Transcript Launching Medical Devices in the US

What You Should Know About
Launching Medical Devices
in the North American Market
By
Daniel R. Matlis
President,
Axendia Inc.
September 21, 2008
email:
phone:
website:
Journal:
[email protected]
(215) 262-8037
www.axendia.com
http://LSP.axendia.com
 Copyright 2008 by Axendia, Inc.
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Prepared for Advamed 2008
Agenda
Start with the end in mind
Secure your IP
Build the right team
Navigating the FDA approval roadmap
Don’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.
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Prepared for Advamed 2008
Start 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.
3
Prepared for Advamed 2008
Agenda
Start with the end in mind
Secure your IP
Build the right team
Navigating the FDA approval roadmap
Don’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.
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Prepared for Advamed 2008
Secure Your IP
Protect your IP before you disclose it
Peer Reviews
Publications
Presentations
Get professional help
You go the a doctor for your health issues
Go to an IP Attorney for you Patent
 Copyright 2008 by Axendia, Inc.
5
Prepared for Advamed 2008
Agenda
Start with the end in mind
Secure your IP
Build the right team
Navigating the FDA approval roadmap
Don’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.
6
Prepared for Advamed 2008
Build the Right Team
Identify complimentary skills
Business
Finance
Business Development
Sales and Marketing
Operations / Supply Chain
Technology
Product
Process
Regulatory
Design Controls
Submissions
Quality System Regulations
Post Market
Other applicable regulations
 Copyright 2008 by Axendia, Inc.
7
Prepared for Advamed 2008
Agenda
Start with the end in mind
Secure your IP
Build the right team
Navigating the FDA approval roadmap
Don’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.
8
Prepared for Advamed 2008
Regulatory Requirements for
Medical 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.
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Prepared for Advamed 2008
Patchwork of Regulatory
Requirements
Food and Drug Administration
Safety
Effectiveness
Clinical utility
Hospital and Clinical Laboratory
FDA
Health Care Financing Administration (HCFA)
Clinical Laboratory Improvement Amendments (CLIA)
Mammography Quality Standards Act (MQSA)
Other Authorities
Federal Communications Commission (wireless,
telemetry)
Nuclear Regulatory Commission (Nuclear radiation)
 Copyright 2008 by Axendia, Inc.
10
Prepared for Advamed 2008
Agenda
Start with the end in mind
Secure your IP
Build the right team
Navigating the FDA approval roadmap
Don’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.
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Prepared for Advamed 2008
Don’t Wait for Perfect!
Know when to stop
Draw the line in the sand
Safe and effective
Be strict on setting release date goals
 Copyright 2008 by Axendia, Inc.
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Prepared for Advamed 2008
Same or Novel
The 510(k) paradox
Proving Equivalency
Different but not too different
If you goal is to run a business
Let the pendulum swing to approvable
Then iterate for improvements
Systems Approach to bringing device to market
Involve all the key stake holder from the beginning
 Copyright 2008 by Axendia, Inc.
13
Prepared for Advamed 2008
Agenda
Start with the end in mind
Secure your IP
Build the right team
Navigating the FDA approval roadmap
Don’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.
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Prepared for Advamed 2008
Quality System Regulation (QSR)
21 CFR Part 820
QSR Compliance begins at Design Input, NOT Manufacturing
Regulates methods and controls used for:
Designing
Changing
Purchasing
Manufacturing
Packaging
Labeling
Storing
Installing
Servicing
License holders will undergo FDA inspections to assure compliance
with the QSR
 Copyright 2008 by Axendia, Inc.
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Prepared for Advamed 2008
Define Post Approval Strategy
Manufacturing and Distribution
Internal
Outsourced
Combination
Reporting
Field Inquiries
Adverse Events
 Copyright 2008 by Axendia, Inc.
16
Prepared for Advamed 2008
Agenda
Start with the end in mind
Secure your IP
Build the right team
Navigating the FDA approval roadmap
Don’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.
17
Prepared for Advamed 2008
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.
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Prepared for Advamed 2008
Reimbursement Strategy
Reimbursement 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 strategy
Who 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.
19
Prepared for Advamed 2008
Agenda
Start with the end in mind
Secure your IP
Build the right team
Navigating the FDA approval roadmap
Don’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.
20
Prepared for Advamed 2008
Go to Market Strategy
No mater how great your device is,
It will not sell itself
How will you sell the product?
Direct Sales Force
Partnership
Contract Sales Organization
Hybrid
 Copyright 2008 by Axendia, Inc.
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Prepared for Advamed 2008
Summary
Start with the end in mind
Secure your IP
Build the right team
Navigating the FDA approval roadmap
Don’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.
22
Prepared for Advamed 2008
Thank You
Daniel R. Matlis
email:
[email protected]
phone:
(215) 262-8037
website:
www.axendia.com
Journal:
http://LSP.axendia.com
 Copyright 2008 by Axendia, Inc.
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Prepared for Advamed 2008