Btobioinnovation.com

Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #5

The US FDA has approved a record 106 new medical devices in 2018

This impressive showing follows 98 approvals in 2017. Without the partial government shutdown which took effect on December 22, the number of FDA clearance may even have exceeded this figure. These approvals include, premarket approvals and panel-track supplements, de novo and 510(k) clearances as well as humanitarian device exemptions (HDEs).

In 2018, the agency has approved nine breakthrough device designations out of the 112 selected since the program was launched back in 2015.

In November 2018, the agency had indicated that it wants to become the international leader in medical safety through better use of data, in establishing an active surveillance built on real-world evidence, and by seeking authorities to take faster actions on postmarket safety.  The statement came shortly after an International Consortium of Investigative Journalists (ICIJ), analyzing 10 years’ worth US FDA data, found out that more than 1.7 million injuries and 83,000 deaths were directly linked to approved and cleared devices. The agency has committed new resources to rapidly enable its National Evaluation System for health Technology (NEST) to analyse real-world data from patient registries. $3 additional millions have already been allocated to the 2018 annual NEST funding and the Trump administration has requested an additional $46 million for fiscal 2019 to support the project.

The agency has now outlined its latest plan to strengthen its 510(k) clearance program including a new final guidance for safety and performance-based pathway to allow manufacturers to use a separate set of criteria in their demonstration of substantial equivalence to already-marketed drugs.

The US FDA did also adopt a new definition of “novel device” to include HDEs and breakthrough device 510(k) clearances. “We need to be able to continually adapt our frameworks, try new approaches, and, where necessary, seek new authorities because science does not stand still” said Dr. Scott Gottlieb, the current FDA Commissioner.  “Advances in material science, digital health, 3D printing and other technologies continue to drive an unparalleled period of invention in medical devices” said the Center for Devices and Radiological Health (CDRH) Director Dr. Jeffrey Shuren.

It may come as a surprise for some of our readers that btobioinnovation shows a genuine interest in the medical device business. We tend to believe that an increasing number of new disease treatments will come through a “therapeutic solution” where drugs will no longer be the dominant or unique component of care, much less that of health. The targeted response will often get integrated into a “therapeutic solution” adapted to each individual or to a specific population. The economic value will therefore be increasingly related to the solution rather than to its isolated components, including drugs, as it is the case, for example, in computing or in the cell phone industry. This new approach, which can be described as systemic, will likely have important consequences on the overall strategy of biopharmaceutical companies. They will not only need to find partners and alliances with other manufacturers of health goods -such as medical devices or diagnostic tools-, of health services, or with data platform providers, but they also need to find new ways of pricing the “therapeutic solution”. In its annual business review of 29 January 2019, Novartis’ CEO Vas Narasimhan, emphasised clearly the value of such an approach and indicates that “we wish to combine medicines with cutting edge technology …. to advance our enterprise-digital transformation” across all the organization.

This document has been prepared by btobioinnovation and is provided to you for information purposes only.  The information contained in this document has been obtained from sources that btobioinnovation believes are reliable but btobioinnovation does not warrant that it is accurate or complete. The views presented in this document are those of btobioinnovation’s editor at the time of writing and are subject to change.  btobioinnovation has no obligation to update its opinions or the information in this document.