Medical Devices and Comparative Effectiveness Research

'Better than' versus 'different from'
Devices are usually marketed (and purchased) based on their features and benefits. One device floats on air, the other has a holographic keyboard. We rarely make claims of 'better than', we make claims of 'different from'.

Comparative effectiveness research (CER) looks at the issue of better than. Which device has the better outcome, fewer number of adverse device effects, or longer survival; these are the typical key questions of such research. Comparative effectiveness research is now imperative.

[1] It is mandated by the American Recovery and Reinvestment Act of 2009. Someone will conduct it.
[2] If you don't control the message someone else will.
[3] Comparitive effectiveness research is valuble to marketing.
[4] Soon enough, comparative effectiveness research will be necessary for healthcare reimbursement.
[5] There's a trillion dollars of grant money available if you have a non-profit partner.

What is Comparative Effectiveness Research?
CER is the process of comparing one treatment option to another to determine which is more effective. It is old-school clinical research, usually done on commercially available devices, but with the critical new twist of a legal mandate.

Consider an example
The Agency for Healthcare Research and Quality (AHRQ) publishes comparative effectiveness literature reviews regularly. In 2007 they published "Comparative Effectiveness of Percutaneous Coronary Interventions and Coronary Artery Bypass Grafting for Coronary Artery Disease". ARHQ asked several key questions having to do with outcomes and survival using PCI versus CABG. Which is better? You'll have to read the report for yourself, but Medicare and private health insurance companies use this information to make reimbursement decisions. Click here to request a copy.

Funding
The American Recovery and Reinvestment Act of 2009 designated ~1.2 trillion dollars in grant money to conduct comparative effectiveness studies; about 1/3 is administered by AHRQ and 2/3 is administered by the National Institute of Medicine. Your investigators, as non-profit entities, can apply for this funding. By working with them, you can have indirect access to the funding, too.

Learning objective
You will learn why everyone is so concerned with comparative effectiveness and how to apply the research methods to your own devices.

You will receive
[x] PowerPoint slides.
[x] Knowledge of CER and why it matters.
[x] How to apply CER methods to your devices.
[x] How to apply for CER grant money.
[x] An expert speaker.
[x] Opportunity for QnA.
[x] CEUs and certificate of attendance.

Who should attend
[x] People who manage clinical trials.
[x] People who design clinical trials.
[x] People who market medical devices.
[x] People who make strategic company decisions.

Presenter
ELISE BERLINER, Ph.D., is the Director of the Technology Assessment Program at the Agency for Healthcare Research and Quality (AHRQ). The Technology Assessment program provides technology assessments to the Centers for Medicare & Medicaid Services (CMS) to inform Medicare coverage decisions and other policy issues.  Prior to joining AHRQ, Dr. Berliner worked as a consultant to pharmaceutical and medical device companies on cost-effectiveness and outcomes research, technology assessment and reimbursement planning. She also has several years of experience in research and development at a number of innovative medical technology companies. She was a Congressional Fellow at the Office of Technology Assessment. Dr. Berliner received her Ph.D. in biophysics from Brandeis University. 

The purchase is $426 for OnDemand access and $476 for the CD. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.