MEDICAL DEVICE

With access to real-time device data, Bolt Data remotely monitors field-based device performance to ensure patient safety and device reliability. Bolt Data can be configured to provide real-time notifications when performance anomalies are detected or when an unplanned change of state occurs. To avoid false positives, Bolt Data partners with medical device manufacturers to define data cleansing and validation protocols.

By monitoring real-time data, Bolt Data tracks actual device usage, enabling medical device manufacturers to transition from time-based preventative maintenance to usage-based preventative maintenance. This helps the service teams coordinate maintenance when its needed rather than on a predetermined calendar date.

As asset data is gathered over time, Bolt Data uses advanced analytics and Al to identify performance trends, predict failures, and drive service responses based on the context of the asset. Medical device manufacturers can configure Bolt Data to evaluate each device's condition to auto-create either Work Orders for entitled assets to avoid unplanned failures or Cases for unentitled assets so account managers could contact and inform customers that service was recommended. Because asset performance data is readily available in Bolt Data, that data is attached to the recommendation as supporting evidence.

In addition to entitlements-driven workflows, Bolt Data respects the full context of an asset when automating service workflows. Medical device manufacturers use Bolt Data to evaluate customer account information associated with assets before automating the service response. Account priority, PO requirements for unentitled services, Finance Hold status, and other relevant information are all considered when automating the service response. With a broad spectrum of asset information available in the Field Service Management solution, real-time and trending machine data can be evaluated against multiple parameters to determine the correct course of action, streamlining service operations, and reducing service costs.

The COVID-19 pandemic amplifies the need for remote device access. While site access restrictions have always been a challenge for service technicians (e.g., limited access when assets are in use with a patient), the pandemic created entirely new barriers to accessing device locations for normal service. This adversely impacts product uptime and service costs. With Bolt Data's ability to remotely access and control devices from the Bolt Data app, medical device manufacturers can enable their call center agents and service technicians to triage and deliver select services remotely. This helps avoid unnecessary truck rolls and site/access denial risks in those cases. Beyond reducing service response time and costs, medical device manufacturers also improved business continuity (service revenue) and worker safety by delivering service remotely.

Medical device manufacturers improve their ability to report relevant device issues and observations efficiently and confidently to the FDA. While issues such as patient injury are more straightforward to report, medical device manufacturers have traditionally struggled to report issues such as repeat repairs within the stringent FDA requirements. Bolt Data can evaluate each asset's performance with respect to FDA standards to detect reportable events, create summarized reports, and facilitate the compliance review/submission process. With Bolt Data, medical device manufacturers can ensure compliance adherence and protect their license to operate.