Blog

Why It Takes So Long to Develop a Medical Technology (Part 4)

Written by Mark Carol, MD
Published:
Part 4: Reimbursement – Reimbursement includes all the steps necessary to get paid by insurance payors for using a technology. All parties in a technology company – management, board, investors, employees – should understand the true requirements for a successful reimbursement strategy. While there are exceptions to every rule, the process generally flows in a consistent direction from regulatory through coding to assignment of payment to determining coverage, with the final step being payors paying (or not) the physician and/or facility.
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Patent Strategy for Business Advantage: Insights for Focused Ultrasound Manufacturers

Written by Rick Hamilton
Published:
Rick Hamilton is a named inventor on more than 1,045 issued US patents and has more than 25 years of patent portfolio development and governance experience and 13 years of portfolio usage and organizational strategy experience. In this blog, he aims to share a high-level “Patent Strategy 101” overview with focused ultrasound ecosystem participants. It explores the questions of “why patent,” and “what to patent,” among other topics.
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Why It Takes So Long to Develop a Medical Technology (Part 3)

Written by Mark Carol, MD
Published:
Part 3: Regulatory Authorization – In this blog, Mark Carol, MD, a senior consultant at the Foundation, gives an overview of the ways medical device companies can approach US FDA approval. FDA regulatory authorization is required to sell a device in the US. There are three main paths toward achieving authorization in the USA: PMA approval, 510(k) clearance, or De Novo grant. Approximately 4,000 510(k) applications are submitted to the FDA each year, compared to less than 100 PMA applications.
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Why It Takes So Long to Develop a Medical Technology (Part 2)

Written by Mark Carol, MD
Published:
Part 2: Novel Technology Development – In this blog, Mark Carol, MD, a senior consultant at the Foundation, shares his insight for successful technology development in the medical device space. Using a real-world case study, this blog addresses many common mistakes made by new companies and how to avoid them to make it to market successfully.
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New Medical Device Regulation in Europe The Complex Ecosystem of a Medical Device Startup Focused Ultrasound Treatment for Essential Tremor Now Reimbursed in Germany Cost Comparison Between Standard-of-Care and Focused Ultrasound Therapies The Role of Advocacy in Advancing the Field of Focused Ultrasound