D'Vice Squad

This group is a collection of all registered users. You can find general updates and other PDC news within this group.

Regulatory Resources for Pediatric Device Innovators

The Pediatric Device Consortia Program Office at FDA recently shared some regulatory updates and resources relevant to pediatric medical device innovators that we wanted to pass along:

  • Changes to FDA's IDE and Early Feasibility Clinical Trials Process. The slide presentation attached to this post describes recent changes to the Investigational Device Exemption (IDE) process designed to speed time to approval and increase the number of early feasibility/first-in-human studies conducted in the U.S.

Finally, if you have specific questions regarding the regulatory pathway for a pediatric medical device you are developing, our consortium is always happy to put you in touch with contacts at FDA who can best direct you. Email Elizabeth.Gress@ucsfmedctr.org for assistance.

PDC Announcements - Tuesday, September 16

Receive feedback on your pediatric device at a PDC meeting

As many of you know, the UCSF PDC holds weekly open meetings that pediatric innovators from anywhere can attend remotely or in person to receive free clinical and technical feedback and development advice from our multidisciplinary team of clinicians, engineers, scientists, and device industry professionals. Email Elizabeth.Gress@ucsfmedctr.org with a 1-paragraph summary of your idea/project to get on our meeting schedule. 

APSA Annual Meeting 2015 – Abstracts due September 22

Submit your abstract for the American Pediatric Surgical Association’s 46th Annual Meeting by Monday, September 22. Abstracts detailing new techniques, therapies, or devices that have the potential to improve treatment of pediatric patients are specifically encouraged and may be submitted under the “Innovation” category. Innovation abstracts are eligible for the Sheikh Zayed Institute for Pediatric Surgical Innovation Award, which includes a monetary prize of $10,000, a personalized plaque, and framed certificate. Details and abstract submission at http://www.eapsa.org/Abstracts1.htm?utm_source=APSA-Informz&utm_medium=email&utm_campaign=default.

Pediatric Surgical Innovation Symposium – October 24 @ The Newseum, Washington, DC

The Sheikh Zayed Institute for Pediatric Surgical Innovation's 2nd Annual Symposium, Lessons from Drugs to Devices: A Pediatric Perspective, will be held Friday, October 24, at The Newseum in Washington, DC. Now in its 2nd year, the Symposium brings together leaders and problem solvers in pediatric surgery and the medical device industry for the purpose of fostering the collaborations needed to speed and improve pediatric R&D. The Symposium includes a full day of highly engaging panels and audience participation, and concludes with a cocktail party and awards ceremony where the two best pediatric device projects/companies, selected by a panel of experts, receive $50,000 each.* Information and registration at http://www.pediatric-surgery-symposium.org/.

* Medical Device Pitch for Kids! Competition – Apply by September 22. The organizers of the Symposium are seeking proposals from inventors in medical institutions, private practices, device companies, and academic researchers who have medical device concepts or ideas for use with pediatric patients. Proposals should address a significant, yet unmet need within the pediatric population with a device idea that lends itself to commercialization. Following the competition process, two prizes will be given, each for up to $50,000. Follow this link http://www.pediatric-surgery-symposium.org/prizes/ to review the submission guidelines and to submit your application online by September 22 at 17:00 EST. 

ISRBP Young Investigators Pre-Symposium – September 25 @ Hotel Nikko, San Francisco

UCSF is hosting the 22nd Annual Meeting of the International Society for Rotary Blood Pumps (ISRBP) in downtown San Francisco September 25-27. In the meeting’s tradition of providing an open scientific hybrid platform for engineers and clinicians, the Young Investigators Pre-Symposium on September 25 is open to students, trainees and junior engineers free of charge. Pre-Symposium attendees may stay for the remainder of the day to enjoy the scientific program and invited lectures (PDC Director Michael Harrison, MD, will be delivering the keynote lecture at 12:45 pm). To register for the Pre-Symposium, email Elizabeth.Gress@ucsfmedctr.org by Friday, September 19. Those interested in attending the full meeting may register at http://isrbp2014.org/registration.html. 

Upcoming UCSF Events/Opportunities of Interest:

Moneyball for Medical Device Startups – September 17, 5-7 pm @ UCSF Mission Bay

The Rosenman Institute is proud to introduce the D-Series, our own forum on medical device development in the Bay Area. Join us at the D-Series to learn about the latest technology and meet leaders in the field. Investment banker Aaron Travis helped raise $30 million for 17 startups in the past year, including a $3.9M round for medical device company Consano Medical. Travis is managing director at Deal Labs, a firm that uses big data and automated marketing to pair startups with investors. He'll explain how the Deal Labs system works and advise why you need to find the right investors; how to create a demand; and what unique challenges early stage medical device companies face in raising capital. Sign up at http://www.eventbrite.com/e/d-series-aaron-travis-deal-labs-moneyball-for-medical-device-startups-tickets-12534205145?aff=eventsemail.

Intellectual Property Workshop – September 17, 5-8 pm @ UCSF Parnassus

Todd Esker, Intellectual Property Partner at Morgan Lewis and Karin Immergluck, Director of the Office of Technology Management at UCSF will address the IP issues that have been on your mind: How do I know when I should file IP? What can I say to the outside world about my invention? Is it OK to talk to investors about my technology? When should I make a disclosure to the University? How does Technology Management work at UCSF?  How much protection can I get from a provisional patent? Do I need an IP attorney to help me or can I do this myself? This is a 3 hour workshop that will cover the basics of the complicated topic of IP. Sign up at http://www.eventbrite.com/e/ip-workshop-tickets-12462278009.

Catalyst Awards Program – Applications due September 22

The UCSF Clinical and Translational Science Institute’s Catalyst Award combines customized expert feedback and advice with funding to help drive promising early-stage research through the lengthy and complex process of translating ideas into patient benefit. Several projects of the UCSF PDC have been funded through this mechanism. The expert consultation and funding they received enabled them to advance promising early research findings along the most effective path toward safe and effective medical treatment and health outcomes. Submit your application by 2:00 pm on Monday, September 22 at http://rap.ucsf.edu/catalyst-awards-development-diagnostics-devices-therapeutics-and-digital-health.

Sheikh Zayed Awards for Pediatric Device Projects | Call for Proposals

The Sheikh Zayed Institute for Pediatric Surgical Innovation's 2nd Annual Symposium, Lessons from Drugs to Devices: A Pediatric Perspective, will be held Friday, October 24, 2014, at The Newseum in Washington, DC. 

Information and registration here: http://www.pediatric-surgery-symposium.org/

Call for Proposals

The organizers of the Symposium are seeking proposals from inventors in medical institutions, private practices, device companies, and academic researchers who have medical device concepts or ideas for use with pediatric patients. 

Proposals should address a significant, yet unmet need within the pediatric population with a device idea that lends itself to commercialization. Following the competition process, two prizes will be given, each for up to $50,000

Please follow this link http://www.pediatric-surgery-symposium.org/prizes/ to review the submission guidelines and to submit your application online by September 22, 2014 at 17:00 EST.

About the Symposium

Now in its 2nd year, the Sheikh Zayed Pediatric Surgical Innovation Symposium brings together leaders and problem solvers in pediatric surgery and the medical device industry for the purpose of fostering the collaborations needed to speed and improve pediatric R&D. The Symposium includes a full day of highly engaging panels and audience participation, and concludes with a cocktail party and awards ceremony where the two best pediatric device projects/companies, selected by a panel of experts, receive $50,000 each.