Wearable Devices (Clinical Trials) Market Intelligence

Industry Outlook & Drivers

Global Market Outlook on Wearable Devices

• The Center for Technology and Aging, has stated that $200 billion can be saved for the next 25 years by the US healthcare system by the adoption of remote patient monitoring technologies. However, the implementation of these technologies like wearable medical devices in the clinical trials is at infancy
• Mobile Health Technology, though in early stages, has attracted pharma industry to utilize them in clinical trial for better trial outcomes and also to shorten the trial timeline. In a survey, which included respondents from sponsors, consultants, CROs, academia, and labs said that the ~78 percent of them have been using mHealth in clinical trials for more than a year (Sources: Applied Clinical Trials, SCORR Marketing)
• In spite of massive benefits of implementing the wearables in clinical trials, two-third of the industry has not seen the RoI because they have not used wearables in long term and drug development timeline are on average 10 years now

Challenges In Using Wearables

Accuracy, standardization and analysis of wearable-generated data

The data associated with wearables are voluminous. It has always been a challenge for the CROs and sponsors on how to handle wearable-generated data. It is important that the data received should be standardized and ready to be integrated in to the clinical trial platforms and data collected in an uncontrolled research environment should be converted into meaningful outcomes by laying structured guidance/procedures to be clinical trial-compliant

Data Security/Privacy Concerns and misuse

Cisco predicts that there would be 600 million wearables data online, globally by 2020. This demands the regulators and device manufacturers to pack in data security protocols into the wearable devices to prevent the patients from encountering cybersecurity attacks. As these data are stored in clouds they could be retrieved without the knowledge of the user. Activity trackers, are however considered as inoffensive, but the user maybe unaware of how those long-term collected data could be misused by a third-party. E.g., insurance providers, who can either cancel the policy or quote high health insurance price

Reluctance in adoption of wearable devices

Though the use of mobile phones and apps might advance, there will be only less than ten percent of clinical trials that will use wearables by 2017, according to Gartner. Wider adoption of wearables could be a challenge and barriers to recommendation to the patients are:

1) Unavailability of smart phones with all patients

2) Device used inconsistently hence incomplete data

3) Integration of the wearable data with the existing e-health management systems

4) Reluctance showed by the physicians to adopt this technology as the data collected are large and data analysis is a challenge to them as they don't have time or does not have the skill set

Lack of guidance from FDA to use wearable devices in CTs

With the upsurge in use of wearables for health monitoring and social media for patient recruitment in clinical trials Association of Clinical Research (ACRO) has sked the FDA to update the guidelines for the wearables and softwares, so that the sponsor and CRO can be encouraged to use it.

• Issue a public statement for the use of new technologies in a clinical trial conduct
• To analyze the barriers and benefits with the help of the industry (pharma, CRO, patients, and technology providers)
• Provide clear guidance documents for use of tech-driven solutions in terms of data security and monitoring parameters/requirements

Trends in Wearables 

• Healthcare providers can collect data from patients, as well as use wearable technology to keep doctors connected to co-workers and data without the hassle of a pager or phone system
• The boom in wearable technology market has been mainly fueled by fitness, such as wearable gadgets that monitor heart rate or track your exercise. These gadgets have been successful because they are helpful to the user and easy to integrate into everyday life
• Market's growth will be fueled almost exclusively by smartwatches and wrist-worn fitness trackers. Compared to other modes of wearables, wrist wear shipment is forecast to be 126.1 million by 2019

Trends 

Precision Medicine

• Data from wearables can be valuable in personalized medicine when combined with the genetic data, aiding to identify right patients for the right treatment at the right time 

• Precision Medicine Initiative: The Precision Medicine Initiative launched by President Obama valued $215 million (for the fiscal year 2016), out of which, $130 million is allocated to create the database (participant group or cohort) and $5 million to facilitate clinical data inter-operability

Phase-I Trials

The crucial of all the phases in clinical development is Phase-I, as it tests the drug safety on healthy volunteers. Incorporating wearable devices can:

• Continuously monitor the patients and supply real-time data
• Eradicate human errors associated with data capture
• Detect medication adherence and response to the treatment off-site through remote monitoring

IoT System

• The technologies with the perceived most disruptive potential in the next five years are artificial intelligence and remote monitoring. Wearables, IoT, virtual reality, 3D printing, and blockchain are next in the ranking, leaving 5G as the least disruptive
• Most mobile health publishers are rather new to the market, these established and successful stakeholders can serve as best-in-class or role models and pave the way for the new breed of digital intruders
• The popularity of health insurers as a distribution channel has been slowly increasing over the years and has even overtaken “app stores” as the best distribution channel

Technology Innovation in Sensors

• These are digital devices, which can be worn on the body, ingestible pill-like sensors, patches, tattoos, ring, spectacles, and clothing that captures continuous patient biometric data
• SPHERE (Sensor Platform for healthcare in a residential environment), an Interdisciplinary Research Collaboration (IRC) with the vision of establishing a common platform of non-medical/environmental sensors to impact a variety of healthcare needs
• Wireless BSN technology: A mobile physiological monitoring system, which is able to continuously monitor the patient’s heartbeat, blood pressure, and other critical parameters in the hospital. The system is able to carry out long-term monitoring on patient’s condition