Explore the most recent editions of MPO Magazine, featuring expert commentary, industry trends, and breakthrough technologies.
Access the full digital version of MPO Magazine anytime, anywhere, with interactive content and enhanced features.
Join our community of medical device professionals. Subscribe to MPO Magazine for the latest news and updates delivered straight to your mailbox.
Explore the transformative impact of additive manufacturing on medical devices, including design flexibility and materials.
Learn about outsourcing options in the medical device sector, focusing on quality, compliance, and operational excellence.
Stay updated on the latest electronic components and technologies driving innovation in medical devices.
Discover precision machining and laser processing solutions that enhance the quality and performance of medical devices.
Explore the latest materials and their applications in medical devices, focusing on performance, biocompatibility, and regulatory compliance.
Learn about advanced molding techniques for producing high-quality, complex medical device components.
Stay informed on best practices for packaging and sterilization methods that ensure product safety and compliance.
Explore the latest trends in research and development, as well as design innovations that drive the medical device industry forward.
Discover the role of software and IT solutions in enhancing the design, functionality, and security of medical devices.
Learn about the essential testing methods and standards that ensure the safety and effectiveness of medical devices.
Stay updated on innovations in tubing and extrusion processes for medical applications, focusing on precision and reliability.
Stay ahead with real-time updates on critical news affecting the medical device industry.
Access unique content and insights not available in the print edition of the MPO Magazine.
Explore feature articles that delve into specific topics within the medical device industry, providing in-depth analysis and insights.
Gain perspective from industry experts through regular columns addressing key challenges and innovations in medical devices.
Read the editor’s thoughts on the current state of the medical device industry.
Discover the leading companies in the medical device sector, showcasing their innovations and contributions to the industry.
Explore detailed profiles of medical device contract manufacturing and service provider companies, highlighting their capabilities and offerings.
Learn about the capabilities of medical device contract manufacturing and service provider companies, showcasing their expertise and resources.
Watch informative videos featuring industry leaders discussing trends, technologies, and insights in medical devices.
Short, engaging videos providing quick insights and updates on key topics within the medical device industry.
Tune in to discussions with industry experts sharing their insights on trends, challenges, and innovations in the medical device sector.
Participate in informative webinars led by industry experts, covering various topics relevant to the medical device sector.
Stay informed on the latest press releases and announcements from leading companies in the medical device manufacturing industry.
Access comprehensive eBooks covering a range of topics on medical device manufacturing, design, and innovation.
Highlighting the innovators and entrepreneurs who are shaping the future of medical technology.
Explore sponsored articles and insights from leading companies in the medical device manufacturing sector.
Read in-depth whitepapers that explore key issues, trends, and research findings for the medical device industry.
Discover major industry events, trade shows, and conferences focused on medical devices and technology.
Get real-time updates and insights live from the CompaMed/Medica conference floor.
Join discussions and networking opportunities at the MPO Medtech Forum, focusing on the latest trends and challenges in the industry.
Attend the MPO Summit for insights and strategies from industry leaders shaping the future of medical devices.
Participate in the ODT Forum, focusing on orthopedic device trends and innovations.
Discover advertising opportunities with MPO to reach a targeted audience of medical device professionals.
Review our editorial guidelines for submissions and contributions to MPO.
Read about our commitment to protecting your privacy and personal information.
Familiarize yourself with the terms and conditions governing the use of MPOmag.com.
What are you searching for?
Manufacturers are focusing ever more closely on service strategies and excellence in system uptime as a complement to the overall efficacy of their devices.
June 4, 2020
By: Mark Villanova
Service Operations Manager and Sustaining Engineer, Dedicated Computing
In healthcare, clinical effectiveness and system performance are closely related but separate issues facing manufacturers of medical devices. As the World Healthcare Organization points out, clinical effectiveness is a good indicator of device performance, yet its technical functions contribute dramatically to that success and may even be easier to measure and quantify objectively. After all, if the customer perceives an issue with a device, there is indeed an issue with the device. This very real snapshot of the healthcare universe is driving medical device manufacturers to focus ever more closely on service strategies and excellence in system uptime as a complement to the overall efficacy of their devices. Four key themes arise in this shift, pointing to the need for a phased strategy centered on managing the compute system at the heart of the healthcare device: scoring product reliability, grading responsiveness, analyzing true costs, and understanding broad ways remote connectivity can create impact throughout the manufacturing entity. These themes are demonstrated in action by taking a look at a healthcare device manufacturer’s particular experience solving a system performance issue. The manufacturer featured here is a multifaceted healthcare leader developing a range of surgical tools and systems, with its proven, core platform passing the 14-year mark in global deployment. 1. Score Your Product Reliability The manufacturer’s service partner—supplier of the industrial compute system behind the device—maintained a Pareto report documenting any service issues for this platform. When reports of sluggishness with their compute platform were noted and tracked, they were quickly validated by the industrial compute supplier as a temperature-related issue that was ultimately degrading CPU performance. The service team determined the system’s relatively inexpensive fans were overworked and under-performing. These low-cost fans were proactively replaced in all deployed systems, an activity conveniently added to every routine service call. Not only was this a low-cost part, but proactive replacement prevented more serious and expensive failures from occurring. In contrast to their experience, a computer with a performance question may often just be pulled and replaced, with the assumption being this ensures a high level of customer service. In reality, replacement without reaching for more insight on the problem can drive reliability problems to soar, resulting in a corresponding drop in end-user satisfaction. As a manufacturer, look closely at your internal organization and score yourself on whether service is handled quickly or subverted with a replacement policy that is potentially more costly and far less efficient for long-term success. 2. Grade Your Responsiveness Without a clear process for customers to request assistance for a system issue, device manufacturers may be perceived as lacking responsiveness. When there is no inherent path to easily diagnose and service machines, any issue has the potential to be big and costly, involving both software and hardware challenges. In this type of framework, there is no such thing as a simple maintenance matter. A combination of issues can contribute to the root of this problem: Medical device manufacturers’ expertise is typically centered on their instrument, with understandably less focus on the computing system behind it. Once the system leaves the warehouse and lands in a healthcare provider’s real world environment, there is commonly loss of control over potential service methods. To combat this, the device manufacturer’s industrial compute supplier worked closely with their repair depot, developing consistent protocols for verifying repairs before systems were returned to the field. Using remote diagnostics, test packets are downloaded and run on-site, testing devices at the repair depot with guidance from the manufacturer. Repairs are now validated more intelligently and quickly than prior to connectivity deployment, ensuring the issue is solved and reducing the need to return systems for further examination. Manufacturers must ask themselves some tough questions. When a system is down, does your slow phone response or unhurried arrival for onsite maintenance meet end-user expectations? Once service techs do respond, are you fully confident the issue is handled to complete resolution every time? Inadequate follow up and parts availability should be part of a strategic review, as they are issues that intensify end-user irritation over service calls. This pass or fail grade is less about the actual technical issue at hand and more about your group’s culture of service. 3. Consider Hidden as Well as Hard Costs On an annual basis, a manufacturer needed to re-image and execute patch maintenance on a deployed base of more than 3,000 devices worldwide. Each traditional service visit could be pegged at a cost of $1,800, including vehicles and vehicle insurance, fuel, and tools, along with the field service engineer’s salary. Inspired by the success of proactively replacing system fans as well as a more efficient repair depot, driving down costs became a company-wide priority. As a first step in gaining greater efficiency, the manufacturer’s industrial compute supplier deployed remote diagnostics on the manufacturer’s service bench. All field repairable systems were being processed through a central repair depot, with as many as half returning to the field noted as either “fixed” or “no problem found.” A deeper dive into repair depot processes uncovered operations far less stringent than they needed to be, as well as testing environments that did not properly replicate actual deployment. By installing a simple connectivity framework, the manufacturer was empowered to connect in real-time to its service team, running test packets on multiple devices simultaneously. Any service recommendations that follow are generally executed at the manufacturer’s service depot; once complete, test packets are run again to validate the system as ready for release back into the production environment, such as a hospital or clinic. Importantly, this process adds long-term design value, capitalizing on longtime performance data and comparing test results for every serial-numbered device with those conducted at its original date of manufacture. All test data is compiled and stored, building a database of insight that continually gets smarter on the manufacturer’s behalf. As performance data grows, it has the potential to drive new tests and development strategies, reducing the manufacturer’s costs even further. The question here is whether or not a manufacturing organization is properly treating the cost equation. Salaries, fixed vehicle expenses, inventory, tools and their care and calibration, as well as travel to and from remote locations—all these factors must be part of evaluating service costs. Also, beyond basic repairs, more urgent service requests can quickly escalate costs further. With planning and a smart, phased approach, traditional service can be transformed into a highly responsive, yet cost efficient, white glove support strategy. This in turn drives improved product reliability, reduced costs, and better staff retention—positioning the manufacturer for a much more competitive future. 4. Evaluate Company-Wide Awareness or Resistance to Remote Connectivity The lion’s share of service issues can be assisted or solved with a smart remote connectivity strategy. To address a software issue, remote imaging can typically solve the problem. To manage a hardware issue, remote diagnostics can determine a failed component and its repair path. Extended strategies can even reach the medical device through its compute engine, obtaining and analyzing thresholds for error states and alerting the medical device manufacturer to a pending problem or an existing failure. Manufacturers can ultimately track failure of hardware components in a more comprehensive manner, becoming better armed with a stronger field front stock and inventory for the service engineer. No service staff needs to visit the deployment site for routine activities like patches or updates. Indeed, a different skill set emerges for field service engineers, powering a bigger career path and long-term job satisfaction. Will connectivity as a strategy become a clearer priority for your organization when all the stakeholders on the product manufacturing team are tasked with reducing costs and keeping customers happy? Embrace More Innovative Service Strategies Before Competitors As this medical device manufacturer modernized its strategies to be more competitive overall, the phased approach was empowering. Incremental successes created advocates within various teams across the company, pointing to early advantages such as specific validation of cost savings or reduced failure rates. In changing its service mindset, this medical device manufacturer accepted that there are secure, palatable methods to access and diagnose compute systems remotely. In their case, all communications between server and client are encrypted and no end-user data (i.e., patient records or other sensitive or personally identifiable information) is accessible; connections are at the kernel level, outside of the operating system, and require authorization each time they are performed. As their repair depot proves this secure approach, the next phase of the remote strategy has field engineers carrying service keys. Systems can be diagnosed while they remain in their deployed environment, enabling real-time troubleshooting and eliminating unnecessary repairs—as well as remote re-imaging or installation of patches. Reap the Rewards of Remote Service Models When system uptime is crucial, tapping into remote diagnostics is both expected and necessary. It is ambitious too, which may be why barriers continue to exist at various levels of management and engineering in many industry-leading medical manufacturing organizations. In reality, there are ways to collaborate to ensure maintenance processes are both efficient and compliant. By sharing information with a mindset to transformation, industry leaders can better understand what they need to give in order to establish effective remote service models and what they can expect in return.
Enter your account email.
A verification code was sent to your email, Enter the 6-digit code sent to your mail.
Didn't get the code? Check your spam folder or resend code
Set a new password for signing in and accessing your data.
Your Password has been Updated !