While attending the AdvaMed annual meeting, I heard several issues and challenges discussed that serve as a great basis for a series of resolutions that the industry as a whole should consider for 2017. Among these are enhancing the interoperability of technologies, leveraging cost controls, continued emphasis on patient safety, and ultimately, a focus on the patient. [On a related note, get more information about why you may want to attend the AdvaMed annual meeting in this issue’s Datawatch column.]
The first proposed industry resolution involves the communication between healthcare technologies—let’s try to get everyone speaking the same language. The interoperability of medical devices is a topic I’ve been hearing about for a number of years. As the Internet of Things continues to permeate the healthcare space, more devices are connected and have the ability, in theory, to communicate with each other. The problem is, they don’t always speak the same language. While there are software solutions that serve as translators, this isn’t a perfect fix to the problem. The ideal would be to have a universally agreed upon language that all devices speak so as to be able to share data across multiple platforms and technologies. This would also include electronic health records (EHRs).
One of the problems with “big data” is the collection of it and making efficient use of it. There is data from healthcare devices, including more traditional monitoring technologies, in hospitals and doctor’s offices. However, perhaps more useful could be the data collected from mobile devices the patient uses at home. The challenge is getting that data into the patient’s EHR and analyzed such that a doctor gains true value from it. Making use of clinical data from home-based technologies could significantly enhance the quality of care that’s able to be realized. (On a side note, one of the problems here is the lack of clinically relevant data from consumer-based health “gadgets.” These devices must be enhanced to provide clinical-grade data before health-related decisions can be made from the information they provide.) Again, finding a common language between all of these devices is critical to success.
Another potential resolution for industry—leverage cost controls—involves news that came out of the aforementioned AdvaMed meeting. At the event, a group purchasing program was announced for the medtech industry. Especially beneficial to smaller OEMs, the program could offer significant savings on commonly purchased supplies universally needed by most companies. The program is only in the early stages but is already garnering enthusiastic responses from a number of companies reviewing the option. In the Medtech Exchange interview in this issue with AdvaMed’s incoming chairman of the board, Nadim Yared, there is more information about this program as well as other benefits AdvaMed is looking to offer its members.
The next resolution—a continued emphasis on safety—is proposed due to multiple factors. First, the signing of the 21st Century Cures Act, while advantageous for the investments in R&D and promotion of innovation, could be seen as a weakening of FDA oversight. Some would argue the FDA’s current policies are unnecessarily burdensome to getting cutting-edge medical technologies to market in a timely fashion, while others would say the agency is simply protecting patients. Regardless, the Cures Act changes some of the data required by the agency to approve a medical device.
Further, President Trump has stated he’s going to decrease regulations for business. Whether this includes oversight of device makers by the FDA remains to be seen, but if it does, this could further erode the power of the agency to protect patients. As such, it’s going to be dependent upon medical device manufacturers to ensure they are putting safe products on the market.
One possible solution discussed at AdvaMed that could contribute to this effort was the use of virtual patients in clinical trials. The use of simulation is actually something the FDA has advocated for several years, but with the pending changes for the regulatory agency, its use could be even more critical to ensuring patient safety.
Overall, the industry outlook in 2017 looks bright with a device tax repeal virtually inevitable and the positive changes that are expected to come from the 21st Century Cures Act. In our exuberance, however, please take care to remember who the industry is ultimately serving. Hopefully, these suggested resolutions help medtech firms provide the very best possible technologies to improve the health of patients and, most importantly, keep them safe.