5 key considerations in connected device development

1. Understand how connectivity benefits your business

Aside from the staggering market value, what is the direct value of having connectivity embedded within your device? The answer primarily is data. Well access to data. Giving operators and companies access to real-time data, streamed directly from a device, enables them to make instant, better-informed decisions and optimisations. Instead of a snapshot of data, that may only provide part of a story and may no longer be relevant at the time of analysis, connected devices are continuously sharing data, painting a more complete picture, leading to a more informed response.

This is especially the case in connected medical devices, where (continuous) remote monitoring provides a more detailed account of the patient’s health and enables clinicians to accurately diagnose, provide urgent care, optimise treatment, and personalise the provision of care.

Enhanced efficiencies, cost savings, real-time tracking and more personalised outputs are products of this continual data analysis and understanding this data allows businesses to create new value propositions and revenue-generating opportunities.

2. Employ a robust data management strategy

With data being the main source of currency in connected devices, it is crucial to have a robust data management plan. As data is being gathered, processed, transmitted and analysed, considerations must be made regarding the amount of data collected, the rate at which it is generated, the quality and accuracy of data, the diversity of data and what insights you can extract.

Each of these considerations has an impact on the other and trade-offs may need to be made to ensure the output is optimal. For example, it may be necessary to cap the volume of data collected to optimise velocity, if real-time analysis and interpretation is a priority. Equally, if the veracity of your data is questionable, then the value is compromised. A solid data strategy should address each of these key considerations, whilst incorporating risk management, regulatory alignment and device classification and will form the backbone of your product strategy.

3. Ensure Cybersecurity is central to your programme

Unfortunately, with data comes security challenges. According to Forrester, IoT and mobile devices are two of the biggest sources of data breaches during an external attack. Smart connected devices often have limited processing power and can therefore lack a solid defence against attack. This can act as a barrier to adoption as many users are concerned about data vulnerabilities and need reassurance that their personal data is going to be secure. Many innovators are tempted to take cybersecurity into their own hands by writing custom encryption software, but rolling your own security is not recommended and can again leave you open to data breaches. The primary messaging around cybersecurity is that a dedicated, integrated strategy is a must when developing a connected device.

4. Gain a thorough understanding of applicable regulations

The complexities of navigating the IoT/connected device regulatory landscape are well known. Historically there has been a lack of consensus regarding standards, but in recent years the UK government have introduced the Product Security and Telecommunications Infrastructure Bill – meaning connected products must meet cybersecurity standards, and the European Commission have published the Cyber Resilience Act – to plug any gaps in existing EU legislation. When it comes to connected medical devices, the regulatory landscape is even more stringent. New devices must comply with the MDR before their launch to European markets and the FDA have issued further guidance relating directly to connected devices and those using Artificial Intelligence or Machine Learning. Any medical device software must be developed in accordance with IEC 62304, and in 2021 the IEC released the supplementary IEC 81001-5 which is importantly dedicated to cybersecurity issues in connected health technologies. It must also be remembered that ‘software as a medical device (SaMD)’ falls under the same standards as software embedded in a standard device, whether that be ISO 14971 or IEC 60601.

All in all, there are numerous hurdles to conquer when it comes to connected device regulation (and I’ve not even mentioned ‘Matter’ – the smart home protocol), so not only is it important to factor this into your development from the beginning but expert guidance is strongly recommended.

5. Plan your development and follow a rigorous programme

A common pitfall that many companies fall into when developing products, is failing to create a long-term strategy for success and therefore an optimum route to market. This strategy should be holistic, overlay your industry schedule and include user insight, risk management, market access, intellectual property and commercialisation, as well as engineering. A well-planned and fully integrated development strategy will provide complete visibility of each step within your route to market. Each element of your project should be fully managed, incorporating systematic testing, verification, quality control, detailed documentation and clear, direct communication. Integrating key capabilities into one dynamic, end-to-end process (designed to manage risk, cost and time effectively) maximises the likelihood of a successful route to market.

These are just a few of the considerations that must be factored into a connected device development. It is not an easy process and may not be the right pathway for all businesses, but if connectivity is a must, then the development must be carefully managed. eg technology specialise in product innovation and development and have extensive experience in connected device development. As such, we have created a free eBook to share some of our experience and help organisations create a refined development programme ensuring complete project visibility and a streamlined route to market.