REST IN PIECES

By Shankar Arun, VP, Member Board and Head - India Business Operations, Chiltern

A group of people get miniaturized into tiny human beings and they in turn board a submarine “Proteus”, which is the size of a millimeter. This submarine is “injected” into the bloodstream of a patient lying comatose in a hospital bed. The tiny “Lilliputians” go through the heart, the lungs, the inner ear and finally to the brain of the patient. They remove the blood clot in the patient’s brain and bring him back to life. The above scene is from a movie “Fantastic Voyage”, a sci-fi thriller that predicted the IOT revolution (not the miniaturization) way back in 1966.

Fast forward to the present. Proteus Digital Health, a healthcare company based in Redwood California, develops an ingestible sensor that promises to usher in the concept of “Digital Medicines”. The sensor once ingested gets activated when it comes in contact with stomach acid and it starts to send signals to a wearable device attached to the body.From then on, data related to timing, identity, heart rate and body position gets relayed from the sensor inside the body to the cloud.  Now for those who are still curious to know what happens to the sensor inside the body - the chip dissolves and passes out from the body as waste.

Welcome to the world of “Internet of Things” in Clinical Research!!

IOT in Clinical Research

It is predicted that by the year 2020 there will be 25 Billion connected objects, a 3 fold increase from the current levels. IOT is changing much about the world we live in, right across the business spectrum. Whether it be traffic sensing, health monitor or supply chain planning, the footprint is getting deeper by the day.

From clinical research perspective, the advent of wearables, mHealth and ingestible sensors has clearly provided a fillip to IOT.  If market data was any indication, then it’s public news that major pharma companies have embraced this sphere as is evident with a slew of investments last 2 years. Big Pharma have embarked on ambitious projects that hold a lot of promise to bring IOT into the field of clinical research.

IOT – Benefits & Challenges

Together with its cousins Big Data and Analytics, IOT will no doubt be a disruptive innovation that will substantially change the way we lead our life, the way we interact and the way we do business across the world. Here are a few of them listed below

·        Patient Centric Therapy –

o   Most of the above-mentioned projects embarked by the big pharma are around automatic sensing of patient data through sensors.

o   Medical adherence that benefits patients who lack the ability to remember consumption as demonstrated by the Proteus experiment

o   When deployed appropriately, patients can effectively avoid entering data into multiple devices which can further help saving time and improving quality.

·        Drug Supply Management –

o   Sensor based tracking of temperature and shock can provide data on the medication condition which proactively identifies damaged packages that can be excluded proactively.

o   Automation of site activities involving the clinical data coordinators and pharmacists through the usage of bar-code scanners

·        Recruitment –

o   Patient Recruitment is increasingly relying on social media and search engine marketing to enhance patient participation. Big data collected from such forums reveal online behavioral patterns that can help in targeted recruitments improving its overall effectiveness.

o   Remote participation becomes a reality with patients saving time and energy avoiding long commutes to the site.

Every reward comes with a risk. And every benefit comes with its challenges. There are a few challenges with the adoption of IoT in Pharma.

o   Privacy and Security – As health data needs to be protected as it gets transmitted across devices, this is a challenge which poses an opportunity for innovators to build encryption routines that safeguard data.

o   Regulatory Validation - The clinical arena demands that the devices meet the regulatory guidelines of the agencies like FDA.  While some see these FDA regulations as a huddle to IoT, it is widely believed that the agency is moving much faster in trying to address this rapid pace of innovation.

o   Time and money – As is the case with disruptors, there is an element of time and money that one needs to be conscious of.

Conclusion

The world of IOT is evolving continuously and it certainly holds a lot of promise. The clinical world is still in its days of experiment with IoTand it will take a few more years to gain visibility into tangible results. That the Industry is investing in IOT in a major way is proof of the fact that the technology has arrived. That medical technologies such as these might actually come to fruition is still pretty exciting and a welcome move forward.

A character in the super-hit “The Lego Movie” utters these lines before blowing up a bridge - “REST IN PIECES”. This analogy is most appropriate in the context of IOT in medical research. As the individual pieces get connected, there is substantial hope for rapid progress in Innovation through IoT. Saddled with a highly regulated environment and a huge upfront investment, naysayers predicted a different “RIP” for IoT in Pharma. But clearly, this RIP is “Rest in Pieces”!!

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