“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.