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 Generis0 Comments

medical devicesThe 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 into the design process before development, manufacturers are able to improve the long-term viability of their device, and potentially avoid the substantial investment in developing a product that does not satisfy a need. This type of innovation is what positions a company for sustainable growth.”

Donnelly is a “firm believer in bringing the customer into development,” and warns that “if you don’t bring the customer into development before you come up with something other than your intended use, then you are going to: 1) sell them short, and 2) put yourself at risk for not building a product that effectively meets your customers’ needs. If you can’t articulate your intended use and fully understand your market requirements, then don’t build or develop the product.”

If you are moving towards a collaborative culture that considers the needs of both the patient and the end user, or are looking to reevaluate the processes you already have in place, then take Donnelly’s advice. Ask yourself the following questions about your relationship with your collaborators and customers:

1. Do they share their concerns with you and what their next pressures will be?

2. Do they consider you a trusted partner?

3. Are you building the product that is going to present value to them and that will sustain and grow their business, and yours?


To hear more from James Donnelly and Siemens Healthcare, join us at the American Medical Device Summit 2015 taking place in Chicago next week!

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