Date post: | 20-Jul-2015 |
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implantable drug infusion pumps
with remote physician control
for chronic pain patients at home
“the right dose at the right time and place”
Christian Gutierrez (EL), Ellis Meng (PI), Carol Christopher (IM), Tuan Hoang (FE)
PatientsTraining
Hospitals
Unit sales
Trade shows
Clinicians
Institutions
Support Services
Pain clinics
Clinical dataKOLs Formulary Acceptance
FDA
IP
Advocacy Groups
Foundations
OEMs
Wireless Developers
Manufacturing Costs
Product Dev Costs
FDA/Clinical Trials
Chronic Pain v5 FS Team
Payors/ICA
Marketing Costs
Faster relief
• Efficient patient management• Dosing flexibility• Reliable access to intrathecal space
Access to high-value therapies and pharmacoeconomics
pharmacoeconomics
Support
Proprietary knowledge
Human Resources
Electronic records
Electronic health record providers
Bundled kits
CMS (Medicare)
Current Pumps
Channel Incentives
Hospitals
Pain Clinics
Private Hospitals, specialty clinics
HMO, ACO, Non-profit, University Hospitals
All Institutions
VP
High Value Therapies
Pharmacoeconomics
Dosing flexibility
Efficient patientmanagement
Demand Creation
Budget ~ $300 k/year
Regulatory Pathway (Class III)
$2-3MM
1-2YR$3-5MM
30 patients
1-2YR
US IDE
EU CE
$15-22MM
150 patients
2-3YR
$2MM
1YR$2-3MM
<20 patients
1YR
$5-8MM
<60 patients
1-2YR
$2MM
1YR$2-3MM
<20 patients
1YR
$6-9MM
<60 patients
1-2YR
US HDE
US PMA
US HUD
EU CE
$20-30MM
4-7YR
$10-14MM
3-4YR
$9-13MM
3-4YR
Take-aways • New VP: Simpler more reliable surgery (smaller size), volume, stable long
term access to intrathecal space (for several indications)• Mini-Pivot – Opportunity to target multiple indications. Doctors use
intrathecal pumps for multiple conditions (not just pain)• Some institutions specialize in high volume of implants
Next Steps • Talk to high-volume specialty centers• Evaluate steps to file IDE application• Investigate additional indications for intrathecal space• New addressable markets?
PatientsTraining
Hospitals
Unit sales
Trade shows
Clinicians
Institutions
Support Services
Pain clinics
Clinical dataKOLs Formulary Acceptance
FDA
IP
Advocacy Groups
Foundations
OEMs
Wireless Developers
Manufacturing Costs
Product Dev Costs
FDA/Clinical Trials
Chronic Pain v5 FS Team
Payors/ICA
Marketing Costs
Faster relief
• Efficient patient management• Dosing flexibility• Reliable access to intrathecal space
Access to high-value therapies and pharmacoeconomics
pharmacoeconomics
Support
Proprietary knowledge
Human Resources
Electronic records
Electronic health record providers
Bundled kits
CMS (Medicare)
Getting out
• Dr. Mark Kreiger, Pediatric Neurosurgeon, CHLA• Dr. Terry Sanger, Pediatric Movement Disorders, CHLA• Dr. Hung Tran, Pediatric Oncologist, CHLA• Dr. Steven Richeimer, Head of USC pain center
• Medtronic pump user – Pump user and creator of support forum
Clinicians
Institutions/patients
In motion • Dr. Mark Jamieson – Medical Device Regulatory
strategist• Dr. Jamie Henderson (Stanford, Spasticity)• Miller Children’s Hospital• Oakland Children’s Hospital (Oakland)
Patients
Product flow/Channel
Fluid SynchronyElectronic
Health Records
Partners/
OEMS
Hospitals
(Anesthesiologists
Neurosurgeons)
Pain Clinic
(Anesthesiologists
Neurosurgeons)
Pump + Controller
Support Services
Bundled Kits
Electronic Records
Patient Care Flow (Now)
Fluid Synchrony
Hospitals
(Anesthesiologists
Neurosurgeons)
Pain Clinic
(Anesthesiologists
Neurosurgeons)Scheduled follow-up
Patient Discharged
Surgery/Rx/
reprogramming
Trial period/ Home setting
Weeks/monthsKey factors: Reimbursement , state regulations
Pump + Controller
Support Services
Bundled Kits
Partners/
OEMS
Patient Care Flow (Proposed)
Fluid SynchronyElectronic
Health Records
Hospitals
(Anesthesiologists
Neurosurgeons)
Pain Clinic
(Anesthesiologists
Neurosurgeons)
Pump + Controller
Support Services
Bundled Kits
Electronic Records
Scheduled follow-up
Patient Discharged
Surgery/Rx/
reprogramming
Trial period/ Home setting
Partners/
OEMS
Actionable feedbackto doctors/institutions
E-prescription / closing loop
Key factors: Reimbursement , state regulationsDays