A review of life science current events reported by MedCity News this week:
An online glimpse into Medtronic CEO Omar Ishrak. Medtronic wouldn’t grant access to Ishrak on his first day, but thanks to his online footprint, a pattern emerges. Ishrak is deeply interested in global markets. While some believe that medical devices for developing markets like China and India will likely be low-end products to address basic needs of access and affordability, Ishrak appears to believe that price considerations will not compromise innovation.
Inside an Automated Healthcare Practice: Redesigning Care Around People, Not Paperwork
By reducing administrative burden and redesigning workflows around human needs, it creates space for what matters most: connection between clinicians and patients.
Mid-sized CROs perform as good or better than larger ones, survey says. Kevin Olson, CEO of ISR, said that the survey responses and data do not show why mid-sized CROs as a whole scored better than larger ones. But he theorizes the smaller CROs might be seen as offering better service because while they may not have the breadth of services of the larger CROs, their smaller sizes give them more focus and efficiencies in the services they do offer.
Philip’s Healthcare’s Cleveland imaging center gets FDA warning letter. The FDA listed 15 specific violations uncovered during inspections of Philips’s imaging center in Highland Heights, Ohio last year. For example, the company failed to report to the FDA device malfunctions that “would be likely to cause or contribute to a death or serious injury if the malfunction were to recur,” according to the warning letter.
Cleveland Clinic physician-entrepreneur Mark Penn leaving CCF. Dr. Marc Penn will become director of research for the Summa Cardiovascular Institute and also a professor at Northeast Ohio Medical University (NEOMED) in Rootstown, according to a statement from Summa. Penn will start with Summa next month. His five-person research team will make the transition with him.
How to sell medical devices in Europe. The general industry perception is that the European regulatory process is quicker, more efficient and more predictable than the U.S. Food and Drug Administration’s process for clearing medical devices. Start-ups, then, which must constantly focus on capital efficiency, may find that Europe holds lots of appeal for early commercialization.