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Frank Baylis on behalf of Kris Shah
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Frank Baylis on behalf of Kris Shah

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Frank Baylis on behalf of Kris Shah Frank Baylis on behalf of Kris Shah Presentation Transcript

  • Starting a Medical Device Company
    • What Early Stage Medical Technology Companies Need to Succeed
  • Starting a Medical Device Company
    • What value will your product provide?
    • Who will pay for it and why?
    • What evidence will be required to get regulatory approval and market acceptance?
  • Starting a Medical Device Company
    • Medical Device Start-up companies have the same business needs as other Start-ups.
    • However Medical Device Start-ups also have additional, specific requirements that are needed to be successful.
  • Starting a Medical Device Company
    • Medical Device Start-up companies need to consider:
      • Regulatory strategy
        • Ever changing landscape (FDA, Health Canada)
      • Reimbursement strategy by geography
        • Health Technology Assessments
      • IP
        • Freedom to operate
        • Patentability
      • Quality System
      • All these aspects are interrelated
  • Case Study Innovation to Standard of Care Development of the SInergy™ System for the Treatment of SIJ Syndrome SInergy is a trademark of Baylis Medical Company in the United States and/or other countries
  • Unmet Need: Sacroiliac Joint Syndrome
    • Sacroiliac Joint Syndrome is pain that originates in or around the sacroiliac joints
    • No effective surgical or pharmacological intervention for SIJS
    Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  • Anatomical Research Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  • Device Development:
    • First Design
    • Failed – did not properly treat the area in question
    • Second Design
    • Failed – Outcomes were not predictable due the nature of the tissues in and around the joint
    Patents pending and/or issued
  • Solution Mono-polar Cooled-RF Lesion Treatment Area (AP View) Patents pending and/or issued Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  • SInergy System - Procedure
    • An internally Cooled-RF electrode is used to create a series of spherical lesions
    • Technology permits simplified surgical access to treatment site
    Patents pending and/or issued Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  • Intellectual Property (USPTO) Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research Provisional Patent Applications Technology Platform Patents Medical Procedure Method Patents SInergy Device Patents Other Device Patents Other Method Patents
  • Regulatory Clearance
    • Regulatory Approval Strategy
      • US FDA
      • Health Canada*
      • EU
      • TGA
      • Other Countries
    • Facilitates market access & accelerates product adoption
    Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  • Manufacturing
    • Product Launch  Outsourced Subassemblies & Component Sourcing
    • Early Adoption  Manual Production
    • Commercial Acceptance  “Insourcing” + Automation
    USA USA Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  • Reimbursement
    • Health Technology Assessment
    • Payer Education
    • Reimbursement Support
    USA Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  • Clinical Trials
    • Safety Study
    • Limited Release Clinical Trial
    • Randomized Control Trial
      • Johns Hopkins
    • Randomized Control Trial
      • Health Care Utilization
    USA Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  • Sales & Marketing
    • US, International Distribution Network
    • US, International Cadaver Courses
    • Publications (Studies, White Papers, Textbooks)
    • Specialty Societies (ASIPP, ASA, ISIS…) add procedure to educational curriculum
    Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
    • Process, not product
    • Inter-related set of activities
    Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  • Conclusions
    • Starting a medical device company requires a deep consideration of a number of complex, inter-related activities.
    • All functions must work in concert for success