Authors: Elizabeth Goldenberg, Wesley Pedersen.
A compelling “need” identification is essential prior to initiating the lengthy, demanding and often frustrating pathway necessary for cardiovascular device innovation and development. Over the past few decades both iterative and transformational treatments have been especially profound in cardiovascular interventional and surgical approaches which have necessitated innovation in devices to bring these novel approaches to fruition. Stakeholders in the development of such devices have included amongst others, clinicians, patients and institutions. Given the numerous hurdles for medical device development including the need for multidisciplinary teams, establishing intellectual property portfolios, conducting market in tandem with academic research, funding, identifying regulatory and reimbursement strategies, a rigorous process for needs verification is mandatory. This vital first step needs to be methodical and is the topic of brief discussion in this perspective manuscript.
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