It’s no secret that healthcare providers, payers and patients want to improve outcomes and lower costs. Technology and device connectivity play a key role in making that happen. It’s important to look for every opportunity to increase results while keeping the patient in mind.
But as well as connectivity, design, and cloud-based infrastructure also influence how effective your device will be. Patients want intuitive features and ease of use, while providers need devices that fit treatment plans and successfully integrate with their current technology.
Here are seven critical areas to consider when designing a new device:
1. Data: What type of data is generated, and what type of data will be transmitted?
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- Every application has specific needs. For example, a wearable ECG monitor requires continuous and real-time streaming of data with a throughput of tens of kB/s while an autoinjector only demands a few logging events per day and hundreds of Bytes transmitted per day.
2. User experience: How is the device used? What is the patient role in communicating? When will data be transmitted?
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- A very common dilemma in the industry is whether to involve the patient in the communication process between the device and the reader or to make the transmission a seamless, hands-off experience. There are pros and cons for each solution.
3. Data Reader: What type of reader is needed? Is the phone the main communication hub?
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- The early days of connected medical devices were dominated by custom protocols and custom readers. Part of the reason was due to very special needs for a highly reliable channel that was not available on smartphones. The complexity of the validation process of a non-medical device in the loop was also an issue. But the market is very quickly adopting the latest trends and along with the more open attitude of regulators, a number of industry players have created smartphone-based apps as a complementary way to interact with their devices.
4. Mechanics: What are the mechanical constraints to fit connectivity within the existing device?
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- Very often, smart connected devices are the result of retro-fitting electronics into devices that were not designed to include extra components like PCBs, battery and antennas. A lot of focus is often spent in the design of custom solutions to cope with the tight mechanical constraints set by the legacy product.
5. Power: How will the energy stored in the battery be spent and how is it affected by radio frequency performance?
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- For the same reason as above, space is very often a major constraint, specifically when considering the power need of a connected device. There are a number of considerations to be made around battery technologies and low power design in order to select the optimal solution and squeeze its energy as much as possible.
6. Cost: What is the budget available for connectivity? Is an application-specific integrated circuit (ASIC) the way to go?
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- While connectivity is a clear trend in this market there’s very little documented evidence around the added value of these devices and pharma companies still have to prove the added value of connectivity. Without clear evidence it is difficult to define a price for a new generation of connected devices. For this reason, there’s very little space – at this specific point in time – for extra costs associated to these types of devices. Currently, a lot of effort is spent in aggressive cost optimisations as Bluetooth low energy (BLE) systems on a chip (SoC) represent a major share of the costed bill-of-material
7. Regulatory: In what environment is the device meant to be used (hospital, home, indoor, outdoor)?
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- It is mandatory to consider all regulatory constraints and guidelines to design a proper connected device. The main driver is the ‘Quality of Service’ that has to be guaranteed in accordance to the risk profile of the application.
The role of proper connectivity
The type of connectivity makes a huge difference. For example, some wearables connect to a smartphone app through short-range, near-field communication (NFC). Others use BLE to connect with the cloud. It’s an important decision to make, because the choice affects user experience. With NFC, patients have to trigger communication by holding their smartphone close to the device. With BLE, patients connect once at the first interaction, and then the device and smartphone will be continually connected to share data.
Flex works with providers to create hospital devices, elderly care applications and emergency management devices. Generally speaking, these devices may need long-range connectivity technologies such as low-power wide area networks (LPWAN) to provide direct access to the cloud. For any type of device, it’s vital to determine the proper connectivity that’s right for your product as well as end users.
Get a closer look at everything you need to know
From connectivity standards to antenna choices and regulatory considerations, you need to ask the right questions and consider all options. This will help you design devices that succeed in the marketplace and help provide the best medical outcomes.
By Dr Tommaso Borghi, Flex Design Program Manager
