Unleashing Service Excellence in the MedTech Industry with the Internet of Medical Things
Life Sciences | 7 min READ
    
Why Is Servicing Critical For Medical Devices?
Until a couple of years ago, medical device manufacturers could contain their focus on delivering excellent quality medical devices. However, the new FDA regulations necessitate original equipment manufacturers to follow strict guidelines around servicing capabilities, reporting around malfunctions and recalls, and quick corrections and removals of faulty equipment. Therefore, the focus is slowly shifting toward the safety and efficiency of medical devices throughout their lifecycle.
John Danese
John Danese

Industry Director

Life Sciences

Birlasoft

 
While this is a critical step towards boosting the safety levels and making medical devices more patient-centric in the ecosystem of care, the number of medical device recalls have tripled over the last three years. What's more, software issues have been the top cause of recalls in the previous four years. In addition, the satisfaction levels of medical device buyers aren't on the stellar side either, with NPS scores hovering around 40-44%. Yet, some consider the addition of service capabilities in a previously product-focused environment an opportunity for generating 35-50% profit margins annually. Here are a few critical factors that are turning this opportunity into a reality.
Internet of Medical Things (IoMT): More Than A Buzzword
While the Internet of Things (IoT) is a well-established term in the manufacturing companies' board rooms, the Internet of Medical Things is turning into a reality at least as fast. This can be attributed to the rapid adoption of enabling technologies and their reducing costs over time. For instance, the cost of sensors and embeddable computing chips is going down, network technologies are expanding in scope, and the adoption of digital enterprise software is accelerating.
Internet of Medical Things Market
Considering the immense gains that IoT adoption has brought within the Industry 4.0 enterprise, the Internet of Medical Things is only expected to grow faster. In fact, according to a Deloitte report, 70% of medical devices will be connected to networks by 2025.
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Moreover, the market for connected MedTech devices is expected to hit $158 bn by 2022. All these factors and projections have only been dwarfed by the pandemic, accelerating the demand for connectivity and intelligence within the medical device ecosystem since 2020.
So how does this shift aid MedTech manufacturers to deliver service excellence? To begin with, a connected ecosystem of medical devices is a significant step towards adopting open standards within the software environment and digitizing other capabilities in the upstream and downstream value chain. In addition, connected medical devices can broadcast data across networks and enterprises, thereby paving the way for big data applications in the Medtech device servicing landscape and other value-added service opportunities.
Service Excellence Through Effective Medical Device Data Management
With the expansion of the IoMT, medical devices will relay real-time information through various sensors that reflect the status of the device - this data will then be warehoused to construct rich data repositories. MedTech manufacturers can then leverage this data to derive insights about the status of a device and make informed decisions about its performance and quality issues over time and into the future. However, much of these workflows must be automated within a more extensive, master data management framework.
As a result, MedTech manufacturers can gain precise and granular control over their products' status and quickly fulfill FDA requirements around urgent reporting and recalls of malfunctioning units, including their service status. But what's more interesting is the opportunities that such capabilities will open up. For instance, the IoMT will enable new-age value propositions like remote servicing and predictive maintenance, which can contribute significantly towards the delivery of value-based care, while boosting patient-centricity across the ecosystem through the following benefits:
  • Improved quality of product.
  • Risk-sharing will lead to better equipment handling.
  • Predictive maintenance will lead to shorter downtimes of devices and wait times for patients.
  • Improved customer satisfaction with a significant boost to patient centricity.
These benefits drive service revenues comparable to revenues from product sales for leading MedTech companies (one global player logged service revenues as 20% of their product sales revenues). Considering the 360-degree benefits that a strong service portfolio brings to the medical device ecosystem, service capabilities can be used to differentiate product offerings from competing enterprises. However, the incentive to build solid and cost-effective service capabilities is no longer purely financial but increasingly becoming a requirement for operating in this fast-moving industry segment.
Medical Device Recalls
In addition to being a leading industry going by the number of recalls, the statistics are only expected to perpetuate this trend in 2021. A few factors amplify this trend - like digital marketing information and online complaints to assess quality issues and virtual audits. In addition, sanctioning the use of medical devices and equipment in urgent situations within the FDA backed medical device regulatory compliance in the post-COVID era might lead to a more significant number of recalls over the coming year.
Unleashing Service Excellence in the MedTech Industry with the Internet of Medical Things
In line with the move to tighten regulations for quality assurance and make healthcare more patient-centric, the UDI system introduced by the FDA also necessitates MedTech players to register their devices with a unique serial number, which makes the device (and the information around it) identifiable while being deployed in use. This results in more robust post-market surveillance, which makes a significant case for MedTech players to add strong servicing capabilities based on predictive rather than reactive approaches to maintaining safety statuses and device health across the product's lifecycle.
These factors result in the rise of predictive recalls - a set of techniques that enable medical device manufacturers to forecast whether a device will malfunction, require repair, or produce suboptimal results - based on real-time data streams from sensors located within the machine. This information is then used to identify and recall a device before posing any risks to the patient in deployment. Other approaches have been leveraged, too - for instance, using publicly available datasets to improve quality at every stage of the product lifecycle. So how are predictive recalls accomplished?
Predictive And Preventive Maintenance of Medical Devices With AI & Advanced Analytics
The core technologies that drive predictive maintenance and predictive recalls are primarily similar - and more importantly, rely thoroughly on the IoMT to forecast a point of failure or suboptimal performance of a device or an asset in deployment remotely.
To do this, the real-time data streams collected from devices are warehoused - and this data is then used by AI and machine learning (ML) algorithms to scan for anomalies in the incoming data streams. These anomalies are then compared to the data footprint of the devices as they function in the optimal state. The information delivered by this system is enriched by making it a constantly evolving one - which means that each issue is labeled, and new instances of failure become a learning point for the algorithm.
By identifying an impending failure or deviation from optimal function, service engineers can trigger a batch or a device recall and deliver software patches if the reason for failure is not a hardware replacement. In the latter case, the engineers and service teams can collectively identify the maintenance routine and send the on-site engineers on a single trip to the deployment site while assuring the client of a repair within an anticipated timeline.
Enterprises with a more significant digital maturity will ultimately automate such processes end-to-end - thereby requiring the inputs of engineering teams only on the most complex points of failure. Therefore, predictive maintenance can improve asset efficiency, minimize the cost of service and loss while significantly enhancing device uptime.
But what happens when things go wrong at the site?
Remote Servicing: Need of the Hour
While predictive maintenance can help MedTech enterprises take out high costs and downtime from their service offerings, the global pandemic has brought a stronger emphasis than ever on the need for touchless servicing capabilities. While software patches can be delivered effortlessly over the network, hardware repairs can be delivered remotely, too - with the proper assistance from the manufacturers using the right bridge.
Augmented Reality (AR) and Virtual Reality (VR) have delivered promising results in this area's more significant manufacturing industry. Here, AR and VR can simplify the collaboration process between the ecosystem partners and customers in the value chain. However, AR and VR capabilities will ultimately depend on the degree of digital maturity and security of the bridges between the links in the value chain.
Moreover, the right AR capabilities will inject information derived from the connected device under repair into the serviceman's field of vision in real-time. Such collaboration models have made it easier to deliver servicing capabilities remotely while enriching the customer experience and keeping a stressed healthcare system functional during peak demand levels.
Concluding Words
Takeaway 1
Service capabilities are becoming critical to pursue financial gains amidst single-digit margins in an increasingly competitive industry. Tightening medical device disclosure and recall regulations amidst various legislations like the FDA and the EUMDR necessitate MedTech manufacturers to pursue these capabilities.
Takeaway 2
Internet of Medical Things (IoMT) forms the baseline of digital maturity levels that make a MedTech manufacturer capable of adopting preventive service capabilities. In addition, a solid data management and data security strategy are crucial to creating scalable and privacy-preserving medical device service capabilities.
Takeaway 3
Preventive recalls and maintenance technologies based on AI and ML, in conjunction with remote service capabilities based on AR and VR, are the pillars of service excellence in a modern-day MedTech enterprise.
 
 
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