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Small Company Perspective
510k vs. PMA
Avenue to Market
Christine W. Meehan
General Manager
Praxim, Inc.
Getting to Market
510k Route versus PMA Route
Advantages
Disadvantages
Issues to Address
Reimbursement Considerations
Experience
Small innovative start-up companies
Implantable Pumps and Vascular Access Devices – 510k
Non-Surgical Alternatives
Microwave for BPH Therapy – PMA
High Frequency focused Ultrasound for PCa- PMA
Computer Assisted Surgical Navigation Devices for ENT, Neuro, Ortho applications – 510k
Advantages of 510k
Once file is submitted it can be a 90 day review process
Does not require a randomized, statistically significant clinical study…however
If the product is a complicated 510k…it can end up feeling like a PMA
Clinical information or cadaver study for safety and efficacy may be requested by the FDA ( least burdensome..)
Asses your product early – review all other 510ks to see if they were 90 days or 90 days+++ = questions
Disadvantages of 510k
Once approved, you reach the market without statistical clinical proof of improved outcomes
Medical community is very cautious of any new product without well controlled clinical outcomes – Market acceptance is slow
The commercial market can now do clinical use/testing without your control and can report results in the literature
Positive
Negative (Gets published immediately)
What to do?
Have some kind of clinical experience with the 510k product/prototype as early as possible
Collect all clinical experience and database it, company works with clinical site
Have lead physician write a white paper, submit abstract to major/minor meeting, submit an article to peer reviewed journal
Choose a lead physician who likes to write, publish and speak (include a site with Fellows)
Continue clinical study after 510k approval to keep generating clinical results
IDE/PMA
Required for NEW and INNOVATIVE products
Randomized clinical study to show safety and efficacy usually versus the “Gold” or standard treatment option
Disadvantages of IDE/PMA
Time 1-2 years to complete clinical study
Review time of a PMA is on average 1 yr once submitted (includes GMP inspection)
Cost
Delay to market
Advantages of IDE/PMA
Statically significant clinical results which can be used to convince medical community
Results can be published in peer reviewed literature
Has big marketing/launch impact but
You must work on this early
One year (avg) from submission to publication unless MD agrees to alternative journals = faster
Clinical results are the only thing that convince physicians
Market acceptance is quicker due to clinical results
Advantages of IDE/PMA
CMS and Insurance Providers require this kind of clinical data to justify payment
Request a “Technology Assessment”
Requirement of NCQA
Make sure your clinical data is sufficient
Powerful marketing and reimbursement tool
What to Do - PMA
Get your clinical results published soon and often
Work with Specialty Group early if you are a new therapy or change to existing practice
They will determine if new CPT code is needed
Find out who the specialty advisors are to CMS on the state level
Have them include your product in their annual billing seminars at annual meeting
Amend Clinical Guidelines to include new therapy
Not likely but it would be great if they would make a policy statement regarding the therapy
Update their Patient Information pamphlets
What to Do - PMA
Develop a clinically relevant web site
Provide “balanced” information for both patient and MD
Include all required disclaimers
FAQs
Links to other sites
Where to find a “trained” MD or clinical study site
Which insurance companies provide coverage
Provide Clinical publications
More people go to the web for medical information than for any other reason
Reimbursement - 510k or PMA
Start as soon as possible
Applied for new CPT code if needed (ICD-9)
Put together billing information if using existing codes
How to bill, not what to bill
Work with BC/BS, CMS, Prudential, or others on a “Technology Assessment”
Single most important document to help show improved net health outcomes = Reimbursement
Review of all the published literature of well controlled studies
Plus several other criteria
Reimbursement
Don’t go it alone
Work with competitors and their data on clinical outcomes (its not a competitive issue)
Work with Advocacy Groups
MassMedic
AdvaMed
NEMA
Thank you for your attention
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