Systems design, wireless design, cloud architecture, usability engineering, integrated artificial intelligence (AI) and machine learning (ML), cybersecurity — the list of technical requirements to consider seems endless when it comes to designing a connected medical device.
While an existing product might look the same as a connected device, the product design is fundamentally more complicated. Connectivity requirements launch the design process into a larger network of associated products and processes in a wider and interdependent ecosystem.
This article highlights development strategies for patient-operated devices that embrace technology (AI, ML, sensors) and meet regulatory requirements. It will explain how applying good human factors principles to the design process will lead to safer and more effective designs. We’ll also define the technical challenges in developing a connected device and look at the partnerships necessary to drive future innovation.
Acceleration of distance care practices
COVID certainly is an accelerant to instigate more focus on the needs of patient-operated healthcare. In fact, the practice of in-home monitoring and drug delivery has become so widespread that “distance care” is now a common term that includes everything from wearables to in-home devices for real-time monitoring, therapy and chronic drug delivery applications.
Secure data collection and transfer to professional healthcare providers for oversight and interaction are powerful features in these new devices. Many also include sophisticated embedded intelligence that not only provides optimized performance but also feeds vital data into remote databanks for analysis and AI advancement. In addition, the latest smartphone computing capabilities, telemetry and imaging features are increasingly leveraged to reduce device costs.
The development of more sophisticated and even smarter devices for patient self-care is expected to continue. But in the design and development processes, manufacturers must be particularly cognizant of the added usability requirements for the patient. Just the demographic and psychographic variations among patients present numerous design challenges to overcome comorbidity-driven limitations such as strength, vision, dexterity and social/cultural variabilities to assure predictable operability and use safety.
Usability engineering provides the platform for design
Usability engineering requires several steps: discovery research, design confirmation and risk-based validation through user studies. This approach provides an opportunity to identify and mitigate potential end-user challenges, which may be demographic, i.e. anatomical, economic, psychographic and cultural variation. It also considers patient safety if potential or actual comorbidities are involved. The environment in which the device will be used is also identified if, for instance, hygiene or hazardous situations cannot be predicted. The usability approach also looks at how the device can be designed to blend inconspicuously into a home setting or, if wearable, can be non-intrusive or perhaps worn comfortably under a patient’s clothing. It additionally considers regulatory requirements upfront so specific issues can be adequately addressed during the design process.
While this human factors approach supports a comprehensive roadmap, there are several other considerations when it comes to the successful development of a connected device.
Getting the wireless and medtech design teams in sync
One of the emerging challenges of connected medical device design is that wireless design has historically resided within consumer and commercial industries and therefore has not been subjected to stringent medtech design controls requirements (ISO 13485, ISO 14971, 21 CFR Part 820).
This creates unfamiliar development methodologies for these wireless engineers who are not familiar with the specific and complex design process requirements needed for medical devices and the patients that will need to operate them in a safe and effective manner. Quality and risk management standards applied to the combined ecosystem of wireless and medtech design teams often create misaligned procedural expectations that may result in development delays and associated cost increases.
Professional and cultural disconnects between an integrated wireless and medtech design team can lead to inefficient development methodologies. This leads to human resource issues, necessitating the need for a new type of management resource that understands both professional cultures and has solutions to enhance workplace cohesion and efficiency.
The solution to this challenge may sound simple, but recruiting project managers who can demonstrate superior skills to manage these disparate teams both individually and as an integrated team is not a trivial matter. We should expect to see specialized academic cross-training of these connected medtech managers in the near future.
Overcoming challenges with technology standards
Further complicating device design and development for connected devices is that wireless telemetry protocols and hardware are not standardized internationally, making it virtually impossible to develop a single device that will be able to operate globally.
Regional differences in radio standards and institutional infrastructure require multiple design versions or duplicated components (like global cellphones), further complicating R&D for device manufacturers.
And various design versions need to not only meet regional standards (for example, set by the FCC in the U.S.) but also must be created to meet specific global regulatory requirements.
The future promises innovation
As AI and ML technologies continue to mature from consumer to medical platforms, corporate partnerships and incentive subsidies will be desirable to share in the substantial design/development overhead necessary to build, test and validate robust and reliable software algorithms required to guide and control medical devices.
Additionally, support is needed from governments, related industries and clinical and insurance communities. Without this support, the return on investment for manufacturers is difficult to predict and may stall the pace of new technology integration into the design process.
With appropriate concurrent commitments from all of these entities, the advancement of this new and exciting MedTech paradigm can absolutely elevate opportunities for patients to interact with their clinicians to improve healthcare at reduced operating costs.