December 7, 2012   Posted by: thomasetoconnor

Checklist for FDA 510(k) Submissions

Screening Checklist for Traditional/Abbreviated Premarket Notification [510(k)] Submissions based on Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s   OConnor BMC FDA checklist 18F

Successfully navigating the 510(K) submission process is essential to launching your medical device. This checklist will provide a useful road map for novices as well as those who have been through the process before.  The current state of Regulatory Affairs is subject to changes in the months ahead. If you are in need of practical advice as you are actively working to bring a device to market please do not hesitate to contact BioMarketing Consulting, LLC for help with:

  • Selecting your devices regulation number and product code
  • Selecting the predicate device
  • Finding relevant Guidance documents
  • Choosing the best 510(k) format; traditional, abbreviated, special
  • Review of recent changes to FDA regulations for medical devices
  • Review of proposed changes to FDA regulation and what we think is going to happen
  • Progress of CDRH and HHS 2010 Action Plan

 

BioMarket Consulting, LLC  (716) 201-0228

to@biomarketconsulting.com  www.biomarketconsulting.com

BioMarket Consulting, LLC Our experienced advisory team will accelerate the go-to-market strategy for entrepreneurs and investors in biomedical, molecular diagnostic & life science ventures. We can reduce the time-to-market, reduce the risk and optimize the return on investment.

August 23, 2012   Posted by: thomasetoconnor

EVALUATING DIAGNOSTIC TESTS …… Where do the performance numbers come from?

By Dr. John Alsobrook, PhD, DABCC, FACB

IT ONLY SEEMS COMPLICATED. REALLY.
Diagnostic tests are typically marketed based on their performance claims, the numbers that describe how well the test works. You’ll hear numbers (usually percentages) quoted for “sensitivity”, “specificity”, “accuracy”, and more. The general idea is very intuitive: larger numbers usually mean better performance. The performance is based on comparing the test results against a gold-standard clinical evaluation. But where do those numbers come from, and what do they mean? Understanding diagnostic test performance statistics can appear to be daunting. Here you’ll see that the underlying principles and the necessary arithmetic are straightforward and not very deserving of the anxiety they can generate.

Please see the entire white paper by By Dr. John Alsobrook, PhD, DABCC, FACB by selecting this link here.

Feel free to contact us for additional information on the topic of the proper way to evaluate diagnostic tests and have a greater clarity to performance numbers at (716) 201-0228 or to@biomarketconsulting.com.

August 23, 2012   Posted by: thomasetoconnor

LABS BRACE FOR CMS DECISION ON MOLECULAR TESTS

The Centers for Medicare & Medicaid Services is expected to announce
some key decisions affecting molecular and genetic tests in early September.
The agency is likely to decide that 100+ new molecular CPT codes
will be placed on the Part B clinical lab fee schedule (as opposed to the
Medicare Physician Fee Schedule), according to Bruce Quinn, MD, PhD,
senior health policy specialist at the law firm Foley Hoag LLP. Quinn thinks
pricing will be set near the average or median prices currently charged by
labs using code stacks.
Contact BioMarket Consulting, LLC to understand the impact of this to you business or investments.

August 14, 2012   Posted by: thomasetoconnor

BioMarket Consulting, LLC Austin, TX (716) 201-0228

BioMarket Consulting, LLC … Our experienced advisory team will accelerate the go-to-market strategy for entrepreneurs and investors in biomedical, molecular diagnostic & life science ventures. We can reduce the time-to-market, reduce the risk and optimize the return on investment.

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