Blue Goat CyberSMMedical Device Cybersecurity
    K
    Podcast · Episode 68

    Why MedTech Needs More Than Approval with Michael Branagan Harris of HealthTech Strategies Limited

    With Michael Branagan Harris - A device can clear regulatory hurdles and still struggle commercially if the evidence is too narrow. MedTech companies need proof that speaks to affordability, care quality, operational impact, and long term value, not just technical performance.

    Christian Espinosa, Founder & CEO at Blue Goat Cyber

    By Christian Espinosa, MBA, CISSP

    Founder & CEO · Blue Goat Cyber

    Last reviewed: May 1, 2026

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    Episode breakdown

    Key takeaways

    • Beyond regulatory approval, MedTech companies must demonstrate a device's value proposition across affordability, care quality, operational impact, and long-term value.
    • Market selection is a critical commercialization factor, as reimbursement models and care delivery systems significantly differ between countries like the United States, the UK, Germany, and the Netherlands.
    • A strong adoption case for medical devices requires evidence that extends beyond narrow technical performance data.
    • Understanding economic logic across diverse healthcare markets is essential for successful MedTech product launches.
    • The efficacy of a medical device in one regulatory environment does not guarantee commercial success or equivalent fit in others due to varying healthcare infrastructures.

    A device can clear regulatory hurdles and still struggle commercially if the evidence is too narrow. MedTech companies need proof that speaks to affordability, care quality, operational impact, and long term value, not just technical performance.

    Market selection matters just as much. The same solution may fit the United States, the UK, Germany, or the Netherlands very differently because reimbursement models, provider incentives, and care delivery systems are not built the same way.

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