Tag Archives: IDE

Recent Pre-Market Activities at FDA

By Sangita Viswanathan
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FDA recently released changes and updated guidance documents to its pre-market assessment of medical devices. Susan Alpert, M.D., Ph.D., Principal, SFA Consulting LLC, provides the perspective of the industry and offers suggestions on what can be done to improve pre-market risk management.

FDA recently released changes and updated guidance documents to its pre-market assessment of medical devices. Susan Alpert, M.D., Ph.D., Principal, SFA Consulting LLC, provides the perspective of the industry and offers suggestions on what can be done to improve pre-market risk management.

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Beyond the Patient – The Recipe for a Successful Product

As a designer, it can be easy fall into the trap of focusing on and designing for the user. While this is all very good for the user, it’s not so great for the many other people who must interact with the product throughout its life. The intended user of a product is not the only user and there are a number of “stakeholders” in a product’s life.

As a designer, it can be easy fall into the trap of focusing on and designing for the user. While this is all very good for the user, it’s not so great for the many other people who must interact with the product throughout its life. The intended user of a product is not the only user and there are a number of “stakeholders” in a product’s life.

Continue reading