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Innovative Product Shelved in US
Due to Unacceptable Regulatory
Hurdles
One Example and Lessons Learned
February 10, 2014
...
Innovative Treatment for Chronic Lower Back
Pain Due to Degenerative Disc Disease (DDD)
30 million US citizens afflicted w...
Present Therapeutic Options
Present Therapeutic Options
Potential Area of Treatment
by Innovative Device
Innovative Treatment for Chronic Lower
Back Pain - Benefits and Risks
Benefits
• Relieves Pain
• Less invasive than
fusion...
Obstacle in Pathway to US Market: FDA
Designated “Gold Standard” Control
IDE for Pivotal Trial (2 years in FDA negotiation...
Issues
• Patient enrollment rate much slower than
expected – increasing project study duration by
2 years
• Costs much hig...
Lessons Learned
• Early understanding of FDA requirements for
determining safety and efficacy is key in
managing investor ...
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Innovative Product Shelved in US Due to Unacceptable Regulatory Hurdles

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Jane Metcalf of Interventional Spine

Published in: Health & Medicine, Business
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Innovative Product Shelved in US Due to Unacceptable Regulatory Hurdles

  1. 1. Innovative Product Shelved in US Due to Unacceptable Regulatory Hurdles One Example and Lessons Learned February 10, 2014 Jane Metcalf (949) 525 - 1493
  2. 2. Innovative Treatment for Chronic Lower Back Pain Due to Degenerative Disc Disease (DDD) 30 million US citizens afflicted with lower back pain and @ 3 million suffer from debilitating chronic back pain.
  3. 3. Present Therapeutic Options
  4. 4. Present Therapeutic Options Potential Area of Treatment by Innovative Device
  5. 5. Innovative Treatment for Chronic Lower Back Pain - Benefits and Risks Benefits • Relieves Pain • Less invasive than fusion surgery • Lower cost • Faster return to normal activities • Potential to delay further degeneration • Reversible Risks • Long term results not studied • Same as minimally invasive facet screws
  6. 6. Obstacle in Pathway to US Market: FDA Designated “Gold Standard” Control IDE for Pivotal Trial (2 years in FDA negotiation) • Multicenter, prospective, randomized control, 250+ patients, followed for 24 months Control versus Test Arms of Study • Control: Fusion surgery with interbody cage, several days in hospital, general anesthesia, six week recovery, cost @ $28K • Test: Percutaneous out-patient surgery, local anesthesia, 3 day recovery, cost @ $3K
  7. 7. Issues • Patient enrollment rate much slower than expected – increasing project study duration by 2 years • Costs much higher (@ $15 million) than expected • Population for new device indication not addressed
  8. 8. Lessons Learned • Early understanding of FDA requirements for determining safety and efficacy is key in managing investor expectations

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