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  What Teams Get Wrong in Early Medical Device Design

  After years of working with founders and technical teams, I have learned that early design missteps rarely come from engineering flaws. More often than not, they come from missing conversations.

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  Exit Optimization: Building Strategic Optionality

  In Medtech, a successful exit isn’t just about having an innovative device, it’s about building a business that potential buyers and investors can clearly see a future in.

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  How Minimum Viable Products Deliver the Most Valuable Products (MVP) for Medical Device Development

  Achieve more accurate budgeting in medical device development by clearly defining the intent of the Minimum Viable Product (MVP).

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  FDA Draft guidance: Marketing Submission PCCP Recommendations for AI/ML-Enabled Device Software Functions

  Review of April 2023 FDA draft guidance on PCCP Recommendations for AI/ML-Enabled Device Software Functions.

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  FDA Action Plan for AI/ML in SaMD (Software as a Medical Device)

  Overview of the FDA action plan for AI/ML in software as a medical device (SaMD) and list of best practices.

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  Qualifying and Managing RoHS and REACH suppliers

  RoHS and REACH are two regulations that requires compliance if a company intends to sell in the European Union.

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