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Overcoming Medical Device Manufacturing Challenges

Today's hospital bears little resemblance to its predecessor of just a few short decades ago, with the adoption of internet-enabled medical equipment and devices now a central part of diagnosing, treating, and monitoring patients. Connected health, or technology-enabled care (TEC), is a healthcare management and delivery model that uses technology to provide healthcare services remotely.

While these technologies have significantly improved the standard of care, they also introduce various challenges for healthcare practitioners, administrators, and patients. The good news is these issues can be mitigated—or sometimes eliminated—in the engineering and design phase.

With that in mind, the following are five important considerations for manufacturers to support connected healthcare's continued acceleration.

1. Harden medical device manufacturing security threats with protocol fuzzing

According to one study, 53% of connected medical devices contain critical vulnerabilities that threaten patient privacy and patient safety. Healthcare institutions are aware of their presence in hackers' crosshairs but often overlook upstream supply chain weaknesses when it comes to bolstering device security. These flaws are typically hidden deep inside third-party manufacturers' protocol stacks on embedded systems. As such, they are often undetected in security scans and subsequently make their way into devices in production—enabling hackers to bypass onboard security controls and crash, deadlock, or freeze a device.

Device manufacturers must implement a comprehensive protocol fuzzing testing mechanism to combat these threats. The process injects various errors into a communication exchange to confuse the entity at the other end of a connection and enable teams to identify protocol-level vulnerabilities. It is also a best practice to integrate protocol stress testing into the overall cybersecurity validation strategy to prevent device hacks on an ongoing basis and ensure that patient privacy and safety are protected as connected health innovations are introduced.

2. Automate medical device testing to better ensure a positive user experience

Addressing user experience concerns is another critical step in supporting connected health's ongoing innovation. This can be challenging from a testing perspective, as there are typically many different users for a given device or application. Hiring numerous testers to test and validate performance manually is a costly, time-intensive endeavor that fails to account for the different user demographics interacting with the technology daily. Often these users aren't trained medical personnel but the patients themselves, meaning that the user profiles span a range of ages, backgrounds, and degrees of technical savvy. Also, users often expect healthcare applications to run correctly on various physical platforms and operating systems. Just think of the many types in desktop and laptop computers, tablets, phones, and even smartwatches, as well as the different operating systems that support them.

For these reasons, a better approach is to use AI-driven test automation to evaluate the user experience. Software-based solutions can find more paths through complex applications and test all possible user journeys. In addition, they can deliver results significantly faster than traditional testing and automatically focus more on testing areas where defects are prevalent, ensuring manufacturers offer an effective, safe, and productive device to all user segments on time.

3. Use battery emulation and profiling to determine the best medical device battery

While their specifications may say otherwise, not all batteries are the same, and picking the wrong one can curtail a device's lifespan and overall capabilities. To ensure you're using the correct battery, use emulation software to create a profile of actual batteries. These profiles can then be imported and used in tests without involvement from the physical counterparts. Teams can measure and record battery conditions as the charge is depleted, better understand battery behavior and use these insights to determine which battery is best for the device.

4. Ensure health device signal integrity with software emulation tools

Increased data processing in connected devices can present signal integrity challenges, which are exacerbated as new health innovations are rolled out. Crosstalk from adjacent traces, boards running at lower voltage levels, and more onboard processing are just a few factors that interfere with the quality of electrical signals. Because the efficacy of smart health devices is heavily reliant on signal integrity, manufacturers must overcome any issues. A good first step is using software emulation tools to identify and eliminate problems before fabricating the board, saving time and money. Another best practice is documenting learnings in the quality management system to reduce risk and get to market faster with future designs.

5. Reduce measurement errors to make better decisions

Finally, manufacturers must address drift to ensure they can continuously make consistent, accurate, and repeatable measurements. Regular and proper verification is essential for making sure instruments are accurate, that they are operating within specifications, and that they have traceability backed by certification. In addition, regular calibration also enables teams to reduce work, avoid delays, and ensure that connected health innovations deliver maximum value to patients.

We can only expect connected medical devices to grow more complex in the years ahead and, along with them, their path to the marketplace. Manufacturers must recognize that security, usability, battery life, and other connected healthcare considerations must be addressed during the design phase. Organizations that re-engineer their workflows, as needed, will be best positioned to develop safe, productive, and intuitive technologies that have market-staying power.