Starting a Medical Device Company <ul><li>What Early Stage Medical Technology Companies Need to Succeed </li></ul>
Starting a Medical Device Company <ul><li>What value will your product provide? </li></ul><ul><li>Who will pay for it and ...
Starting a Medical Device Company <ul><li>Medical Device Start-up companies have the same business needs as other Start-up...
Starting a Medical Device Company <ul><li>Medical Device Start-up companies need to consider: </li></ul><ul><ul><li>Regula...
Case Study Innovation to Standard of Care Development of the SInergy™ System for the Treatment of SIJ Syndrome SInergy is ...
Unmet Need: Sacroiliac Joint Syndrome <ul><li>Sacroiliac Joint Syndrome is pain that originates in or around the sacroilia...
Anatomical Research Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of ...
Device Development: <ul><li>First Design </li></ul><ul><li>Failed – did not properly treat the area in question </li></ul>...
Solution Mono-polar Cooled-RF Lesion  Treatment Area (AP View) Patents pending and/or issued  Sales & Marketing Clinical T...
SInergy System - Procedure <ul><li>An internally Cooled-RF electrode is used to create a series of spherical lesions </li>...
Intellectual Property (USPTO) Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance St...
Regulatory Clearance <ul><li>Regulatory Approval Strategy </li></ul><ul><ul><li>US FDA </li></ul></ul><ul><ul><li>Health C...
Manufacturing <ul><li>Product Launch     Outsourced Subassemblies &  Component Sourcing </li></ul><ul><li>Early Adoption ...
Reimbursement <ul><li>Health Technology Assessment </li></ul><ul><li>Payer Education </li></ul><ul><li>Reimbursement Suppo...
Clinical Trials <ul><li>Safety Study </li></ul><ul><li>Limited Release Clinical Trial </li></ul><ul><li>Randomized Control...
Sales & Marketing <ul><li>US, International Distribution Network </li></ul><ul><li>US, International Cadaver Courses </li>...
<ul><li>Process, not product </li></ul><ul><li>Inter-related set of activities </li></ul>Sales & Marketing Clinical Trials...
Conclusions  <ul><li>Starting a medical device company requires a deep consideration of a number of complex, inter-related...
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Frank Baylis on behalf of Kris Shah

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Frank Baylis on behalf of Kris Shah

  1. 1. Starting a Medical Device Company <ul><li>What Early Stage Medical Technology Companies Need to Succeed </li></ul>
  2. 2. Starting a Medical Device Company <ul><li>What value will your product provide? </li></ul><ul><li>Who will pay for it and why? </li></ul><ul><li>What evidence will be required to get regulatory approval and market acceptance? </li></ul>
  3. 3. Starting a Medical Device Company <ul><li>Medical Device Start-up companies have the same business needs as other Start-ups. </li></ul><ul><li>However Medical Device Start-ups also have additional, specific requirements that are needed to be successful. </li></ul>
  4. 4. Starting a Medical Device Company <ul><li>Medical Device Start-up companies need to consider: </li></ul><ul><ul><li>Regulatory strategy </li></ul></ul><ul><ul><ul><li>Ever changing landscape (FDA, Health Canada) </li></ul></ul></ul><ul><ul><li>Reimbursement strategy by geography </li></ul></ul><ul><ul><ul><li>Health Technology Assessments </li></ul></ul></ul><ul><ul><li>IP </li></ul></ul><ul><ul><ul><li>Freedom to operate </li></ul></ul></ul><ul><ul><ul><li>Patentability </li></ul></ul></ul><ul><ul><li>Quality System </li></ul></ul><ul><ul><li>All these aspects are interrelated </li></ul></ul>
  5. 5. 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
  6. 6. Unmet Need: Sacroiliac Joint Syndrome <ul><li>Sacroiliac Joint Syndrome is pain that originates in or around the sacroiliac joints </li></ul><ul><li>No effective surgical or pharmacological intervention for SIJS </li></ul>Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  7. 7. Anatomical Research Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  8. 8. Device Development: <ul><li>First Design </li></ul><ul><li>Failed – did not properly treat the area in question </li></ul><ul><li>Second Design </li></ul><ul><li>Failed – Outcomes were not predictable due the nature of the tissues in and around the joint </li></ul>Patents pending and/or issued
  9. 9. 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
  10. 10. SInergy System - Procedure <ul><li>An internally Cooled-RF electrode is used to create a series of spherical lesions </li></ul><ul><li>Technology permits simplified surgical access to treatment site </li></ul>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
  11. 11. 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
  12. 12. Regulatory Clearance <ul><li>Regulatory Approval Strategy </li></ul><ul><ul><li>US FDA </li></ul></ul><ul><ul><li>Health Canada* </li></ul></ul><ul><ul><li>EU </li></ul></ul><ul><ul><li>TGA </li></ul></ul><ul><ul><li>Other Countries </li></ul></ul><ul><li>Facilitates market access & accelerates product adoption </li></ul>Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  13. 13. Manufacturing <ul><li>Product Launch  Outsourced Subassemblies & Component Sourcing </li></ul><ul><li>Early Adoption  Manual Production </li></ul><ul><li>Commercial Acceptance  “Insourcing” + Automation </li></ul>USA USA Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  14. 14. Reimbursement <ul><li>Health Technology Assessment </li></ul><ul><li>Payer Education </li></ul><ul><li>Reimbursement Support </li></ul>USA Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  15. 15. Clinical Trials <ul><li>Safety Study </li></ul><ul><li>Limited Release Clinical Trial </li></ul><ul><li>Randomized Control Trial </li></ul><ul><ul><li>Johns Hopkins </li></ul></ul><ul><li>Randomized Control Trial </li></ul><ul><ul><li>Health Care Utilization </li></ul></ul>USA Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  16. 16. Sales & Marketing <ul><li>US, International Distribution Network </li></ul><ul><li>US, International Cadaver Courses </li></ul><ul><li>Publications (Studies, White Papers, Textbooks) </li></ul><ul><li>Specialty Societies (ASIPP, ASA, ISIS…) add procedure to educational curriculum </li></ul>Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  17. 17. <ul><li>Process, not product </li></ul><ul><li>Inter-related set of activities </li></ul>Sales & Marketing Clinical Trials Manufacturing Define Unmet Need IP Regulatory Clearance Standard of care Device Development Medical Procedure Development Research
  18. 18. Conclusions <ul><li>Starting a medical device company requires a deep consideration of a number of complex, inter-related activities. </li></ul><ul><li>All functions must work in concert for success </li></ul>

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