As part of FDA approval, a new medical device must follow guidelines for “Human Factors,” which address design and encompass usability and ergonomics. Because medical devices are so diverse, manufacturers often struggle to understand how the guidelines apply to their own product. At this talk, Dr. Russell Branaghan, Founder/President at Research Collective will describe strategies to help companies (1) improve their time to market and overall design through early implementation of human factors, and (2) pass their human factors validation test for FDA clearance.
The Rosenman Symposium is the premier event for the San Francisco Bay Area’s health technology community. It is held annually in June at the UCSF Mission Bay campus. Join us to learn from leaders in the health technology industry, meet dynamic startups, and connect with hundreds of players in the Bay Area ecosystem.
The federal government can be a key source of non-dilutive funding to fuel your advance to commercialization in health technology. But where to begin looking, and how to be sure you have not missed any opportunities? A comprehensive strategy is necessary, one that includes all relevant programs and players as well as granular details on which program managers to work with. Join us on June 5 to learn firsthand from Dr. Anna Kushnir and Bill McCann of SMI, a consulting firm that has helped hundreds of early-stage companies develop strategic plans to win federal funding.
Digital health is a sector of the health ecosystem that has enormous growth potential. What’s really piquing investors’ interest these days? Are there any special factors that make certain digital health companies more attractive than others? What trends are emerging, and what major unmet needs are still crying out for a solution that would bring investors running? Join us on May 1 to get answers from David Kim of the investment firm DigiTx Partners.
There is a seemingly limitless number of frameworks for strategy development. Using them well lays a critical foundation for aligning teams and investors and ensuring long term success. Kirsten Carroll will review the role strategy plays in business planning and the importance of not just developing a great one, but also communicating it effectively. She will provide examples of the frameworks that have served her particularly well in her own career with advice on when and how to use them.
Join us on Thursday, March 8, when Rosenman Institute Director Christine Winoto will interview Eric Stone, CEO and co-founder of Velano Vascular. Under Eric’s leadership, Velano’s PIVO needleless blood draw technology won FDA approval; the company raised $17 million this past March; and Velano has just been named to the 2017 Fierce 15 in Medtech.
Mr. Mehrdad Farhangnia serves as the Chief Executive Officer and President at Roxwood Medical, Inc. Mr. Farhangnia joined Roxwood Medical at its formation in January of 2011 and has a successful track record of launching novel medical devices. He has two decades of technical and commercial experience, with prior management roles at Spiracur, Rubicor Medical, FoxHollow Technologies and CardioVention Inc. Prior to his career in medical devices, he spent six years at NASA Ames Research Center, leading collaboration efforts with key aerospace manufacturers and national laboratories. He serves as Director at Roxwood Medical, Inc. He is an inventor of 8 issued patents and has co-authored 10 published articles or conference proceedings. Mr. Farhangnia received his BS and MS degrees in Aerospace Engineering from the University of Colorado.
Amr Salahieh is a seasoned medical device entrepreneur with over 25 years of experience in the medical device industry. Amr is the founder of Shifamed LLC, a Silicon Valley based medical device incubator founded in 2009, from which Legacy Portfolio Companies Maya Medical, Kalila Medical, and Apama Medical have successfully exited and through which three additional companies are currently under incubation. Prior to founding Shifamed, Amr founded Sadra Medical, a percutaneous aortic valve replacement company, which was sold to Boston Scientific in 2011 and co-founded Embolic Protection, Inc. (EPI) which was sold to Boston Scientific in 2001. Amr has extensive R&D management experience stemming from his engineering consulting firm, Sobek Medical LLC which he sold to EPI, and from his work at CardioThoracic Systems and Guidant. Amr is either the inventor or co-inventor on >100 granted and >140 published US patent applications. He holds a B.S. in Biomedical Engineering and a B.S. in Electrical Engineering from Case Western Reserve University.
Dr. Stevens is the CEO of HeartFlow, a company focused on using data from standard CT scans, to create personalized 3D models of the coronary arteries and analyzes the impact that blockages have on blood flow. Trained as a cardiovascular surgeon, He had a distinguished career as an health care professional and entrepreneur. He was the Co-Founder and CTO of Heartport, the Co-Founder and Executive Chairman of Amp Resources, Co-Founder and Chairman and CEO of Sundrop Fuels. He has had extensive experience founding, investing and leading technology focused companies.
Dr. Stevens received his B.S. from the University of Utah and M.D. from the Stanford University School of Medicine. He was an Assistant Professor of Cardiovascular Surgery at Stanford University.
Thomas has 28 years of experience in healthcare with medical devices, biologics, and diagnostics. He has worked with global public companies, private equity, startups, and nonprofits.
He was CEO of Gambro and led the company in the largest private equity transaction in Europe at the time. Previously, Thomas was CEO of HemoCue, which he led to a successful exit. Prior, he was Senior Vice President of Baxter Healthcare / Baxter International and President of Baxter Bioscience. He has also been CEO of Immuno International, a leading global plasma and vaccines company. He was a Managing Director at the World Economic Forum, Davos.
Currently, Thomas is Vice Chairman of Grifols SA, a board member of Sulzer AG and Alkahest, as well as a Healthcare Advisor to Madison Dearborn and Partners.
Thomas is a graduate of Dartmouth College and holds an MBA from IMD in Switzerland. He has a Board of Directors Certification from the UCLA Anderson School of Management. Currently he commutes between the US, Switzerland, and Sweden.
