You wear it so well: designing clinical-grade wearables
Shimmer Sensing is a specialist in clinical-grade wearable sensing systems. In a world where disruptive med-tech start-ups and global fortune 500 companies alike are pursuing wearable tech, Martina Donohue, marketing manager at Shimmer spoke to MTI’s Dave Gray about the rapidly evolving landscape.
The group develops, manufactures and markets a full range of clinical grade wearable wireless sensors including; wearable electrocardiogram (ECG), electromyography (EMG), galvanic skin response (GSR), and body worn motion sensors for the clinical, research, and OEM markets.
With data becoming progressively more important, finding ways to accurately capture, communicate and synthesise the data for actionable decision making can be challenging. Shimmer is developing smaller, more discrete sensors with multiple sensing capabilities.
But working in the wearables field, while rewarding, is not without its challenges, as Donohue explains:
“Most studies in wearables view the long-term outlook for wearable medical devices with strong growth into the future. In the last few years there has been exceptional technological innovation in wearable electronics, sensors and wireless platforms, but there are challenges ahead as the industry moves from simply reporting real-time data to tracking, diagnosing and ultimately treating healthcare issues.
“Average activity trackers will have to become smarter by measuring other biometrics beyond steps and movement while maintaining a cost-effective model. Other challenges lie in the area of continuous monitoring, for example in ECG. Stringent regulatory requirements may delay time to market for some solutions. In the smart wearables segment - i.e. those that have hardware with multiple applications and platform integration as opposed to basic wearables which have limited functionality - the issue of regulatory challenges is raised as more medical grade wearables begin to be used by professionals to diagnose or influence the course of care.
“And in the medical community, challenges in protection around privacy and access of data are becoming much more prevalent. Security and data privacy around wearables could act as a competitive edge for some companies, especially for the enterprise and medical–grade wearable segment.”
All of these challenges, Shimmer believes, build the case for a more active participation by key stakeholders such as governments or state healthcare agencies to provide funding for development and deployment of a cost effective approach.
“Much more value will be placed on clinically relevant wearables in the future that can address unmet health and wellness needs,” said Donohue
The wearables market is defined by its creativity, with innovative new technologies emerging at pace. And Ireland is no exception, says Donohue: “There are many reasons why Ireland is so successful in medtech, but the key reason that we believe Ireland has come out on top, is a the relationship fostered between the medtech industry, Irish SMEs and leading Irish academic centres of excellence. These cohesive relations allow for a structured and common approach to solving healthcare issues in the industry, such as treatment efficacy, all while maintaining a focus on cost reduction.
“The essential investment in R&D and innovation this region has seen over the last five years has delivered huge job creation and a speciality skill set unique to Ireland. The success stories that we see today compound the need for further collaboration to produce much needed novel technologies.”
One of the most fascinating applications for wearable devices is in clinical trials. Real world evidence is increasingly sought after in proving the efficacy of drugs and devices. Donohue says the potential here for firms in the wearables sector is huge. “Many factors are driving clinical trials towards the use of wearable sensors. The cost of sensors is coming down and the science of interpreting the data is improving rapidly. Just as important, sensors can provide quantitative measures of the effectiveness of interventions (clinical endpoints) as well as early identification of adverse events.
“At the most basic level, measures of activity levels and sleep quality are such fundamental indicators of health that we believe every clinical trial will need to monitor them in the not too distant future. Beyond that, it is possible to monitor a wide variety of clinically important parameters. We believe that wearable sensors will generate the primary endpoints on almost every clinical trial within 5-10 years.”
Shimmer Sensing will be showcasing its full range of wearable enabling technology form its stand at Med In Ireland.