March 2013

9
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Here it is: The Biodesign Alumni Association Monthly Newsletter! The alumni association is growing at a rapid pace, and we get weekly communiqué from people wanting to get in touch with you – from Biodesign leadership to those with new job or funding opportunities. Instead of cluttering your inbox with one-off emails, we have decided to try a new format and compile all announcements into a monthly e-newsletter, to be sent out the first Monday of every month. All newsletters will be archived on the Biodesign Alumni Webpage for your reference.
In this March issue:
  • Upcoming Alumni Association Events
  • General Announcements
    • Become a 2013 Alumni Association Member!
    • Outreach opportunity: Med School 101 with Makower   
  • New Biodesign Alumni Blog Posts
  • Policy Changes that Affect You

Upcoming Alumni Association Events

FROM THE INNOVATOR’S WORKBENCH | MONDAY, MARCH 4

5:30pm | Li Ka Shing Berg Hall, Stanford University
Ferolyn Powell and Fred St. Goar
Co-Founders, Evalve
Event Details & Sign Up

TSC WITH MARK LEAHEY & THOMAS NOVELLI | THURSDAY, MARCH 14

6:30-9:30pm | Zibibbo
Mark Leahey and Thomas Novelli will be discussing unique insights and strategies to govern the 510(k) and PMA regulatory pathways, as well as what changes to expect with the implementation of the user fee reauthorization and FDA reforms.

Event Details & Sign Up

MDMA CONFERENCE & BREAKFAST WITH CHRISTY FOREMAN | FRIDAY, MARCH 15

7:45-9:00am | Crowne Plaza Cabana Hotel
The Biodesign Alumni Association policy initiative has secured an exclusive breakfast with Christy Foreman, the Director of the Office of Device Evaluation. This opportunity will provide a forum to convey our recommendations on how FDA can improve, providing examples of good interactions as well as those that could have been better.
Event Details & Sign Up

STANFORD GSB HEALTHCARE INNOVATION SUMMIT | WEDNESDAY, APRIL 17

1-8pm | Knight Management Center, Stanford University
This year’s Summit will explore how information technology has the potential to be a lightning rod for disruptive change in the healthcare field.
Event Details & Sign Up

General Announcements

BECOME A 2013 BIODESIGN ALUMNI ASSOCIATION MEMBER!
Gain access to exclusive Alumni Association events. New member benefits this year 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.
Join Today!

PARTICIPATE IN STANFORD MED SCHOOL 101!

Help High School students make the right career decision! Our very own Josh Makower is looking for volunteers to give high school students a fun experience to understand what medical device development is all about with some really fun brainstorming activities. Of course, he needs you to make this all work! It’s a blast, and you’re guaranteed to have fun. He is looking for 5-6 volunteers.Please RSVP to Ken Wu – kenneth.wu@gmail.com – by Friday, 3/15.Here are the details:What: Stanford Med School 101
When: April 19, 9:30am – 10:40am
What: Help with brainstorming

New Biodesign Alumni Blog Posts

 

GINGER GRAHAM: THE CHANGING LANDSCAPE IN HEALTHCARE INNOVATION
by Ritu Kamal
Posted February 11, 2013
Ginger Graham delivered the 14th Annual Thomas Fogarty Lecture this year, focusing on changing landscape in healthcare innovation. With her extensive experience in both the pharmaceutical and medical device industries, Ms. Graham gave a thought-provoking talk that challenged conventional views on healthcare innovation.
Read More

 

MUSINGS WITH ANGELA MACFARLANE
by Ryan Van Wert
Posted February 25, 2013
The Biodesign Alumni Association had the pleasure of dining with Angela Macfarlane at the October Tableside Chat.  She has spent time with some of the fundamental medical device innovators, from Tom Fogarty, to ExploraMed, to The Foundry.  She is currently the CEO of ForSight Labs, an ophthalmology incubator, that she helped to create with Eugene de Juan, Jr. MD and The Foundry in 2005.  ForSight Labs has spun out 5 companies over the last 6 years, each focused on a key clinical need in ophthalmology, including device and drug-device combinations.
Read More

 

Policy Changes that Affect You

MEDICAL DEVICE TAX MORE LIKELY TO RAISE PRICES THAN LOWER HEADCOUNTS, SURVEY SAYS
More than 40% of medical device makers surveyed said they would raise prices to deal with some or all of the impact of the new 2.3% sales tax, compared with only 11% who said they would reduce their staff.
Read More

FDA 510(K) REVIEW TIMES SEE IMPROVEMENTS
Review times for medical device 510(k) premarket notifications by the U.S. Food and Drug Administration (FDA) improved somewhat in 2011 after several years of lengthening review times, according to a new analysis of publically available FDA data by Emergo Group.
Read More

USPTO PUBLISHES NEW RULES FOR FIRST-TO-FILE 

The USPTO published final rules and guidance implementing the first-inventor-to-file provision of the America Invents Act.  The provision is effective on March 16, 2013.
– Read More: First-Inventor-to-File Final Rules (78 Fed. Reg. 11024)
– Read More: First-Inventor-to-File Final Guidance (78 Fed. Reg. 11059)
The USPTO is hosting a public forum on Friday, March 8, 2013 in the Madison Auditorium on the USPTO’s Alexandria campus.  The forum will run from 10:00 AM to 12:30 PM Eastern Daylight Time. There will also be a webcast (instructions will be announced soon).


USPTO NEW FEE SCHEDULE

The USPTO published its final fee-setting rules based upon Section 10 of the Leahy-Smith America Invents Act that provides the USPTO with broad authority to set fees with the major caveat being that the fees as a whole be set to recover the aggregate costs of the Patent Office. The new fees are scheduled to become effective on March 19, 2013.
Read More

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