Medical Device MANUFACTURERS

COMMON SERVICE CHALLENGES FOR MEDICAL DEVICE MANUFACTURERS

Medical device manufacturers provide critical equipment that helps health care providers diagnose and treat a variety of patient conditions. While medical devices differ in purpose, each is governed by the FDA and national formularies to ensure patient safety and improved patient outcomes. With so much on the line, medical device manufacturers need to consistently deliver the right services and support at the right time.

Modern Field Service solutions such as Service Cloud, Salesforce Field Service and ServiceMax centrally manage core Service operations such as Cases, Work Orders, Entitlements, and Dispatching. However, other Service challenges require connected assets and AIoT solutions, such as scheduling device service to avoid failures, minimizing service response and on-site service times, losing access to devices, and reporting relevant compliance information (e.g., safety incidents, repeat device failures, etc.) to the FDA.

These challenges were the catalyst for Connected Field Service. Connected Field Service enables organizations to transform the way they provide service from a costly break-fix model to a proactive and predictive service model by combining IoT diagnostics, asset management and resource management on an integrated Service platform.

Historically, hospitals and medical centers have been reluctant to allow data to leave their local networks due to stringent HIPAA requirements and other security risks. As the benefits of connected assets and AIoT solutions have become impossible to ignore, the medical device and healthcare industries have worked together to recognize that medical device operating data can assuredly exclude all patient data, and that end-to-end data transmissions can be securely and confidently managed using industry-leading protocols.

Customer Journey

Global medical device manufacturers partner with Spoke AIOT to connect their field-based capital assets to their Service Management solutions to improve asset reliability, enhance Call Center support, and reduce service costs. Partnerships typically begin with Visioning and Value Determination sessions to identify various ways that IoT and AI can create value and improve patient outcomes. As Use Cases are defined, business benefits are estimated based on actual business performance data and industry value metrics. In parallel, an evaluation of asset connectivity options, machine trajectory data, and security risks is conducted to confirm the technical viability of achieving the defined Use Cases. Once technical viability is confirmed and business benefits are defined, Spoke AIOT partners with customers to define deployment plans and implementation cost estimates for adopting their Connected Field Service vision.

AIoT projects are most successfully delivered in smart phases. Typically progressing from single-asset pilots to full asset family deployments, to regional deployments, to national deployments, and beyond. Governance checkpoints between deployment phases generally require evidence that technical goals have been achieved and business value has been confirmed.

As medical devices are typically classified as high-tech assets, it’s common that medical devices have multiple onboard sensors and integrated connectivity capabilities that make machine data available for consumption. To enable edge connectivity, Spoke AIOT installs virtual and physical gateways to enable and securely govern data connectivity between medical devices, the AIoT Cloud, and Service Management solutions. Once the data is flowing, Spoke AIOT’s out-of-the-box service tools quickly enable remote performance monitoring, anomaly detection, predictive analytics, digital twin visualization, and service workflow automation.

In cases where medical device manufacturers already manage an installed base of connected assets and an IoT-cloud for collecting machine data, Spoke AIOT helps them integrate their IoT Cloud solution to their service management and ERP systems. Spoke AIOT’s out-of-the-box service tools quickly augment existing remote performance monitoring capabilities by delivering no-code service workflow automation. These capabilities combine to ensure the field-based assets are operating properly and enable appropriate service responses. Spoke AIOT extends the value of previous IoT investments by providing the capabilities needed to deliver the “last mile” of Connected Field Service.

Remote performance monitoring ensures field-based medical devices operate as expected. As anomalies are detected, Spoke AIOT immediately notifies the right people to ensure the proper service response is coordinated. As machine data is gathered over time, advanced analytics begin to identify performance trends, predict asset failures, and recommend the best course of action to avoid unplanned downtime. In the field, the service technicians have access to real-time and historic asset data to quickly triage and resolve device issues. Starting with a single asset class, medical device manufacturers can rapidly scale Spoke AIOT to multiple asset families around the world.

How Spoke AIoT helps Medical Device Customers

     Remote Monitoring & Alerts

With access to real-time device data, Spoke AIOT remotely monitors field-based device performance to ensure patient safety and device reliability. Spoke AIOT 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, Spoke AIOT partners with medical device manufacturers to define data cleansing and validation protocols.

     Usage-based Preventative Maintenance

By monitoring real-time data, Spoke AIOT 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.

     Analytics & Predictive Maintenance

As asset data is gathered over time, Spoke AIOT uses advanced analytics and AI to identify performance trends, predict failures, and drive service responses based on the context of the asset. Medical device manufacturers can configure Spoke AIOT 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 Spoke AIOT, that data is attached to the recommendation as supporting evidence.

     Service Automation

In addition to entitlements-driven workflows, Spoke AIOT respects the full context of an asset when automating service workflows. Medical device manufacturers use Spoke AIOT 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.

     Mitigate Site & Device Access Denials

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 Spoke AIOT’s ability to remotely access and control devices from the Spoke AIOT 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.

     Improve Service Outcomes

When service technicians are required to be on-site, having access to both real-time and historic device operating data helps them quickly and accurately diagnose and resolve issues. Medical device manufacturers can enable their field service technicians with the Spoke AIOT mobile app so they can see real-time and historic performance data as part of their triage process. With these new insights, service teams can quickly identify root causes; enabling them to spend less time figuring out what was wrong and improve their chances of fixing the issue correctly the first time. As a result, medical device manufacturers commonly see improvements in Mean Time to Repair (MTTR) and First Time Fix (FTF) metrics. Service teams also reports higher service technician job satisfaction and loyalty resulting from the adoption of modernized service capabilities.

     Improve Regulatory Reporting

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. Spoke AIOT 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 Spoke AIOT, medical device manufacturers can ensure compliance adherence and protect their license to operate.

     Beyond Service

Medical device manufacturers commonly identify opportunities to leverage Spoke AIOT beyond service. For example, comparing actual patient device usage to prescribed device usage helps health care workers monitor patient adherence to a prescribed treatment plan. This also allows medical device manufacturers to defend formulary positions should non-adherence lead to diminished patient outcomes. Access to real-time and historic device operating data provides product engineering teams with deep insights to drive next generation product improvements. Medical device manufacturers can leverage Spoke AIOT to adopt a new revenue models, where the goal is to sell patient outcomes instead of assets.

Solution Summary & benefits

From improving service efficiency and effectiveness to improving patient outcomes, Spoke AIOT can transform how medical devices are sold, supported, and serviced. Talk to an expert at Spoke AIOT to learn more about how connected assets and AIoT-enabled solutions can transform your medical device service team.

 

  • Improved asset uptime/reliability

  • Reduced service costs

  • Reduced service response time

  • Improved First Time Fix (FTF)

  • Improved workforce productivity & utilization

  • Improved business continuity

  • Improved technician safety

  • Improved regulatory compliance reporting

  • Provided deep insights to support other business functions

The future is AIoT enabled Service

Artificial Intelligence can exponentially increase the value of IoT by using all the data from the asset/install base to accurately predict outcomes and promote a collective intelligence.

Trillion ECONOMIC VALUE WILL BE CREATED BY AIOT ENABLED SERVICES BY 2025

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EXECUTIVES CURRENTY USING AIOT ARE EXCEEDING EXPECTATIONS FOR THE VALUE

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EXECUTIVES BELIEVE AIOT WILL ENABLE THEM TO ENHANCE PRODUCTS & SERVICES OVER THE NEXT 3 YEARS

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MANUFACTURERS’ COMPLEX EQUIPMENT WILL EXECUTE IOT-ENABLED SERVITIZATION STRATEGIE BY 2025

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INDUSTRIAL MANUFACTURERS EXPECT TO AIOT FOR PREDICTIVE MAINTENANCE BY 2022

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MANUFACTURERS CURRENTLY EITHER USING OR PILOTING IOT IN PRODUCTION