By Vaishali Kamat, Head of Digital Health, Cambridge Consultants
The world as we know it today relies heavily on connectivity. Digital technology is enabling more and more things to become part of an immense network. It’s changing every business and forcing the C-suite to think of ways to live up to market expectations with respect to cloud connectivity, data access, availability, digital presence, and more. In the healthcare market, this is even more significant as payment models shift and payers focus on evidence-based medicine – making connected medical devices an important part of every manufacturer’s portfolio.
Gone are the days of standalone medical devices whose only data output methods were on-device displays or a paper printout. Devices are now expected to be able to connect to a network via a wired or more likely a wireless connection. Development of connected devices poses several new questions that you may not have thought about before. For example, how will adding wireless technology affect device design? Which wireless technology is appropriate? How will the user interface and use instructions need to change? What level of encryption and security is required? Device makers should not underestimate the impact that adding connectivity to a device can have – it would be a folly to view this as adding just another chip to the existing PCB!
The first thing to think about when embarking on any product development is what the device needs to do and the experience you want the user to have. That dictates the physical features as well as the softer things such as the number of steps required prior to use, the time between battery replacements or recharge, the range for wireless transmission etc. These requirements obviously drive the hardware and software design but it is important to note that they are very interrelated and the relationship between them can be an inverse one. For example, the device power budget is greatly dependent on what the device is connecting to, and how much data it acquires, processes and transfers, as well as the use scenarios between the transmitting device and the receiver (e.g. ‘line of sight’ or ‘no line of sight’). Trade-offs and difficult optimizations are often necessary to hit all the requirements. This is why it is important to flag the must-have requirements or a ‘minimally viable product’ early in the process. This will reduce the chance of compromises on aspects that are likely to dictate the success of your new product.
While connected device design is complex, it is unfortunately not the only thing you need to consider when going down this path. Most medical device manufacturers are acutely aware of the reimbursement issue and until now have looked at reimbursement as the key and sometimes only feasible path to market. In the changing global healthcare economic environment – and especially in the U.S., where Accountable Care Organizations are sprouting up and most payers, including large self-insured employers, are looking for ways to control the overall cost of care for their constituents – the path to revenue could be independent of the traditional reimbursement model. Service-based business models that have been prevalent in other sectors for several years are now making an entry into healthcare. Careful consideration is required when developing a connected device to determine how it fits within the wider network, what value it is able to offer and thus what service, if any, can be provided using it. This will help determine the business model that will be best suited to your particular device.
A summary of the various design issues can be found in this ‘top 10′ guide to the factors that need to be considered during connected device design. The insights captured in the guide are based on Cambridge Consultants’ extensive work in enabling connectivity for medical devices as well as consumer and industrial products, which face similar issues. The guide can be downloaded at: www.CambridgeConsultants.com/connected-device-guide.