Nov 6 First Friday Bioscience – It Shouldn’t Be So Hard, Roy Wallen & David Cassidy
Full Title: It Shouldn’t Be So Hard: A novel Non Invasive, Low Cost, Accurate, Easy to Use lifesaving technology – It shouldn’t be hard to bring to market, but it is.
The development of the device is easy compared to the challenges of regulatory approval, and most of all reimbursement and adoption. David Cassidy and Roy Wallen discuss their challenges and their strategies for a path to market.
Arterial stiffness by Pulse Wave Velocity (PWV) is a proven predictor of cardiovascular disease. The European Society of Hypertension officially recommended PWV to be part of all routine exams for high blood pressure patients since 2007. Cre8MDI’s new device is non-invasive and simple to use and provides a high margin revenue stream for a disposable component while giving patients peace of mind from infections. Cre8MD boasts a team that has successfully brought medical devices to market before. With all of these advantages, this should not be so hard but, it is.
Cre8MDI is a medical device development company. The company’s mission is to apply innovative technology to improve the quality of healthcare. They believe that the key to improved health is through prevention and early diagnosis. Cost effective, easily accessible, devices are essential.
To learn more about Cre8MD, visit http://cre8mdi.com.
Offices of McLane Law
300 TradeCenter, 7th Floor
Woburn MA USA
Date and Time
Begins: 11/06/2015 12:30 PM
Ends: 11/06/2015 02:00 PM
Speaker: Dave Cassidy
David Cassidy, President and Founder, Cre8MDI
David is President and Founder of Cre8MDI, LLC, a medical device, start-up company. David has more than 25 years experience in the medical device industry including designing heart assist and IV infusion systems. He has taken a number of medical devices from concept through production and has authored multiple patents.
David’s most recent success waes as co-founder and inventor for Enginivity LLC, where he created and brought to production a sophisticated, mobile, IV fluid warmer called enFlow. Enginivity LLC was sold 3-1/2 years after the product’s inception to Vital Signs, a GE Healthcare company.
Speaker: Roy Wallen
Roy Wallen, Chief Business Officer, Cre8MD
Roy has served in leadership roles for new product initiatives in medical technology companies ranging from pre-revenue start-up to multi-billion dollar, global concerns. He has a global understanding of import, regulatory, and reimbursement elements needed for successful commercialization. In addition to his US-based work, he lived for 8 years in Europe and has extensive experience launching products in Asia. Roy has an undergraduate degree in electrical engineering with a biomedical focus, as well as graduate studies in biomedical engineering and business. Mr. Wallen has published 13 peer-reviewed papers and 20 abstracts and short papers related to healthcare technology and its implementation.
Registration, networking and lunch start at 12:30; Program
begins at 1 p.m.
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Online registration closes at 5 p.m. the day before this event. While walk-ins are never turned away, advance registration helps the team and is greatly appreciated.
Please note: There is an additional $5 charge for all walkins.
Pizza, salad, and soft drinks will be served.
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