what you should know about launching medical devices in the north american market
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Copyright 2008 by Axendia, Inc. 1 Prepared for Advamed 2008
What You Should Know About What You Should Know About Launching Medical Devices Launching Medical Devices
in the North American Market in the North American Market ByBy
Daniel R. MatlisDaniel R. MatlisPresident, President,
Axendia Inc. Axendia Inc.
September 21, 2008September 21, 2008
email: email: dmatlis@axendia.comdmatlis@axendia.comphone:phone: (215) 262-8037(215) 262-8037website: website: www.axendia.comwww.axendia.comJournal: Journal: http://LSP.axendia.comhttp://LSP.axendia.com
Copyright 2008 by Axendia, Inc. 2 Prepared for Advamed 2008
AgendaAgenda
Start with the end in mindSecure your IPBuild the right teamNavigating the FDA approval roadmapDon’t wait for perfect!Build in Quality Now (QSR)You want to get paid?If you built it, they still won’t come
Copyright 2008 by Axendia, Inc. 3 Prepared for Advamed 2008
Start with the End in MindStart with the End in Mind
What is your Exit Strategy?Merger & Acquisition
Self funded organic growth
Externally funded growth
Partnerships
Each calls for a different strategy
Copyright 2008 by Axendia, Inc. 4 Prepared for Advamed 2008
AgendaAgenda
Start with the end in mindSecure your IPBuild the right teamNavigating the FDA approval roadmapDon’t wait for perfect!Build in Quality Now (QSR)You want to get paid?If you built it, they still won’t come
Copyright 2008 by Axendia, Inc. 5 Prepared for Advamed 2008
Secure Your IPSecure Your IP
Protect your IP before you disclose itPeer Reviews
Publications
Presentations
Get professional helpYou go the a doctor for your health issues
Go to an IP Attorney for you Patent
Copyright 2008 by Axendia, Inc. 6 Prepared for Advamed 2008
AgendaAgenda
Start with the end in mindSecure your IPBuild the right teamNavigating the FDA approval roadmapDon’t wait for perfect!Build in Quality Now (QSR)You want to get paid?If you built it, they still won’t come
Copyright 2008 by Axendia, Inc. 7 Prepared for Advamed 2008
Build the Right TeamBuild the Right TeamIdentify complimentary skills
BusinessFinanceBusiness Development Sales and MarketingOperations / Supply Chain
TechnologyProductProcess
RegulatoryDesign ControlsSubmissionsQuality System RegulationsPost MarketOther applicable regulations
Copyright 2008 by Axendia, Inc. 8 Prepared for Advamed 2008
AgendaAgenda
Start with the end in mindSecure your IPBuild the right teamNavigating the FDA approval roadmapDon’t wait for perfect!Build in Quality Now (QSR)You want to get paid?If you built it, they still won’t come
Copyright 2008 by Axendia, Inc. 9 Prepared for Advamed 2008
Regulatory Requirements for Regulatory Requirements for Medical DevicesMedical Devices
Manufacturers and Importers of medical devices distributed in the U.S. must comply with:
Premarket Approval (PMA) or Premarket Notification 510(k), unless exempt
Establishment registration on form FDA-2891
Medical Device Listing on form FDA-2892
Quality System Regulation 21 CFR § 820 (QSR)
Labeling Requirements
Medical Device Reporting (MDR)
Copyright 2008 by Axendia, Inc. 10 Prepared for Advamed 2008
Patchwork of Regulatory Patchwork of Regulatory RequirementsRequirements
Food and Drug AdministrationSafetyEffectivenessClinical utility
Hospital and Clinical LaboratoryFDAHealth Care Financing Administration (HCFA) Clinical Laboratory Improvement Amendments (CLIA)Mammography Quality Standards Act (MQSA)
Other AuthoritiesFederal Communications Commission (wireless, telemetry)Nuclear Regulatory Commission (Nuclear radiation)
Copyright 2008 by Axendia, Inc. 11 Prepared for Advamed 2008
AgendaAgenda
Start with the end in mindSecure your IPBuild the right teamNavigating the FDA approval roadmapDon’t wait for perfect!Build in Quality Now (QSR)You want to get paid?If you built it, they still won’t come
Copyright 2008 by Axendia, Inc. 12 Prepared for Advamed 2008
Don’t Wait for Perfect!Don’t Wait for Perfect!
Know when to stop
Draw the line in the sandSafe and effective
Be strict on setting release date goals
Copyright 2008 by Axendia, Inc. 13 Prepared for Advamed 2008
Same or NovelSame or Novel
The 510(k) paradox Proving EquivalencyDifferent but not too different
If you goal is to run a businessLet the pendulum swing to approvableThen iterate for improvements
Systems Approach to bringing device to marketInvolve all the key stake holder from the beginning
Copyright 2008 by Axendia, Inc. 14 Prepared for Advamed 2008
AgendaAgenda
Start with the end in mindSecure your IPBuild the right teamNavigating the FDA approval roadmapDon’t wait for perfect!Build in Quality Now (QSR)You want to get paid?If you built it, they still won’t come
Copyright 2008 by Axendia, Inc. 15 Prepared for Advamed 2008
Quality System Regulation (QSR) Quality System Regulation (QSR) 21 CFR Part 82021 CFR Part 820
QSR Compliance begins at Design Input, NOT Manufacturing
Regulates methods and controls used for:DesigningChangingPurchasingManufacturingPackagingLabelingStoringInstallingServicing
License holders will undergo FDA inspections to assure compliance with the QSR
Copyright 2008 by Axendia, Inc. 16 Prepared for Advamed 2008
Define Post Approval StrategyDefine Post Approval Strategy
Manufacturing and DistributionInternal
Outsourced
Combination
ReportingField Inquiries
Adverse Events
Copyright 2008 by Axendia, Inc. 17 Prepared for Advamed 2008
AgendaAgenda
Start with the end in mindSecure your IPBuild the right teamNavigating the FDA approval roadmapDon’t wait for perfect!Build in Quality Now (QSR)Do you want to get paid?If you built it, they still won’t come
Copyright 2008 by Axendia, Inc. 18 Prepared for Advamed 2008
Do You Want to Get Paid?Do You Want to Get Paid?
Then your device must be covered by health plans
Reimbursement plays a key role in the success and valuation of Devices
Focus on achieving milestones during the reimbursement process
Position your device’s optimal market launch
Define and provide a realistic and credible idea of the value of their technology
Copyright 2008 by Axendia, Inc. 19 Prepared for Advamed 2008
Reimbursement StrategyReimbursement StrategyReimbursement planning should be conducted along with FDA approval:
Ensure the data captured addresses the demands of the FDA Requirements of the major insurance carriers to enable a favorable coverage decision.
Things to consider in developing a reimbursement strategyWho will benefit most?
Seniors, children, women, others?Where will the benefit be delivered?
Institutions, outpatient, home care?What are the expected clinical outcomes?Are there services that are comparable, but inferior or superior?How much is the expected financial impact for the payer/consumer?Are there Immediate v. long-term benefits?
Copyright 2008 by Axendia, Inc. 20 Prepared for Advamed 2008
AgendaAgenda
Start with the end in mindSecure your IPBuild the right teamNavigating the FDA approval roadmapDon’t wait for perfect!Build in Quality Now (QSR)You want to get paid?If you built it, they still won’t come
Copyright 2008 by Axendia, Inc. 21 Prepared for Advamed 2008
Go to Market StrategyGo to Market Strategy
No mater how great your device is,
It will not sell itselfIt will not sell itself
How will you sell the product?Direct Sales Force
Partnership
Contract Sales Organization
Hybrid
Copyright 2008 by Axendia, Inc. 22 Prepared for Advamed 2008
SummarySummary
Start with the end in mindSecure your IPBuild the right teamNavigating the FDA approval roadmapDon’t wait for perfect!Build in Quality Now (QSR)You want to get paid?If you built it, they still won’t come
Copyright 2008 by Axendia, Inc. 23 Prepared for Advamed 2008
Thank YouThank You
Daniel R. Matlisemail: dmatlis@axendia.com
phone: (215) 262-8037
website: www.axendia.com
Journal: http://LSP.axendia.com
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