Cambridge Consultants recently held a neurostimulation workshop with leading innovators in the field. Following the workshop, the company released a working paper that looks at the potential of neurostimulation in the next ten years. Titled “Neurostimulation 2024” the report from the group believes that this promising new therapy has the ability to revolutionize patient care by delivering “immediate outcomes that relieve patients of debilitating pain, drugs and accompanying side effects.” We had a chance to speak with Simon Karger, who is a head of surgical and interventional products at Cambridge Consultants, about the report and what the future holds for neurostimulation.
Medgadget: In Neurostimulation 2024, the panel talks about the “new therapeutic ecosystem” for patients with lifestyle-conditions, such as obesity, depression, migraines, etc. Can you explain what this new ecosystem is, and how it is going to impact delivery of care for individual patients and health care as a whole?
Simon Karger, Cambridge Consultants: The next generation of neurostimulation systems will comprise multiple components that allow therapy to be delivered at different ‘levels’ and to be tailored by patient and condition:
Level 1 – “In the patient”: a lightweight implanted device that will deliver the actual stimulation but contain minimal electronics or battery to minimize its size and the need for repeat surgery.
Level 2 – “On the patient”: an external patient / physician control unit that will provide an interface to the implanted system. While simple controllers exist today, our vision is that this system will provide for real-time communication with the implant, deliver power wirelessly, and allow for much more recording and processing of data than is practical on current implants. Potentially integrated into a common consumer platform (like a phone or tablet), this system will provide the ability to manage therapy in a highly contextualized way, responding to the needs of the patient in real-time and potentially even ‘closing the loop’.
Level 3 – “Near the patient”: an infrastructure of digital services that will link a patient, their condition and their therapy to key clinical stakeholders, caregivers and potentially even provide healthcare system-level data.
It is the combination of these networks, and their interaction through the ‘near the patient’ element that delivers the new therapeutic ecosystem. Real-time contextual control and feedback that’s linked to a network of digital services is going to be incredibly powerful, enhancing the ability of physicians and caregivers to track patient conditions, monitor their therapy (particularly for chronic conditions), and tweak their therapies accordingly. It’s worth noting that this ecosystem (along with implant size) is one of the key enablers of neurostimulation’s application to many new, chronic conditions. Episodic conditions like migraines are characterized by discreet ‘episodes,’ and therapy that can be invoked as needed and tailored to the needs of each episode and patient.
Medgadget: What role do you envision Cambridge Consultants will play in developing and implementing the necessary features of the future neurostimulation landscape?
Karger: Today’s neuromodulation implant manufacturers have appropriately focused their expertise in the challenges of the implant itself – waveforms, control systems and implantable power storage, for instance. However, this next generation of neurostimulation systems demand a much broader set of expertise: through-body wireless technology, specialized low power electronics, custom ASICs for implanted applications, novel power transmission modalities, context aware control systems, closed loop control, human factors and interface design, as well as digital service development. Cambridge Consultants packages these unique areas of expertise to work with companies looking to develop a next generation neurostimulation system.
Medgadget: Your report mentions that the neurostim industry is dominated by a few large players and many smaller ambitious startups working in “a highly fractured clinical landscape.” What do you think needs to be done to encourage these startups and increase collaboration between them?
Karger: The big players in the market need to establish their visions for the future and help the small companies align with those. Clinically, the industry needs to demonstrate the clinical value of these technologies and make clear where the financial value is likely to be. Ultimately, funding needs to be made available and clinical appetite enhanced to explore and implement this therapy for new applications.
Medgadget: Do you think that open source solutions that other industries employ can repair the fractured clinical landscape of neuroscience, and everyone from patients to companies will benefit?
Karger: Potentially. As a therapy relying on concentric rings of devices and services, there is great potential for an open source model. However, such systems can only thrive if standards for interfacing between sub-systems are clearly defined. That is always a challenge and is made even harder in the regulated world of medical devices.
Medgadget: How can we push big and small players to go open source?
Karger: Regulators must drive the creation of standards from the top-down, providing a framework for interoperation that is both safe and demonstrates the willingness of the clinical industry to adopt such a model. In doing so, they demonstrate where the dollars flow in the system in such a way that each component is viable.
Medgadget: Closing thoughts?
Karger: Neurostimulation is an incredibly exciting therapy that is at a tipping point. The technologies to deliver the vision are there, the clinical case is building and the potential for that vision to impact patients’ lives is clear. They key next step needs to be the alignment of technology expertise, clinical application, reimbursement models and regulatory structures. Everyone in the industry has a great opportunity to make this happen.