Working with 3rd-Party Service Providers
Traditionally, medical devices have been black boxes that are fit for purpose. They have been designed to function within their indications for use. Over the decades, as medical device communications standards such as DICOM and HL-7 were established, these devices began to communicate. That trend continues with the relentless innovations in medical AI and the computerization of virtually all electronic medical devices—more communication in more forms. Despite all the ways that devices reach out today, the boxes remain largely "black".
There is a natural tension between medical device manufacturers and 3rd-party providers of medical device management and service. In instances where hospitals and medical clinics engage 3rd-party providers to service products, they often do it with economics in mind. The question is, what can manufacturers do to ensure their products are properly maintained, irrespective of who is assigned the task of maintaining them?
Throughout this article, we will refer to the following example:
The Good X-ray Company (GXC) manufactures the X2500 X-ray machine. One is sold to HealthyPeople Hospital. When it is installed, the X2500 is electronically connected to GXC’s Service Relationship Management (SRM) software. The X2500 regularly sends telemetry data back to the factory. GXC can monitor that telemetry data to look for trends or outright failures, and can remotely access the X2500 for diagnosis and repair of problems.
Telemetry as Oversight. Telemetry is a tremendously useful tool for monitoring device health and for detecting or predicting device failure. But it adds an additional benefit that may not be apparent: post-market surveillance.
Post-market Surveillance. Telemetry sent directly from the device is the purest form of oversight. It provides a level of post-market surveillance that is not subjective in nature and is therefore free of interpretation by a 3rd party. In many cases it is better, and richer, than more customary post-market surveillance that is based on complaints alone. By designing robust telemetry data collection into its products, the manufacturer can up its post-market surveillance game and better satisfy its regulatory obligations.
Working with 3rd Party Service Providers. Manufacturers are often not comfortable when a 3rd party is in the loop. This is understandable because it lowers the manufacturer’s service revenue, and it raises the possibility that less qualified or less well-trained service engineers will have access to the manufacturer’s products. However, there may be no choice—the economics of the hospital’s equipment maintenance plan might override the manufacturers’ concerns.
This isn’t all bad news for the manufacturer. Even if a 3rd-party is given responsibility for service, the manufacturer is still privy to the telemetry data from the device. That provides direct manufacturer oversight of the device, even if the manufacturer isn’t providing the service. That is better for the manufacturer, better for the hospital, and better for patients and patient safety.
For the right price, manufacturers might open a portal in the SRM system for the 3rd party. That could give the service provider access to a carefully selected subset of the telemetry data, and even to remote access to the device. Overall, it would not only let the 3rd-party provide better service (which the hospital would appreciate) but also keep the manufacturer firmly in the loop.
HealthyPeople Hospital decides that they can get a better service deal from Fix3, an independent 3rd party service provider. Fix3 has two choices—they can work blind and service the device without the advantages of what GXC knows, or they can work with GXC and deliver better, faster service.
GXC decided to support 3rd party service with oversight by opening their SRM system to companies like Fix3. Because of the power it brings to their offering, Fix3 decides to pay GXC for access to the X2500 at HealthyPeople Hospital, including telemetry data and remote access to the machine. The Fix3 deal adds incremental revenue for GXC.
Having access to both telemetry data and remote service capabilities would greatly accelerate diagnosis and repair, as well as reduce the necessity for travel by field service engineers. Thus, even if the manufacturer’s price for telemetry and access is high, the 3rd-party service provider might still be better off. By being open-minded about supporting 3rd-party service providers, manufacturers can make the best of an awkward situation; they win and the hospitals win. And it just so happens that the 3rd-party service providers win, too.
maiLink SRM software is a service relationship management platform that helps you build a rich database about your installed devices. It also seamlessly integrates telemetry from your products and has no per-user fee (so any employee you authorize can have access to the data). To learn more about maiLink SRM, visit www.maiData.io and sign up for a free trial.