Fluid synchrony lecture 7 partners
-
Upload
steve-blank -
Category
Education
-
view
293 -
download
1
Transcript of Fluid synchrony lecture 7 partners
implantable drug infusion pumps
with remote physician control
for at home care
“the right dose at the right time and place”
1
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 v6 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)
2
• Hardware kit:
• Refill kits
• Software add-on services• Remote control software • Electronic record service
Product offering
4
+ +Pump Catheter + tools
(OEM)External
controller
Payment flows
5
Fluid Synchrony
Pay for coverage
Hospital reimbursement
Product purchase
Service provided
6
Pricing for Outpatient Facilities(2011 Medicare Reimbursement)
PumpBundled KitSupportEHR
Patient UsePump(Replace/Revise)
Refill events
LTV
$13,305 $13,305 $2,887 $450 $400 $50 ??? ???
20 yrs 20 yrs 2 pump 2 pump 150 150
$47,265
Existing CPTFull Cost Fluid Synchrony
New CPT (30% Premium)Full Cost Fluid Synchrony
$17,297 $17,297
$59,240
New CPT application cost
$2-3MM; Approval not guaranteed~2-3 years review process (lost sales)
Income Statement ($MM)
0 0 0 0 0
0
8 (1.0)(1.5)(0.8) (0.2)
(3.5)
(3.5)
IncomePatientsPumpBundled kitSupportEHR
Subtotal:
ExpenseHead CountFDA/TrialsProduct R&DManufactureMarketing
Subtotal:
Net
0 0 0 0 0
0
20 (4.0) (2.0) (1.0) (0.5)
(7.5)
(7.5)
0 0 0 0 0
0
30 (9.0) (2.0) (1.0) (0.5)
(12.5)
(12.5)
100 1.3
0.4
0.1 0.0
1.8
50 (1.5) (1.0) (1.5) (1.0)
(5.0)
(3.2)
100013.3
4.5
1.0 0.0
18.8
70 (1.0) (1.0) (2.0) (1.0)
(5.0)
13.8
Getting out
• Dr. Terry Sanger, Pediatric Movement Disorders, CHLA• Dr. Hung Tran, Pediatric Oncologist, CHLA• Dr. Leslie Saxon, Directon USC Body Computing
• Diana Ferman – Physician assistant, USC Neurology• Dr. George Tolomiczenko, Direct of health technologies
USC. • Dr. Shinyi Yi Wu, Healthcare operations, USC
• Dr. Mark Jamieson – Medical Device Regulatory strategist
• Dr. Justin Boland Co-founder Looxcie
Clinicians
Institutions/patients
Regulatory
Entrepreneurs
8
Take-aways • New VP: Simpler more reliable surgery (smaller size), volume, stable long
term access to intrathecal space (for several indications)• Same pump and procedures are applied to multiple indications (pain,
spasticity, cancer)• E-health record market is a highly fragmented market with high growth
(partnership opportunities)• ~ 30% failure rate in first year – infection (refill), catheter issues, huge
issues
Next Steps • Continue investigations into other indications• Figure out how to best integrate EHR• Pathway to IDE
9
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
11
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
12
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 regulationsDays13
14
Intrathecal catheter
Intrathecal pump
Catheter complication Patients affected (%)
Dislodgement/migration 6.1
Fracture/break 5.1
Kink/occlusion 4.0Cut/puncture 3.0
Disconnected from pump 0.7Leak 0.4
Disconnect 0.3
Misplacement 0.3
Unknown 0.1
Tip fibrosis 0.1
Distal segment in cerebrospinal fluid
0.1
Table 2Catheter complications from three Meditronic sponsored clinical studies (http://www.medtronic.com/)
Complications from 3 Medtronic clinical trials(http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2080496/)