JD – Principal, Fish & Richardson | Emerging Markets Panel – New Frontier of Growth Moderator | Expanding middle class Health care system consuming implants, disposables and diagnostic imaging |
| Nancy Travis – Vice President Global Strategy Advamed, former Deputy Director of US State Dept Office of Economic Policy in the Bureau of Easter Asia and Pacific Affairs | Panelist | In the next 5 years, China will export more med tech to the UYS/EU—current quality is low, counterfeit |
| Wendy X. Shao – Managing Director & Chairman of Board of R&D Systems China Co. Ltd. | Panelist | Healthcare identified as a key industry in the 12th 5-yr plan |
| Natasha Leskovesk, RN, JD – Partner, Cooley LLP, former researcher, NIH | Regulatory Panel – Panels, Pivotals and Pain Moderator | Data needed to satisfy agency is also needed to sell product to customers |
| Debra J. Rasmussen – Senior Director Regulatory Affairs, Companion Diagnostic CoE, Johnson & Johnson | Panelist | JNJ keeps submitting on schedule, focused on customer needs and wants |
| Jonette Foy, Ph.D. – Acting Deputy Director for Science & Regulatory Policy, Office of Device Evaluation, CDRH | Panelist | Communicate with agency early and often, flurry of draft guidance—please comment, improving transparency and predictability |
| Elaine Tseng, JD – Partner King & Spalding LLP, former FDA Counsel | Panelist | Draft guidance is making more clear the practice that has developed and is in use |
| Cindy Domecus, RAC (US & EU) – Principal, Domecus Consulting Services LLC | Panelist | “I no longer have the answer, just pray” 510(k): there’s a lower tolerance for the gap between base products and equivalents trend toward de novo process |
| Tamara Fraizer, JD, PhD – Principal, Fish & Richardson | Entrepreneurship Panel – Starting and Building Successful Companies in the New World Order Moderator | Patent reform bill signed into law by Obama Are leaders born or made? |
| Stacy Enxing Seng – President, ev3/Covidien Peripheral Vascular | Panelist | Born + rise to occasion Find the unmet and unfunded needs |
| Denise Zarins – Co-Founder, Ardian/Medtronic | Panelist | Born + education + luck (track record) |
| Karen Talmadge, PhD – Co-Founder of Kyphon and former start-up CEO | Panelist | Born (passion) Prove the opportunity to yourself—be skeptical No short cuts, do each step |
| Erica Rogers – COO, Medicines360 and co-founder of Visiogen | Panelist | Born + big company experience See one; do one Not all great ideas get enough funding to get to market |
Related Links:
MedTech Vision 2011 Conference
2011 (C) eGold Solutions and pH Consulting; all rights reserved.
[...] Friday AM [...]