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Nov 6 First Friday Bioscience – It Shouldn’t Be So Hard….

Nov 6 First Friday Bioscience – It Shouldn’t Be So Hard….

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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 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 the while giving patients peace of mind from infections. Cre8MD boasts a team that has brought medical devices to market before and success before. With all of these advantages, this should not be so hard – but, it is.

About Cre8MDI

Cre8MDI is a medical diagnostics 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, diagnostic devices are essential.

To learn more about Cre8MDI, visit their webiste: 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

Cassidy 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 heart assist and IV infusion. He has taken a number of medical devices from concept through production and has authored multiple patents.
David’s most recent success comes 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, global concerns. He has a global understanding of import, regulatory safety, and reimbursement elements needed for successful commercialization after 8 years living in Europe and experience in launching products in Japan. Roy has an undergraduate degree in electrical engineering and 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.

Our Host:

host logo Council

Safety Partners of Bedford, MA delivers customized best-in-class EHS
programs, training and permitting. Whether they’re developing a regulatory
compliance program, streamlining and tailoring manuals, or providing
practical guidance for sale use of hazardous materials, the company’s
Consulting Safety Officers leverage their own science backgrounds to
understand the intricacies of the life science EHS space and customize
solutions that are the right fit for each client.

Safety Partners
Phone: 781.222.1022
19A Crosby Drive, Suite 300
Bedford, MA 01730

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OnLine Registration

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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