Design for the real world: the development process for device design
Philip Remedios, principal and director of design and development, BlackHägen Design, discusses the development process for connected device design.
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.
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 optimised performance but also feeds vital data into remote databanks for analysis and AI advancement.
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 cognisant 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 user 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. 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 also considers regulatory requirements upfront so that specific issues can be adequately addressed during the design process.
Overcoming Challenges with Technology Standards
Further complicating device design and development for connected devices is that wireless telemetry protocols and hardware are not standardised 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, further complicating R&D for device manufacturers. And various design versions need to not only meet regional standards 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 (ROI) 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 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.