The time and cost it takes to bring a device over 510 (k) versus PMA to market makes the 510 (k) path a popular choice when available. Every insurer has the opportunity to decide differently how medical devices are covered and reimbursed. Many medical device manufacturers are forced to reduce the cost of their products in order to adapt to increasingly cost-conscious hospitals. There is also the difficulty medical device companies face when it comes to simply maintaining profitability in the current healthcare landscape.
A certain level of regulatory review is a prerequisite before medical devices can be marketed. Decisions about coverage, pricing, and reimbursement then follow. Wenzl and Mossialos provide strong evidence that medical device cost and spending should be considered as part of proposals to promote high-quality care. To improve health system efficiency, it is important for stakeholders to better understand the factors that could impact these large price differences for medical devices. The Massachusetts Medical Devices Journal is the online journal of the medical device industry in the Commonwealth and New England, which reports daily on the devices that save lives, the people behind them, and the emerging trends and developments in the industry.
Another consideration is that medical device start-ups play an important role in the development of novel medical technology. Medical technology innovation is breaking the regulatory process to market medical devices in the states as “unpredictable, inefficient and expensive.” However, medical devices range from scalpels to PET scans to medical software and are used in all areas of the healthcare system, and accurate quantification of device spending remains elusive. He said as long as these medical devices are properly labeled and as long as there are adequate safety and efficacy guarantees for these products, they will be used properly by doctors.
However, medical device cost companies routinely pay out tens or hundreds of millions of dollars to settle product liability lawsuits. Wenzl and Mossialos offer an innovative study of the price differences for medical devices between the USA and Europe. While product development is an expensive undertaking in itself, this is particularly the case in a highly regulated environment such as the medical device industry. The marketing of medical devices is a multi-body diligence test that includes market size, technology risk, regulatory pathways, intellectual property, and medical economics.
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substitute for professional medical advice, diagnosis, treatment, or disease prevention. Always seek the
advice of your physician or qualified healthcare providers for any questions you have regarding a medical
The views and opinions expressed on this blog are solely those of the original authors and other
contributors. These views and opinions do not necessarily represent those of Gabriel Nieves, LAC
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