Why You Should Create a Collaborative Culture in the Pre-Development Stage

In manufacturing, medical device, medtech, mfg, product design, QMS, Quality by design, siemens by GenerisLeave a Comment

The medical device industry has seen substantial growth in past years and the need for innovative, value-driven devices is rising. The sustainability of the current healthcare system, however, is dependent on minimizing spend and maximizing resources to ensure that for each dollar spent, there is some improvement to the health and quality of life of the individual. In order to achieve the necessary value and quality in the design of new devices, more and more manufacturers are striving to develop a collaborative culture in which the needs of the patient and those of the end user, such as the nurse, physician or other care giver, are taken into account during the pre-development stage. James Donnelly, Ph.D., Chief Scientific Officer, Global VP, Medical, Scientific & Statistical Affairs, Siemens Healthcare Diagnostics says “it’s not just how the patient benefits from a product, procedure, or test result—it’s everybody in between us and the patient that also need to be considered. It’s how the device and its functions will fit into their workflow and how it will add value to their system. You can build the best product in the world, but if they can’t use it in a way that is efficient and cost effective for them, it will fail.” “Device manufacturers need to look now and act fast to understand whether or not, in this changing environment, they are still creating products that represent today’s definition of state-of-the-art while anticipating what is needed in the future,” Donnelly says. “By bringing the patient and user perspective …

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The Implications of a Changing Healthcare Environment

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An Interview with Siemens Healthcare Diagnostics’ Dr. James Donnelly. The medical device industry has achieved significant growth over recent years, with the industry expected to generate $365 billion in sales by the end of 2015, and $460 billion by 2018 (information sourced from TÜV SÜD). The initial and continued success of a medical device is dependent on the value it brings to the delivery of healthcare, where there is a need to reduce waste in an evolving regulatory and reimbursement climate. Prior to his speaking engagement at the upcoming American Medical Device Summit 2015 in Chicago next week, we had the opportunity to sit down with James Donnelly ,Ph.D., Chief Scientific Officer, Global VP, Medical, Scientific & Statistical Affairs, Siemens Healthcare Diagnostics to gather his perspective on the medical device industry in the U.S., and understand how changes to the healthcare system will influence the industry moving forward. Donnelly has been with Siemens for more than eight years, beginning as Global Vice President of Medical, Clinical and Statistical Affairs. He is passionate about integrating customer input, quality, and innovation into the design of products. He also believes the customer must be an active partner in product lifecycle management and that innovation without purpose will not consistently add value to the healthcare system. Jim, how would you describe the current healthcare environment in the U.S. for medical devices? The current healthcare spend is not sustainable. We spend too much on healthcare delivery without the expected return in value. The healthcare system and its stakeholders are all experiencing significant …

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