A hub for device personalisation in the treatment of congenital diseases

Between two and five babies in 100 are born with some defects that may require medical interventions. Clinical treatment of physical abnormalities often involves invasive surgery, which can be associated with serious complications, long stays in intensive care, prolonged hospitalisation, and even death. As devices and tools purposefully designed for treating children born with these defects are rare, clinicians often have to make do, adapting adult devices to the child's body. This is due to the small size of the paediatric market compared to the adult population market, but also, more importantly, to the huge variations that are encountered in birth defects compared to the adult world. Children born with the same syndrome present many different shapes and sizes of their physical defect. It is clear that in these cases, and unlike treatment of the elderly, one device cannot fit all.

More effort should be put into the development of new methods and technologies to create suitable devices for paediatric patients. These should be customisable for each individual patient in order to offer the best and safest treatment. Personalisation and bespoke devices are already commonly available in people's life: glasses, dental crowns, foot insoles. Customisation should be even more important and should play a critical role, when the device itself can make the difference between life and death. However, the cost and time demand of their production cannot be met by the biomedical industry, as the research efforts to test each device safety and efficacy are too high. In addition, the bioengineering industry does not have sufficient clinical knowledge and the understanding of different childhood diseases to develop such devices.

I am an engineer by training, but I have spent the last 10 years at Great Ormond Street Hospital for Children, a recognised world-leading children's hospital and the UK's largest paediatric centre. Here I have gained important knowledge of the clinical environment, birth defects and current clinical treatments. I have good understanding of the engineering technologies and work in close collaboration with the Mechanical Engineering Department (Dr Gaetano Burriesci) for all aspects related to device development and testing. In this project, I am proposing to work as a link between engineers and clinicians, university and industry, to drive the development of bespoke devices and tailored therapies for children and young adults born with physical defects.

I plan to use engineering methods and computer virtual reality to study the shape of the patient defects, and design new devices that can be easily tailored to individual need, on demand. I will create computer models of the defects, as well as virtual simulations to enable development of devices tailored to the specific anatomy of each patient. By studying the interaction between the site where the device is placed and the device itself, it will be possible to determine design changes, and predict device success or failure before the actual implantation, with no need for animal and bench experiments.
The methods I develop during this research project would be applicable to many different devices and technologies designed for treating children in the future. This may ultimately lead to significant reductions in both the number of manufactured prototypes (which will reduce cost of developing new technology) and the number of animal experiments in research work. Furthermore, device failure and other problems are expected to decrease, as we would be practising on patient-specific models before the real procedure, for the first time anticipating problems and adjusting accordingly to avoid them.

Biomedical engineers working within this project will be exposed to the day-to-day clinical problems routinely encountered in the paediatric setting, to fully understand the wide range of anatomy and function present in congenital disease patients and the challenges that clinicians face in their treatment. This will enable them to focus and adapt their technical engineering skills to effectively help solve these problems.

Paediatric clinicians at GOSH will benefit from this project in the short-term as they will become more aware of the already available engineering technologies that could help improve their clinical practice and will get easier access to some of these technologies in house. In addition, in the long-term, a wider range of devices and tools for paediatric interventions will become available for clinicians not only from GOSH, but also from other Centres. The currently limited development of paediatric devices means that clinicians have to make do; they engineer solutions adapting available adult devices and tools, and face the extra challenges that come with such options that are not purposely designed for the child, resulting in higher risks for patients, longer operating time and suboptimal outcomes.

If the computational modelling framework developed for device customisation is proven successful, the national and international regulatory bodies may decide to change the way medical devices are approved by introducing patient-specific in silico clinical trials to shorten the pathway from bench to bedside.

The Healthcare system will ultimately be able to reduce the costs associated with the care of patients that cannot currently benefit from minimally-invasive interventions, by reducing long operating times secondary to ill-fitting devices and tools, and reducing long hospital stays due to high procedural risks and complications.

New device technologies will be developed that may find broader applications and interest from the biomedical device industry. The introduction of relevant and validated computational modelling in the device design and approval process would cut down the expenses of many failing prototypes, and reduce animal and bench experiments during the product development process.

Ultimately, this programme of work could be beneficial for the children and young adults born with anatomical defects, thanks to the availability of customised devices, more insightful planning of the surgery and interventions, thus potentially expanding the number of patients suitable for minimally-invasive treatments.