This set of conditions is particularly challenging to treat, yet its effect on patient quality of life can be immense. Anatomically these disorders are complex, often involving the mysteries of the brain and spinal column. Pharmaceuticals – always the first port of call – have a systemic effect, with side effects common. Surgery offers little value. Patients need a new therapeutic option.
Enter neurostimulation – which directly influences the body's regulation systems by applying electrical signals to specific nerves. Implanted neurostimulation devices are well recognised for a small set of conditions – in particular, for cardiac rhythm management (CRM) and chronic pain management.
But the CRM devices of the past decade have been large (requiring big internal pockets), their need for internal batteries and long leads has compromised their longevity (meaning regular repeat surgery), and they have been ‘place-and-forget’ devices offering little or no ability to respond dynamically to patients.
The balance between clinical benefit and patient compromise inherent in these devices makes sense for debilitating conditions like chronic pain. However, that balance no longer holds as the industry looks to use neurostimulation to treat disorders such as migraine or incontinence – and even cases of obesity. For these new applications, traditional devices will no longer meet the clinical and patient needs.
To be successful in these new applications, the use and configuration of devices needs to be optimised, the devices need to be smaller and ‘connected’, the need for re-operation needs to be reduced, and the therapy needs to become responsive to the needs of the patient.
These are long-term treatments. Financially, there is a large upfront investment needed for a long-term clinical benefit. Devices need to be married with services – pulling usage and condition data out of the body to inform individual treatment and, potentially, even the whole healthcare system.
This ‘digital ecosystem of care’ is a key enabler of success for these next-generation devices – yet it is a continual challenge for device manufacturers, physicians, regulators and healthcare payers.
To explore this challenge – and set out a vision for neurostimulation in 10 years’ time – we hosted a workshop involving 18 leading players in the neurostimulation sector. You can read the workshop report at: www.CambridgeConsultants.com/neurostimulation-2024
Read more from Simon and his colleagues in our Interface magazine.