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Vascular Sciences





Company Headquarters

2105 Twain Avenue,
Carlsbad, CA 92008
United States

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    Related Content

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      Mike Drues and Sean Fenske discuss the European Commission’s guidelines for reprocessing single-use devices and the concerns with them.
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    • Mike on Medtech: Communicating with the FDA

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    • Mike on Medtech: COVID-19, Part 2

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    • Mike on Medtech: COVID-19, Part 1

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    • Packaging & Sterilization
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      Mike Drues and Sean Fenske discuss the controversy surrounding the most commonly used sterilization method for medical devices—EtO.
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    • Testing
      Mike on Medtech: Human Factors/Usability, Part 2

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    • Testing
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      Mike on Medtech: Human Factors/Usability, Part 1

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    • Surgical
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    • Diagnostics
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      Mike on Medtech: Beyond 510(k)/PMA—Safer Technologies Program

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    • Mike on Medtech: The NYT Editorial Board Statement

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    • Mike on Medtech: 510(k) Modernization

      Mike on Medtech: 510(k) Modernization

      Sean Fenske and Mike Drues discuss the potential changes coming to the 510(k) regulatory pathway and examine the issues around predicate devices.
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    • Mike on Medtech: Regulating the Practice of Medicine

      Mike on Medtech: Regulating the Practice of Medicine

      Sean Fenske and Mike Drues discuss the FDA's regulation of healthcare (or lack thereof) and if changes need to be made.
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    • Mike on Medtech: The Bleeding Edge, Part 3

      Mike on Medtech: The Bleeding Edge, Part 3

      The conversation on The Bleeding Edge documentary concludes in this portion of the three-part podcast series.
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    • Surgical
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      Mike on Medtech: The Bleeding Edge, Part 2

      The discussion over the controversial Netflix documentary continues between Sean Fenske and Mike Drues in this episode.
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    • Surgical
      Mike on Medtech: The Bleeding Edge, Part 1

      Mike on Medtech: The Bleeding Edge, Part 1

      Sean Fenske and Mike Drues begin a multi-part series on the controversial Netflix documentary on the medtech industry.
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    • Mike on Medtech: Breakthrough Designation Program

      Mike on Medtech: Breakthrough Designation Program

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    • Mike on Medtech: 15 Tips for Getting New Products Through FDA

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    • Digital Health | Electronics
      Mike on Medtech: Voice-Enabled Medtech

      Mike on Medtech: Voice-Enabled Medtech

      Sean Fenske and Mike Drues discuss voice-enabled medtech and its potential in healthcare.
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    • Mike on Medtech: Changing Pathway to Market?

      Mike on Medtech: Changing Pathway to Market?

      Sean Fenske and Mike Drues discuss the changing MDR for CE mark and its impact on the “first to market” route companies take.
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    • 3D/Additive Manufacturing
      Mike on Medtech: 3D Printing Healthcare at the Point of Care

      Mike on Medtech: 3D Printing Healthcare at the Point of Care

      Sean Fenske and Mike Drues discuss the regulatory implications with 3D printing devices at a healthcare facility.
      Sean Fenske, Editor 03.23.18
    • Mike on Medtech: Quality vs. Regulatory

      Mike on Medtech: Quality vs. Regulatory

      Mike Drues and Sean Fenske discuss these interrelated terms and their relevance to the industry, while offering examples.
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    • Mike on Medtech: The

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      Mike Drues and Sean Fenske discuss a recently announced 510(k) pathway that actually resembles an already existing option.
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    • Materials
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    • R&D & Design | Testing
      Mike on Medtech: Pre-Sub with the FDA

      Mike on Medtech: Pre-Sub with the FDA

      Mike Drues and Sean Fenske discuss the benefits of the FDA's pre-submission review process for medical device manufacturers.
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    • R&D & Design | Testing
      Mike on Medtech: Human Factors

      Mike on Medtech: Human Factors

      Mike Drues and Sean Fenske discuss the importance and benefits of human factors design in medical device development.
      Sean Fenske, Editor-in-Chief 10.09.17
    • Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical
      Mike on Medtech: MDUFA IV and Its Impact on Medtech Innovation

      Mike on Medtech: MDUFA IV and Its Impact on Medtech Innovation

      Mike Drues and Sean Fenske discuss the harmful effect the latest version of MDUFA could have on medtech development.
      Sean Fenske, Editor-in-Chief 09.07.17
    • Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical
      Mike on Medtech: Off-Label Use

      Mike on Medtech: Off-Label Use

      Mike Drues and Sean Fenske discuss the off-label use of medical devices and the promotion of such use.
      Sean Fenske, Editor-in-Chief 08.25.17
    • Materials
      Mike on Medtech: Biomaterials, Biocompatibility, and Bioabsorbable

      Mike on Medtech: Biomaterials, Biocompatibility, and Bioabsorbable

      Mike Drues speaks with Sean Fenske to discuss biomaterials, biofriendly, biocompatible, bioabsorbable, and more.
      Sean Fenske, Editor-in-Chief 07.24.17
    • 3D/Additive Manufacturing
      Mike on Medtech: 3D Printing in Healthcare

      Mike on Medtech: 3D Printing in Healthcare

      Mike Drues joins Sean Fenske to chat about the role of 3D printing in medtech and healthcare today and challenges that exist.
      Sean Fenske, Editor-in-Chief 06.05.17
    • R&D & Design
      Mike on Medtech: Reimbursement for Engineers

      Mike on Medtech: Reimbursement for Engineers

      Sean Fenske and Mike Drues take a look at the relationship between medical device reimbursement and medtech product design and development.
      Sean Fenske, Editor-in-Chief 05.05.17
    • Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical
      Mike on Medtech: Device Incident Reporting

      Mike on Medtech: Device Incident Reporting

      Sean Fenske and Mike Drues discuss the topic of hospitals reporting medical device incidents and what needs to change with the process.
      Sean Fenske, Editor-in-Chief 03.30.17
    • Mike on Medtech: Real World Evidence

      Mike on Medtech: Real World Evidence

      Sean Fenske and Mike Drues delve into the use of real world evidence in medtech regulatory approval processes and what matters to manufacturers.
      Sean Fenske, Editor-in-Chief 02.24.17

    • NeoChord Passes 500 Patient Treatment Milestone

      Two-year clinical data shows sustained outcomes in patients treated with the NeoChord System.
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    • Contract Manufacturing | R&D & Design | Software & IT | Testing
      Mike on Medtech: Guidance on Medical Device Changes Submitted to FDA

      Mike on Medtech: Guidance on Medical Device Changes Submitted to FDA

      In August, the FDA released guidances offering insight on what changes need to be reported to the agency.
      Sean Fenske, Editor
    • Contract Manufacturing
      Mike on Medtech: FDA

      Mike on Medtech: FDA's Additive Manufacturing & 3D Printing Guidance

      On this debut episode, MPO Editor Sean Fenske and regulatory guru Mike Drues examine the recently released guidance.
      Sean Fenske, Editor
    • Video Interview: Tips for Ensuring Supplier Quality in an Era of Consolidation

      Video Interview: Tips for Ensuring Supplier Quality in an Era of Consolidation

      Michael Drues, Ph.D., president of Vascular Sciences, talks quality at MPO Summit 2015.