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When can I start prototyping my medical device?

Question: When can prototyping begin in medical device product development? Some of my colleagues say I can’t use prototypes until I am under design controls and have all my design inputs defined. On the other hand, I can’t generate my design inputs until I use prototypes to better understand the user and the problem I’m…
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Integrating Reimbursement into Medical Device Design

Medical Device & Diagnostic Industry (MDDI)  recently included an article, Tips for Designing with Reimbursement in Mind, summarizing a presentation by Mark Domyahn, of St. Jude Medical, covering tips related to reimbursement. Some key points from the article are as follows: • Reimbursement is separate from regulatory approvals • Understand the requirements for approvals and…
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