Electrical medical device design: integration of smart technologies
Published: November 2024
James McLusky
Director
Will Davies
Design Consultant
What is a smart medical device?
There is no strict definition of a “smart” device, but it generally refers to the integration of electronics that enable communication with other devices or networks wirelessly, often within the Internet of Things (IoT).
Connecting a device, independently or through a parent device like a smartphone, unlocks a world of possibilities for any new medical device. For instance, guiding patients in the self-administration of a drug with fewer use errors and better efficacy; or enabling home testing and speeding up diagnosis by transmitting results for central analysis, reducing hospital visits and allowing more patients to be screened in a less stressful environment.
From a technical standpoint, the device that users physically interact with no longer needs to be stand-alone; it can take advantage of the common features of a connected parent device, like a smartphone, offering a more efficient and cost-effective experience. For instance, a smartphone app can provide a high-definition display, processing power, and intuitive user interface, creating a richer experience.
This article (part 3 of our electrical devices series) builds on the foundation laid in parts 1 and 2, which we strongly recommend reading first to gain a comprehensive understanding of the fundamental principles of electrical medical device design and developing ingress-protected products.
In this instalment we’ll discuss our experiences of creating smart devices, and then look to answer the question: should you do it?
Example: small enough to fit inside a syringe
We’ll begin with a training device that was developed to help teach Health Care Professionals (HCPs) how to re-suspend the contents of a pre-filled syringe. The device, designed to track and communicate dynamic shaking techniques, is equipped with electronics compact enough to fit inside a small syringe form and paired with a tablet-based training app.
We developed a syringe mimic housing containing a rechargeable battery and a PCB complete with a microprocessor, Bluetooth chip and antenna, magnetometer, accelerometer, multi-coloured LEDs and a haptic vibration motor. Illustrating how small connected electronics have become, the largest item is the custom lithium-ion battery.
We developed a bespoke companion app which enables the training experience to take full advantage of the device’s sensors, providing an engaging User Interface with real-time feedback on their shaking technique based on gamification principles. Controlling access to the iPad’s settings avoided the need for complex maintenance of iOS update cycles and ensuring zero risk to patient confidentiality.
Example: moving complex tasks within a controlled system
As part of our contribution to PharmaSens’s family of insulin patch pump systems, we helped realise their products’ connected environment. A cornerstone of the pump’s development was the use of connected technology to help reduce the size of the on-body device by offloading all non-essential functions into the app.
Placing these functions on the app has distinct advantages: it makes good use of a well-understood, common user interface allowing complex tasks to be completed easily, creating a visually engaging interface the user instantly connects with, often supported with onscreen tutorials. Applying insights from various human factors studies we optimised the user experience, capturing everything in a revision-controlled User Interface (UI) specification. This was then used by the software engineers to code and verify the successful implementation of the interface to ISO 62304.
Patient confidentiality and regular software maintenance were managed by locking the tablets in kiosk mode, which limited user access and protected software updates and settings. In the future there will be a migration onto more open digital platforms but only when the time is right.
Example: smart connectivity for a single-use device
The team at Ypsomed wished to expand the functionality of their successful YpsoMate 1 mL and 2.25 mL autoinjectors. However, these devices had no electrical power source, a low unit cost, and were single-use. The solution was to develop a reusable clip-on attachment that contained the required electronics and justified the increased unit cost. Shore helped develop the design’s ergonomic form and minimal but critical on-device user feedback. This attachment provided critical feedback while functioning independently if the app connection was unavailable.
Integrating the device within Ypsomed’s larger digital health platform allowed the device to safely connect within a secure environment fully compliant with GDPR, HIPAA, etc. Once this had been achieved it enabled powerful features for the user and the parent company.
Working with the companion app, the user can be guided through the injection process step-by-step, recording the date and time and their success. It also compares this data with their treatment schedule, allowing them to share it with their doctor. The device itself can also check the drug type, expiry date, and lot number of the drug about to be administered and warn the user if appropriate.
The data gathered also offers the parent company insights into patient adherence to inform future improvements and detailed insights on any handling errors.
The smart way forward
As you will have seen from these examples, the incredible improvements in the complexity, size, cost, and – importantly – the availability of smart electronics have lowered the barriers to physically designing a smart medical device. While hardware components such as microprocessors, power sources, and Bluetooth Low Energy (BLE) chips are much more accessible, integrating these to create a truly “smart” device still requires careful engineering and design expertise that often needs to go beyond the device itself.
This technical ability, an urge to compete in the marketplace and the commercial value of the data gathered has seen the proliferation of smart devices in all aspects of our lives.
So, what’s the catch?
Coupled with that strong sense that you need to maintain pace with your competition, the upfront potential of a smart-enabled device is compelling, but there is more to consider than just fitting a Bluetooth chip, designing an app, and launching your product.
Protecting patient confidentiality, complying with privacy and security laws, and managing adverse event reporting are crucial. Without the correct strategy it can cause unexpected delays and even block device approval. Additionally, but often overlooked, the device software must be developed in line with ISO 62304, and starting with the right design controls is essential to avoid expensive re-work. Adding electronics and a power source to a traditional mechanical device will increase unit costs and pull in additional regulatory standards.
It can’t be overlooked either that the environmental impact of electrical components and battery manufacture is significant, with CO2 emissions twenty times that of a plastic component. However, if done well, the increases can be justified through improved healthcare, adherence, monitoring, or device re-use.
Integrating smart technologies
Many factors need to be addressed when considering a smart or connected healthcare device. However, considered implementation can open benefits far beyond those of purely mechanical solutions. Not just improving direct treatment efficacy but positively impacting the wider healthcare system, and with the right products reducing the net environmental impact of delivering ever more complex care through the reduction of downstream emissions.
The key to successfully delivering a smart product is to design the entire ecosystem from the outset. Combining excellent UX and UI design and attention to detail ensures that the value of that smart technology is backed up by solid functionality and reliability.
The team here at Shore has the collective expertise and experience to support all aspects of your smart healthcare design. Contact our Business Development Manager, Holly Milston, to find out more.
This was part 3 of our electrical medical device design series.
