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medical revolution

Yesterday, FDA Commissioner Scott Gottlieb made a statement on the new steps that the FDA is taking to improve innovation in medical devices. Like we have seen by authorities around the world, helping patients get more timely access to new innovations and medicines had been a top priority. In his statement, Gottlieb emphasized how often small changes and adjustments existing to the functionality of medial devices can have meaningful improvements.

These goals are a part of the new Medical Innovation Access Plan. In today’s fast-paced economy, and with an increasingly aging population, there is a growing demand for new innovative therapies worldwide. Patients are more involved in their healthcare than ever before, with digital access to information at their fingertips. Additionally, chronic conditions are on the rise across all ages making health care a top priority.

The announcement yesterday was in regards to the first qualification of a medical device development tool (MDDT) in which Commissioner Gottlieb explained:

Today’s newly qualified MDDT is a 23-item questionnaire that measures health information that is reported directly by patients with heart failure. The tool can be used to measure a heart failure patient’s health status, including clinical symptoms and the physical and social limitations caused by this condition. Such a tool has the potential to help engineers designing heart failure devices to more efficiently and accurately quantify how much their device could actually improve a patient’s quality of life. By qualifying the tool under the FDA’s new, voluntary program, it will make it easier for product developers to rely on the outputs of this newly qualified tool as part of their development plans. Innovators can trust in advance that the agency has already found the outputs of these measures to be reliable.”

Medical Device Development Tools (MDDT)

The FDA’s Medical Device Development Tools (MDDT) program can help evaluate a tool and weigh its claims against its functionality. They can then “qualify” if the tool measures what it supposed to and can do it reliably. As part of the MDDT program three categories of tools were identified; clinical outcome assessments, biomarker tests, and nonclinical assessments. These can be found in the FDA guidance issued in August .

Three new guidance documents were released yesterday in relation to medical devices by the FDA. With these draft guidance documents the commitment, to reducing barriers for introducing new technology and improving existing devices, is evident.

Earlier this year, also as a part of the Medical Innovation Access plan, a pilot program dealing with digital health devices was released. This pilot which looks at digital health tools such as apps is challenged with products that don’t fit the typical medical device structure. However, in our rapidly digitalized economy, there can be a great value for these types of tools to help individuals manage their health. To learn more about this exciting pilot program, check out the announcement here.

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