In recent years, two major healthcare sectors—pharmaceuticals and medical devices—have become increasingly connected through advancements made in digital medicine. Digital medicine is the application of technology in healthcare, not just to better understand and track physiological systems, but also to process the vast amounts of data generated by medical devices that can collect patient data, such as patient monitoring devices. Among the many applications of digital medicine are Drug-Device Combinations (DDCs), where a medical device sensor is used to monitor drug activity.
Many factors are encouraging the adoption of DDCs, and major pharma and medical device companies are highly receptive to new developments in the industry. An illustration of this is the recent FDA approval of the Abilify MyCite pill, which was developed collaboratively by Otsuka and Proteus to track drug compliance in schizophrenic patients. This pill consists of an aripiprazole tablet (from Otsuka), which contains an ingestible Proteus sensor that can be used to remotely monitor patient activity and response through a smartphone.
Another promising development in the field of digital medicine and DDC is the launch of Onduo, a $500 million joint venture between Sanofi and Google’s Verily aimed at producing digital diabetes solutions by developing digital components for conventional diabetes drugs. Other companies such as Glytec and Voluntis have already partnered with Onduo to develop and launch digital diabetes devices.
Furthermore, the FDA has been strongly supportive of DDC development, most prominently through the establishment of a Combination Products Policy Council, which was set up to support companies in managing the different regulatory requirements for drugs and devices. Pharma and medical device companies will be looking to leverage this opportunity to quickly establish themselves as pioneers and innovators in this industry.
On the other hand, digital medicine represents a significant threat to medical device companies that are dependent on traditional diagnostics manufacturing or those with limited ways to incorporate digital solutions into their products. The growing potential of DDCs also poses a threat to generic drug companies that have a limited capacity for developing new drugs and novel drug delivery devices. Nevertheless, there remains a lot of room in the nascent field of digital medicine for these companies to collaborate and innovate in order to maintain their competitiveness.
Okay, so it sounds like digital medicine is definitely here to stay, but what will that mean for the industry?
The impact that digital medicine will have on both the medical device and pharma industry, as well as the progress of the regulatory landscape for combination products, will be significant in the coming years. For instance, considering that the Abilify MyCite pill allows continuous monitoring to happen remotely, its adoption—and that of similar products—will eliminate the need for repeated in-person monitoring, hence negatively impacting the existing diagnostic device industry. Meanwhile, companies that are able to capitalize on or have already started developing digital solutions are well positioned for years to come.