Forum Summary

Before attempting to bring new biomedical technology from the bench to the bedside, one must assess the value of the technology to the consumer, considering the market size and competing products.  A new piece of technology will only be a commercial success if it is both useful and affordable.  The utility of a product is sometimes difficult to perceive immediately.  Consider, for example, a rapid Streptococcus test with a false negative rate of twenty percent.  The alternative to this test is a throat culture, which takes days to produce a result.  The true value of the rapid test lies not in its accuracy but in the fact that it prevents worried parents with sick children from constantly calling the doctor’s office, wasting nurses’ time.  This observation is consistent with a recent survey conducted by the diagnostic marker industry suggesting that peace of mind is a priority for patients.  The value of a new biomarker, particularly one used for screening purposes, is also influenced by its cost effectiveness.  The willingness-to-pay threshold for most medical interventions, including screening technology, is usually approximately $50,000 per quality year of life saved.  If a screening test is more expensive than this threshold, it will not be adopted.  As one begins to develop a product, one should consider decisions related to the product’s regulatory pathway early in the development process.  Blocking and potentially facilitating intellectual property rights should also be investigated.  Teaming up with another company with facilitating intellectual property can lead to a highly productive collaboration.  Throughout the development process, teamwork and perseverance are vital.       

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