Change is hard. This may be the understatement of the year when it comes to moving toward remote service strategies in the realm of medical design and development. Why is it so difficult for medical device OEMs to embrace the remote aspect of machine diagnosis and problem resolution? Many are simply in a position where they don’t know what they don’t know. But working to understand where remote services are today—as well as what is on the near horizon—is of significant, long-term competitive value to these organizations. It may not be an easy transition, though, and it represents a shift not only in mindset but also operations, costs analyses, and competitive priorities. The takeaway is that the industry is at a crossroads in remote diagnostics, driving the need for OEMs to consider how past processes or presumed limitations can color decisions today.
Recognizing a COVID Wake-Up Call
Reducing COVID risks may make it even more desirable for OEMs to have a path to protect service engineers, but that goal does not necessarily make remote service any easier to embrace. Generally, medical OEMs launching a new product consider themselves much better suited to act upon the remote opportunity, empowered to reduce service costs from the very beginning of a system’s deployed life. Processes and troubleshooting flows are aligned early as part of the overall design strategy and total cost of ownership. This contrasts sharply to OEMs considering adding a connectivity strategy to an existing product. Certainly, re-evaluating and changing service protocols is more daunting than accepting that a device’s new compute system should be packaged with monitoring upfront. But the opportunity is equally important to both scenarios—especially as today’s real-world health risks demonstrate the value provided by an extra layer of protection for the OEM and its staff of service engineers.
In either case, the end-user customer often may not even be aware that the compute system supporting their custom device is capable of remote services. All these challenges work together to create a new role for the Original Design Manufacturers (ODMs) in the equation, stepping up to support OEMs in creating their own sales advantage through remote services.
Redefining What Low Cost Means to Device Design and Longevity
One of the most significant roadblocks in remote monitoring strategies is the continued focus on sourcing personnel in evaluating the compute systems behind the devices. Considered commodity devices, these systems must meet the lowest purchase cost with the ideal technical requirements. One issue is the definition of ‘lowest cost,’ which may vary greatly once real-world service costs are factored into the system. The focus shifts only as these service costs are included from all perspectives—for example, evaluated by service teams also responsible for reducing overall costs.
In many cases, field service engineers may not even possess full awareness of remote service options already integrated into the system. Once these become known, it is easy for them to point out to service managers that the hours-long drive and personal visit was unnecessary. The second trip, this time with the correct part, could also have been avoided.
When this shift occurs, remote strategies become driven from the bottom up instead of the top down…with field technicians advising decisionmakers up the chain. This is a monumental shift from the traditional hierarchy in how change occurs at a large OEM organization and raises up the companywide mandate for increasing customer satisfaction along with cost management.
Remote Strategies Address Both Connectivity and Security
System security is one of the biggest pushbacks from medical device OEMs. Their customers are concerned with meeting privacy and data regulations such as HIPAA and also potentially restricting any type of Internet connectivity. However once the OEM’s IT personnel becomes involved and evaluates system protocols for security performance, they routinely discover that security parameters are met and acceptable to the requirements of the both the device and the healthcare organization.
Security requirements are addressed with remote diagnostics tools that operate at the LINUX kernel, a pure hardware level outside the application or operating system. When the remote agent, a relatively simple set of software instructions included on the image of the device’s compute system, resides at this level, there is no ability to access any type of personally identifiable information (PII) or other sensitive data. This is an important and potentially unrecognized distinction between a remote agent for compute diagnostics versus a remote agent handling system patches or software updates. While neither needs or should have access to PII, the latter does require access to the OS, making it critical that OEMs understand that difference between the two and their various security protocols.
Going Beyond the Compute System to the Device Level
Remote monitoring systems are still unique and potentially undervalued in their capabilities and therefore young in their industry acceptance. It is a short leap, however, from monitoring compute systems to monitoring the medical device that is attached to the compute system—a feature poised to create a much greater level of value for medical OEMs. Using APIs to easily connect a broad and diverse range of devices, error messaging and notifications can report device performance in real-time. The remote-enabled OEM, for example, can gain insight on a respirator that has exceeded its air threshold a number of times, ensuring immediate and appropriate service attention to these lifesaving devices. The next short leap, anticipated withing the next 12 months, is the analytics of the data using artificial intelligence to fine tune performance and service expectations like never before. For instance, OEMs can be informed that if parameter A, B, and C are aligned in a specific way, this system component is anticipated to fail in two weeks. Monitoring services become truly predictive and preventive, a rich differentiator for medical device OEMs.
Increased Understanding, Greater Acceptance of Remote Servicing
ODMs are also evolving as part of remote monitoring landscape—smoothing the transition, partnering for ongoing OEM support, and bundling services as a means of reducing costs and gaining efficiencies compared to an a la carte slate of remote monitoring options. That said, as ODMs integrate these bundled remote services into their compute systems, the expectation is that OEMs may not immediately recognize their value. This may in turn become its own stage of acceptance—not a roadblock, but rather a tangible proof of concept. As service issues arise, ODMs can point to remote capabilities that are readily available (and already paid for) to demonstrate new value in managing service calls.
Spreading new service protocols throughout an established customer base is still too often perceived as a shake-up, even if costs can ultimately be reduced with remote capabilities. Yet the medical device landscape is too diverse and competitive to miss opportunities that simultaneously reduce costs and improve services. Meeting customer expectations, along with improving service and reducing costs, are increasingly competitive drivers—and can be well managed with a smarter, more efficient and proactive approach to device diagnostics and service.