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It's the time of year to celebrate another successful group of Biodesign Fellows and welcome them into the alumni network!
In this JUNE issue:
Upcoming Alumni Association Events
General Announcements
CALL FOR NOMINATIONS TO THE BIODESIGN ALUMNI BOARD!
Amazing opportunity with Design Health Barcelona
Help with Biodesign Application Screening
Policy Changes that Affect You
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Upcoming Alumni Association Events
BIODESIGN ALUMNI ANNUAL EVENT | MONDAY, JUNE 10
6-9:30pm | Faculty Club, Stanford University
This year's annual event will feature Duke Rohlen and his team from CV Ingenuity, a company focused on drug-coated angioplasty balloons for treatment of peripheral vascular disease. Learn about their lightning-fast acquisition by Covidien, catch up with alumni who are in town for graduation, and feast on an upscale sit-down dinner as we up the ante to the Faculty Club this year! This event is FREE for all current fellows and members of the Biodesign Alumni Association. Remember to sign up by THIS Wednesday, June 5th!
Event Details & Sign Up
BIODESIGN ALUMNI FACULTY BREAKFAST | TUESDAY, JUNE 11
7:30-8:30am | Clark Center, Room S360, Stanford University
Take this unique opportunity to catch up with the Biodesign faculty and get updated on all things Biodesign!
Event Details & Sign Up
BIODESIGN FELLOWS GRADUATION | TUESDAY, JUNE 11
5pm | Alumni Lawns at the Li Ka Shing Center, Stanford University
2012-2013 Biodesign Fellows Graduation Ceremony and Reception.
FROM THE INNOVATOR'S WORKBENCH | MONDAY, JUNE 17
5:30pm | Li Ka Shing Berg Hall, Stanford University
John Dineen
CEO & President, GE Healthcare / GE Medical Systems
Event Details & Sign Up
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General Announcements
CALL FOR NOMINATIONS TO THE BIODESIGN ALUMNI BOARD
The Biodesign Alumni Board is looking for two new members to serve this coming year. Voting will occur at the Annual Event. If you would like to nominate someone (or yourself) for the position, please email your nomination to: kenneth.wu@gmail.com.
UNIQUE OPPORTUNITY - DESIGN HEALTH BARCELONA
With the help of Stanford Biodesign, Design Health Barcelona will be launching a new Biodesign-like program and need your help! They are looking for someone to take on the following responsibilities for 6-7 months while ideally living in Barcelona:
1. Coaching and mentoring the Fellows: meeting with the teams once per week and helping them advance in the Biodesign process (much like what Todd Brinton does)
2. Teaching the lectures related to the Biodesign process (5 or 6 lectures each)
3. Running the mini-case during the Bootcamp
See: www.moebio.org for more information about the program, and emailbtangy@stanford.edu if you are interested in finding out more about the position.
HELP WITH BIODESIGN APPLICATION SCREENING
The Biodesign Faculty are looking for alumni to help with applicant screening in the upcoming application cycle. This is a rewarding way to give back to Biodesign and provides interesting insight into the selection process. Please contact Beverly Tang (btangy@stanford.edu) if you are interested in participating.
FREE CONFERENCE REGISTRATION TO THE WSGR MEDICAL DEVICE CONFERENCE
Limited passes available - get yours now!
MEDTECH IDOL AT THE WSGR MEDICAL DEVICE CONFERENCE
Applications are now being accepted from Medtech startup companies for an opportunity to present at the First Annual Medtech Idol pitch session. For those interested in applying, please submit an application at medtechidol.com.
The Medtech Idol pitch session, hosted by RCT Ventures, will be held on June 19, 2013 at the WSGR Medical Device Conference at the InterContinental Hotel in San Francisco. Four companies selected by a panel of investors will present at the conference, and this panel of investors will give feedback to each of the presenting companies. In addition, the audience will vote electronically for the most outstanding Medtech Business Opportunity. The winner will receive recognition at an awards ceremony during the conference. They will also get a presenting slot at an upcoming IN3 Medical Device conference, and they will be profiled in an upcoming issue of Elsevier's monthly magazine START-UP: The Review of Emerging Medical Ventures.
BECOME A 2013 BIODESIGN ALUMNI ASSOCIATION MEMBER!
Gain access to exclusive Alumni Association events. New member benefits include exclusive access to the VIP Innovator's Workbench Dinners (alumni invitations now only open to members) and one free Innovator's Workbench speaker ticket. Don't forget that you need to be a member to attend the Annual Event!
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Policy Changes that Affect You
SENATE VOTES TO CONFIRM MARILYN TAVENNER TO HEAD CMS
In an overwhelming 91-7 vote this week, the Senate approved Marilyn Tavenner's nomination to become administrator of the Centers for Medicare & Medicaid Services (CMS). Tavenner, a nurse who has been the acting administrator for over a year becomes the first CMS head to be confirmed by the Senate since 2006. In this capacity, Tavenner will continue to be responsible for directing Medicare and Medicaid programs as well as implementing a large portion of the Affordable Care Act (ACA). In a press release issued after the confirmation vote, Health & Human Services (HHS) Secretary Kathleen Sebelius issued the following statement, "I'm pleased to announce that the Senate voted today to confirm Marilyn Tavenner as administrator of the Centers for Medicare & Medicaid Services making her the first CMS administrator to be confirmed in over nine years. Marilyn brings with her a breadth of experience and expertise from virtually all angles of health care policy and delivery, having served as a hospital CEO, a state health official, and a registered nurse. Marilyn will serve in a critical role at CMS as we work to improve the health care for hundreds of millions of Americans."
CDRH REVEALS UPDATED APPEALS PROCESS GUIDANCE
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) recently released long-awaited guidance detailing updated processes for appealing a rejection for a premarket approval (PMA) or 510(k) premarket notification application. The guidance, intended to finalize draft guidance issued December 28, 2011 comes in the form of two documents, one set that's final guidance and one set that's draft guidance.
June 2013
- Upcoming Alumni Association Events
- General Announcements
- CALL FOR NOMINATIONS TO THE BIODESIGN ALUMNI BOARD!
- Amazing opportunity with Design Health Barcelona
- Help with Biodesign Application Screening
- Policy Changes that Affect You
_
Upcoming Alumni Association Events
6-9:30pm | Faculty Club, Stanford University
This year’s annual event will feature Duke Rohlen and his team from CV Ingenuity, a company focused on drug-coated angioplasty balloons for treatment of peripheral vascular disease. Learn about their lightning-fast acquisition by Covidien, catch up with alumni who are in town for graduation, and feast on an upscale sit-down dinner as we up the ante to the Faculty Club this year! This event is FREE for all current fellows and members of the Biodesign Alumni Association. Remember to sign up by THIS Wednesday, June 5th!
Event Details & Sign Up
BIODESIGN ALUMNI FACULTY BREAKFAST | TUESDAY, JUNE 11
Event Details & Sign Up
BIODESIGN FELLOWS GRADUATION | TUESDAY, JUNE 11
5pm | Alumni Lawns at the Li Ka Shing Center, Stanford University
2012-2013 Biodesign Fellows Graduation Ceremony and Reception.
_
General Announcements
CALL FOR NOMINATIONS TO THE BIODESIGN ALUMNI BOARD
The Biodesign Alumni Board is looking for two new members to serve this coming year. Voting will occur at the Annual Event. If you would like to nominate someone (or yourself) for the position, please email your nomination to: kenneth.wu@gmail.com.
UNIQUE OPPORTUNITY – DESIGN HEALTH BARCELONA
With the help of Stanford Biodesign, Design Health Barcelona will be launching a new Biodesign-like program and need your help! They are looking for someone to take on the following responsibilities for 6-7 months while ideally living in Barcelona:
1. Coaching and mentoring the Fellows: meeting with the teams once per week and helping them advance in the Biodesign process (much like what Todd Brinton does)
2. Teaching the lectures related to the Biodesign process (5 or 6 lectures each)
3. Running the mini-case during the Bootcamp
See: www.moebio.org for more information about the program, and emailbtangy@stanford.edu if you are interested in finding out more about the position.
HELP WITH BIODESIGN APPLICATION SCREENING
The Biodesign Faculty are looking for alumni to help with applicant screening in the upcoming application cycle. This is a rewarding way to give back to Biodesign and provides interesting insight into the selection process. Please contact Beverly Tang (btangy@stanford.edu) if you are interested in participating.
FREE CONFERENCE REGISTRATION TO THE WSGR MEDICAL DEVICE CONFERENCE
Limited passes available – get yours now!
MEDTECH IDOL AT THE WSGR MEDICAL DEVICE CONFERENCE
Applications are now being accepted from Medtech startup companies for an opportunity to present at the First Annual Medtech Idol pitch session. For those interested in applying, please submit an application at medtechidol.com.
The Medtech Idol pitch session, hosted by RCT Ventures, will be held on June 19, 2013 at the WSGR Medical Device Conference at the InterContinental Hotel in San Francisco. Four companies selected by a panel of investors will present at the conference, and this panel of investors will give feedback to each of the presenting companies. In addition, the audience will vote electronically for the most outstanding Medtech Business Opportunity. The winner will receive recognition at an awards ceremony during the conference. They will also get a presenting slot at an upcoming IN3 Medical Device conference, and they will be profiled in an upcoming issue of Elsevier’s monthly magazine START-UP: The Review of Emerging Medical Ventures.
BECOME A 2013 BIODESIGN ALUMNI ASSOCIATION MEMBER!
Gain access to exclusive Alumni Association events. New member benefits include exclusive access to the VIP Innovator’s Workbench Dinners (alumni invitations now only open to members) and one free Innovator’s Workbench speaker ticket. Don’t forget that you need to be a member to attend the Annual Event!
_
Policy Changes that Affect You
In an overwhelming 91-7 vote this week, the Senate approved Marilyn Tavenner’s nomination to become administrator of the Centers for Medicare & Medicaid Services (CMS). Tavenner, a nurse who has been the acting administrator for over a year becomes the first CMS head to be confirmed by the Senate since 2006. In this capacity, Tavenner will continue to be responsible for directing Medicare and Medicaid programs as well as implementing a large portion of the Affordable Care Act (ACA). In a press release issued after the confirmation vote, Health & Human Services (HHS) Secretary Kathleen Sebelius issued the following statement, “I’m pleased to announce that the Senate voted today to confirm Marilyn Tavenner as administrator of the Centers for Medicare & Medicaid Services making her the first CMS administrator to be confirmed in over nine years. Marilyn brings with her a breadth of experience and expertise from virtually all angles of health care policy and delivery, having served as a hospital CEO, a state health official, and a registered nurse. Marilyn will serve in a critical role at CMS as we work to improve the health care for hundreds of millions of Americans.”
The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently released long-awaited guidance detailing updated processes for appealing a rejection for a premarket approval (PMA) or 510(k) premarket notification application. The guidance, intended to finalize draft guidance issued December 28, 2011 comes in the form of two documents, one set that’s final guidance and one set that’s draft guidance.
Biodesign Alumni 