Focus On Medical Device Service Management In Health And Life Sciences

Professionals in the Health and Life Sciences (HLS) industry rely on fully operational medical devices to provide elevated patient care in a highly regulated environment. Within the HLS industry, there are many types of companies with varying business models and needs, which adds to the complexity of ensuring medical devices are correctly working.

Due to strict regulations and ever-increasing customer expectations, medical device manufactures must assume the responsibility of maintaining equipment with a heightened dedication to indirect patient care. As technology evolves and becomes more complex, the cost of devices is also skyrocketing, making elevated customer service a necessity and machine down-time an unacceptable occurrence.

To keep up with demands, medical device manufacturers are evolving their service models to contend with HLS industry trends. Manufacturers are also relying on technology tools and software to automate, organize, and predict maintenance to improve the customer experience and patient outcomes.

Services Requirements

Medical device manufacturers often rely on the traditional service model, including a full breadth of service delivery, for devices used in the HLS industry. Customers depend on access to technical support, service contracts, preventative maintenance, inventory management, field technician service and more to keep the devices fully operational.

However, traditional service contracts may impede a manufacturer’s attempt to provide a superior level of service, although unintentional. Typical service contracts identify the number of visits per year, service level agreements (SLA), services performed, parts covered, etc. While their use is wide-spread and has been the foundation of many successful service organizations, these types of contracts tend to be internally focused and do not drive forward-thinking customer engagement.

FDA Requirements

Manufacturers are responsible for adhering to the Food and Drug Administration (FDA) guidelines from a service standpoint, which includes the right process and tools for compliance. For example, for any device that comes in contact with a patient, the FDA requires a Unique Device Identification (UDI) number. The UDI, typically a barcode, is tied to a serial number and a unique service record, which catalogs the service performed and use of a specific device over time. From the manufacturer’s standpoint, ensuring FDA compliance includes providing field technicians access to robust handheld mobile applications to scan UDIs, capture information, and comply with FDA compliance and service obligations.

Medical Devices And IoT

Although many medical device manufacturers adhere to a traditional service model (as outlined above), some are already moving toward outcome-based service offerings that drive increased customer engagement. By leveraging the Internet of Things (IoT), manufacturers can focus on an outcome services-based contract model, rather than a traditional one, which will promote revenue opportunities, customer engagement, and operational efficiencies.

Performance-based service contracts (PBSC) are results-oriented and focused on the outputs, quality, or outcomes of deliverables desired by the customer (i.e., medical device uptime) and provided by the service organization. Manufacturers who offer a PBSC model truly focus on outcomes and customer desires. For example, in the HLS industry, a service provider might guarantee 99.9 percent up-time for an X-ray machine. Ultimately, a medical provider or hospital is most concerned whether the up-time promise is adhered to, not how many times a technician completed service visits. By guaranteeing up-time, a manufacturer also can charge a premium over traditional contract values.

Also, manufacturers that implement a PBSC model can access and collect relevant equipment and service information, which improves the customer experience. By providing transparency to customers, there’s a direct correlation to retention. Migrating to a PBSC model and utilizing IoT provides insight into predictive maintenance, is a win-win for all involved.


As service expectations in the Health and Life Sciences industry are rapidly evolving, medical device manufacturers are faced with the challenge of providing little down-time and increased customer experience. The option of keeping the status quo with traditional service models is quickly becoming obsolete, whereas, transitioning to a PBSC model opens the door to revenue opportunities, customer engagement, and operational efficiencies. By utilizing a PBSC model combined with the right tools and technologies (hardware and software), medical device manufacturers can support elevated patient care while deepening their relationship with customers.