Meet Matt Hedges, Senior Consultant in Sogeti Ireland's new Life Science practice
Matt says connected devices the future of the medical device industry
Sogeti Ireland recently launched a new Life Science department and we would like to take a moment to introduce Matt Hedges, Senior Consultant and one of our key people on the team.
Matt is a senior Life Sciences consultant with Sogeti and holds a PhD in material science. His PhD research explored the processing of novel alloys to allow them to withstand higher temperatures for longer periods of time for the Aerospace Industry. This research helped him land his first job following his PhD with Altran (a consultancy which, recently joined the Capgemini group.) Following a move to Ireland and into the world of medical devices, Matt has specialised in the area of interventional devices for both coronary and peripheral vascular applications. This work has included projects in drug eluting stents, structural heart valves and a variety of interventional delivery systems.
So, what does Matt see as the future of the medical device industry? Connected health care and connected devices will be more widely relevant in the future. While connectivity will enable many new therapeutic and real-time monitoring devices, we will also see connectivity and layers of intelligence being introduced into what we would consider to be well established traditional devices.
In Matt’s experience, the development of a connected medical device has many parallels with traditional device development in that it will need to follow established design and validation steps, but there are additional considerations and regulatory standards to be considered. Sensor and power requirements are fundamental building blocks of the embedded technology and should have well-defined use parameters, use environment and risk profile. The connectivity of the device is something that should be considered in terms of the size, frequency and direction of the data, as this will direct the IoT networks or communication protocol. Cyber security needs to be considered from the early days of the technology development to ensure system compliance and risk management across the development cycle.
Matt explained that the usability and user experience of connected devices are key to success. “From a user perspective, clearly defined usability and human factors processes must be established from the outset, to ensure we are creating the right device for the intended user and use case. Connected devices bring the ability to present previously unknown data to both patients, healthcare providers and care givers, so the presentation of this data, through smart phone apps or web portals to these user types must be well considered and integrated in to established work flows and care practices.”
According to Matt, Regulatory bodies such as FDA and EMA’s EU MDR are catching up in the connected device space and are issuing updated guidance and directives associated in putting connected devices on the market. Network architecture and device security are now critical to comply with regulatory requirements. While the updated regulations clarify what processes and standards relate to connected devices, there is still a significant burden of validation and testing to show proof of consistent reliable functionality relative to the risks. The more critical the device to human life, the greater the risk and the tougher the validation requirements.
To conclude, Matt’s advice in commencing a connected device is to ensure that there is a full and informed exploration of the initial design brief, with expansion to allow for some novel potential solutions, rather than narrow lines of investigation. It is also important to maintain that connectivity is an enabler of medical device innovation but needs to be harnessed correctly to deliver improved patient outcomes. “Working at Sogeti and under the umbrella of the Capgemini group, we are fortunate to be able to bring to our clients the full spectrum of design and development capabilities, from a wide team that have experience of product development within the medical regulatory environment. This combined with our expertise in IoT, network architectures and robust cyber security make us a strong partner in connected health and IoMT.” For now, there’s a lot more work needed to get to these devices to such medically advanced stages- but that just means more motivation to continue discovering and progressing in the field.