Chelmsford, MA 01824, US
Medical Devices & Equipment
Cre8MDI designs, develops, and patents medical devices. Our mission is to develop and commercialize innovative devices that will improve the quality of health care and reduce cost through prediction, early detection, and management.
Over 300 million people suffer from cardiovascular disease – nearly 17 million will die from it this year but they don’t all have to. Further, clinicians do not have reliable and easy-to-use tools to assess risk or direct therapy. Researchers from the Framingham Heart Study, Johns Hopkins Hospital, and others have identified Pulse Wave Velocity (PVW) as an early indicator of cardiovascular events. Cre8MDI’s technology provides quick, reliable, and easy-to-use measurement of PWV.
Cre8MDI’s novel technology measures PWV and arterial stiffness in a simple, non-invasive, low-cost system that contains reusable sensors, single-use disposable components, and an instrument for user interface. The disposable portion gives patients peace of mind from infections while providing a continuous, high-margin revenue stream for the company. The instrument provides instant, accurate, visual information for both the clinician and patient.
Cre8MDI’s team has successfully brought a number of medical devices from concept to market, including a previous successful acquisition by GE Healthcare. The team currently consists of David Cassidy, Founder and President; Marie Getchell, VP, Quality & Regulatory; Mark Lewis, VP, Operations and Manufacturing; Allison Reveley, VP, Marketing & Public Relations; Roy Wallen, Chief Business Officer. Cassidy and Wallen each have over 25 years’ experience in developing innovative medical products. Additional support is in software development, IP development, finance, and grant writing and by clinicians at Johns Hopkins University.
Products / Services
Cardio 1:1 (TM) Pulse Wave Velocity System
The Cardio 1:1 device is a simple, non-invasive, low-cost system that contains reusable sensors, single-use disposable components, and an instrument for user interface. The disposable portion gives patients peace of mind from infections while providing a continuous, high-margin revenue stream for the company. The instrument provides instant, accurate, visual information for both the clinician and patient. The system can be used as a stand-alone product to assess cardiovascular risk in a doctor’s office (and, eventually, at home). In addition, a simple interface allows for integration into existing hospital patient monitoring systems and for data acquisition.
The initial work on a bench-top system and related proof of concept has been completed. Supported in part by a grant from the Massachusetts Life Sciences Center (MLSC), a clinical prototype is currently in development. Current efforts are focused on transforming the previous work into a fully functional, clinical system.
President Technology Officer
David Cassidy is president and founder of Cre8MDI, LLC, a medical device, start-up company. Cre8MDI’s mission is to develop and commercialize innovative diagnostic devices that will improve the quality of healthcare and reduce cost through early detection of disease. This echoes David’s lifelong commitment to helping others. 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.
David resides in Massachusetts with his wife and four sons. He enjoys exploring the Southwest with his family, hiking and restoring and building cars.
Managing Director Executive Officer
Roy Wallen is Chief Business Officer of Cre8MDI. He brings over 25 years of experience in product marketing, new product development, and operations, having overseen the successful launch of new technologies in medicine. Revenue from his introductions exceed $1 billion. Specific application areas include critical care medicine, anesthesiology (monitoring and anesthesia delivery), cardiac surgery (monitoring and circulatory support,among others.
Mr. Wallen’s global experience includes worldwide product marketing, developing and directing a sales organization in Europe, and regulatory and reimbursement support in Japan. A significant portion of his product marketing and market development work (8 years) was done in Germany, where he became fluent in the local language and the business culture of Europe. Market development in the Asia-Pacific rim includes significant experience in development and support of distributors in Japan, Korea, southeast Asia, Australia, and New Zealand.