May 22, 2012   Posted by: admin

Genetic Testing Reimbursement and Regulation…What You Need to Know

AACC will present this Webinar Wednesday, August 01

Genetic testing has become a major revenue stream for many labs. As this emerging field continues to expand, so does the payment and regulatory burdens. In the near future, your laboratory will be subject to new requirements that will significantly impact reimbursement and lab administration and operations. Attend this webinar to get the information you need to ensure your laboratory is prepared (AACC website).

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April 6, 2012   Posted by: admin

Life Science Products to Market

“The development of a medical device from concept to product launch typically takes between 4-10 years and costs between $5 and $300 million dollars depending on the complexity of the device and required regulatory process.” – Alfred E. Mann Foundation for Biomedical Engineering

While most life science industry professionals understand the product development process from concept and design through proof of concept, the product-to-market stage can be just as complicated. Considering the time and effort required to bring a new product to the point of launch, this might be the most difficult obstacle to overcome.

With a proven concept, what comes next? Should the market entry point be through the FDA, CLIA-waiver, as an LDT or through a partnership with another life science company? If the product is an instrument, assay or both, what will bring the best possibility for success? Sometimes a strong “inside” group is not enough. Success also requires strong “outside” people.

BioMarket Consulting, LLC brings tried and tested plans of action for taking life sciences and/or medical device products and services to commercial viability. It has been our experience that many products do not reach the market or do not perform well in the marketplace for a variety of reasons; everything from unrealistic expectations to regulatory barriers have kept valuable products off the market or have prevented a good product from reaching peak market performance. For new products, sales and marketing strategies should be initiated early. For under-performing products, sales and marketing needs to be analyzed and optimized.

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