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Happy Independence week - a perfect time to celebrate equality!

In this July issue:

Upcoming Alumni Association Events
General Announcements

Biodesign Alumni Board Welcomes New Members!
Help with Biodesign Application Screening

New Biodesign Alumni Blog Posts
Policy Changes that Affect You

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Upcoming Alumni Association Events

THE EVOLVING PARADIGM FACING MEDTECH STARTUPS | TUESDAY, JULY 16

12:00pm | Li Ka Shing Center, Room 130, Stanford University
Fred St. Goar
Physician Founder of Evalve and Director of Fogarty Institute for Innovation
In 1999, Dr. St Goar founded Evalve and helped develop the MitraClip which has become the leading technology in the percutaneous mitral valve repair space. Now fourteen years later, it is a global technology used in over 30 countries but still has yet to be approved by the FDA. He will share some thoughts and insights on the inception and development of the technology as well as some of the barriers and challenges getting it to the point of being a readily available therapy.
Sponsored by the Stanford School of Medicine Career Center
Event Details & Sign Up

HEALTH INNOVATION SUMMIT | THURSDAY & FRIDAY, AUGUST 8-9

W Hotel, San Francisco
Rock Health's Health Innovation Summit brings together diverse minds from healthcare, technology, and beyond to wrestle with healthcare's most challenging problems. This one-of-a-kind, high-energy event features prominent thought-leaders and entrepreneurs in raw and insightful conversations you won't hear anywhere else.
Event Details & Sign Up

General Announcements

BIODESIGN ALUMNI BOARD WELCOMES NEW MEMBERS!
The Biodesign Alumni Board would like to welcome two new members to the board: Justin Williams ('12-'13 Fellow) and Richard "Andy" Rink ('12-'14 Fellow). Justin was the 2012-2013 Fogarty Fellow and previously worked at MAQUET Cardiovascular as a Product Marketing Manager for New Product Development. Andy is a second year fellow who is in the midst of surgical residency at Northwestern. We're excited to have them on board and look forward to their contributions and involvement.

At the same time, two instrumental board members who have benefited the organization with their service years will be moving on from active board duties. As the outbound president, Jessica Hudak ('05-'06 Fellow) has grown the organization to its current state with a solid membership base, great content, and solid industry partnerships which have expanded our event offerings significantly. While she is formally stepping down, she will remain in touch as part of the Advisory / Chairman board along with Evan Anderson ('03-'04 Fellow) and Gary Binyamin ('05-'06 Fellow). In addition, our current policy guru and former financial officer, Pedram Afshar ('09-'10 Fellow) has been central to establishing our non-profit status as developing our policy initiative, which now is well positioned for future growth. We all thank you for your service.

Stepping into their roles will be current board members Ken Wu ('06-'07 Fellow), who will serve as the new Alumni Board President, and Mike Schaller ('10-'11 Fellow), who will continue in his role as Board Treasurer. Brandon Felkins ('10-'11 Fellow), Ravi Pamnani ('10-'11 Fellow), and Beverly Tang ('07-'08 Fellow) will maintain their active positions on the board.

HELP WITH BIODESIGN APPLICATION SCREENING
The Biodesign Faculty are looking for just a couple more 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.

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New Biodesign Alumni Blog Posts

MOVING FORWARD TOGETHER: MDMA AND FDA
by Pedram Afshar
Posted June 4, 2013
Though he admits to feeling like a "grim reaper" at times, Mark Leahey, CEO of the Medical Device Manufacturers Association (MDMA), is "actually an optimist" about the future of the industry. One of the reasons for his optimism is the recent FDA effort of enhanced transparency and accountability led by Christy Foreman, Director of the Office of Device Evaluation (ODE) at the FDA. Last month, Biodesign Alumni sat down with both Leahey and Foreman to discuss their work, challenges, and opportunities for help.
Read More

WHAT IS UP WITH VCs AND HEALTH IT?
by Jeremy Johnson
Posted June 15, 2013
Missy Krasner is currently looking for good opportunities for series A investments in this space as an EIR at Morgenthaler Ventures. She also consults with Box on their healthcare vertical, which supports HIPAA-compliant cloud storage and content collaboration for healthcare and life science customers. Missy was also one of the founding members of Google Health and has over 20 years of marketing, communications, and business development experience in health IT and consumer health.
Read More

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Policy Changes that Affect You

SUNSHINE ACT IMPLEMENTATION IMMINENT  
Tracking payments to US physicians for companies with "covered products" to beginAugust 1st, under the "Sunshine Law". While many large companies have systems in place (and will be most scrutinized), smaller companies and start-ups are doing their best to comply with the law in the least burdensome approach, and are preparing for the investigations that may follow. Doctors will have the right to challenge data that was collected and reported, making the responsibility of maintaining excellent documentation fall on the manufacturer... how is Sunshine affecting you?
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SUPREME COURT RULES THAT HUMAN GENES CANNOT BE PATENTED 
Not exactly Medical Devices, but this may impact the field of "personalized medicine", or may have very little impact, since many gene patents were expiring anyway. Some believe this will lead the way to more affodable, whole-genome sequencing.
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